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900
[ "Bisphosphonate", "risedronate", "prevents", "bone", "loss", "in", "women", "with", "artificial", "menopause", "due", "to", "chemotherapy", "of", "breast", "cancer", ":", "a", "double", "-", "blind", ",", "placebo", "-", "controlled", "study", ".", "To", "determine", "the", "effectiveness", "and", "safety", "of", "the", "bisphosphonate", "risedronate", "in", "preventing", "bone", "loss", "in", "young", "women", "with", "breast", "cancer", "and", "early", "menopause", "induced", "by", "chemotherapy", "who", "are", "at", "major", "risk", "for", "the", "development", "of", "postmenopausal", "osteoporosis", ".", "Fifty", "-", "three", "white", "women", ",", "aged", "36", "to", "55", "years", ",", "with", "breast", "cancer", "and", "artificially", "induced", "menopause", "were", "stratified", "according", "to", "prior", "tamoxifen", "use", ".", "Thirty", "-", "six", "patients", "received", "tamoxifen", "(", "20", "mg", "/", "d", ")", ".", "Within", "each", "stratum", ",", "patients", "were", "randomly", "assigned", "to", "receive", "risedronate", "(", "n", "=", "27", ")", "or", "placebo", "(", "n", "=", "26", ")", ".", "Treatment", "consisted", "of", "eight", "cycles", "oral", "risedronate", "30", "mg", "/", "d", "or", "placebo", "daily", "for", "2", "weeks", "followed", "by", "10", "weeks", "of", "no", "drug", "(", "12", "weeks", "per", "cycle", ")", ".", "Patients", "were", "monitored", "for", "a", "third", "year", "without", "treatment", ".", "Main", "outcomes", "of", "the", "study", "were", "changes", "in", "lumbar", "spine", "and", "proximal", "femur", "(", "femoral", "neck", ",", "trochanter", ",", "and", "Ward", "'s", "triangle", ")", "bone", "mineral", "density", "(", "BMD", ")", ",", "and", "biochemical", "markers", "of", "bone", "turnover", ".", "In", "contrast", "to", "a", "significant", "decrease", "of", "BMD", "at", "the", "lumbar", "spine", "and", "hip", "in", "the", "placebo", "group", ",", "there", "was", "an", "increase", "in", "BMD", "in", "the", "risedronate", "group", ".", "On", "treatment", "withdrawal", ",", "bone", "loss", "ensued", ",", "which", "suggests", "that", "treatment", "needs", "to", "be", "continuous", "to", "maintain", "a", "protective", "effect", "on", "bone", "mass", ".", "At", "2", "years", ",", "the", "mean", "difference", "(", "+", "/-", "SEM", ")", "between", "groups", "was", "2.5", "%", "+", "/-", "1.2", "%", ",", "(", "95", "%", "confidence", "interval", "[", "CI", "]", ",", "0.2", "to", "4.9", ")", "at", "the", "lumbar", "spine", "(", "P", "=", ".", "041", ")", "and", "2.6", "%", "+", "/-", "1.1", "%", ",", "(", "95", "%", "CI", ",", "0.3", "to", "4.8", ")", "at", "the", "femoral", "neck", "(", "P", "=", ".", "029", ")", ".", "Similar", "results", "were", "observed", "at", "the", "hip", "trochanter", ".", "Results", "by", "stratum", "indicate", "a", "beneficial", ",", "although", "partial", ",", "effect", "of", "tamoxifen", "in", "reducing", "bone", "loss", ".", "Risedronate", "was", "well", "tolerated", "and", "showed", "a", "good", "safety", "profile", ",", "with", "no", "evidence", "of", "laboratory", "abnormalities", ".", "Risedronate", "appears", "to", "be", "a", "safe", "treatment", "that", "prevents", "both", "trabecular", "and", "cortical", "bone", "loss", "in", "women", "with", "menopause", "induced", "by", "chemotherapy", "for", "breast", "cancer", "." ]
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901
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902
[ "Randomized", "Multicenter", "Placebo", "-", "Controlled", "Trial", "of", "Omega-", "3", "Fatty", "Acids", "for", "the", "Control", "of", "Aromatase", "Inhibitor", "-", "Induced", "Musculoskeletal", "Pain", ":", "SWOG", "S", "0927", ".", "Musculoskeletal", "symptoms", "are", "the", "most", "common", "adverse", "effects", "of", "aromatase", "inhibitors", "(", "AIs", ")", "and", "can", "result", "in", "decreased", "quality", "of", "life", "and", "discontinuation", "of", "therapy", ".", "Omega-", "3", "fatty", "acids", "(", "O", "3", "-", "FAs", ")", "can", "be", "effective", "in", "decreasing", "arthralgia", "resulting", "from", "rheumatologic", "conditions", "and", "reducing", "serum", "triglycerides", ".", "Women", "with", "early", "-", "stage", "breast", "cancer", "receiving", "an", "AI", "who", "had", "a", "worst", "joint", "pain", "/", "stiffness", "score", "≥", "5", "of", "10", "using", "the", "Brief", "Pain", "Inventory", "-", "Short", "Form", "(", "BPI", "-", "SF", ")", "were", "randomly", "assigned", "to", "receive", "either", "O", "3", "-", "FAs", "3.3", "g", "or", "placebo", "(", "soybean", "/", "corn", "oil", ")", "daily", "for", "24", "weeks", ".", "Clinically", "significant", "change", "was", "defined", "as", "≥", "2", "-point", "drop", "from", "baseline", ".", "Patients", "also", "completed", "quality", "-", "of", "-", "life", "(", "Functional", "Assessment", "of", "Cancer", "Therapy", "-", "Endocrine", "Symptoms", ")", "and", "additional", "pain", "/", "stiffness", "assessments", "at", "baseline", "and", "weeks", "6", ",", "12", ",", "and", "24", ".", "Serial", "fasting", "blood", "was", "collected", "for", "lipid", "analysis", ".", "Among", "262", "patients", "registered", ",", "249", "were", "evaluable", ",", "with", "122", "women", "in", "the", "O", "3", "-", "FA", "arm", "and", "127", "in", "the", "placebo", "arm", ".", "Compared", "with", "baseline", ",", "the", "mean", "observed", "BPI", "-", "SF", "score", "decreased", "by", "1.74", "points", "at", "12", "weeks", "and", "2.22", "points", "at", "24", "weeks", "with", "O", "3", "-", "FAs", "and", "by", "1.49", "and", "1.81", "points", ",", "respectively", ",", "with", "placebo", ".", "In", "a", "linear", "regression", "adjusting", "for", "the", "baseline", "score", ",", "osteoarthritis", ",", "and", "taxane", "use", ",", "adjusted", "12", "-week", "BPI", "-", "SF", "scores", "did", "not", "differ", "by", "arm", "(", "P", "=", ".", "58", ")", ".", "Triglyceride", "levels", "decreased", "in", "patients", "receiving", "O", "3", "-", "FA", "treatment", "and", "remained", "the", "same", "for", "those", "receiving", "placebo", "(", "P", "=", ".", "01", ")", ".", "No", "between", "-", "group", "differences", "were", "seen", "for", "HDL", ",", "LDL", ",", "or", "C", "-", "reactive", "protein", ".", "We", "found", "a", "substantial", "(", ">", "50", "%", ")", "and", "sustained", "improvement", "in", "AI", "arthralgia", "for", "both", "O", "3", "-", "FAs", "and", "placebo", "but", "found", "no", "meaningful", "difference", "between", "the", "groups", "." ]
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903
[ "Neuropsychological", "functioning", "in", "postmenopausal", "breast", "cancer", "patients", "treated", "with", "tamoxifen", "or", "exemestane", "after", "AC", "-", "chemotherapy", ":", "cross", "-", "sectional", "findings", "from", "the", "neuropsychological", "TEAM", "-", "side", "study", ".", "Previous", "studies", "have", "indicated", "that", "a", "subset", "of", "cancer", "patients", "treated", "with", "chemotherapy", "show", "cognitive", "deficits", "and/or", "experience", "cognitive", "complaints", ",", "whereas", "literature", "about", "the", "influence", "of", "hormonal", "therapies", "on", "cognition", "is", "sparse", ".", "Because", "of", "the", "accumulating", "knowledge", "about", "the", "importance", "of", "estrogen", "for", "cognitive", "functioning", ",", "there", "is", "growing", "concern", "about", "adjuvant", "hormonal", "therapy", "for", "breast", "cancer", "(", "BC", ")", "affecting", "cognition", ".", "We", "examined", "the", "cognitive", "functioning", "of", "postmenopausal", "BC", "patients", "who", "were", ",", "following", "doxorubicin", "/", "cyclophosphamide", "(", "AC", ")", "chemotherapy", ",", "randomized", "to", "tamoxifen", "or", "exemestane", ",", "and", "compared", "their", "performance", "with", "that", "of", "non", "-", "cancer", "controls", ".", "Thirty", "BC", "patients", "using", "tamoxifen", "and", "50", "patients", "using", "exemestane", "underwent", "interviews", ",", "questionnaires", "and", "cognitive", "tests", ",", "on", "average", "two", "years", "after", "completion", "of", "AC", "chemotherapy", ".", "Forty", "eight", "healthy", "controls", "were", "tested", "with", "similar", "measures", ".", "Memory", "complaints", "were", "reported", "by", "28", "%", "of", "AC", "/", "tamoxifen", "users", ",", "24", "%", "of", "AC", "/", "exemestane", "users", "and", "6", "%", "of", "healthy", "controls", "(", "p=", "0.02", ")", ".", "Cognitive", "testing", "revealed", "no", "statistically", "significant", "differences", "between", "tamoxifen", "and", "exemestane", "users", ",", "but", "suggested", "that", "tamoxifen", "use", "is", "possibly", "related", "to", "worse", "verbal", "functioning", ",", "while", "exemestane", "use", "is", "possibly", "related", "to", "slower", "manual", "motor", "speed", ".", "Both", "patient", "groups", "performed", "significantly", "worse", "than", "healthy", "controls", "on", "verbal", "fluency", "and", "information", "processing", "speed", ".", "Our", "findings", "show", "that", "sequential", "treatment", "of", "AC", "-", "chemotherapy", "and", "hormonal", "therapy", "in", "postmenopausal", ",", "primary", "BC", "is", "associated", "with", "lower", "test", "scores", "for", "certain", "cognitive", "functions", ",", "and", "provide", "indications", "for", "possibly", "distinctive", "associations", "for", "different", "types", "of", "hormonal", "treatment", ".", "Future", "research", "with", "larger", "groups", "is", "recommended", "to", "obtain", "a", "more", "definite", "picture", "." ]
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904
[ "Randomized", "phase", "III", "trial", "of", "APF", "530", "versus", "palonosetron", "in", "the", "prevention", "of", "chemotherapy", "-", "induced", "nausea", "and", "vomiting", "in", "a", "subset", "of", "patients", "with", "breast", "cancer", "receiving", "moderately", "or", "highly", "emetogenic", "chemotherapy", ".", "APF", "530", "provides", "controlled", ",", "sustained", "-", "release", "granisetron", "for", "preventing", "acute", "(", "0", "-", "24", "h", ")", "and", "delayed", "(", "24", "-", "120", "h", ")", "chemotherapy", "-", "induced", "nausea", "and", "vomiting", "(", "CINV", ")", ".", "In", "a", "phase", "III", "trial", ",", "APF", "530", "was", "noninferior", "to", "palonosetron", "in", "preventing", "acute", "CINV", "following", "single", "-", "dose", "moderately", "(", "MEC", ")", "or", "highly", "emetogenic", "chemotherapy", "(", "HEC", ")", "and", "delayed", "CINV", "in", "MEC", "(", "MEC", "and", "HEC", "defined", "by", "Hesketh", "criteria", ")", ".", "This", "exploratory", "subanalysis", "was", "conducted", "in", "the", "breast", "cancer", "subpopulation", ".", "Patients", "were", "randomized", "to", "subcutaneous", "APF", "530", "250", "or", "500", "mg", "(", "granisetron", "5", "or", "10", "mg", ")", "or", "intravenous", "palonosetron", "0.25", "mg", "during", "cycle", "1", ".", "Palonosetron", "patients", "were", "randomized", "to", "APF", "530", "for", "cycles", "2", "to", "4", ".", "The", "primary", "efficacy", "end", "point", "was", "complete", "response", "(", "CR", ",", "no", "emesis", "or", "rescue", "medication", ")", "in", "cycle", "1", ".", "Among", "breast", "cancer", "patients", "(", "n", "=", "423", "MEC", ",", "n", "=", "185", "HEC", ")", ",", ">", "70", "%", "received", "anthracycline", "-", "containing", "regimens", "in", "each", "emetogenicity", "subgroup", ".", "There", "were", "no", "significant", "between", "-", "group", "differences", "in", "CRs", "in", "cycle", "1", "for", "acute", "(", "APF", "530", "250", "mg", ":", "MEC", "71", "%", ",", "HEC", "77", "%", ";", "500", "mg", ":", "MEC", "73", "%", ",", "HEC", "73", "%", ";", "palonosetron", ":", "MEC", "68", "%", ",", "HEC", "66", "%", ")", "and", "delayed", "(", "APF", "530", "250", "mg", ":", "MEC", "46", "%", ",", "HEC", "58", "%", ";", "500", "mg", ":", "MEC", "48", "%", ",", "HEC", "63", "%", ";", "palonosetron", ":", "MEC", "52", "%", ",", "HEC", "52", "%", ")", "CINV", ".", "There", "were", "no", "significant", "differences", "in", "within", "-", "cycle", "CRs", "between", "APF", "530", "doses", "for", "acute", "and", "delayed", "CINV", "in", "MEC", "or", "HEC", "in", "cycles", "2", "to", "4", ";", "CRs", "trended", "higher", "in", "later", "cycles", ",", "with", "no", "notable", "differences", "in", "adverse", "events", "between", "breast", "cancer", "and", "overall", "populations", ".", "APF", "530", "effectively", "prevented", "acute", "and", "delayed", "CINV", "over", "4", "chemotherapy", "cycles", "in", "breast", "cancer", "patients", "receiving", "MEC", "or", "HEC", ".", "Clinicaltrials.gov", "identifier", ":", "NCT", "00343460", "(", "June", "22", ",", "2006", ")", "." ]
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905
[ "Decreased", "use", "of", "adjuvant", "breast", "cancer", "therapy", "in", "a", "randomized", "controlled", "trial", "of", "a", "decision", "aid", "with", "individualized", "risk", "information", ".", "Oncology", "patients", "often", "seek", "involvement", "in", "their", "medical", "consultations", ".", "Such", "involvement", "is", "endorsed", "by", "most", "health", "care", "providers", "and", "mirrored", "in", "practice", "guidelines", ".", "However", ",", "oncologists", "exhibit", "great", "variation", "in", "how", "they", "provide", "patients", "with", "disease", "-", "relevant", "information", ",", "and", "many", "remain", "reluctant", "to", "do", "so", "at", "all", ".", "The", "authors", "examined", "the", "impact", "of", "a", "patient", "-", "specific", "decision", "aid", "on", "women", "'s", "decisions", "about", "adjuvant", "therapy", "for", "breast", "cancer", ".", "386", "women", "with", "breast", "cancer", "were", "randomized", "to", "receive", "either", "an", "informational", "pamphlet", "about", "adjuvant", "therapy", "(", "usual", "care", ")", "or", "a", "patient", "-", "specific", ",", "evidence", "-", "based", "decision", "aid", "about", "adjuvant", "therapy", ".", "The", "authors", "compared", "rates", "of", "adjuvant", "therapy", "between", "the", "groups", "controlling", "for", "age", ",", "education", ",", "marital", "status", ",", "race", ",", "tumor", "severity", ",", "and", "practice", "type", "of", "their", "physician", "(", "university", "-", "based", "or", "community", "-", "based", ")", ".", "Among", "women", "with", "low", "tumor", "severity", ",", "only", "58", "%", "(", "35", "/", "60", ")", "of", "women", "in", "the", "decision", "aid", "group", "chose", "adjuvant", "therapy", ",", "compared", "to", "87", "%", "(", "33", "/", "38", ")", "of", "their", "counterparts", "in", "usual", "care", "(", "P", "<", "0.01", ")", ".", "This", "study", "illustrates", "the", "important", "impact", "of", "medical", "decision", "aids", "on", "treatment", "choices", ",", "particularly", "for", "patients", "for", "whom", "treatment", "has", "little", "benefit", ".", "In", "the", "case", "of", "adjuvant", "therapy", "for", "breast", "cancer", ",", "providing", "individualized", ",", "evidence", "-", "based", "risk", "information", "for", "shared", "decision", "making", "resulted", "in", "fewer", "women", "with", "low", "tumor", "severity", "choosing", "adjuvant", "treatment", "." ]
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906
[ "Primary", "analysis", "of", "a", "prospective", ",", "randomized", ",", "single", "-", "blinded", "phase", "II", "trial", "evaluating", "the", "HER", "2", "peptide", "GP", "2", "vaccine", "in", "breast", "cancer", "patients", "to", "prevent", "recurrence", ".", "GP", "2", "is", "a", "HER", "2", "-", "derived", ",", "HLA", "-", "A", "2", "+", "restricted", "peptide", ".", "Phase", "I", "studies", "showed", "GP", "2", "administered", "with", "GM", "-", "CSF", "to", "be", "safe", "and", "immunogenic", ".", "Here", "we", "report", "the", "primary", "analysis", "of", "a", "prospective", ",", "randomized", ",", "multicenter", "phase", "II", "adjuvant", "trial", "conducted", "to", "determine", "the", "vaccine", "'s", "efficacy", ".", "The", "trial", "enrolled", "HLA", "-", "A", "2", "+", ",", "clinically", "disease", "-", "free", ",", "node", "-", "positive", "and", "high", "-", "risk", "node", "-", "negative", "breast", "cancer", "patients", "with", "tumors", "expressing", "HER", "2", "(", "immunohistochemistry[IHC", "]", "1", "+", "-", "3", "+", ")", ".", "Patients", "were", "randomized", "to", "GP", "2", "+GM", "-", "CSF", "versus", "GM", "-", "CSF", "alone", ".", "Disease", "-", "free", "survival", "(", "DFS", ")", "was", "analyzed", "in", "intention", "-", "to", "-", "treat", "(", "ITT", ")", "and", "per", "-", "treatment", "cohorts", ";", "pre", "-", "specified", "subgroup", "analyses", "were", "performed", "for", "patients", "with", "IHC", "3", "+", "or", "FISH+", "disease", ".", "The", "trial", "enrolled", "180", "patients", ";", "89", "received", "GP", "2", "+GM", "-", "CSF", "and", "91", "received", "GM", "-", "CSF", "alone", ".", "The", "groups", "were", "well", "-", "matched", "for", "clinicopathologic", "characteristics", ".", "Toxicities", "have", "been", "minimal", ".", "The", "Kaplan", "-", "Meier", "estimated", "5", "-year", "DFS", "rate", "in", "the", "ITT", "analyses", "was", "88", "%", "(", "95", "%", "CI:", "78", "-", "94", "%", ")", "in", "vaccinated", "vs.", "81", "%", "(", "95", "%", "CI:", "69", "-", "89", "%", ")", "(", "P", "=", "0.43", ")", "in", "control", "patients", "after", "a", "34", "month", "median", "follow", "-", "up", ".", "In", "the", "per", "-", "treatment", "analysis", ",", "the", "estimated", "5", "-year", "DFS", "rates", "were", "94", "%", "(", "95", "%", "CI:", "83", "-", "98", "%", ")", "and", "85", "%", "(", "73", "-", "92", "%", ")", "(", "P", "=", "0.17", ")", ".", "In", "IHC", "3", "+", "/FISH+", "patients", ",", "the", "estimated", "5", "-year", "DFS", "rate", "was", "94", "%", "(", "82", "-", "98", "%", ")", "in", "vaccinated", "patients", "(", "n", "=", "51", ")", "vs.", "89", "%", "(", "71", "-", "96", "%", ")", "in", "control", "patients", "(", "n", "=", "50", ")", ",", "(", "P", "=", "0.86", ")", "in", "the", "ITT", "analyses", "and", "100", "%", "vs.", "89", "%", "(", "71", "-", "96", "%", ")", "in", "vaccinated", "vs.", "control", "patients", "in", "the", "per", "-", "treatment", "analyses", "(", "P", "=", "0.08", ")", ".", "While", "the", "overall", "ITT", "analysis", "did", "not", "demonstrate", "benefit", "to", "vaccination", ",", "this", "trial", "confirmed", "that", "the", "GP", "2", "vaccine", "is", "safe", "and", "suggests", "that", "vaccination", "may", "have", "clinical", "activity", ",", "particularly", "in", "patients", "with", "HER", "2", "overexpression", "who", "received", "the", "full", "vaccine", "series", "(", "ie", "per", "-", "treatment", "group", ")", "." ]
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907
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908
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"whereas", "prior", "randomized", "use", "of", "CEE", "plus", "MPA", ",", "compared", "with", "placebo", ",", "among", "women", "who", "had", "an", "intact", "uterus", ",", "was", "significantly", "associated", "with", "a", "higher", "breast", "cancer", "incidence", "but", "no", "significant", "difference", "in", "breast", "cancer", "mortality", "." ]
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909
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910
[ "Self", "-", "reported", "physical", "activity", "behavior", "of", "breast", "cancer", "survivors", "during", "and", "after", "adjuvant", "therapy", ":", "12", "months", "follow", "-", "up", "of", "two", "randomized", "exercise", "intervention", "trials", ".", "Exercise", "during", "and", "after", "breast", "cancer", "treatment", "has", "shown", "several", "health", "benefits", ".", "However", ",", "little", "is", "known", "about", "the", "courses", ",", "patterns", ",", "and", "determinants", "of", "physical", "activity", "of", "breast", "cancer", "patients", ",", "and", "the", "role", "of", "exercise", "interventions", "on", "their", "physical", "activity", "behavior", "in", "the", "long", "run", ".", "Self", "-", "reported", "physical", "activity", "was", "assessed", "in", "227", "breast", "cancer", "survivors", "before", ",", "during", ",", "and", "three", ",", "six", ",", "and", "12", "months", "post", "-", "intervention", "within", "two", "randomized", "resistance", "exercise", "trials", "performed", "during", "adjuvant", "chemo-", "or", "radiotherapy", ",", "respectively", ",", "with", "similar", "designs", ".", "Multiple", "ordinal", "logistic", "regression", "analyses", "were", "performed", "to", "identify", "determinants", "of", "physical", "activity", "at", "these", "time", "points", ".", "While", "the", "intervention", "group", "exercised", "a", "median", "1.8", "h", "/", "week", "during", "adjuvant", "therapy", "(", "interquartile", "range", "1.4", "-", "2.5", ")", ",", "68", "%", "of", "controls", "did", "not", "engage", "in", "any", "exercise", ".", "At", "12", "-months", "follow", "-", "up", "32", "%", "of", "patients", "did", "not", "engage", "in", "any", "exercise", "irrespective", "of", "the", "intervention", ".", "Of", "the", "patients", "who", "cycled", "for", "transportation", "pre", "-", "diagnosis", "about", "half", "stopped", "cycling", "in", "the", "long", "term", "in", "both", "groups", ".", "In", "contrast", ",", "walking", "was", "maintained", "over", "time", ".", "Major", "determinants", "of", "low", "levels", "of", "exercise", "at", "12", "-months", "follow", "-", "up", "were", "low", "pre", "-", "diagnosis", "levels", "of", "exercise", ",", "lower", "education", ",", "being", "postmenopausal", ",", "and", "having", "breast", "problems", "or", "depressive", "symptoms", ".", "Further", ",", "the", "intervention", "appeared", "to", "influence", "the", "type", "of", "sports", "performed", ",", "with", "strength", "exercise", "being", "the", "most", "common", "type", "of", "exercise", "at", "follow", "-", "up", "in", "the", "exercise", "group", ",", "more", "frequently", "compared", "to", "the", "control", "group", ".", "The", "exercise", "intervention", "effectively", "countervailed", "the", "decrease", "in", "physical", "activity", "during", "cancer", "therapy", "and", "boosted", "strength", "exercise", "in", "the", "months", "following", "the", "intervention", ",", "but", "in", "the", "longer", "term", "many", "survivors", "were", "insufficiently", "active", ".", "Breast", "cancer", "survivors", "may", "need", "continued", "motivation", "and", "practical", "support", "tailored", "to", "their", "individual", "characteristics", "and", "physical", "activity", "history", "to", "incorporate", "exercise", "in", "everyday", "routine", "in", "the", "long", "term", "." ]
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911
[ "DNA", "repair", "gene", "expression", "and", "risk", "of", "locoregional", "relapse", "in", "breast", "cancer", "patients", ".", "Radiation", "therapy", "appears", "to", "kill", "cells", "mainly", "by", "inducing", "DNA", "double", "-", "strand", "breaks", ".", "We", "investigated", "whether", "the", "DNA", "repair", "gene", "expression", "status", "might", "influence", "the", "risk", "of", "locoregional", "recurrence", "(", "LRR", ")", "in", "breast", "cancer", "patients", ".", "We", "used", "a", "quantitative", "reverse", "transcriptase", "PCR", "-", "based", "approach", "to", "measure", "messenger", "RNA", "levels", "of", "20", "selected", "DNA", "repair", "genes", "in", "tumor", "samples", "from", "97", "breast", "cancer", "patients", "enrolled", "in", "a", "phase", "III", "trial", "(", "Centre", "René", "Huguenin", "cohort", ")", ".", "Normalized", "mRNA", "levels", "were", "tested", "for", "an", "association", "with", "LRR", "-", "free", "survival", "(", "LRR", "-", "FS", ")", "and", "overall", "survival", "(", "OS", ")", ".", "The", "findings", "were", "validated", "in", "comparison", "with", "those", "of", "an", "independent", "cohort", "(", "Netherlands", "Cancer", "Institute", "(", "NKI", ")", "cohort", ")", ".", "Multivariate", "analysis", "encompassing", "known", "prognostic", "factors", "was", "used", "to", "assess", "the", "association", "between", "DNA", "repair", "gene", "expression", "and", "patient", "outcome", ".", "RAD", "51", "was", "the", "only", "gene", "associated", "with", "LRR", "in", "both", "cohorts", ".", "With", "a", "median", "follow", "-", "up", "of", "126", "months", "in", "the", "CRH", "cohort", ",", "the", "5", "-year", "LRR", "-", "FS", "and", "OS", "rates", "were", "100", "%", "and", "95", "%", "in", "the", "61", "patients", "with", "low", "RAD", "51", "expression", ",", "compared", "with", "70", "%", "and", "69", "%", "in", "the", "36", "patients", "with", "high", "RAD", "51", "expression", ",", "respectively", "(", "p", "<", "0.001", ")", ".", "RAD", "51", "overexpression", "was", "associated", "with", "a", "higher", "risk", "of", "LRR", "(", "hazard", "ratio", "[", "HR", "]", ",", "12.83", ";", "95", "%", "confidence", "interval", "[", "CI", "]", ",", "3.6", "-", "45.6", ")", "and", "death", "(", "HR", ",", "4.10", ";", "95", "%", "CI", ",", "1.7", "-", "9.7", ")", ".", "RAD", "51", "overexpression", "was", "also", "significantly", "associated", "with", "shorter", "LRR", "-", "FS", "and", "OS", "in", "the", "NKI", "cohort", ".", "Overexpression", "of", "RAD", "51", ",", "a", "key", "component", "of", "the", "homologous", "DNA", "repair", "pathway", ",", "is", "associated", "with", "poor", "breast", "cancer", "outcome", ".", "This", "finding", "warrants", "prospective", "studies", "of", "RAD", "51", "as", "a", "prognosticator", "and", "therapeutic", "target", "." ]
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912
[ "Are", "mammographic", "changes", "in", "the", "tumor", "bed", "more", "pronounced", "after", "intraoperative", "radiotherapy", "for", "breast", "cancer", "?", "Subgroup", "analysis", "from", "a", "randomized", "trial", "(", "TARGIT", "-", "A", ")", ".", "Intraoperative", "radiotherapy", "(", "IORT", ")", "with", "low", "-", "energy", "x", "-", "rays", "is", "increasingly", "used", "in", "breast", "-", "conserving", "therapy", "(", "BCT", ")", ".", "Previous", "non", "-", "randomized", "studies", "have", "observed", "mammographic", "changes", "in", "the", "tumor", "bed", "to", "be", "more", "pronounced", "after", "IORT", ".", "The", "purpose", "of", "this", "study", "was", "to", "reassess", "the", "postoperative", "changes", "in", "a", "randomized", "single", "-", "center", "subgroup", "of", "patients", "from", "a", "multicenter", "trial", "(", "TARGIT", "-", "A", ")", ".", "In", "this", "subgroup", "(", "n", "=", "48", ")", "27", "patients", "received", "BCT", "with", "IORT", ",", "21", "patients", "had", "BCT", "with", "standard", "whole", "-", "breast", "radiotherapy", "serving", "as", "controls", ".", "Overall", "258", "postoperative", "mammograms", "(", "median", "follow", "-", "up", "4.3", "years", ",", "range", "3", "-", "8", ")", "were", "retrospectively", "evaluated", "by", "two", "radiologists", "in", "consensus", "focusing", "on", "changes", "in", "the", "tumor", "bed", ".", "Fat", "necroses", "showed", "to", "be", "significantly", "more", "frequent", "(", "56", "%", "versus", "24", "%", ")", "and", "larger", "(", "8.7", "versus", "1.6", "sq", "cm", ",", "median", ")", "after", "IORT", "than", "those", "in", "controls", ".", "Scar", "calcifications", "were", "also", "significantly", "more", "frequent", "after", "IORT", "(", "63", "%", "versus", "19", "%", ")", ".", "The", "high", "incidence", "of", "large", "fat", "necroses", "in", "our", "study", "confirms", "previous", "study", "findings", ".", "However", ",", "the", "overall", "higher", "incidence", "of", "calcifications", "in", "the", "tumor", "bed", "after", "IORT", "represents", "a", "new", "finding", ",", "requiring", "further", "attention", "." ]
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913
[ "The", "prevalence", "of", "immunohistochemically", "determined", "oestrogen", "receptor", "positivity", "in", "primary", "breast", "cancer", "is", "dependent", "on", "the", "choice", "of", "antibody", "and", "method", "of", "heat", "-", "induced", "epitope", "retrieval", "-", "prognostic", "implications", "?", "Oestrogen", "receptor", "(", "ER", ")", "status", "is", "important", "for", "the", "choice", "of", "systemic", "treatment", "of", "breast", "cancer", "patients", ".", "However", ",", "most", "data", "from", "randomised", "trials", "on", "the", "effect", "of", "adjuvant", "endocrine", "therapy", "according", "to", "ER", "status", "are", "based", "on", "the", "cytosol", "methods", ".", "Comparisons", "with", "immunohistochemical", "methods", "have", "given", "similar", "results", ".", "The", "aim", "of", "the", "present", "study", "was", "to", "examine", "whether", "different", "ER", "antibodies", "and", "heat", "-", "induced", "epitope", "retrieval", "(", "HIER", ")", "methods", "influence", "the", "prevalence", "of", "ER", "-", "positivity", "in", "primary", "breast", "cancer", ".", "This", "study", "is", "based", "on", "patients", "included", "in", "a", "clinical", "trial", "designed", "to", "compare", "the", "effect", "of", "two", "years", "of", "adjuvant", "tamoxifen", "versus", "no", "adjuvant", "systemic", "treatment", "in", "premenopausal", "women", ".", "From", "1986", "to", "1991", ",", "564", "patients", "from", "two", "study", "centres", "in", "Sweden", "were", "enrolled", "and", "randomised", ".", "Patients", "were", "randomised", "independently", "of", "ER", "status", ".", "In", "the", "present", "study", ",", "ER", "status", "was", "assessed", "on", "tissue", "microarrays", "with", "the", "three", "different", "ER", "antibody", "/", "HIER", "combinations", ":", "1", "D", "5", "in", "citrate", "pH", "6", "(", "n", "=", "390", ")", ",", "SP", "1", "in", "Tris", "pH", "9", "(", "n", "=", "390", ")", "and", "PharmDx", "in", "citrate", "pH", "6", "(", "n", "=", "361", ")", ".", "At", "cut", "-", "offs", "of", "1", "%", "and", "10", "%", ",", "respectively", ",", "the", "prevalence", "of", "ER", "-", "positivity", "was", "higher", "with", "SP", "1", "(", "75", "%", "and", "72", "%", ")", "compared", "with", "1", "D", "5", "(", "68", "%", "and", "66", "%", ")", "and", "PharmDx", "(", "66", "%", "and", "62", "%", ")", ".", "At", "these", "cut", "-", "offs", ",", "patients", "in", "the", "discordant", "groups", "(", "SP", "1", "-", "positive", "and", "1", "D", "5", "-", "negative", ")", "seem", "to", "have", "a", "prognosis", "intermediate", "between", "those", "of", "the", "double", "-", "positive", "and", "double", "-", "negative", "groups", ".", "Comparison", "with", "the", "ER", "status", "determined", "by", "the", "cytosol", "-", "based", "methods", "in", "the", "discordant", "group", "also", "showed", "an", "intermediate", "pattern", ".", "The", "repeatability", "was", "good", "for", "all", "antibodies", "and", "cut", "-", "offs", ",", "with", "overall", "agreement", "≥", "93", "%", ".", "The", "present", "study", "shows", "that", "the", "choice", "of", "antibody", "and", "HIER", "method", "influences", "the", "prevalence", "of", "ER", "-", "positivity", ".", "We", "suggest", "that", "this", "be", "taken", "into", "consideration", "when", "choosing", "a", "cut", "-", "off", "for", "clinical", "decision", "making", "." ]
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914
[ "[", "Neoadjuvant", "treatment", "for", "locally", "advanced", "breast", "cancer", ".", "Comparison", "of", "two", "schemes", "based", "on", "docetaxel", "-", "epirubicin", "vs.", "5", "-fluorouracil", "-", "epirubicin", "-", "cyclophosphamide", "]", ".", "Breast", "cancer", "is", "the", "most", "common", "type", "of", "cancer", "in", "women", "worldwide", ".", "In", "Mexico", ",", ">", "34", "%", "of", "patients", "are", "in", "locally", "advanced", "stages", "at", "the", "time", "of", "diagnosis", ".", "Neoadjuvant", "chemotherapy", "is", "administered", "to", "control", "local", "disease", ",", "make", "surgical", "resection", "possible", "and", "increase", "the", "possibility", "of", "breast", "tissue", "conservation", ".", "We", "performed", "a", "double", "-", "blind", ",", "randomized", "clinical", "trial", "in", "patients", "with", "locally", "advanced", "breast", "cancer", "(", "stages", "IIB", "and", "IIIA", ")", "with", "two", "therapy", "schemes", ";", "5", "-fluorouracil", "-", "epirubicin", "-", "cyclophosphamide", "(", "control", "group", ")", "vs.", "docetaxel", "-", "epirubicin", "(", "study", "group", ")", ".", "Both", "were", "indicated", "in", "three", "preoperative", "cycles", ",", "and", "patients", "were", "submitted", "afterwards", "to", "surgery", ".", "Pathological", "response", "was", "measured", ".", "Forty", "one", "patients", "were", "included", "in", "our", "study", ".", "They", "were", "distributed", "in", "two", "homogeneous", "groups", ":", "21", "in", "the", "control", "group", "and", "20", "in", "the", "study", "group", ".", "Dimensional", "pathological", "response", "was", "higher", "in", "the", "study", "group", "than", "in", "the", "control", "one", "(", "p", "<", "0.05", ")", ".", "Five", "patients", "in", "the", "control", "group", "and", "ten", "patients", "of", "the", "study", "group", "experienced", "complete", "pathological", "response", "(", "p", "<", "0.05", ")", ".", "The", "most", "common", "secondary", "events", "were", "leucopenia", ",", "neutropenia", "and", "fever", ".", "Morbidity", ",", "number", "of", "lymph", "nodes", ",", "disease", "-", "free", "survival", "and", "general", "survival", "did", "not", "show", "significant", "differences", "between", "groups", ".", "No", "mortality", "was", "reported", "during", "a", "minimum", "follow", "-", "up", "of", "28", "months", ".", "Our", "results", "confirm", "the", "effectiveness", "of", "docetaxel", "-", "epirubicin", "to", "obtain", "complete", "pathological", "response", ".", "Neoadjuvant", "therapy", "has", "been", "shown", "to", "increase", "the", "pathological", "response", "when", "a", "taxane", "is", "added", "to", "an", "anthracycline", ".", "This", "combination", "presented", "more", "secondary", "events", ",", "but", "they", "can", "be", "effectively", "managed", "medically", ".", "Neoadjuvant", "docetaxel", "-", "epirubicin", "followed", "by", "surgery", "is", "an", "appropriate", "regimen", "for", "patients", "with", "locally", "advanced", "breast", "cancer", "." ]
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915
[ "Population", "-", "based", "breast", "cancer", "screening", "in", "a", "primary", "care", "network", ".", "To", "assess", "the", "ability", "of", "a", "health", "information", "technology", "system", "to", "facilitate", "population-", "based", "breast", "cancer", "screening", ".", "Cohort", "study", "with", "2", "-year", "follow", "-", "up", "after", "a", "1", "-year", "cluster", "randomized", "trial", ".", "Study", "population", "was", "women", "42", "to", "69", "years", "old", "receiving", "care", "within", "a", "12", "-practice", "primary", "care", "network", ".", "The", "management", "informatics", "system", "(", "1", ")", "identified", "women", "overdue", "for", "mammograms", ",", "(", "2", ")", "connected", "them", "to", "primary", "care", "providers", "using", "a", "web", "-", "based", "tool", ",", "(", "3", ")", "created", "automatically", "generated", "outreach", "letters", "for", "patients", "specified", "by", "providers", ",", "(", "4", ")", "monitored", "for", "subsequent", "mammography", "scheduling", "and", "completion", ",", "and", "(", "5", ")", "provided", "practice", "delegates", "with", "a", "list", "of", "women", "remaining", "unscreened", "for", "reminder", "phone", "calls", ".", "Eligible", "women", "overdue", "for", "a", "mammogram", "during", "a", "1", "-year", "study", "period", "included", "those", "overdue", "at", "study", "start", "(", "prevalent", "cohort", ")", "and", "those", "who", "became", "overdue", "during", "follow", "-", "up", "(", "incident", "cohort", ")", ".", "The", "main", "outcome", "measure", "was", "mammography", "completion", "rates", "over", "3", "years", ".", "Among", "32", ",", "688", "eligible", "women", ",", "9795", "(", "30", "%", ")", "were", "overdue", "for", "screening", "(", "4487", "intervention", ",", "5308", "control", ")", ".", "Intervention", "patients", "were", "somewhat", "younger", ",", "more", "likely", "to", "be", "non", "-", "Hispanic", "white", ",", "and", "more", "likely", "to", "have", "health", "insurance", "compared", "with", "control", "patients", ".", "Adjusted", "completion", "rates", "in", "the", "prevalent", "cohort", "(", "n", "=", "6697", ")", "were", "significantly", "higher", "among", "intervention", "patients", "after", "3", "years", "(", "51.7", "%", "vs", "45.8", "%", ";", "P", "=", ".", "002", ")", ".", "For", "patients", "in", "the", "incident", "cohort", "(", "n", "=", "3098", ")", ",", "adjusted", "completion", "rates", "after", "2", "years", "were", "53.8", "%", "versus", "48.7", "%", ",", "respectively", "(", "P", "=", ".", "052", ")", ".", "Population", "-", "based", "informatics", "systems", "can", "enable", "sustained", "increases", "in", "mammography", "screening", "rates", "beyond", "rates", "seen", "with", "office", "-", "based", "visit", "reminders", "." ]
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916
[ "Effect", "of", "progressive", "resistance", "training", "on", "health", "-", "related", "quality", "of", "life", "in", "the", "first", "year", "after", "breast", "cancer", "surgery", "-", "results", "from", "a", "randomized", "controlled", "trial", ".", "Aims", ":", "To", "examine", "the", "effect", "of", "progressive", "resistance", "training", "(", "PRT", ")", "on", "health", "related", "quality", "of", "life", "and", "a", "predefined", "symptom", "cluster", "of", "pain", "-", "sleep", "-", "fatigue", ".", "Methods", ":", "This", "study", "was", "a", "planned", "secondary", "analysis", "of", "a", "randomized", "controlled", "trial", "examining", "the", "effect", "of", "PRT", "on", "prevention", "of", "arm", "lymphedema", "in", "a", "population", "of", "women", "between", "18", "and", "75", "years", "undergoing", "breast", "cancer", "surgery", "with", "axillary", "lymph", "node", "dissection", ".", "Participants", "were", "allocated", "by", "computer", "randomization", "to", "usual", "care", "control", "or", "a", "PRT", "intervention", "in", "a", "1", ":1", "ratio", ".", "The", "intervention", ",", "initiated", "in", "the", "third", "post", "-", "operative", "week", ",", "consisted", "of", "three", "times", "PRT", "per", "week", ",", "supervised", "in", "groups", "in", "the", "first", "20", "weeks", ",", "and", "self", "-", "administered", "in", "the", "following", "30", "weeks", ".", "Questionnaire", "assessments", "were", "made", "at", "baseline", ",", "20", "weeks", "and", "12", "months", ",", "with", "the", "European", "Organization", "for", "Research", "and", "Treatment", "in", "Cancer", "Core", "questionnaire", "(", "EORTC", "QLQ", "C", "30", ")", "and", "the", "Functional", "Assessment", "of", "Chronic", "Illness", "Therapy-", "(", "FACIT", ")", "fatigue", "questionnaire", ".", "The", "symptom", "cluster", "of", "pain", "-", "sleep", "-", "fatigue", "was", "measured", "with", "a", "constructed", "score", "adding", "EORTC", "C", "30", "subscales", "of", "insomnia", ",", "pain", ",", "and", "fatigue", ".", "Data", "were", "treated", "as", "repeated", "measurements", "and", "analyzed", "with", "mixed", "models", ".", "Results", ":", "Among", "158", "recruited", "participants", ",", "we", "found", "a", "clinically", "relevant", "increased", "emotional", "functioning", "with", "nine", "points", "at", "both", "follow", "-", "ups", "(", "p", "=", ".", "02", ")", ",", "and", "16", "and", "11", "points", "at", "20", "weeks", "and", "12", "months", "respectively", "(", "p", "=", ".", "04", ")", "in", "social", "functioning", ".", "Furthermore", ",", "in", "the", "subgroup", "of", "women", "with", "the", "symptom", "cluster", "pain", "-", "sleep", "-", "fatigue", "present", "at", "baseline", ",", "a", "significant", "effect", "was", "found", "for", "global", "health", "status", "(", "p", "=", ".", "01", ")", "and", "social", "functioning", "(", "p", "=", ".", "02", ")", ".", "Conclusion", ":", "To", "our", "knowledge", ",", "this", "is", "the", "first", "study", "to", "report", "clinically", "relevant", "effects", "of", "PRT", "on", "social", "and", "emotional", "functioning", "in", "the", "first", "postoperative", "year", "after", "breast", "cancer", "surgery", ".", "Furthermore", ",", "a", "subgroup", "of", "women", "with", "the", "pain", "-", "sleep", "-", "fatigue", "symptom", "cluster", "had", "particular", "benefit", "from", "PRT", "on", "global", "health", "status", "and", "social", "functioning", "." ]
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917
[ "Evaluation", "of", "oral", "care", "to", "prevent", "oral", "mucositis", "in", "estrogen", "receptor", "-", "positive", "metastatic", "breast", "cancer", "patients", "treated", "with", "everolimus", "(", "Oral", "Care", "-", "BC", ")", ":", "randomized", "controlled", "phase", "III", "trial", ".", "This", "is", "a", "randomized", ",", "multi", "-", "center", ",", "open", "-", "label", ",", "phase", "III", "study", "to", "evaluate", "the", "efficacy", "of", "professional", "oral", "care", "in", "preventing", "oral", "mucositis", "induced", "by", "everolimus", "in", "postmenopausal", "estrogen", "receptor", "-", "positive", "metastatic", "breast", "cancer", ".", "Patients", "will", "be", "randomized", "into", "professional", "oral", "care", "and", "control", "groups", "(", "1", ":1", "ratio", ")", ".", "All", "patients", "will", "receive", "everolimus", "with", "exemestane", "and", "will", "continue", "everolimus", "until", "disease", "progression", ".", "In", "the", "professional", "oral", "care", "group", ",", "patients", "will", "receive", "teeth", "surface", "cleaning", ",", "scaling", "and", "tongue", "cleaning", "before", "starting", "everolimus", ",", "and", "will", "continue", "to", "receive", "professional", "oral", "care", "weekly", "from", "oral", "surgeons", "throughout", "the", "8", "week", "treatment", ".", "In", "the", "control", "group", ",", "patients", "will", "brush", "their", "own", "teeth", "and", "gargle", "with", "0.9", "%", "sodium", "chloride", "solution", "or", "water", ".", "The", "primary", "endpoint", "is", "the", "incidence", "of", "all", "grades", "of", "oral", "mucositis", ".", "Target", "accrual", "is", "200", "patients", "with", "a", "two", "-", "sided", "type", "I", "error", "rate", "of", "5", "%", "and", "80", "%", "power", "to", "detect", "25", "%", "risk", "reduction", "." ]
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918
[ "Effects", "of", "a", "green", "tea", "extract", ",", "Polyphenon", "E", ",", "on", "systemic", "biomarkers", "of", "growth", "factor", "signalling", "in", "women", "with", "hormone", "receptor", "-", "negative", "breast", "cancer", ".", "Observational", "and", "experimental", "data", "support", "a", "potential", "breast", "cancer", "chemopreventive", "effect", "of", "green", "tea", ".", "We", "conducted", "an", "ancillary", "study", "using", "archived", "blood", "/", "urine", "from", "a", "phase", "IB", "randomised", ",", "placebo", "-", "controlled", "dose", "escalation", "trial", "of", "an", "oral", "green", "tea", "extract", ",", "Polyphenon", "E", "(", "Poly", "E", ")", ",", "in", "breast", "cancer", "patients", ".", "Using", "an", "adaptive", "trial", "design", ",", "women", "with", "stage", "I", "-", "III", "breast", "cancer", "who", "completed", "adjuvant", "treatment", "were", "randomised", "to", "Poly", "E", "400", "mg", "(", "n", "=", "16", ")", ",", "600", "mg", "(", "n", "=", "11", ")", "and", "800", "mg", "(", "n", "=", "3", ")", "twice", "daily", "or", "matching", "placebo", "(", "n", "=", "10", ")", "for", "6", "months", ".", "Blood", "and", "urine", "collection", "occurred", "at", "baseline", ",", "and", "at", "2", ",", "4", "and", "6", "months", ".", "Biological", "endpoints", "included", "growth", "factor", "[", "serum", "hepatocyte", "growth", "factor", "(", "HGF", ")", ",", "vascular", "endothelial", "growth", "factor", "(", "VEGF", ")", "]", ",", "lipid", "(", "serum", "cholesterol", ",", "triglycerides", ")", ",", "oxidative", "damage", "and", "inflammatory", "biomarkers", ".", "From", "July", "2007", "-August", "2009", ",", "40", "women", "were", "enrolled", "and", "34", "(", "26", "Poly", "E", ",", "eight", "placebo", ")", "were", "evaluable", "for", "biomarker", "endpoints", ".", "At", "2", "months", ",", "the", "Poly", "E", "group", "(", "all", "dose", "levels", "combined", ")", "compared", "to", "placebo", "had", "a", "significant", "decrease", "in", "mean", "serum", "HGF", "levels", "(", "-", "12.7", "%", "versus", "+", "6.3", "%", ",", "P", "=", "0.04", ")", ".", "This", "trend", "persisted", "at", "4", "and", "6", "months", "but", "was", "no", "longer", "statistically", "significant", ".", "For", "the", "Poly", "E", "group", ",", "serum", "VEGF", "decreased", "by", "11.5", "%", "at", "2", "months", "(", "P", "=", "0.02", ")", "and", "13.9", "%", "at", "4", "months", "(", "P", "=", "0.05", ")", "but", "did", "not", "differ", "compared", "to", "placebo", ".", "At", "2", "months", ",", "there", "was", "a", "trend", "toward", "a", "decrease", "in", "serum", "cholesterol", "with", "Poly", "E", "(", "P", "=", "0.08", ")", ".", "No", "significant", "differences", "were", "observed", "for", "other", "biomarkers", ".", "Our", "findings", "suggest", "potential", "mechanistic", "actions", "of", "tea", "polyphenols", "in", "growth", "factor", "signalling", ",", "angiogenesis", "and", "lipid", "metabolism", "." ]
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919
[ "Exercise", "type", "and", "fat", "mass", "loss", "regulate", "breast", "cancer", "-", "related", "sex", "hormones", "in", "obese", "and", "overweight", "postmenopausal", "women", ".", "The", "aim", "of", "the", "study", "was", "to", "examine", "the", "effects", "of", "a", "time", "-", "matched", "endurance", "versus", "concurrent", "training", "on", "circulating", "sex", "hormone", "levels", "and", "body", "composition", "in", "postmenopausal", "women", ".", "Thirty", "-", "five", "sedentary", "and", "obese", "postmenopausal", "women", "were", "recruited", "and", "randomly", "divided", "into", "endurance", "training", "(", "EN", ",", "n", "=", "10", ")", ",", "concurrent", "training", "(", "CON", ",", "n", "=", "13", ")", ",", "or", "control", "group", "(", "C", ",", "n", "=", "12", ")", ".", "Participants", "took", "part", "in", "a", "12", "-week", "supervised", "intervention", ",", "training", "3", "days", "/", "week", "and", "60", "min", "/", "session", ".", "Before", "and", "after", "the", "intervention", ",", "body", "composition", "was", "assessed", ",", "and", "blood", "samples", "were", "obtained", "to", "evaluate", "estradiol", ",", "testosterone", ",", "DHEA", "-", "S", ",", "and", "SHBG", ".", "In", "response", "to", "training", ",", "a", "reduction", "in", "total", "fat", "mass", "was", "found", "(", "5.3", "%", ";", "P", "<", "0.05", ")", ",", "while", "an", "increase", "in", "lean", "body", "mass", "was", "observed", "in", "the", "CON", "group", "(", "1.5", "%", ";", "P", "<", "0.05", ")", ".", "There", "was", "a", "significant", "decrease", "in", "DHEA", "-", "S", "(", "-", "13", "%", ")", ",", "total", "(", "-", "40", "%", ")", "and", "free", "testosterone", "(", "-", "41", "%", ")", "in", "the", "EN", "group", ",", "while", "in", "the", "CON", "group", ",", "total", "(", "25", "%", ")", "and", "free", "testosterone", "(", "21", "%", ")", "increased", "significantly", "(", "P", "<", "0.05", ")", ".", "When", "participants", "were", "stratified", "according", "to", "fat", "mass", "loss", "(", ">", "or", "<", "2", "kg", ")", ",", "a", "statistically", "significant", "increase", "in", "circulating", "SHBG", "(", "21", "%", ")", "and", "decrease", "in", "DHEA", "-", "S", "(", "-", "13", "%", ")", "were", "found", ".", "The", "type", "of", "exercise", "and", "exercise", "-", "induced", "fat", "mass", "loss", "seem", "to", "modify", "the", "sex", "hormone", "profile", "in", "postmenopausal", "women", "that", "is", "an", "established", "risk", "factor", "of", "breast", "cancer", ".", "Thus", ",", "this", "study", "provides", "additional", "evidences", "to", "the", "intricated", "interaction", "among", "sex", "hormones", ",", "adipose", "tissue", ",", "and", "muscle", "mass", "in", "postmenopausal", "women", "." ]
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920
[ "Evaluation", "of", "axillary", "reverse", "mapping", "(", "ARM", ")", "in", "clinically", "axillary", "node", "negative", "breast", "cancer", "patients", "-", "Randomised", "controlled", "trial", ".", "Axillary", "lymph", "node", "dissection", "(", "ALND", ")", "is", "an", "important", "procedure", "for", "control", "of", "axillary", "nodal", "metastasis", "in", "breast", "cancer", "patients", ".", "Lymphedema", ",", "restriction", "of", "shoulder", "movement", "and", "axillary", "nodal", "recurrence", "are", "the", "most", "disabling", "complications", "of", "the", "procedure", ".", "Axillary", "reverse", "mapping", "(", "ARM", ")", "procedure", "for", "arm", "lymph", "node", "identification", "emerged", "as", "a", "step", "for", "their", "preservation", "during", "ALND", ".", "Here", "we", "are", "testing", "the", "effect", "of", "ARM", "on", "lymphedema", "development", "and", "whether", "it", "compromises", "oncological", "safety", "in", "early", "breast", "cancer", "patients", ".", "98", "clinically", "node", "free", "breast", "cancer", "female", "patients", "undergoing", "completion", "ALND", "after", "positive", "sentinel", "lymph", "node", "biopsy", "were", "recruited", "in", "the", "study", ".", "They", "were", "put", "into", "group", "A", "(", "49", "patients", "with", "ARM", "+", "ve", "preservation", "ALND", ")", "and", "group", "B", "(", "49", "patients", "in", "the", "conventional", "ALND", "group", ")", ".", "ARM", "procedure", "was", "performed", "in", "both", "groups", ",", "ARM", "positive", "nodes", "were", "preserved", "in", "group", "A", ",", "marked", "and", "taken", "out", "with", "other", "axillary", "LN", "in", "group", "B", ".", "The", "outcome", "was", "histopathology", "of", "ARM", "+", "ve", "LN", ",", "development", "of", "arm", "lymphedema", ",", "and", "restriction", "of", "shoulder", "movement", "on", "follow", "-", "up", ".", "ARM", "was", "positive", "in", "46", "patients", "(", "93.8", "%", ")", "in", "group", "A", "and", "43", "patients", "(", "87.8", "%", ")", "in", "group", "B", ",", "ARM", "+", "ve", "LN", "revealed", "positive", "metastasis", "only", "in", "1", "patient", "(", "2.3", "%", ")", "in", "group", "B", ".", "Lymphedema", "developed", "in", "3", "(", "6.5", "%", "patients", "in", "group", "A", "and", "9", "patients", "(", "20.9", "%", ")", "in", "group", "B", ".", "Restriction", "of", "shoulder", "movement", "showed", "a", "non", "-", "significant", "difference", "between", "the", "two", "groups", ".", "Axillary", "reverse", "mapping", "and", "preservation", "of", "arm", "lymphatics", "helped", "to", "decrease", "the", "lymphedema", "rate", "without", "compromising", "oncological", "safety", "in", "early", "breast", "cancer", "." ]
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921
[ "Randomized", "multicenter", "trial", "of", "sentinel", "node", "biopsy", "versus", "standard", "axillary", "treatment", "in", "operable", "breast", "cancer", ":", "the", "ALMANAC", "Trial", ".", "Sentinel", "lymph", "node", "biopsy", "in", "women", "with", "operable", "breast", "cancer", "is", "routinely", "used", "in", "some", "countries", "for", "staging", "the", "axilla", "despite", "limited", "data", "from", "randomized", "trials", "on", "morbidity", "and", "mortality", "outcomes", ".", "We", "conducted", "a", "multicenter", "randomized", "trial", "to", "compare", "quality", "-", "of", "-", "life", "outcomes", "between", "patients", "with", "clinically", "node", "-", "negative", "invasive", "breast", "cancer", "who", "received", "sentinel", "lymph", "node", "biopsy", "and", "patients", "who", "received", "standard", "axillary", "treatment", ".", "The", "primary", "outcome", "measures", "were", "arm", "and", "shoulder", "morbidity", "and", "quality", "of", "life", ".", "From", "November", "1999", "to", "October", "2003", ",", "1031", "patients", "were", "randomly", "assigned", "to", "undergo", "sentinel", "lymph", "node", "biopsy", "(", "n", "=", "515", ")", "or", "standard", "axillary", "surgery", "(", "n", "=", "516", ")", ".", "Patients", "with", "sentinel", "lymph", "node", "metastases", "proceeded", "to", "delayed", "axillary", "clearance", "or", "received", "axillary", "radiotherapy", "(", "depending", "on", "the", "protocol", "at", "the", "treating", "institution", ")", ".", "Intention", "-", "to", "-", "treat", "analyses", "of", "data", "at", "1", ",", "3", ",", "6", ",", "and", "12", "months", "after", "surgery", "are", "presented", ".", "All", "statistical", "tests", "were", "two", "-", "sided", ".", "The", "relative", "risks", "of", "any", "lymphedema", "and", "sensory", "loss", "for", "the", "sentinel", "lymph", "node", "biopsy", "group", "compared", "with", "the", "standard", "axillary", "treatment", "group", "at", "12", "months", "were", "0.37", "(", "95", "%", "confidence", "interval", "[", "CI", "]", "=", "0.23", "to", "0.60", ";", "absolute", "rates", ":", "5", "%", "versus", "13", "%", ")", "and", "0.37", "(", "95", "%", "CI", "=", "0.27", "to", "0.50", ";", "absolute", "rates", ":", "11", "%", "versus", "31", "%", ")", ",", "respectively", ".", "Drain", "usage", ",", "length", "of", "hospital", "stay", ",", "and", "time", "to", "resumption", "of", "normal", "day", "-", "to", "-", "day", "activities", "after", "surgery", "were", "statistically", "significantly", "lower", "in", "the", "sentinel", "lymph", "node", "biopsy", "group", "(", "all", "P", "<", ".", "001", ")", ",", "and", "axillary", "operative", "time", "was", "reduced", "(", "P", "=", ".", "055", ")", ".", "Overall", "patient", "-", "recorded", "quality", "of", "life", "and", "arm", "functioning", "scores", "were", "statistically", "significantly", "better", "in", "the", "sentinel", "lymph", "node", "biopsy", "group", "throughout", "(", "all", "P", "<", "or", "=", ".", "003", ")", ".", "These", "benefits", "were", "seen", "with", "no", "increase", "in", "anxiety", "levels", "in", "the", "sentinel", "lymph", "node", "biopsy", "group", "(", "P", ">", ".", "05", ")", ".", "Sentinel", "lymph", "node", "biopsy", "is", "associated", "with", "reduced", "arm", "morbidity", "and", "better", "quality", "of", "life", "than", "standard", "axillary", "treatment", "and", "should", "be", "the", "treatment", "of", "choice", "for", "patients", "who", "have", "early", "-", "stage", "breast", "cancer", "with", "clinically", "negative", "nodes", "." ]
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922
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923
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924
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925
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926
[ "Sequential", "versus", "concurrent", "trastuzumab", "in", "adjuvant", "chemotherapy", "for", "breast", "cancer", ".", "NCCTG", "(", "North", "Central", "Cancer", "Treatment", "Group", ")", "N", "9831", "is", "the", "only", "randomized", "phase", "III", "trial", "evaluating", "trastuzumab", "added", "sequentially", "or", "used", "concurrently", "with", "chemotherapy", "in", "resected", "stages", "I", "to", "III", "invasive", "human", "epidermal", "growth", "factor", "receptor", "2", "-positive", "breast", "cancer", ".", "Patients", "received", "doxorubicin", "and", "cyclophosphamide", "every", "3", "weeks", "for", "four", "cycles", ",", "followed", "by", "paclitaxel", "weekly", "for", "12", "weeks", "(", "arm", "A", ")", ",", "paclitaxel", "plus", "sequential", "trastuzumab", "weekly", "for", "52", "weeks", "(", "arm", "B", ")", ",", "or", "paclitaxel", "plus", "concurrent", "trastuzumab", "for", "12", "weeks", "followed", "by", "trastuzumab", "for", "40", "weeks", "(", "arm", "C", ")", ".", "The", "primary", "end", "point", "was", "disease", "-", "free", "survival", "(", "DFS", ")", ".", "Comparison", "of", "arm", "A", "(", "n", "=", "1", ",", "087", ")", "and", "arm", "B", "(", "n", "=", "1", ",", "097", ")", ",", "with", "6", "-year", "median", "follow", "-", "up", "and", "390", "events", ",", "revealed", "5", "-year", "DFS", "rates", "of", "71.8", "%", "and", "80.1", "%", ",", "respectively", ".", "DFS", "was", "significantly", "increased", "with", "trastuzumab", "added", "sequentially", "to", "paclitaxel", "(", "log", "-", "rank", "P", "<", ".", "001", ";", "arm", "B", "/", "arm", "A", "hazard", "ratio", "[", "HR", "]", ",", "0.69", ";", "95", "%", "CI", ",", "0.57", "to", "0.85", ")", ".", "Comparison", "of", "arm", "B", "(", "n", "=", "954", ")", "and", "arm", "C", "(", "n", "=", "949", ")", ",", "with", "6", "-year", "median", "follow", "-", "up", "and", "313", "events", ",", "revealed", "5", "-year", "DFS", "rates", "of", "80.1", "%", "and", "84.4", "%", ",", "respectively", ".", "There", "was", "an", "increase", "in", "DFS", "with", "concurrent", "trastuzumab", "and", "paclitaxel", "relative", "to", "sequential", "administration", "(", "arm", "C", "/", "arm", "B", "HR", ",", "0.77", ";", "99.9", "%", "CI", ",", "0.53", "to", "1.11", ")", ",", "but", "the", "P", "value", "(", ".", "02", ")", "did", "not", "cross", "the", "prespecified", "O'Brien", "-", "Fleming", "boundary", "(", ".", "00116", ")", "for", "the", "interim", "analysis", ".", "DFS", "was", "significantly", "improved", "with", "52", "weeks", "of", "trastuzumab", "added", "to", "adjuvant", "chemotherapy", ".", "On", "the", "basis", "of", "a", "positive", "risk", "-", "benefit", "ratio", ",", "we", "recommend", "that", "trastuzumab", "be", "incorporated", "into", "a", "concurrent", "regimen", "with", "taxane", "chemotherapy", "as", "an", "important", "standard", "-", "of", "-", "care", "treatment", "alternative", "to", "a", "sequential", "regimen", "." ]
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927
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928
[ "A", "randomized", "controlled", "trial", "of", "emotionally", "expressive", "writing", "for", "women", "with", "metastatic", "breast", "cancer", ".", "To", "test", "the", "effects", "of", "emotionally", "expressive", "writing", "in", "a", "randomized", "controlled", "trial", "of", "metastatic", "breast", "cancer", "patients", "and", "to", "determine", "whether", "effects", "of", "the", "intervention", "varied", "as", "a", "function", "of", "perceived", "social", "support", "or", "time", "since", "metastatic", "diagnosis", ".", "Women", "(", "N", "=", "62", ")", "living", "with", "Stage", "IV", "breast", "cancer", "were", "randomly", "assigned", "to", "write", "about", "cancer", "-", "related", "emotions", "(", "EMO", ";", "n", "=", "31", ")", "or", "the", "facts", "of", "their", "diagnosis", "and", "treatment", "(", "CTL", ";", "n", "=", "31", ")", ".", "Participants", "wrote", "at", "home", "for", "four", "20", "-min", "sessions", "within", "a", "3", "-week", "interval", ".", "Depressive", "symptoms", ",", "cancer", "-", "related", "intrusive", "thoughts", ",", "somatic", "symptoms", ",", "and", "sleep", "quality", "at", "3", "months", "postintervention", ".", "No", "significant", "main", "effects", "of", "experimental", "condition", "were", "observed", ".", "A", "significant", "condition", "x", "social", "support", "interaction", "emerged", "on", "intrusive", "thoughts", ";", "EMO", "writing", "was", "associated", "with", "reduced", "intrusive", "thoughts", "for", "women", "reporting", "low", "emotional", "support", "(", "eta", "2", "=", ".", "15", ")", ".", "Significant", "condition", "x", "time", "since", "metastatic", "diagnosis", "interactions", "were", "also", "observed", "for", "somatic", "symptoms", "and", "sleep", "disturbances", ".", "Relative", "to", "CTL", ",", "EMO", "participants", "who", "were", "more", "recently", "diagnosed", "had", "fewer", "somatic", "symptoms", "(", "eta", "2", "=", ".", "10", ")", ",", "whereas", "EMO", "participants", "with", "longer", "diagnosis", "duration", "exhibited", "increases", "in", "sleep", "disturbances", "(", "eta", "2", "=", ".", "09", ")", ".", "Although", "there", "was", "no", "main", "effect", "of", "expressive", "writing", "on", "health", "among", "the", "current", "metastatic", "breast", "cancer", "sample", ",", "expressive", "writing", "may", "be", "beneficial", "for", "a", "subset", "of", "metastatic", "patients", "(", "including", "women", "with", "low", "levels", "of", "emotional", "support", "or", "who", "have", "been", "recently", "diagnosed", ")", "and", "contraindicated", "for", "others", "(", "i.e.", ",", "those", "who", "have", "been", "living", "with", "the", "diagnosis", "for", "years", ")", "." ]
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929
[ "Can", "polyacrylic", "acid", "treat", "sexual", "dysfunction", "in", "women", "with", "breast", "cancer", "receiving", "tamoxifen", "?", "There", "is", "a", "lack", "of", "safety", "data", "supporting", "the", "use", "of", "hormone", "therapy", "in", "women", "who", "have", "had", "breast", "cancer", "and", "who", "have", "complained", "of", "genitourinary", "syndrome", "of", "menopause", "(", "GSM", ")", ".", "The", "objective", "was", "to", "test", "the", "efficacy", "of", "two", "non", "-", "hormonal", "therapies", "for", "vaginal", "dryness", ".", "This", "was", "a", "randomized", "trial", "with", "52", "women", "with", "breast", "cancer", "who", "were", "being", "treated", "with", "tamoxifen", "and", "who", "complained", "of", "vaginal", "dryness", ".", "The", "volunteers", "answered", "two", "questionnaires", "to", "evaluate", "sexual", "function", "(", "Female", "Sexual", "Function", "Index", ",", "FSFI", ")", "and", "a", "customized", "GSM", "questionnaire", ".", "The", "women", "were", "randomized", "into", "two", "groups", ":", "25", "(", "48.1", "%", ")", "in", "the", "polyacrylic", "acid", "group", "and", "27", "(", "51.9", "%", ")", "in", "the", "lubricant", "group", ",", "using", "either", "one", "of", "the", "treatments", "for", "30", "days", ",", "and", "after", "they", "were", "invited", "to", "answer", "the", "questionnaires", "again", ".", "There", "was", "improvement", "in", "the", "FSFI", "after", "both", "treatments", ".", "The", "polyacrylic", "acid", "group", "showed", "a", "decrease", "in", "sexual", "dysfunction", "from", "96", "%", "to", "24", "%", "(", "p", "<", "0.0001", ")", "and", "the", "lubricant", "group", "showed", "a", "decrease", "from", "88.9", "%", "to", "55.6", "%", "(", "p", "=", "0.0027", ")", ".", "The", "results", "of", "this", "study", "showed", "that", "both", "treatments", "improved", "sexual", "function", ";", "however", ",", "polyacrylic", "acid", "was", "superior", "to", "the", "lubricant", "in", "treating", "sexual", "dysfunction", "." ]
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930
[ "Efficacy", "of", "first", "-", "line", "letrozole", "versus", "tamoxifen", "as", "a", "function", "of", "age", "in", "postmenopausal", "women", "with", "advanced", "breast", "cancer", ".", "To", "compare", "the", "efficacy", ",", "in", "regard", "to", "time", "to", "progression", "(", "TTP", ")", "and", "objective", "response", "rate", "(", "ORR", ")", ",", "of", "letrozole", "(", "Femara", ";", "Novartis", "Pharma", "AG", ";", "Basel", "Switzerland", ")", ",", "an", "oral", "aromatase", "inhibitor", ",", "with", "that", "of", "tamoxifen", "(", "Tamofen", ";", "Leiras", "OY", ";", "Turku", ",", "Finland", ")", "as", "first", "-", "line", "therapy", "in", "younger", "(", "<", "70", "years", ")", "and", "older", "(", ">", "/=", "70", "years", ")", "postmenopausal", "women", "with", "advanced", "breast", "cancer", ".", "Nine", "hundred", "seven", "patients", "with", "advanced", "breast", "cancer", "were", "randomly", "assigned", "to", "receive", "2.5", "mg", "letrozole", "(", "n", "=", "453", ")", "or", "20", "mg", "tamoxifen", "(", "n", "=", "454", ")", "once", "daily", "in", "a", "double", "-", "blind", ",", "multicenter", ",", "international", "trial", ".", "Among", "the", "prospectively", "planned", "analyses", "were", "analyses", "of", "TTP", "and", "ORR", "by", "age", "(", "<", "70", "and", ">", "/=", "70", "years", ")", ".", "The", "results", "of", "these", "prospectively", "planned", "analyses", "are", "reported", "here", ".", "Letrozole", "was", "as", "effective", "in", "older", "postmenopausal", "women", "(", ">", "/=", "70", "years", "of", "age", ")", "as", "it", "was", "in", "younger", "postmenopausal", "women", "(", "<", "70", "years", "of", "age", ")", ".", "The", "overall", "ORR", "in", "the", "older", "subgroup", "was", "significantly", "higher", "in", "patients", "treated", "with", "letrozole", "(", "38", "%", ")", "than", "in", "patients", "treated", "with", "tamoxifen", "(", "18", "%", ")", ".", "In", "the", "younger", "subgroup", "of", "postmenopausal", "patients", ",", "the", "ORRs", "were", "not", "significantly", "different", "(", "letrozole", ",", "26", "%", ";", "tamoxifen", ",", "22", "%", ")", ".", "TTP", "was", "significantly", "longer", "for", "letrozole", "than", "for", "tamoxifen", "in", "both", "age", "groups", "(", "younger", ":", "letrozole", "median", "TTP", ",", "8.8", "months", ";", "tamoxifen", ",", "6.0", "months", ";", "older", ":", "letrozole", "median", "TTP", ",", "12.2", "months", ";", "tamoxifen", ",", "5.8", "months", ")", ".", "Although", "age", "was", "independently", "prognostic", "of", "TTP", ",", "there", "was", "no", "significant", "effect", "of", "age", "on", "ORR", "in", "the", "presence", "of", "other", "factors", ".", "The", "data", "show", "that", "letrozole", ",", "2.5", "mg", "once", "daily", ",", "is", "as", "effective", "in", "older", ",", "postmenopausal", "women", "as", "it", "is", "in", "younger", "postmenopausal", "women", "with", "advanced", "breast", "cancer", ".", "In", "addition", ",", "letrozole", "was", "more", "effective", "than", "tamoxifen", "in", "both", "younger", "and", "older", "patients", "." ]
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931
[ "Adjuvant", "docetaxel", "for", "node", "-", "positive", "breast", "cancer", ".", "We", "compared", "docetaxel", "plus", "doxorubicin", "and", "cyclophosphamide", "(", "TAC", ")", "with", "fluorouracil", "plus", "doxorubicin", "and", "cyclophosphamide", "(", "FAC", ")", "as", "adjuvant", "chemotherapy", "for", "operable", "node", "-", "positive", "breast", "cancer", ".", "We", "randomly", "assigned", "1491", "women", "with", "axillary", "node", "-", "positive", "breast", "cancer", "to", "six", "cycles", "of", "treatment", "with", "either", "TAC", "or", "FAC", "as", "adjuvant", "chemotherapy", "after", "surgery", ".", "The", "primary", "end", "point", "was", "disease", "-", "free", "survival", ".", "At", "a", "median", "follow", "-", "up", "of", "55", "months", ",", "the", "estimated", "rates", "of", "disease", "-", "free", "survival", "at", "five", "years", "were", "75", "percent", "among", "the", "745", "patients", "randomly", "assigned", "to", "receive", "TAC", "and", "68", "percent", "among", "the", "746", "randomly", "assigned", "to", "receive", "FAC", ",", "representing", "a", "28", "percent", "reduction", "in", "the", "risk", "of", "relapse", "(", "P=", "0.001", ")", "in", "the", "TAC", "group", ".", "The", "estimated", "rates", "of", "overall", "survival", "at", "five", "years", "were", "87", "percent", "and", "81", "percent", ",", "respectively", ".", "Treatment", "with", "TAC", "resulted", "in", "a", "30", "percent", "reduction", "in", "the", "risk", "of", "death", "(", "P=", "0.008", ")", ".", "The", "incidence", "of", "grade", "3", "or", "4", "neutropenia", "was", "65.5", "percent", "in", "the", "TAC", "group", "and", "49.3", "percent", "in", "the", "FAC", "group", "(", "P", "<", "0.001", ")", ";", "rates", "of", "febrile", "neutropenia", "were", "24.7", "percent", "and", "2.5", "percent", ",", "respectively", "(", "P", "<", "0.001", ")", ".", "Grade", "3", "or", "4", "infections", "occurred", "in", "3.9", "percent", "of", "the", "patients", "who", "received", "TAC", "and", "2.2", "percent", "of", "those", "who", "received", "FAC", "(", "P=", "0.05", ")", ";", "no", "deaths", "occurred", "as", "a", "result", "of", "infection", ".", "Two", "patients", "in", "each", "group", "died", "during", "treatment", ".", "Congestive", "heart", "failure", "and", "acute", "myeloid", "leukemia", "occurred", "in", "less", "than", "2", "percent", "of", "the", "patients", "in", "each", "group", ".", "Quality", "-", "of", "-", "life", "scores", "decreased", "during", "chemotherapy", "but", "returned", "to", "baseline", "levels", "after", "treatment", ".", "Adjuvant", "chemotherapy", "with", "TAC", ",", "as", "compared", "with", "FAC", ",", "significantly", "improves", "the", "rates", "of", "disease", "-", "free", "and", "overall", "survival", "among", "women", "with", "operable", "node", "-", "positive", "breast", "cancer", "." ]
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932
[ "Physical", "activity", "does", "not", "alter", "prolactin", "levels", "in", "post", "-", "menopausal", "women", ":", "results", "from", "a", "dose", "-", "response", "randomized", "controlled", "trial", ".", "Increased", "circulating", "levels", "of", "prolactin", "have", "been", "associated", "with", "increased", "risk", "of", "both", "in", "situ", "and", "invasive", "breast", "cancer", ".", "We", "investigated", "whether", "or", "not", "physical", "activity", "had", "a", "dose", "-", "response", "effect", "in", "lowering", "plasma", "levels", "of", "prolactin", "in", "postmenopausal", "women", ".", "Four", "hundred", "previously", "inactive", "but", "healthy", "postmenopausal", "women", "aged", "50", "-", "74", "years", "of", "age", "were", "randomized", "to", "150", "or", "300", "min", "per", "week", "of", "aerobic", "physical", "activity", "in", "a", "year", "-", "long", "intervention", ".", "Prolactin", "was", "measured", "from", "fasting", "samples", "with", "a", "custom", "-", "plex", "multiplex", "assay", ".", "A", "high", "compared", "to", "moderate", "volume", "of", "physical", "activity", "did", "not", "reduce", "plasma", "prolactin", "levels", "in", "intention", "-", "to", "-", "treat", "(", "Treatment", "Effect", "Ratio", "(", "TER", ")", "1.00", ",", "95", "%", "Confidence", "Interval", "(", "CI", ")", "0.95", "-", "1.06", ")", "or", "per", "-", "protocol", "analyses", "(", "TER", "1.02", ",", "95", "%", "CI", "0.93", "-", "1.13", ")", ".", "It", "is", "unlikely", "that", "changes", "in", "prolactin", "levels", "mediate", "the", "reduced", "risk", "of", "breast", "cancer", "development", "in", "post", "-", "menopausal", "women", "associated", "with", "increased", "levels", "of", "physical", "activity", ".", "clinicaltrials.gov", "identifier", ":", "NCT", "01435005", "." ]
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933
[ "An", "open", "-", "label", ",", "randomized", "phase", "II", "study", "of", "adecatumumab", ",", "a", "fully", "human", "anti", "-", "EpCAM", "antibody", ",", "as", "monotherapy", "in", "patients", "with", "metastatic", "breast", "cancer", ".", "High", "-", "level", "expression", "of", "epithelial", "cell", "adhesion", "molecule", "(", "EpCAM", ")", "is", "associated", "with", "unfavorable", "prognosis", "in", "breast", "cancer", ".", "This", "study", "was", "designed", "to", "investigate", "two", "doses", "of", "the", "fully", "human", "IgG", "1", "anti", "-", "EpCAM", "antibody", "adecatumumab", "(", "MT", "201", ")", "in", "patients", "with", "metastatic", "breast", "cancer", "(", "MBC", ")", ".", "A", "total", "of", "109", "patients", "were", "stratified", "into", "high-", "and", "low", "-", "level", "EpCAM", "expression", "by", "immunohistochemical", "staining", "of", "primary", "tumors", "and", "subsequently", "randomly", "assigned", "to", "receive", "monotherapy", "with", "either", "high-", "(", "6", "mg", "/", "kg", "every", "two", "weeks", "(", "q", "2", "w", ")", ")", "or", "low", "-", "dose", "adecatumumab", "(", "2", "mg", "/", "kg", "/", "q", "2", "w", ")", "until", "disease", "progression", ".", "No", "complete", "or", "partial", "tumor", "responses", "could", "be", "confirmed", "by", "central", "RECIST", "assessment", ".", "The", "probability", "for", "tumor", "progression", "was", "significantly", "lower", "in", "patients", "receiving", "high", "-", "dose", "adecatumumab", "and", "expressing", "high", "levels", "of", "EpCAM", "(", "hazard", "ratio", "0.43", ";", "P", "=", "0.0057", "versus", "low", "dose", "and", "low", "EpCAM", ")", ".", "Three", "of", "18", "patients", "with", "highest", "EpCAM", "expression", "treated", "with", "adecatumumab", "developed", "new", "metastases", "up", "to", "week", "6", ",", "compared", "with", "14", "of", "29", "patients", "with", "low", "EpCAM", ".", "Most", "frequent", "treatment", "-", "related", "adverse", "events", "(", "high", "dose", "/", "low", "dose", ")", "were", "chills", "(", "59", "%", "/", "20", "%", ")", ",", "nausea", "(", "55", "%", "/", "18", "%", ")", ",", "fatigue", "(", "39", "%", "/", "23", "%", ")", "and", "diarrhea", "(", "43", "%", "/", "7", "%", ")", ".", "Single", "-", "agent", "adecatumumab", "shows", "dose-", "and", "target", "-", "dependent", "clinical", "activity", "in", "EpCAM", "-", "positive", "MBC", ",", "albeit", "no", "objective", "tumor", "regression", ".", "Further", "investigation", "of", "adecatumumab", "in", "patients", "with", "EpCAM", "-", "overexpressing", "tumors", "and", "lower", "tumor", "burden", "is", "warranted", "." ]
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934
[ "Resistance", "training", "improves", "fatigue", "and", "quality", "of", "life", "in", "previously", "sedentary", "breast", "cancer", "survivors", ":", "a", "randomised", "controlled", "trial", ".", "The", "primary", "aim", "of", "this", "study", "was", "to", "evaluate", "the", "benefits", "of", "resistance", "training", "(", "RT", ")", "on", "quality", "of", "life", "(", "QOL", ")", "and", "fatigue", "in", "breast", "cancer", "survivors", "as", "an", "adjunct", "to", "usual", "care", ".", "We", "recruited", "39", "women", "who", "had", "survived", "breast", "cancer", "[", "mean", "age", "(", "y", ")", "51.9", "±", "8.8", ";", "time", "since", "diagnosis", "(", "m", ")", "11.6", "±", "13.2", "]", ".", "Primary", "outcomes", "were", "fatigue", "as", "assessed", "by", "the", "Functional", "Assessment", "of", "Chronic", "Illness", "Therapy", "-", "Fatigue", "(", "FACIT", ")", "scale", "and", "QOL", "as", "assessed", "by", "the", "Functional", "Assessment", "of", "Cancer", "Therapy", "-", "General", "(", "FACT", "-", "G", ")", "scale", ".", "ANCOVA", "was", "used", "to", "assess", "the", "change", "in", "the", "primary", "outcomes", "while", "controlling", "for", "baseline", "values", ",", "with", "effect", "sizes", "(", "ES", ")", "displayed", "as", "partial", "Eta", "squared", ".", "The", "experimental", "group", "received", "supervised", "RT", "3", "days", "per", "week", "in", "a", "university", "clinic", "for", "16", "weeks", ".", "Perceptions", "of", "fatigue", "improved", "significantly", "in", "the", "RT", "group", "compared", "to", "controls", "[", "mean", "(", "SD", ")", "6.7", "(", "7.5", ")", "points", "vs.", "1.5", "(", "3.7", ")", "points", "]", ",", "(", "P", "=", "0.006", ",", "ES", "=", "0.20", ")", "as", "did", "QOL", "[", "6.9", "(", "8.5", ")", "points", "vs.", "1.6", "(", "4.4", ")", "points", "]", ",", "(", "P", "=", "0.015", ",", "ES", "=", "0.16", ")", ".", "We", "demonstrated", "both", "statistically", "and", "clinically", "important", "improvements", "in", "fatigue", "and", "QOL", "in", "response", "to", "RT", "in", "breast", "cancer", "survivors", "." ]
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935
[ "Gonadatrophin", "suppression", "to", "prevent", "chemotherapy", "-", "induced", "ovarian", "damage", ":", "a", "randomized", "controlled", "trial", ".", "To", "estimate", "the", "effectiveness", "of", "gonadotropin", "-", "releasing", "hormone", "(", "GnRH", ")", "analogues", "cotreatment", "in", "preventing", "chemotherapy", "-", "induced", "amenorrhea", "in", "young", "breast", "cancer", "patients", "undergoing", "cyclophosphamide", "-", "based", "chemotherapy", ".", "One", "hundred", "hormone", "-", "insensitive", "breast", "cancer", "participants", "(", "aged", "18", "-", "40", "years", ")", "were", "recruited", "from", "two", "university", "-", "affiliated", "oncology", "centers", "in", "Egypt", ".", "Opting", "for", "type", "of", "cotreatment", "was", "based", "on", "available", "timeframe", "until", "start", "of", "chemotherapy", ".", "Fifty", "women", "ready", "for", "early", "chemotherapy", "were", "randomized", "to", "receive", "either", "chemotherapy", "alone", "(", "arm", "I", ")", "or", "chemotherapy", "after", "downregulation", "(", "estradiol", "less", "than", "50", "pg", "/", "mL", ")", "by", "GnRH", "antagonist", "and", "agonist", "(", "arm", "II", ")", ".", "Then", ",", "GnRH", "antagonist", "was", "discontinued", "and", "agonist", "was", "continued", "until", "the", "end", "of", "chemotherapy", ".", "When", "chemotherapy", "was", "to", "start", "later", "than", "10", "days", "after", "study", "inclusion", ",", "50", "women", "were", "randomized", "to", "receive", "either", "chemotherapy", "alone", "(", "arm", "III", ")", "or", "chemotherapy", "after", "downregulation", "with", "GnRH", "agonist", "(", "arm", "IV", ")", ".", "Resumption", "of", "menstruation", "at", "12", "months", "after", "end", "of", "chemotherapy", "was", "the", "primary", "outcome", ".", "Postchemotherapy", "hormonal", "and", "ultrasound", "changes", "were", "secondary", "outcomes", ".", "Twelve", "months", "after", "termination", "of", "chemotherapy", ",", "there", "were", "no", "differences", "in", "menstruation", "resumption", "rates", "between", "GnRH", "-", "treated", "patients", "and", "control", "group", "individuals", "in", "either", "early", "(", "80", "%", "in", "arms", "I", "and", "II", ",", "risk", "ratio", "1", ",", "95", "%", "confidence", "interval", "0.7", "-", ".", "32", ";", "P=", "1.00", ")", "or", "delayed", "chemotherapy", "groups", "(", "80", "%", "and", "84", "%", "in", "arms", "III", "and", "IV", ",", "risk", "ratio", "0.95", ",", "95", "%", "confidence", "interval", "0.73", "-", "1.235", ";", "P=", ".", "71", ")", ".", "There", "were", "no", "differences", "in", "hormonal", "and", "ultrasound", "markers", "between", "GnRH", "analogue", "users", "and", "control", "group", "individuals", ".", "The", "use", "of", "GnRH", "analogue", "cotreatment", "did", "not", "predict", "independently", "the", "odds", "of", "menstruating", "at", "12", "months", ".", "GnRH", "analogue", "cotreatment", "does", "not", "offer", "a", "significant", "protective", "effect", "on", "ovarian", "function", "in", "patients", "treated", "by", "cyclophosphamide", "-", "based", "chemotherapy", ".", "Australian", "New", "Zealand", "Clinical", "Trials", "Registry", ".", "www.anzctr.org.au", ",", "ACTRN", "12609001059257", ".", "I", "." ]
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936
[ "Randomized", "Trial", "of", "Lisinopril", "Versus", "Carvedilol", "to", "Prevent", "Trastuzumab", "Cardiotoxicity", "in", "Patients", "With", "Breast", "Cancer", ".", "Trastuzumab", "is", "highly", "effective", "for", "human", "epidermal", "growth", "factor", "receptor", "type", "2", "(", "HER", "2", ")", "-positive", "breast", "cancer", "but", "is", "associated", "with", "a", "decline", "in", "left", "ventricular", "ejection", "fraction", ".", "The", "purpose", "of", "this", "study", "was", "to", "determine", "whether", "angiotensin", "-", "converting", "enzyme", "inhibitors", "or", "beta", "-", "blockers", "reduce", "the", "rate", "of", "trastuzumab", "-", "induced", "cardiotoxicity", "(", "left", "ventricular", "ejection", "fraction", "decrease", ">", "10", "%", ",", "or", ">", "5", "%", "if", "below", "50", "%", ")", "and", "limit", "treatment", "interruptions", ".", "In", "this", "double", "-", "blind", ",", "multicenter", ",", "placebo", "-", "controlled", "trial", ",", "cardiotoxicity", "and", "treatment", "interruptions", "in", "patients", "with", "HER", "2", "-", "positive", "breast", "cancer", "treated", "with", "trastuzumab", "for", "12", "months", "were", "evaluated", "over", "a", "2", "-year", "period", ".", "Patients", "were", "stratified", "by", "anthracycline", "use", "and", "then", "randomized", "to", "receive", "lisinopril", ",", "carvedilol", ",", "or", "placebo", ".", "The", "study", "included", "468", "women", ",", "age", "51", "±", "10.7", "years", ".", "For", "the", "entire", "cohort", ",", "cardiotoxicity", "was", "comparable", "in", "the", "3", "arms", "and", "occurred", "in", "32", "%", "of", "patients", "on", "placebo", ",", "29", "%", "on", "carvedilol", ",", "and", "30", "%", "on", "lisinopril", ".", "For", "patients", "receiving", "anthracyclines", ",", "the", "event", "rates", "were", "higher", "in", "the", "placebo", "group", "(", "47", "%", ")", "than", "in", "the", "lisinopril", "(", "37", "%", ")", "and", "the", "carvedilol", "(", "31", "%", ")", "groups", ".", "Cardiotoxicity", "-", "free", "survival", "was", "longer", "on", "both", "carvedilol", "(", "hazard", "ratio", ":", "0.49", ";", "95", "%", "confidence", "interval", ":", "0.27", "to", "0.89", ";", "p", "=", "0.009", ")", "and", "lisinopril", "(", "hazard", "ratio", ":", "0.53", ";", "95", "%", "confidence", "interval", ":", "0.30", "to", "0.94", ";", "p", "=", "0.015", ")", "than", "on", "placebo", ".", "In", "the", "whole", "cohort", ",", "as", "well", "as", "in", "the", "anthracycline", "arm", ",", "patients", "on", "active", "therapy", "with", "either", "angiotensin", "-", "converting", "enzyme", "inhibitor", "or", "beta", "-", "blockers", "experienced", "fewer", "interruptions", "in", "trastuzumab", "than", "those", "on", "placebo", ".", "In", "patients", "with", "HER", "2", "-", "positive", "breast", "cancer", "treated", "with", "trastuzumab", ",", "both", "lisinopril", "and", "carvedilol", "prevented", "cardiotoxicity", "in", "patients", "receiving", "anthracyclines", ".", "For", "such", "patients", ",", "lisinopril", "or", "carvedilol", "should", "be", "considered", "to", "minimize", "interruptions", "of", "trastuzumab", ".", "(", "Lisinopril", "or", "Coreg", "CR", "in", "Reducing", "Side", "Effects", "in", "Women", "With", "Breast", "Cancer", "Receiving", "Trastuzumab", ";", "NCT", "01009918", ")", "." ]
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937
[ "Efficacy", "and", "safety", "of", "CT", "-", "P", "6", "versus", "reference", "trastuzumab", "in", "HER", "2", "-", "positive", "early", "breast", "cancer", ":", "updated", "results", "of", "a", "randomised", "phase", "3", "trial", ".", "Neoadjuvant", "CT", "-", "P", "6", ",", "a", "trastuzumab", "biosimilar", ",", "demonstrated", "equivalent", "efficacy", "to", "reference", "trastuzumab", "in", "a", "phase", "3", "trial", "of", "HER", "2", "-", "positive", "early", "-", "stage", "breast", "cancer", "(", "EBC", ")", "(", "NCT", "02162667", ")", ".", "We", "report", "post", "hoc", "analyses", "evaluating", "pathological", "complete", "response", "(", "pCR", ")", "and", "breast", "pCR", "alongside", "additional", "efficacy", "and", "safety", "measures", ".", "Following", "neoadjuvant", "treatment", "and", "surgery", ",", "patients", "received", "adjuvant", "CT", "-", "P", "6", "or", "trastuzumab", "(", "6", "mg", "/", "kg", ")", "every", "3", "weeks", "for", "≤", "1", "year", ".", "In", "total", ",", "271", "and", "278", "patients", "received", "CT", "-", "P", "6", "and", "trastuzumab", ",", "respectively", ".", "pCR", "and", "breast", "pCR", "rates", "were", "comparable", "between", "treatment", "groups", "regardless", "of", "age", ",", "region", ",", "or", "clinical", "stage", ".", "Overall", ",", "47.6", "%", "(", "CT", "-", "P", "6", ")", "and", "52.2", "%", "(", "trastuzumab", ")", "of", "patients", "experienced", "study", "drug", "-", "related", "treatment", "-", "emergent", "adverse", "events", "(", "TEAEs", ")", ",", "including", "17", "patients", "reporting", "heart", "failure", "(", "CT", "-", "P", "6", ":", "10", ";", "trastuzumab", ":", "7", ")", ".", "Two", "CT", "-", "P", "6", "and", "three", "trastuzumab", "patients", "discontinued", "adjuvant", "treatment", "due", "to", "TEAEs", ".", "Adjuvant", "CT", "-", "P", "6", "demonstrated", "comparable", "efficacy", "and", "safety", "to", "trastuzumab", "at", "1", "year", "in", "patients", "with", "HER", "2", "-", "positive", "EBC", ",", "supporting", "CT", "-", "P", "6", "and", "trastuzumab", "comparability", "." ]
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938
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939
[ "Effects", "of", "a", "risk", "-", "based", "online", "mammography", "intervention", "on", "accuracy", "of", "perceived", "risk", "and", "mammography", "intentions", ".", "This", "experiment", "tested", "the", "effects", "of", "an", "individualized", "risk", "-", "based", "online", "mammography", "decision", "intervention", ".", "The", "intervention", "employs", "exemplification", "theory", "and", "the", "Elaboration", "Likelihood", "Model", "of", "persuasion", "to", "improve", "the", "match", "between", "breast", "cancer", "risk", "and", "mammography", "intentions", ".", "2918", "women", "ages", "35", "-", "49", "were", "stratified", "into", "two", "levels", "of", "10", "-year", "breast", "cancer", "risk", "(", "<", "1.5", "%", ";", "≥", "1.5", "%", ")", "then", "randomly", "assigned", "to", "one", "of", "eight", "conditions", ":", "two", "comparison", "conditions", "and", "six", "risk", "-", "based", "intervention", "conditions", "that", "varied", "according", "to", "a", "2", "(", "amount", "of", "content", ":", "brief", "vs.", "extended", ")", "x", "3", "(", "format", ":", "expository", "vs.", "untailored", "exemplar", "[", "example", "case", "]", "vs.", "tailored", "exemplar", ")", "design", ".", "Outcomes", "included", "mammography", "intentions", "and", "accuracy", "of", "perceived", "breast", "cancer", "risk", ".", "Risk", "-", "based", "intervention", "conditions", "improved", "the", "match", "between", "objective", "risk", "estimates", "and", "perceived", "risk", ",", "especially", "for", "high", "-", "numeracy", "women", "with", "a", "10", "-year", "breast", "cancer", "risk", "≤", "1.5", "%", ".", "For", "women", "with", "a", "risk≤", "1.5", "%", ",", "exemplars", "improved", "accuracy", "of", "perceived", "risk", "and", "all", "risk", "-", "based", "interventions", "increased", "intentions", "to", "wait", "until", "age", "50", "to", "screen", ".", "A", "risk", "-", "based", "mammography", "intervention", "improved", "accuracy", "of", "perceived", "risk", "and", "the", "match", "between", "objective", "risk", "estimates", "and", "mammography", "intentions", ".", "Interventions", "could", "be", "applied", "in", "online", "or", "clinical", "settings", "to", "help", "women", "understand", "risk", "and", "make", "mammography", "decisions", "." ]
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940
[ "Effects", "of", "a", "Hypnosis", "Session", "Before", "General", "Anesthesia", "on", "Postoperative", "Outcomes", "in", "Patients", "Who", "Underwent", "Minor", "Breast", "Cancer", "Surgery", ":", "The", "HYPNOSEIN", "Randomized", "Clinical", "Trial", ".", "Hypnosis", "is", "now", "widespread", "in", "medical", "practice", "and", "is", "emerging", "as", "an", "alternative", "technique", "for", "pain", "management", "and", "anxiety", ".", "However", ",", "its", "effects", "on", "postoperative", "outcomes", "remain", "unclear", ".", "To", "evaluate", "the", "efficacy", "of", "a", "preoperative", "hypnosis", "session", "for", "reducing", "postoperative", "breast", "pain", "in", "patients", "who", "underwent", "minor", "breast", "cancer", "surgery", ".", "The", "HYPNOSEIN", "prospective", "randomized", "clinical", "trial", "was", "conducted", "from", "October", "7", ",", "2014", ",", "to", "April", "5", ",", "2016", ".", "In", "this", "multicenter", "study", "in", "France", ",", "150", "women", "scheduled", "for", "minor", "breast", "cancer", "surgery", "were", "randomized", "between", "control", "and", "hypnosis", "arms", ",", "and", "148", "(", "71", "control", "and", "77", "hypnosis", ")", "were", "included", "in", "the", "intent", "-", "to", "-", "treat", "analysis", ".", "On", "the", "day", "of", "surgery", ",", "eligible", "patients", "were", "randomly", "assigned", "(", "1", ":1", ")", "to", "the", "control", "arm", "or", "the", "hypnosis", "arm", ".", "Patients", "(", "but", "not", "the", "care", "teams", ")", "were", "blinded", "to", "the", "arm", "to", "which", "they", "were", "assigned", ".", "A", "15", "-minute", "hypnosis", "session", "before", "general", "anesthesia", "in", "the", "operating", "room", "was", "performed", "in", "the", "hypnosis", "arm", ".", "The", "primary", "end", "point", "was", "breast", "pain", "reduction", "(", "by", "2", "on", "a", "visual", "analog", "scale", ")", ",", "assessed", "immediately", "before", "discharge", "from", 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"cancer", "surgery", ".", "However", ",", "other", "outcomes", "seem", "to", "be", "improved", ",", "which", "needs", "to", "be", "confirmed", "by", "further", "studies", ".", "EudraCT", "Identifier", ":", "2014", "-A", "00681", "-", "46", "and", "ClinicalTrials.gov", "Identifier", ":", "NCT", "03253159", "." ]
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941
[ "Adjuvant", "capecitabine", ",", "docetaxel", ",", "cyclophosphamide", ",", "and", "epirubicin", "for", "early", "breast", "cancer", ":", "final", "analysis", "of", "the", "randomized", "FinXX", "trial", ".", "Capecitabine", "is", "an", "active", "agent", "in", "the", "treatment", "of", "breast", "cancer", ".", "It", "is", "not", "known", "whether", "integration", "of", "capecitabine", "into", "an", "adjuvant", "regimen", "that", "contains", "a", "taxane", ",", "an", "anthracycline", ",", "and", "cyclophosphamide", "improves", "outcome", "in", "early", "breast", "cancer", ".", "Women", "with", "axillary", "node", "-", "positive", "or", "high", "-", "risk", "node", "-", "negative", "breast", "cancer", "were", "randomly", "assigned", "to", "receive", "either", "three", "cycles", "of", "docetaxel", "and", "capecitabine", "(", "TX", ")", "followed", "by", "three", "cycles", "of", "cyclophosphamide", ",", "epirubicin", ",", "and", "capecitabine", "(", "CEX", ";", "n", "=", "753", ")", "or", "three", "cycles", "of", "docetaxel", "(", "T", ")", "followed", "by", "three", "cycles", "of", "cyclophosphamide", ",", "epirubicin", ",", "and", "fluorouracil", "(", "CEF", ";", "n", "=", "747", ")", ".", "The", "primary", "end", "point", "was", "recurrence", "-", "free", "survival", "(", "RFS", ")", ".", "During", "a", "median", "follow", "-", "up", "time", "of", "59", "months", ",", "214", "RFS", "events", "occurred", "(", "local", "or", "distant", "recurrences", "or", "deaths", ";", "TX", "/", "CEX", ",", "n", "=", "96", ";", "T", "/", "CEF", ",", "n", "=", "118", ")", ".", "RFS", "was", "not", "significantly", "different", "between", "the", "groups", "(", "hazard", "ratio", "[", "HR", "]", ",", "0.79", ";", "95", "%", "CI", ",", "0.60", "to", "1.04", ";", "P", "=", ".", "087", ";", "5", "-year", "RFS", ",", "86.6", "%", "for", "TX", "/", "CEX", "v", "84.1", "%", "for", "T", "/", "CEF", ")", ".", "Fifty", "-", "six", "patients", "assigned", "to", "TX", "/", "CEX", "died", "during", "the", "follow", "-", "up", "compared", "with", "75", "of", "patients", "assigned", "to", "T", "/", "CEF", "(", "HR", ",", "0.73", ";", "95", "%", "CI", ",", "0.52", "to", "1.04", ";", "P", "=", ".", "080", ")", ".", "In", "exploratory", "analyses", ",", "TX", "/", "CEX", "improved", "breast", "cancer", "-", "specific", "survival", "(", "HR", ",", "0.64", ";", "95", "%", "CI", ",", "0.44", "to", "0.95", ";", "P", "=", ".", "027", ")", "and", "RFS", "in", "women", "with", "triple", "-", "negative", "disease", "and", "in", "women", "who", "had", "more", "than", "three", "metastatic", "axillary", "lymph", "nodes", "at", "the", "time", "of", "diagnosis", ".", "We", "detected", "little", "severe", "late", "toxicity", ".", "Integration", "of", "capecitabine", "into", "a", "regimen", "that", "contains", "docetaxel", ",", "epirubicin", ",", "and", "cyclophosphamide", "did", "not", "improve", "RFS", "significantly", "compared", "with", "a", "similar", "regimen", "without", "capecitabine", "." ]
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942
[ "Effect", "of", "Patient", "Navigation", "on", "Breast", "Cancer", "Screening", "Among", "African", "American", "Medicare", "Beneficiaries", ":", "A", "Randomized", "Controlled", "Trial", ".", "There", "is", "growing", "evidence", "that", "patient", "navigation", "improves", "breast", "cancer", "screening", "rates", ";", "however", ",", "there", "are", "limited", "efficacy", "studies", "of", "its", "effect", "among", "African", "American", "older", "adult", "women", ".", "To", "evaluate", "the", "effect", "of", "patient", "navigation", "on", "screening", "mammography", "among", "African", "American", "female", "Medicare", "beneficiaries", "in", "Baltimore", ",", "MD", ".", "The", "Cancer", "Prevention", "and", "Treatment", "Demonstration", "(", "CPTD", ")", ",", "a", "multi", "-", "site", "study", ",", "was", "a", "randomized", "controlled", "trial", "conducted", "from", "April", "2006", "through", "December", "2010", ".", "Community", "-", "based", "and", "clinical", "setting", ".", "The", "CPTD", "Screening", "Trial", "enrolled", "1905", "community", "-", "dwelling", "African", "American", "female", "Medicare", "beneficiaries", "who", "were", "≥", "65", "years", "of", "age", "and", "resided", "in", "Baltimore", ",", "MD", ".", "Participants", "were", "recruited", "from", "health", "clinics", ",", "community", "centers", ",", "health", "fairs", ",", "mailings", "using", "Medicare", "rosters", ",", "and", "phone", "calls", ".", "Participants", "were", "randomized", "to", "either", ":", "printed", "educational", "materials", "on", "cancer", "screening", "(", "control", "group", ")", "or", "printed", "educational", "materials", "+", "patient", "navigation", "services", "designed", "to", "help", "participants", "overcome", "barriers", "to", "cancer", "screening", "(", "intervention", "group", ")", ".", "Self", "-", "reported", "receipt", "of", "mammography", "screening", "within", "2", "years", "of", "the", "end", "of", "the", "study", ".", "The", "median", "follow", "-", "up", "period", "for", "participants", "in", "this", "analysis", "was", "17.8", "months", ".", "In", "weighted", "multivariable", "logistic", "regression", "analyses", ",", "women", "in", "the", "intervention", "group", "had", "significantly", "higher", "odds", "of", "being", "up", "to", "date", "on", "mammography", "screening", "at", "the", "end", "of", "the", "follow", "-", "up", "period", "compared", "to", "women", "in", "the", "control", "group", "(", "odds", "ratio", "[", "OR", "]", "2.26", ",", "95", "%", "confidence", "interval", "[", "CI]", "1.59", "-", "3.22", ")", ".", "The", "effect", "of", "the", "intervention", "was", "stronger", "among", "women", "who", "were", "not", "up", "to", "date", "with", "mammography", "screening", "at", "enrollment", "(", "OR", "3.63", ",", "95", "%", "CI", "2.09", "-", "6.38", ")", ".", "Patient", "navigation", "among", "urban", "African", "American", "Medicare", "beneficiaries", "increased", "self", "-", "reported", "mammography", "utilization", ".", "The", "results", "suggest", "that", "patient", "navigation", "for", "mammography", "screening", "should", "focus", "on", "women", "who", "are", "not", "up", "to", "date", "on", "their", "screening", "." ]
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943
[ "Randomized", "phase", "III", "study", "of", "docetaxel", "compared", "with", "paclitaxel", "in", "metastatic", "breast", "cancer", ".", "This", "randomized", ",", "controlled", ",", "multicenter", ",", "open", "-", "label", ",", "phase", "III", "study", "compared", "docetaxel", "versus", "paclitaxel", "in", "patients", "with", "advanced", "breast", "cancer", "that", "had", "progressed", "after", "an", "anthracycline", "-", "containing", "chemotherapy", "regimen", ".", "Patients", "(", "n", "=", "449", ")", "were", "randomly", "assigned", "to", "receive", "either", "docetaxel", "100", "mg", "/", "m", "2", "(", "n", "=", "225", ")", "or", "paclitaxel", "175", "mg", "/", "m", "2", "(", "n", "=", "224", ")", "on", "day", "1", ",", "every", "21", "days", "until", "tumor", "progression", ",", "unacceptable", "toxicity", ",", "or", "withdrawal", "of", "consent", ".", "In", "the", "intent", "-", "to", "-", "treat", "population", ",", "both", "the", "median", "overall", "survival", "(", "OS", ",", "15.4", "v", "12.7", "months", ";", "hazard", "ratio", "[", "HR", "]", ",", "1.41", ";", "95", "%", "CI", ",", "1.15", "to", "1.73", ";", "P", "=", ".", "03", ")", "and", "the", "median", "time", "to", "progression", "(", "TTP", ",", "5.7", "months", "v", "3.6", "months", ";", "HR", ",", "1.64", ";", "95", "%", "CI", ",", "1.33", "to", "2.02", ";", "P", "<", ".", "0001", ")", "for", "docetaxel", "were", "significantly", "longer", "than", "for", "paclitaxel", ",", "and", "the", "overall", "response", "rate", "(", "ORR", ",", "32", "%", "v", "25", "%", ";", "P", "=", ".", "10", ")", "was", "higher", "for", "docetaxel", ".", "These", "results", "were", "confirmed", "by", "multivariate", "analyses", ".", "The", "incidence", "of", "treatment", "-", "related", "hematologic", "and", "nonhematologic", "toxicities", "was", "greater", "for", "docetaxel", "than", "for", "paclitaxel", ";", "however", ",", "quality", "-", "of", "-", "life", "scores", "were", "not", "statistically", "different", "between", "treatment", "groups", "over", "time", ".", "Docetaxel", "was", "superior", "to", "paclitaxel", "in", "terms", "of", "OS", "and", "TTP", ".", "ORR", "was", "higher", "for", "docetaxel", ".", "Hematologic", "and", "nonhematologic", "toxicities", "occurred", "more", "frequently", "in", "the", "docetaxel", "group", ".", "The", "global", "quality", "-", "of", "-", "life", "scores", "were", "similar", "for", "both", "agents", "over", "time", "." ]
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944
[ "Association", "between", "allergies", ",", "asthma", ",", "and", "breast", "cancer", "risk", "among", "women", "in", "Ontario", ",", "Canada", ".", "To", "investigate", "the", "association", "between", "allergies", ",", "asthma", ",", "and", "breast", "cancer", "risk", "in", "a", "large", ",", "population", "-", "based", "case", "-", "control", "study", ".", "Breast", "cancer", "cases", "(", "n", "=", "3", ",", "101", ")", "were", "identified", "using", "the", "Ontario", "Cancer", "Registry", "and", "population", "controls", "(", "n", "=", "3", ",", "471", ")", "through", "random", "digit", "dialing", ".", "Self", "-", "reported", "histories", "of", "allergies", ",", "hay", "fever", ",", "and", "asthma", "were", "collected", "by", "questionnaire", ".", "Logistic", "regression", "was", "used", "to", "assess", "associations", "between", "breast", "cancer", "risk", "and", "history", "of", "allergy", "/", "hay", "fever", "and", "asthma", ",", "with", "16", "possible", "confounders", "examined", ".", "Analyses", "were", "stratified", "by", "menopausal", "status", ".", "A", "history", "of", "allergies", "or", "hay", "fever", "was", "associated", "with", "a", "small", "reduction", "in", "breast", "cancer", "risk", "[", "age", "-", "adjusted", "odds", "ratio", "(", "AOR", ")", "=", "0.86", ",", "95", "%", "confidence", "interval", "(", "CI", ")", "0.77", "-", "0.96", "]", "and", "did", "not", "differ", "by", "menopausal", "status", ".", "Asthma", "was", "not", "associated", "with", "breast", "cancer", "risk", "overall", ";", "however", ",", "among", "premenopausal", "women", ",", "asthma", "was", "associated", "with", "a", "reduced", "risk", "of", "breast", "cancer", "(", "AOR", "=", "0.72", ",", "95", "%", "CI", "0.54", "-", "0.97", ")", ".", "A", "history", "of", "allergies", "may", "be", "associated", "with", "a", "modest", "reduction", "in", "breast", "cancer", "risk", ".", "Asthma", "does", "not", "appear", "to", "be", "associated", "with", "breast", "cancer", "risk", "overall", ";", "however", ",", "asthma", "may", "be", "associated", "with", "reduced", "breast", "cancer", "risk", "among", "premenopausal", "women", "." ]
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945
[ "Reducing", "Radiation", "Dermatitis", "Using", "a", "Film", "-", "forming", "Silicone", "Gel", "During", "Breast", "Radiotherapy", ":", "A", "Pilot", "Randomized", "-", "controlled", "Trial", ".", "To", "evaluate", "whether", "topical", "use", "of", "a", "film", "-", "forming", "silicone", "gel", "(", "StrataXRT", "®", ")", "could", "reduce", "radiation", "dermatitis", "compared", "to", "a", "moisturizing", "cream", "(", "X", "-", "derm", "®", ")", "in", "patients", "receiving", "whole", "breast", "radiotherapy", ".", "A", "total", "of", "56", "patients", "with", "breast", "cancer", "were", "randomized", "to", "use", "StrataXRT", "or", "X", "-", "derm", ".", "The", "severity", "of", "radiation", "dermatitis", "was", "graded", "using", "physiological", "skin", "parameters", ",", "clinician", "-", "assessed", "visual", "rating", "scales", "and", "patient", "-", "reported", "symptoms", ".", "Changes", "in", "these", "parameters", "from", "baseline", "to", "4", "weeks", "post", "-", "radiotherapy", "were", "evaluated", "every", "two", "weeks", ".", "Two", "-", "way", "repeated", "-", "measures", "ANOVA", "revealed", "different", "patterns", "of", "changes", "in", "the", "erythema", "index", "(", "F=", "3.609", ",", "p=", "0.008", ")", "and", "melanin", "index", "(", "F=", "3.475", ",", "p=", "0.015", ")", ".", "The", "post", "hoc", "analysis", "demonstrated", "a", "significantly", "lower", "erythema", "index", "and", "melanin", "index", "in", "the", "patients", "allocated", "to", "the", "StrataXRT", "group", ".", "The", "use", "of", "StrataXRT", "can", "reduce", "radiation", "dermatitis", "with", "respect", "to", "objectively", "measured", "physiological", "skin", "parameters", ".", "The", "results", "of", "the", "present", "study", "will", "support", "the", "feasibility", "of", "conducting", "a", "larger", "randomized", "controlled", "trial", "." ]
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946
[ "Letrozole", "in", "advanced", "breast", "cancer", ":", "the", "PO", "25", "trial", ".", "Tamoxifen", "has", "been", "a", "standard", "first", "-", "line", "endocrine", "therapy", "for", "post", "-", "menopausal", "women", "with", "hormone", "-", "responsive", "advanced", "breast", "cancer", ",", "but", "more", "than", "half", "of", "patients", "fail", "to", "respond", "and", "time", "to", "progression", "is", "less", "than", "12", "months", "in", "responders", ".", "The", "third", "-", "generation", "aromatase", "inhibitors", "were", "developed", "to", "provide", "more", "effective", "alternatives", "to", "tamoxifen", ".", "In", "the", "Femara", "Study", "PO", "25", ",", "post", "-", "menopausal", "women", "with", "advanced", "breast", "cancer", "were", "randomized", "to", "receive", "letrozole", "2.5", "mg", "(", "n=", "453", ")", "or", "tamoxifen", "20", "mg", "(", "n=", "454", ")", "given", "orally", "daily", "until", "progressive", "disease", "occurred", ".", "Patients", "were", "permitted", "to", "cross", "over", "to", "the", "other", "treatment", "at", "progression", ".", "In", "the", "primary", "efficacy", "analysis", ",", "median", "time", "to", "progression", "(", "TTP", ")", "was", "significantly", "longer", "with", "letrozole", "than", "with", "tamoxifen", "(", "9.4", "months", "vs.", "6.0", "months", ",", "respectively", ";", "P", "<", "0.0001", ")", ".", "The", "objective", "response", "rate", "(", "ORR", ")", "was", "significantly", "higher", "for", "letrozole", "than", "for", "tamoxifen", "(", "32", "%", "vs.", "21", "%", ";", "P=", "0.0002", ")", ".", "Prospectively", "planned", "analyses", "of", "the", "intent", "-", "to", "-", "treat", "population", "showed", "that", "letrozole", "significantly", "improved", "overall", "survival", "(", "OS", ")", "compared", "with", "tamoxifen", "over", "the", "first", "24", "months", "of", "the", "trial", ".", "An", "exploratory", "analysis", "of", "patients", ",", "who", "did", "not", "cross", "over", ",", "indicated", "a", "median", "OS", "benefit", "of", "14", "months", "for", "letrozole", "compared", "with", "tamoxifen", ".", "Letrozole", "is", "the", "only", "third", "-", "generation", "aromatase", "inhibitor", "that", "has", "demonstrated", "significant", "improvements", "in", "ORR", ",", "TTP", ",", "and", "early", "OS", "." ]
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947
[ "Phase", "II", "dose", "-", "finding", "study", "of", "balugrastim", "in", "breast", "cancer", "patients", "receiving", "myelosuppressive", "chemotherapy", ".", "Balugrastim", "is", "a", "once", "-", "per", "-", "cycle", ",", "fixed", "-", "dose", "recombinant", "protein", "comprising", "human", "serum", "albumin", "and", "granulocyte", "colony", "-", "stimulating", "factor", "under", "development", "for", "prevention", "of", "severe", "neutropenia", "in", "cancer", "patients", "receiving", "myelosuppressive", "chemotherapy", ".", "This", "phase", "II", ",", "multicenter", ",", "active", "-", "controlled", ",", "dose", "-", "finding", "pilot", "study", "evaluated", "balugrastim", "safety", "and", "efficacy", "versus", "pegfilgrastim", "in", "breast", "cancer", "patients", "scheduled", "to", "receive", "myelosuppressive", "chemotherapy", "and", "investigated", "two", "doses", "with", "similar", "efficacy", "to", "pegfilgrastim", "for", "a", "subsequent", "phase", "III", "study", ".", "Patients", "received", "four", "cycles", "of", "doxorubicin", "/", "docetaxel", "chemotherapy", "and", "with", "each", "successive", "cycle", "were", "randomized", "sequentially", "to", "escalating", "doses", "of", "balugrastim", "[", "30", "(", "n", "=", "11", ")", ",", "40", "(", "n", "=", "21", ")", ",", "or", "50", "mg", "(", "n", "=", "20", ")", "]", "or", "a", "fixed", "dose", "of", "pegfilgrastim", "[", "6", "mg", "(", "n", "=", "26", ")", "]", "post", "-", "chemotherapy", ".", "Balugrastim", "doses", "were", "escalated", "as", "planned", ".", "The", "incidence", "of", "adverse", "events", "was", "similar", "among", "the", "balugrastim", "groups", "and", "between", "all", "balugrastim", "doses", "and", "pegfilgrastim", ".", "The", "most", "frequently", "reported", "adverse", "events", "were", "neutropenia", ",", "alopecia", ",", "and", "nausea", ".", "During", "cycle", "1", ",", "severe", "neutropenia", "(", "absolute", "neutrophil", "count", "of", "<", "0.5", "×", "10", "(", "9", ")", "/L", ")", "occurred", "in", "40", ",", "67", ",", "and", "50", "%", "and", "febrile", "neutropenia", "occurred", "in", "20.0", ",", "9.5", ",", "and", "10.0", "%", "of", "patients", "receiving", "balugrastim", "30", ",", "40", ",", "and", "50", "mg", ",", "respectively", ";", "in", "patients", "receiving", "pegfilgrastim", ",", "48", "%", "experienced", "severe", "neutropenia", "and", "8", "%", "experienced", "febrile", "neutropenia", ".", "Duration", "of", "severe", "neutropenia", "(", "DSN", ")", "for", "each", "treatment", "group", "was", "0.9", ",", "1.6", ",", "1.1", ",", "and", "0.9", "days", ",", "respectively", ".", "In", "the", "remaining", "three", "chemotherapy", "cycles", ",", "DSN", "was", "≤", "1", "day", "across", "all", "treatment", "groups", ".", "Balugrastim", "50", "mg", "was", "comparable", "to", "pegfilgrastim", "in", "terms", "of", "safety", "and", "overall", "efficacy", "in", "breast", "cancer", "patients", "receiving", "myelosuppressive", "chemotherapy", "." ]
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948
[ "Randomized", "phase", "II", "study", "of", "weekly", "paclitaxel", "with", "and", "without", "carboplatin", "followed", "by", "cyclophosphamide", "/", "epirubicin", "/", "5", "-", "fluorouracil", "as", "neoadjuvant", "chemotherapy", "for", "stage", "II", "/", "IIIA", "breast", "cancer", "without", "HER", "2", "overexpression", ".", "Addition", "of", "carboplatin", "to", "neoadjuvant", "chemotherapy", "in", "HER", "2", "-", "negative", "breast", "cancer", "may", "improve", "pathological", "complete", "response", "(", "pCR", ")", "rates", ".", "We", "evaluated", "the", "efficacy", "and", "safety", "of", "carboplatin", "and", "weekly", "paclitaxel", "(", "wPTX", ")", "followed", "by", "cyclophosphamide", ",", "epirubicin", ",", "and", "5", "-fluorouracil", "(", "CEF", ")", "as", "neoadjuvant", "chemotherapy", "for", "HER", "2", "-", "negative", "breast", "cancer", ".", "Patients", "with", "stage", "II", "/", "IIIA", "HER", "2", "-", "negative", "breast", "cancer", "were", "randomly", "assigned", "to", "preoperatively", "receive", "CP", "-", "CEF", "(", "four", "3", "-week", "cycles", "of", "carboplatin", "[", "area", "under", "the", "curve", "5", "mg", "/", "mL", "/", "min", ",", "day", "1", "]", "and", "wPTX", "[", "80", "mg", "/", "m", "(", "2", ")", ",", "day", "1", ",", "8", ",", "15", "]", "followed", "by", "four", "3", "-week", "cycles", "of", "CEF", "[", "500", "/", "100", "/", "500", "mg", "/", "m", "(", "2", ")", "]", "or", "P", "-", "CEF", "(", "four", "cycles", "of", "wPTX", "followed", "by", "four", "cycles", "of", "CEF", ")", ".", "The", "primary", "objective", "was", "pCR", "rate", ".", "Of", "181", "eligible", "patients", ",", "89", "were", "randomly", "assigned", "to", "the", "CP", "-", "CEF", "and", "92", "to", "the", "P", "-", "CEF", ".", "Two", "patients", "in", "each", "arm", "refused", "to", "receive", "neoadjuvant", "chemotherapy", ".", "Overall", "88", "patients", "in", "the", "CP", "-", "CEF", "and", "91", "patients", "in", "the", "P", "-", "CEF", "were", "assessable", "for", "efficacy", "and", "safety", ".", "The", "pCR", "rate", "in", "the", "CP", "-", "CEF", "was", "significantly", "higher", "than", "that", "in", "the", "P", "-", "CEF", "(", "31.8", "vs.", "17.6", "%", ",", "one", "-", "sided", "P", "=", "0.01", ")", ".", "Among", "patients", "with", "triple", "-", "negative", "breast", "cancer", ",", "the", "pCR", "rate", "in", "the", "CP", "-", "CEF", "was", "significantly", "higher", "than", "that", "in", "the", "P", "-", "CEF", "[", "61.2", "(", "23", "/", "37", ")", "vs.", "26.3", "%", "(", "10", "/", "38", ")", ",", "P", "=", "0.003", "]", ".", "Grade", "3", "-", "4", "neutropenia", "was", "observed", "in", "the", "CP", "-", "CEF", "more", "frequently", "than", "in", "the", "P", "-", "CEF", "(", "65.9", "vs.", "38.5", "%", ")", ".", "Adding", "carboplatin", "to", "neoadjuvant", "wPTX", "followed", "by", "CEF", "for", "HER", "2", "-", "negative", "breast", "cancer", "improved", "the", "pCR", "rate", "and", "exacerbated", "hematotoxicity", "." ]
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949
[ "Randomized", ",", "Multicenter", ",", "Placebo", "-", "Controlled", "Clinical", "Trial", "of", "Duloxetine", "Versus", "Placebo", "for", "Aromatase", "Inhibitor", "-", "Associated", "Arthralgias", "in", "Early", "-", "Stage", "Breast", "Cancer", ":", "SWOG", "S", "1202", ".", "Purpose", "Adherence", "to", "aromatase", "inhibitor", "(", "AI", ")", "therapy", "for", "early", "-", "stage", "breast", "cancer", "is", "limited", "by", "AI", "-", "associated", "musculoskeletal", "symptoms", "(", "AIMSS", ")", ".", "Duloxetine", "is", "US", "Food", "and", "Drug", "Administration", "approved", "for", "treatment", "of", "multiple", "chronic", "pain", "disorders", ".", "We", "hypothesized", "that", "treatment", "of", "AIMSS", "with", "duloxetine", "would", "improve", "average", "joint", "pain", "compared", "with", "placebo", ".", "Methods", "This", "randomized", ",", "double", "-", "blind", ",", "phase", "III", "trial", "included", "AI", "-", "treated", "postmenopausal", "women", "with", "early", "-", "stage", "breast", "cancer", "and", "who", "had", "average", "joint", "pain", "score", "of", "≥", "4", "out", "of", "10", "that", "developed", "or", "worsened", "since", "AI", "therapy", "initiation", ".", "Patients", "were", "randomly", "assigned", "1", ":1", "to", "duloxetine", "or", "placebo", "for", "13", "weeks", ".", "The", "primary", "end", "point", "was", "average", "joint", "pain", "through", "12", "weeks", ",", "examined", "using", "multivariable", "linear", "mixed", "models", ",", "adjusted", "for", "stratification", "factors", "(", "baseline", "pain", "score", "of", "4", "to", "6", "v", "7", "to", "10", "and", "prior", "taxane", "use", ")", ".", "Clinically", "significant", "change", "in", "average", "pain", "was", "defined", "as", "a", "≥", "2", "-point", "decrease", "from", "baseline", ".", "Results", "Of", "299", "enrolled", "patients", ",", "127", "patients", "treated", "with", "duloxetine", "and", "128", "who", "received", "placebo", "were", "evaluable", "for", "the", "primary", "analysis", ".", "By", "12", "weeks", ",", "the", "average", "joint", "pain", "score", "was", "0.82", "points", "lower", "for", "patients", "who", "received", "duloxetine", "compared", "with", "those", "who", "received", "placebo", "(", "95", "%", "CI", ",", "-", "1.24", "to", "-", "0.40", ";", "P", "=", ".", "0002", ")", ".", "Similar", "patterns", "were", "observed", "for", "worst", "joint", "pain", ",", "joint", "stiffness", ",", "pain", "interference", ",", "and", "functioning", ".", "Rates", "of", "adverse", "events", "of", "any", "grade", "were", "higher", "in", "the", "duloxetine", "-", "treated", "group", "(", "78", "%", "v", "50", "%", ")", ";", "rates", "of", "grade", "3", "adverse", "events", "were", "similar", ".", "Conclusion", "Results", "of", "treatment", "with", "duloxetine", "for", "AIMSS", "were", "superior", "to", "those", "of", "placebo", "among", "women", "with", "early", "-", "stage", "breast", "cancer", ",", "although", "it", "resulted", "in", "more", "frequent", "low", "-", "grade", "toxicities", "." ]
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950
[ "Lumpectomy", "plus", "tamoxifen", "with", "or", "without", "irradiation", "in", "women", "70", "years", "of", "age", "or", "older", "with", "early", "breast", "cancer", ".", "In", "women", "70", "years", "of", "age", "or", "older", "who", "have", "early", "breast", "cancer", ",", "it", "is", "unclear", "whether", "lumpectomy", "plus", "tamoxifen", "is", "as", "effective", "as", "lumpectomy", "followed", "by", "tamoxifen", "plus", "radiation", "therapy", ".", "Between", "July", "1994", "and", "February", "1999", ",", "we", "randomly", "assigned", "636", "women", "who", "were", "70", "years", "of", "age", "or", "older", "and", "who", "had", "clinical", "stage", "I", "(", "T", "1", "N", "0", "M", "0", "according", "to", "the", "tumor", "-", "node", "-", "metastasis", "classification", ")", ",", "estrogen", "-", "receptor", "-", "positive", "breast", "carcinoma", "treated", "by", "lumpectomy", "to", "receive", "tamoxifen", "plus", "radiation", "therapy", "(", "317", "women", ")", "or", "tamoxifen", "alone", "(", "319", "women", ")", ".", "Primary", "end", "points", "were", "the", "time", "to", "local", "or", "regional", "recurrence", ",", "the", "frequency", "of", "mastectomy", "for", "recurrence", ",", "breast", "-", "cancer", "-", "specific", "survival", ",", "the", "time", "to", "distant", "metastasis", ",", "and", "overall", "survival", ".", "The", "only", "significant", "difference", "between", "the", "two", "groups", "was", "in", "the", "rate", "of", "local", "or", "regional", "recurrence", "at", "five", "years", "(", "1", "percent", "in", "the", "group", "given", "tamoxifen", "plus", "irradiation", "and", "4", "percent", "in", "the", "group", "given", "tamoxifen", "alone", ",", "P", "<", "0.001", ")", ".", "There", "were", "no", "significant", "differences", "between", "the", "two", "groups", "with", "regard", "to", "the", "rates", "of", "mastectomy", "for", "local", "recurrence", ",", "distant", "metastases", ",", "or", "five", "-", "year", "rates", "of", "overall", "survival", "(", "87", "percent", "in", "the", "group", "given", "tamoxifen", "plus", "irradiation", "and", "86", "percent", "in", "the", "tamoxifen", "group", ",", "P=", "0.94", ")", ".", "Assessment", "by", "physicians", "and", "patients", "of", "cosmetic", "results", "and", "adverse", "events", "uniformly", "rated", "tamoxifen", "plus", "irradiation", "inferior", "to", "tamoxifen", "alone", ".", "Lumpectomy", "plus", "adjuvant", "therapy", "with", "tamoxifen", "alone", "is", "a", "realistic", "choice", "for", "the", "treatment", "of", "women", "70", "years", "of", "age", "or", "older", "who", "have", "early", ",", "estrogen", "-", "receptor", "-", "positive", "breast", "cancer", "." ]
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951
[ "The", "Possible", "Preventive", "Role", "of", "Pregabalin", "in", "Postmastectomy", "Pain", "Syndrome", ":", "A", "Double", "-", "Blinded", "Randomized", "Controlled", "Trial", ".", "Chronic", "postmastectomy", "pain", "syndrome", "(", "PMPS", ")", "has", "a", "considerable", "negative", "impact", "on", "the", "quality", "of", "life", "of", "breast", "cancer", "patients", ".", "The", "objective", "of", "this", "study", "was", "to", "assess", "the", "possible", "preventive", "role", "of", "perioperative", "pregabalin", "in", "PMPS", ".", "This", "randomized", "controlled", "study", "included", "200", "patients", "with", "breast", "cancer", "scheduled", "for", "elective", "breast", "cancer", "surgery", ".", "They", "were", "randomly", "assigned", "to", "one", "of", "two", "treatment", "groups", ".", "The", "pregabalin", "group", "received", "75", "mg", "of", "pregabalin", "twice", "daily", "for", "seven", "days", "and", "the", "control", "group", "received", "oral", "equivalent", "placebo", "capsules", ".", "The", "primary", "outcome", "was", "development", "of", "neuropathic", "PMPS", ".", "Neuropathic", "pain", "was", "assessed", "using", "the", "Grading", "System", "for", "Neuropathic", "Pain", ".", "Secondary", "outcome", "measures", "were", "safety", "and", "Visual", "Analogue", "Scale", "scores", ".", "Neuropathic", "pain", "was", "significantly", "less", "frequent", "in", "the", "pregabalin", "group", "compared", "to", "the", "control", "group", "at", "four", "weeks", "(", "P", "=", "0.005", ")", ",", "12", "weeks", "(", "P", "=", "0.002", ")", ",", "and", "24", "weeks", "(", "P", "<", "0.001", ")", "postoperatively", ".", "PMPS", "was", "diagnosed", "in", "11", "patients", "(", "11", "%", ")", "of", "the", "pregabalin", "group", "and", "29", "patients", "(", "29", "%", ")", "of", "the", "control", "group", "(", "P", "<", "0.001", ",", "relative", "risk", ":", "0.26", ",", "95", "%", "CI", ":", "0.12", "-", "0.56", ")", ".", "At", "the", "three", "follow", "-", "up", "time", "points", ",", "Visual", "Analogue", "Scale", "scores", "during", "the", "first", "three", "postoperative", "weeks", "were", "comparable", "in", "both", "groups", "while", "they", "were", "significantly", "lower", "in", "the", "pregabalin", "group", "at", "4", ",", "12", ",", "and", "24", "weeks", ".", "These", "two", "groups", "were", "comparable", "in", "the", "frequency", "of", "adverse", "events", "(", "P", "=", "0.552", ")", ".", "Perioperative", "oral", "pregabalin", "75", "mg", "twice", "daily", ",", "starting", "at", "the", "morning", "of", "surgery", "and", "continued", "for", "one", "week", ",", "could", "reduce", "the", "frequency", "of", "postmastectomy", "pain", "syndrome", "." ]
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952
[ "Prospective", "comparison", "of", "peritumoral", "and", "subareolar", "injection", "of", "blue", "dye", "alone", ",", "for", "identification", "of", "sentinel", "lymph", "nodes", "in", "patients", "with", "early", "stage", "breast", "cancer", ".", "Various", "techniques", "are", "used", "for", "the", "identification", "of", "the", "sentinel", "node", "(", "SLN", ")", ".", "We", "prospectively", "compare", "the", "efficacy", "of", "SLN", "biopsy", "and", "the", "number", "of", "SLNs", "identified", ",", "by", "injecting", "methylene", "blue", "(", "MB", ")", "alone", "in", "the", "subareolar", "area", "(", "SA", ")", "or", "peritumorally", "(", "PT", ")", "in", "patients", "with", "early", "stage", "breast", "cancer", ".", "Patients", "were", "randomized", "in", "two", "groups", "(", "SA", "or", "PT", "injection", ")", ".", "A", "linear", "regression", "model", "was", "used", "to", "estimate", "the", "effect", "of", "various", "parameters", "on", "the", "identification", "rate", "and", "on", "the", "number", "of", "SLNs", "retrieved", ".", "At", "least", "one", "SLN", "was", "identified", "in", "61", "of", "66", "(", "92.4", "%", ")", "procedures", "in", "the", "SA", "group", "and", "in", "57", "of", "60", "(", "95", "%", ")", "procedures", "in", "the", "PT", "group", "(", "P", "=", "0.55", ")", ".", "The", "mean", "number", "of", "SLNs", "removed", "with", "the", "SA", "injection", "method", "was", "1.64", "±", "0.6", "nodes", "compared", "with", "2.23", "±", "0.7", "nodes", "identified", "with", "the", "PT", "injection", "(", "range", ":", "1", "-", "4", ",", "P", "<", "0.001", ")", ".", "The", "injection", "site", "was", "the", "only", "factor", "affecting", "the", "number", "of", "SLNs", "retrieved", ".", "The", "use", "of", "MB", "alone", "is", "an", "efficient", "method", "for", "identification", "of", "the", "SLN", ".", "The", "PT", "injection", "route", "yields", "a", "higher", "number", "of", "SLNs", "than", "the", "SA", "route", ",", "comparable", "with", "the", "number", "of", "SLNs", "retrieved", ",", "when", "combined", "tracing", "agents", "and", "multiple", "injection", "sites", "are", "used", "." ]
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953
[ "Red", "meat", ",", "poultry", ",", "and", "fish", "intake", "and", "breast", "cancer", "risk", "among", "Hispanic", "and", "Non", "-", "Hispanic", "white", "women", ":", "The", "Breast", "Cancer", "Health", "Disparities", "Study", ".", "There", "is", "suggestive", "but", "limited", "evidence", "for", "a", "relationship", "between", "meat", "intake", "and", "breast", "cancer", "(", "BC", ")", "risk", ".", "Few", "studies", "included", "Hispanic", "women", ".", "We", "investigated", "the", "association", "between", "meats", "and", "fish", "intake", "and", "BC", "risk", "among", "Hispanic", "and", "NHW", "women", ".", "The", "study", "included", "NHW", "(", "1", ",", "982", "cases", "and", "2", ",", "218", "controls", ")", "and", "the", "US", "Hispanics", "(", "1", ",", "777", "cases", "and", "2", ",", "218", "controls", ")", "from", "two", "population", "-", "based", "case", "-", "control", "studies", ".", "Analyses", "considered", "menopausal", "status", "and", "percent", "Native", "American", "ancestry", ".", "We", "estimated", "pooled", "ORs", "combining", "harmonized", "data", "from", "both", "studies", ",", "and", "study-", "and", "race-", "/", "ethnicity", "-", "specific", "ORs", "that", "were", "combined", "using", "fixed", "or", "random", "effects", "models", ",", "depending", "on", "heterogeneity", "levels", ".", "When", "comparing", "highest", "versus", "lowest", "tertile", "of", "intake", ",", "among", "NHW", "we", "observed", "an", "association", "between", "tuna", "intake", "and", "BC", "risk", "(", "pooled", "OR", "1.25", ";", "95", "%", "CI", "1.05", "-", "1.50", ";", "trend", "p", "=", "0.006", ")", ".", "Among", "Hispanics", ",", "we", "observed", "an", "association", "between", "BC", "risk", "and", "processed", "meat", "intake", "(", "pooled", "OR", "1.42", ";", "95", "%", "CI", "1.18", "-", "1.71", ";", "trend", "p", "<", "0.001", ")", ",", "and", "between", "white", "meat", "(", "OR", "0.80", ";", "95", "%", "CI", "0.67", "-", "0.95", ";", "trend", "p", "=", "0.01", ")", "and", "BC", "risk", ",", "driven", "by", "poultry", ".", "All", "these", "findings", "were", "supported", "by", "meta", "-", "analysis", "using", "fixed", "or", "random", "effect", "models", "and", "were", "restricted", "to", "estrogen", "receptor", "-", "positive", "tumors", ".", "Processed", "meats", "and", "poultry", "were", "not", "associated", "with", "BC", "risk", "among", "NHW", "women", ";", "red", "meat", "and", "fish", "were", "not", "associated", "with", "BC", "risk", "in", "either", "race", "/", "ethnic", "groups", ".", "Our", "results", "suggest", "the", "presence", "of", "ethnic", "differences", "in", "associations", "between", "meat", "and", "BC", "risk", "that", "may", "contribute", "to", "BC", "disparities", "." ]
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954
[ "Efficacy", "of", "prophylactic", "antibiotic", "administration", "for", "breast", "cancer", "surgery", "in", "overweight", "or", "obese", "patients", ":", "a", "randomized", "controlled", "trial", ".", "To", "assess", "the", "impact", "of", "prophylactic", "antibiotics", "on", "the", "prevention", "of", "surgical", "site", "infection", "(", "SSI", ")", "and", "the", "cost", "-", "effectiveness", "of", "this", "prophylaxis", "for", "breast", "cancer", "surgery", "in", "overweight", "or", "obese", "women", ".", "SSI", "is", "higher", "than", "expected", "after", "breast", "surgery", ".", "Obesity", "was", "found", "to", "be", "one", "of", "the", "risk", "factors", ".", "The", "trial", "was", "designed", "as", "a", "phase", "IV", "randomized", ",", "controlled", ",", "parallel", "-", "group", "efficacy", "trial", ".", "It", "was", "conducted", "at", "a", "tertiary", "university", "hospital", ".", "Overweight", "or", "obese", "women", "with", "clinically", "early", "-", "stage", "breast", "cancer", "who", "had", "been", "assigned", "to", "undergo", "surgery", "were", "eligible", ".", "Patients", "were", "randomly", "allocated", "to", "either", "a", "prophylaxis", "or", "a", "control", "group", "by", "using", "a", "computer", "-", "generated", "list", ".", "The", "prophylaxis", "group", "received", "1", "g", "ampicillin", "-", "sulbactam", "intravenously", "at", "anesthesia", ".", "The", "control", "group", "received", "no", "intervention", ".", "Patients", "and", "observers", "were", "blinded", "to", "the", "assignments", ".", "The", "primary", "outcome", "was", "the", "comparison", "of", "SSI", "incidences", "of", "the", "2", "groups", ".", "Patients", "were", "monitored", "for", "30", "days", ".", "A", "total", "of", "369", "patients", "were", "included", "in", "final", "analysis", ",", "out", "of", "which", "187", "were", "allocated", "for", "prophylaxis", "and", "182", "were", "randomly", "assigned", "to", "the", "control", "group", ".", "Analysis", "was", "done", "according", "to", "the", "intention", "-", "to", "-", "treat", "principle", ".", "Prophylaxis", "significantly", "reduced", "the", "SSI", "rate", "(", "4.8", "%", ")", "in", "the", "prophylaxis", "group", "when", "compared", "with", "that", "in", "the", "control", "group", "[", "13.7", "%", ";", "relative", "risk", "(", "RR", ")", "0.35", ";", "95", "%", "CI", ":", "0.17", "-", "0.73", "]", ".", "No", "adverse", "reaction", "was", "observed", ".", "The", "mean", "SSI", "-", "related", "cost", "(", "20.26", "USD", ")", "was", "found", "to", "be", "significantly", "higher", "in", "the", "control", "group", "when", "compared", "with", "that", "(", "8.48", "USD", ")", "in", "the", "prophylaxis", "group", ".", "Antibiotic", "prophylaxis", "significantly", "decreased", "SSI", "incidence", "after", "elective", "surgery", "and", "was", "shown", "to", "be", "cost", "-", "effective", "in", "obese", "breast", "cancer", "patients", ".", "ClinicalTrials.gov", "Identifier", ":", "NCT", "00356148", "." ]
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955
[ "Quality", "of", "life", "under", "extended", "continuous", "versus", "intermittent", "adjuvant", "letrozole", "in", "lymph", "node", "-", "positive", ",", "early", "breast", "cancer", "patients", ":", "the", "SOLE", "randomised", "phase", "3", "trial", ".", "In", "the", "phase", "III", "SOLE", "trial", ",", "the", "extended", "use", "of", "intermittent", "versus", "continuous", "letrozole", "for", "5", "years", "did", "not", "improve", "disease", "-", "free", "survival", "in", "postmenopausal", "women", "with", "hormone", "receptor", "-", "positive", "breast", "cancer", ".", "Intermittent", "therapy", "with", "3", "-month", "breaks", "may", "be", "beneficial", "for", "patients", "'", "quality", "of", "life", "(", "QoL", ")", ".", "In", "the", "SOLE", "QoL", "sub", "-", "study", ",", "956", "patients", "completed", "the", "Breast", "Cancer", "Prevention", "Trial", "(", "BCPT", ")", "symptom", "and", "further", "QoL", "scales", "up", "to", "24", "months", "after", "randomisation", ".", "Differences", "in", "change", "of", "QoL", "from", "baseline", "between", "the", "two", "administration", "schedules", "were", "tested", "at", "12", "and", "24", "months", "using", "repeated", "measures", "mixed", "-", "models", ".", "The", "primary", "outcome", "was", "change", "in", "hot", "flushes", "at", "12", "months", ".", "There", "was", "no", "difference", "in", "hot", "flushes", "at", "12", "months", "between", "the", "two", "schedules", ",", "but", "patients", "receiving", "intermittent", "letrozole", "reported", "significantly", "more", "improvement", "at", "24", "months", ".", "They", "also", "indicated", "less", "worsening", "in", "vaginal", "problems", ",", "musculoskeletal", "pain", ",", "sleep", "disturbance", ",", "physical", "well", "-", "being", "and", "mood", "at", "12", "months", ".", "Overall", ",", "25", "-", "30", "%", "of", "patients", "reported", "a", "clinically", "relevant", "worsening", "in", "key", "symptoms", "and", "global", "QoL", ".", "Less", "symptom", "worsening", "was", "observed", "during", "the", "first", "year", "of", "extended", "treatment", "with", "the", "intermittent", "administration", ".", "For", "women", "experiencing", "an", "increased", "symptom", "burden", "of", "extended", "adjuvant", "endocrine", "therapy", ",", "an", "intermittent", "administration", "is", "a", "safe", "alternative", ".", "Clinical", "trial", "information", ":", "NCT", "00651456", "." ]
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956
[ "Effect", "of", "penehyclidine", "hydrochloride", "on", "the", "incidence", "of", "intra", "-", "operative", "awareness", "in", "Chinese", "patients", "undergoing", "breast", "cancer", "surgery", "during", "general", "anaesthesia", ".", "Intra", "-", "operative", "awareness", "can", "lead", "to", "serious", "adverse", "psychological", "consequences", ".", "We", "conducted", "a", "prospective", ",", "randomised", ",", "double", "-", "blinded", "trial", "in", "920", "patients", "undergoing", "breast", "cancer", "surgery", "under", "bispectral", "index", "-", "guided", "total", "intravenous", "anaesthesia", "to", "evaluate", "the", "effect", "of", "penehyclidine", "hydrochloride", "on", "intra", "-", "operative", "awareness", ".", "Patients", "were", "randomly", "divided", "to", "receive", "0.01", "mg.kg", "(", "-", "1", ")", "penehyclidine", "hydrochloride", "or", "saline", "intravenously", "30", "min", "before", "surgery", ".", "The", "pre", "-", "administration", ",", "pre", "-", "operative", "anxiety", "levels", "were", "assessed", "using", "a", "100", "-mm", "visual", "analogue", "scale", ".", "Intra", "-", "operative", "awareness", "was", "defined", "as", "recall", "of", "intra", "-", "operative", "events", "using", "a", "modified", "Brice", "interview", "administered", "2", "-", "6", "h", "postoperatively", ",", "and", "in", "the", "next", "24", "-", "48", "h.", "A", "committee", "of", "three", "experts", ",", "blinded", "to", "the", "study", "conditions", ",", "independently", "scrutinised", "all", "reported", "recollections", ".", "We", "found", "no", "differences", "in", "depth", "of", "anaesthesia", "and", "patients", "'", "pre", "-", "operative", "anxiety", "levels", "between", "the", "two", "groups", ".", "The", "incidence", "of", "awareness", "with", "penehyclidine", "hydrochloride", "(", "0", "/", "456", "patients", ";", "0", "%", ")", "was", "significantly", "lower", "than", "with", "saline", "(", "5", "/", "452", ";", "1.1", "%", ")", ",", "p", "=", "0.030", ".", "We", "conclude", "that", "penehyclidine", "hydrochloride", "reduced", "the", "incidence", "of", "intra", "-", "operative", "awareness", "in", "patients", "undergoing", "breast", "cancer", "surgery", "during", "general", "anaesthesia", "." ]
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957
[ "A", "randomised", "phase", "II", "study", "of", "two", "different", "schedules", "of", "pegylated", "liposomal", "doxorubicin", "in", "metastatic", "breast", "cancer", "(", "EORTC-", "10993", ")", ".", "One", "hundred", "and", "sixteen", "women", "with", "measurable", "metastatic", "breast", "cancer", "participated", "in", "a", "randomised", "phase", "II", "study", "of", "single", "agent", "liposomal", "pegylated", "doxorubicin", "(", "Caelyx", ")", "given", "either", "as", "a", "60", "mg", "/", "m", "2", "every", "6", "weeks", "(", "ARM", "A", ")", "or", "50", "mg", "/", "m", "2", "every", "4", "weeks", "(", "ARM", "B", ")", "schedule", ".", "Patients", "were", "over", "65", "years", "of", "age", "or", ",", "if", "younger", ",", "had", "refused", "or", "been", "unsuitable", "for", "standard", "anthracyclines", ".", "The", "aims", "of", "the", "study", "were", "to", "evaluate", "toxicity", "and", "dose", "delivery", "with", "the", "two", "schedules", "and", "obtain", "further", "information", "on", "the", "response", "rate", "of", "liposomal", "pegylated", "doxorubicin", "as", "a", "single", "agent", "in", "anthracycline", "nai", "ve", "advanced", "breast", "cancer", ".", "Twenty", "-", "six", "patients", "had", "received", "prior", "adjuvant", "chemotherapy", "(", "including", "an", "anthracycline", "in", "10", ")", ".", "Sixteen", "had", "received", "non", "-", "anthracycline", "-", "based", "first", "-", "line", "chemotherapy", "for", "advanced", "disease", ".", "One", "hundred", "and", "eleven", "patients", "were", "evaluable", "for", "toxicity", "and", "106", "for", "response", ".", "The", "delivered", "dose", "intensity", "(", "DI", ")", "was", "9.8", "mg", "/", "m", "2", "(", "95", "%", "CI", ",", "7.2", "-", "10.4", ")", "with", "37", "(", "69", "%", ")", "achieving", "a", "DI", "of", ">", "90", "%", "on", "ARM", "A", "and", "11.9", "mg", "/", "m", "2", "(", "95", "%", "CI", ",", "7.5", "-", "12.8", ")", "with", "37", "(", "65", "%", ")", "achieving", "a", "DI", "of", ">", "90", "%", "on", "ARM", "B", ".", "The", "adverse", "event", "profiles", "of", "the", "two", "schedules", "were", "distinctly", "different", ".", "Mucositis", "was", "more", "common", "with", "the", "every", "6", "weeks", "regimen", "(", "35", "%", "CTC", "grade", "3", "/", "4", "in", "ARM", "A", ",", "14", "%", "in", "ARM", "B", ")", "but", "palmar", "plantar", "erythrodysesthesia", "(", "PPE", ")", "was", "more", "frequent", "with", "the", "every", "4", "weeks", "regimen", "(", "2", "%", "CTC", "grade", "3", "/", "4", "in", "ARM", "A", ",", "16", "%", "in", "ARM", "B", ")", ".", "Confirmed", "objective", "partial", "responses", "by", "RECIST", "criteria", "were", "seen", "with", "both", "schedules", ";", "15", "/", "51", "(", "29", "%", ")", "on", "ARM", "A", "and", "17", "/", "56", "(", "31", "%", ")", "on", "ARM", "B", ".", "Liposomal", "pegylated", "doxorubicin", "showed", "significant", "activity", "in", "advanced", "breast", "cancer", "with", "a", "generally", "favourable", "side", "-", "effect", "profile", ".", "The", "high", "frequency", "of", "stomatitis", "seen", "with", "6", "weekly", "treatment", "makes", "this", "the", "less", "preferred", "of", "the", "two", "schedules", "tested", "." ]
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958
[ "Comparison", "of", "the", "sentinel", "node", "procedure", "between", "patients", "with", "multifocal", "and", "unifocal", "breast", "cancer", "in", "the", "EORTC", "10981", "-", "22023", "AMAROS", "Trial", ":", "identification", "rate", "and", "nodal", "outcome", ".", "Multifocal", "breast", "cancer", "is", "associated", "with", "a", "higher", "risk", "of", "nodal", "involvement", "compared", "to", "unifocal", "breast", "cancer", "and", "the", "drainage", "pattern", "from", "multifocal", "localisations", "may", "be", "different", ".", "For", "this", "reason", ",", "the", "value", "of", "the", "sentinel", "node", "biopsy", "(", "SNB", ")", "procedure", "for", "this", "indication", "is", "debated", ".", "The", "aim", "of", "the", "current", "analysis", "was", "to", "evaluate", "the", "sentinel", "node", "identification", "rate", "and", "nodal", "involvement", "in", "patients", "with", "a", "multifocal", "tumour", "in", "the", "EORTC", "10981", "-", "22023", "AMAROS", "trial", ".", "From", "the", "first", "4000", "registered", "patients", ",", "342", "were", "identified", "with", "a", "multifocal", "tumour", "on", "histological", "examination", "and", "compared", "to", "a", "randomly", "selected", "control", "group", "of", "684", "patients", "with", "a", "unifocal", "tumour", ".", "The", "outcome", "of", "the", "SNB", "was", "assessed", ".", "The", "sentinel", "node", "was", "identified", "in", "96", "%", "of", "the", "patients", "with", "a", "multifocal", "tumour", "and", "in", "98", "%", "of", "those", "with", "unifocal", "disease", ".", "In", "the", "multifocal", "group", ",", "51", "%", "had", "a", "metastasis", "in", "the", "sentinel", "node", "compared", "to", "28", "%", "in", "the", "unifocal", "group", ";", "and", "further", "nodal", "involvement", "after", "a", "positive", "sentinel", "node", "was", "found", "in", "40", "%", "(", "38", "/", "95", ")", "and", "39", "%", "(", "39", "/", "101", ")", "respectively", ".", "In", "this", "prospective", "international", "multicentre", "study", ",", "the", "96", "%", "detection", "rate", "indicates", "that", "the", "SNB", "procedure", "can", "be", "highly", "effective", "in", "patients", "with", "a", "multifocal", "tumour", ".", "Though", "the", "tumour", "-", "positive", "rate", "of", "the", "sentinel", "node", "was", "twice", "as", "high", "in", "the", "multifocal", "group", "compared", "to", "the", "unifocal", "group", ",", "further", "nodal", "involvement", "after", "a", "positive", "sentinel", "node", "was", "similar", "in", "both", "groups", ".", "This", "suggests", "that", "the", "SNB", "procedure", "is", "safe", "in", "patients", "with", "multifocal", "breast", "cancer", "." ]
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959
[ "Preliminary", "results", "on", "safety", "and", "activity", "of", "a", "randomized", ",", "double", "-", "blind", ",", "2", "x", "2", "trial", "of", "low", "-", "dose", "tamoxifen", "and", "fenretinide", "for", "breast", "cancer", "prevention", "in", "premenopausal", "women", ".", "To", "determine", "whether", "low", "-", "dose", "tamoxifen", "and", "fenretinide", "have", "a", "synergistic", "effect", "on", "surrogate", "biomarkers", ",", "including", "circulating", "insulin", "-", "like", "growth", "factor", "I", "(", "IGF", "-", "I", ")", "and", "mammographic", "density", ",", "in", "premenopausal", "women", "at", "risk", "for", "breast", "cancer", "and", "to", "study", "drug", "safety", ".", "Premenopausal", "women", "(", "n", "=", "235", ")", "were", "randomly", "assigned", "in", "a", "double", "-", "blind", "four", "-", "arm", "trial", "to", "receive", "tamoxifen", "5", "mg", "/", "d", ",", "fenretinide", "200", "mg", "/", "d", ",", "both", "agents", ",", "or", "placebo", "for", "2", "years", ".", "The", "present", "analysis", "refers", "to", "preliminary", "data", "on", "safety", ",", "IGF", "-", "I", ",", "and", "breast", "cancer", "events", ".", "Patients", "were", "included", "if", "they", "had", "an", "excised", "ductal", "carcinoma", "-", "in", "-", "situ", "(", "57", "%", ")", ",", "lobular", "carcinoma", "-", "in", "-", "situ", "(", "13", "%", ")", ",", "minimal", "invasive", "breast", "cancer", "(", "7", "%", ")", ",", "or", "a", "5", "-year", "Gail", "risk", ">", "or", "=", "1.3", "%", "(", "23", "%", ")", ".", "After", "a", "median", "follow", "-", "up", "of", "40", "months", ",", "there", "was", "a", "reduction", "of", "13", "%", ",", "2", "%", ",", "20", "%", ",", "and", "1", "%", "in", "IGF", "-", "I", "levels", "for", "patients", "on", "tamoxifen", ",", "fenretinide", ",", "tamoxifen", "plus", "fenretinide", ",", "and", "placebo", ",", "respectively", ".", "Recruitment", "was", "stopped", "based", "on", "the", "lack", "of", "an", "interaction", "on", "IGF", "-", "I", "levels", ",", "which", "was", "a", "primary", "end", "point", "for", "the", "study", ".", "Thirty", "-", "six", "patients", "have", "dropped", "out", "of", "the", "study", ",", "17", "because", "of", "adverse", "events", "and", "19", "for", "various", "other", "reasons", ".", "One", "stage", "I", "endometrial", "cancer", "occurred", "in", "a", "patient", "on", "fenretinide", ",", "and", "one", "optic", "nerve", "ischemia", "and", "one", "deep", "venous", "thrombosis", "occurred", "on", "tamoxifen", ".", "There", "was", "no", "difference", "in", "menopausal", "symptoms", ",", "endometrial", "thickness", ",", "polyps", ",", "or", "ovarian", "cysts", "among", "treatment", "arms", ".", "To", "date", ",", "24", "breast", "cancers", "have", "been", "observed", ",", "without", "differences", "among", "arms", ".", "The", "combination", "of", "low", "-", "dose", "tamoxifen", "and", "fenretinide", "is", "safe", "but", "not", "synergistic", "in", "lowering", "IGF", "-", "I", "levels", "in", "premenopausal", "women", ".", "The", "clinical", "implications", "require", "further", "follow", "-", "up", "." ]
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960
[ "Patient", "-", "Reported", "Outcomes", "Predict", "Progression", "-", "Free", "Survival", "of", "Patients", "with", "Advanced", "Breast", "Cancer", "Treated", "with", "Abemaciclib", ".", "Abemaciclib", "is", "a", "CDK", "4", "/", "6", "inhibitor", "used", "to", "treat", "hormone", "receptor", "-", "positive", ",", "human", "epidermal", "growth", "factor", "receptor", "2", "-negative", "advanced", "breast", "cancer", ".", "The", "prognostic", "value", "of", "patient", "-", "reported", "outcomes", "(", "PROs", ")", "has", "been", "minimally", "explored", "for", "treatment", "outcomes", "with", "CDK", "4", "/", "6", "inhibitors", ".", "The", "performance", "of", "PROs", "compared", "with", "Eastern", "Cooperative", "Oncology", "Group", "performance", "status", "(", "ECOG", "-", "PS", ")", "is", "unknown", ".", "This", "study", "pooled", "data", "from", "single", "-", "arm", "trial", ",", "MONARCH", "1", ",", "and", "randomized", "trials", ",", "MONARCH", "2", "and", "3", ".", "In", "total", ",", "900", "patients", "initiated", "abemaciclib", "and", "384", "comparator", "therapy", ".", "Pretreatment", "PRO", "association", "with", "progression", "-", "free", "survival", "(", "PFS", ")", "was", "modeled", "using", "Cox", "proportional", "hazards", "regression", ".", "Prediction", "performance", "was", "assessed", "via", "the", "C", "-", "statistic", "(", "c", ")", ".", "PROs", "were", "recorded", "via", "the", "European", "Organisation", "for", "Research", "and", "Treatment", "of", "Cancer", "QLQ", "-", "C", "30", ".", "Patient", "-", "reported", "physical", "function", ",", "pain", ",", "role", "function", ",", "fatigue", ",", "and", "appetite", "loss", "were", "associated", "with", "PFS", "on", "univariable", "and", "adjusted", "analysis", "(", "p", "<", ".", "05", ")", ".", "Physical", "function", "(", "c", "=", "0.55", ")", "was", "most", "predictive", ",", "superior", "to", "ECOG", "-", "PS", "(", "c", "=", "0.54", ")", ",", "with", "multivariable", "analysis", "indicating", "both", "provide", "independent", "information", "(", "p", "<", ".", "02", ")", ".", "In", "the", "pooled", "randomized", "arms", "of", "MONARCH", "2", "and", "3", ",", "the", "PFS", "treatment", "benefit", "(", "hazard", "ratio", "[", "95", "%", "confidence", "interval", "]", ")", "of", "abemaciclib", "(", "vs.", "comparators", ")", "was", "0.75", "(", "0.57", "-", "1.0", ")", "for", "low", "physical", "function", ",", "compared", "with", "0.48", "(", "0.40", "-", "0.59", ")", "for", "intermediate", "/", "high", "(", "p[interaction", "]", "=", ".", "01", ")", ".", "PROs", "were", "identified", "as", "prognostic", "factors", "for", "PFS", "in", "patients", "initiating", "abemaciclib", ",", "with", "patient", "-", "reported", "physical", "function", "containing", "independent", "predictive", "information", "beyond", "ECOG", "-", "PS", ".", "Low", "physical", "function", "was", "associated", "with", "a", "decrease", "in", "the", "magnitude", "of", "PFS", "benefit", "from", "abemaciclib", ".", "PROs", "should", "be", "explored", "as", "prognostic", ",", "predictive", ",", "and", "stratification", "factors", "for", "clinical", "use", "and", "research", "trials", "of", "CDK", "4", "/", "6", "inhibitors", ".", "For", "the", "first", "time", ",", "pretreatment", "patient", "-", "reported", "outcomes", "have", "been", "shown", "to", "be", "independent", "prognostic", "markers", "for", "progression", "-", "free", "survival", "(", "PFS", ")", "in", "patients", "diagnosed", "with", "hormone", "receptor", "-", "positive", ",", "human", "epidermal", "growth", "factor", "receptor", "2", "-negative", "(", "HR+", "/", "HER", "2", "-", ")", "advanced", "breast", "cancer", "treated", "with", "abemaciclib", ".", "Importantly", ",", "patients", "with", "low", "physical", "function", "had", "a", "smaller", "PFS", "benefit", "from", "abemaciclib", "(", "vs.", "comparator", ")", "than", "patients", "with", "intermediate", "/", "high", "physical", "function", ".", "The", "present", "study", "demonstrates", "patient", "-", "reported", "outcomes", "as", "a", "simple", ",", "effective", ",", "inexpensive", ",", "and", "independent", "prognostic", "marker", "for", "patients", "with", "HR+", "/", "HER", "2", "-", "advanced", "breast", "cancer", "treated", "with", "abemaciclib", "." ]
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961
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962
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963
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964
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965
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966
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967
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968
[ "Pooled", "analysis", "of", "two", "randomized", ",", "double", "-", "blind", "trials", "comparing", "proposed", "biosimilar", "LA", "-", "EP", "2006", "with", "reference", "pegfilgrastim", "in", "breast", "cancer", ".", "Following", "the", "functional", "and", "physicochemical", "characterization", "of", "a", "proposed", "biosimilar", ",", "comparative", "clinical", "studies", "help", "to", "confirm", "biosimilarity", "by", "demonstrating", "similar", "safety", "and", "efficacy", "to", "the", "reference", "product", "in", "a", "sensitive", "patient", "population", ".", "LA", "-", "EP", "2006", "is", "a", "proposed", "biosimilar", "that", "has", "been", "developed", "for", "pegfilgrastim", ",", "a", "long", "-", "acting", "form", "of", "granulocyte", "colony", "-", "stimulating", "factor", "for", "the", "prevention", "of", "neutropenia", ".", "The", "current", "analysis", "reports", "data", "pooled", "from", "two", "independent", ",", "multinational", ",", "prospective", ",", "randomized", ",", "controlled", ",", "double", "-", "blind", "phase", "III", "studies", "of", "similar", "design", "comparing", "the", "safety", "and", "efficacy", "of", "reference", "pegfilgrastim", "with", "LA", "-", "EP", "2006", "in", "patients", "with", "breast", "cancer", "receiving", "myelotoxic", "(", "neo", ")", "adjuvant", "TAC", "(", "docetaxel", ",", "doxorubicin", ",", "and", "cyclophosphamide", ")", "chemotherapy", "and", "requiring", "granulocyte", "colony", "-", "stimulating", "factor", ".", "A", "total", "of", "624", "patients", "were", "randomized", "in", "the", "PROTECT-", "1", "and", "PROTECT-", "2", "studies", "(", "NCT", "01735175", ";", "NCT", "01516736", ")", "(", "LA", "-", "EP", "2006", ":", "n", "=", "314", ";", "reference", ":", "n", "=", "310", ")", ".", "Baseline", "characteristics", "of", "patients", "were", "well", "balanced", "across", "treatment", "groups", ".", "The", "primary", "end", "point", ",", "mean", "duration", "of", "severe", "neutropenia", "in", "the", "first", "chemotherapy", "cycle", "was", "similar", "in", "both", "the", "LA", "-", "EP", "2006", "and", "reference", "groups", "(", "1.05", "±", "1.055", "days", "versus", "1.01", "±", "0.958", "days", ")", ",", "with", "a", "treatment", "difference", "of", "-", "0.04", "days", "[", "95", "%", "confidence", "interval", "(", "CI", ")", ":", "-", "0.19", "to", "0.11", "]", "that", "met", "the", "equivalence", "criteria", "(", "the", "95", "%", "CI", "were", "within", "the", "defined", "margin", "of", "±", "1", "day", ")", ".", "Secondary", "end", "points", ",", "such", "as", "the", "nadir", "of", "absolute", "neutrophil", "count", "and", "the", "incidence", "of", "febrile", "neutropenia", ",", "were", "also", "similar", "between", "LA", "-", "EP", "2006", "and", "reference", "pegfilgrastim", ".", "The", "safety", "and", "tolerability", "profile", "of", "LA", "-", "EP", "2006", "was", "similar", "to", "that", "observed", "with", "reference", "pegfilgrastim", ",", "and", "there", "were", "no", "reports", "of", "neutralizing", "antibodies", ".", "This", "pooled", "analysis", "confirms", ",", "as", "a", "part", "of", "totality", "of", "evidence", "approach", ",", "that", "the", "proposed", "biosimilar", "pegfilgrastim", "LA", "-", "EP", "2006", "has", "a", "comparable", "efficacy", "and", "safety", "profile", "to", "reference", "pegfilgrastim", "in", "patients", "with", "breast", "cancer", "receiving", "TAC", "chemotherapy", ".", "NCT", "01735175", "and", "NCT", "01516736", "." ]
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969
[ "Clinical", "effects", "of", "shenqi", "fuzheng", "injection", "in", "the", "neoadjuvant", "chemotherapy", "for", "local", "advanced", "breast", "cancer", "and", "the", "effects", "on", "T", "-", "lymphocyte", "subsets", ".", "To", "evaluate", "clinical", "effects", "of", "shenqi", "fuzheng", "Injection", "(", "[", "Chinese", "characters", ":", "see", "text", "]", ")", "in", "the", "neoadjuvant", "chemotherapy", "for", "local", "advanced", "breast", "cancer", "and", "the", "effects", "on", "T", "-", "lymphocyte", "subsets", ".", "During", "the", "period", "from", "2000", "to", "2005", ",", "126", "patients", "with", "local", "advanced", "breast", "cancer", "were", "treated", "with", "the", "neoadjuvant", "chemotherapy", ".", "They", "were", "randomly", "divided", "into", "the", "following", "two", "groups", ":", "a", "control", "group", "of", "61", "cases", "treated", "by", "chemotherapy", "alone", "and", "a", "study", "group", "of", "65", "cases", "treated", "by", "chemotherapy", "plus", "shenqi", "fuzheng", "injection", ".", "All", "the", "cases", "of", "both", "groups", "were", "given", "the", "CEF", "(", "CTX", "500", "mg", "/", "m", "2", ",", "d", "1", ",", "8", ";", "EPI", "40", "mg", "/", "m", "2", ",", "d", "1", ",", "8", ";", "and", "5", "-Fu", "500", "mg", "/", "m", "2", "d", "1", ",", "8", ")", "regimen", ".", "The", "clinical", "effects", ",", "the", "effects", "on", "T", "-", "lymphocyte", "subgroup", "and", "NK", "cells", ",", "and", "the", "toxic", "side", "effects", "were", "observed", ".", "All", "the", "patients", "completed", "two", "cycles", "of", "the", "chemotherapy", ",", "and", "the", "efficacy", "and", "the", "toxic", "side", "effects", "were", "evaluated", ".", "For", "the", "primary", "tumor", "in", "the", "breast", ",", "the", "total", "effective", "rate", "was", "69.2", "%", "(", "45", "/", "65", ")", "in", "the", "study", "group", "and", "49.2", "%", "(", "30", "/", "61", ")", "in", "the", "control", "group", "with", "a", "statistically", "significant", "difference", "in", "the", "intergroup", "comparison", "(", "chi", "2", "=", "5.251", ",", "P", "=", "0.022", ",", "<", "0.05", ")", ".", "There", "was", "no", "progression", "of", "the", "disease", "in", "both", "the", "groups", ",", "and", "there", "were", "no", "grade", "IV", "toxic", "side", "effects", "in", "the", "two", "groups", ".", "The", "major", "toxic", "responses", "were", "myelosuppression", "and", "gastrointestinal", "reaction", ",", "which", "were", "milder", "in", "the", "study", "group", "than", "the", "control", "group", ",", "and", "with", "a", "shorter", "recovery", "course", "in", "the", "former", "than", "the", "latter", ".", "Besides", ",", "an", "obvious", "rise", "of", "the", "T", "-", "lymphocyte", "subgroup", "and", "NK", "cells", "was", "found", "in", "the", "study", "group", "after", "the", "neoadjuvant", "chemotherapy", ",", "with", "a", "very", "significant", "difference", "from", "the", "controls", "(", "P", "<", "0.01", ")", ".", "Shenqi", "fuzheng", "Injection", "can", "improve", "and", "regulate", "immune", "function", "of", "the", "patients", "with", "local", "advanced", "breast", "cancer", "given", "the", "neoadjuvant", "chemotherapy", ",", "and", "therefore", "it", "can", "enhance", "the", "curative", "effect", "and", "reduce", "the", "side", "effect", "as", "well", "." ]
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970
[ "Quality", "of", "Life", "in", "a", "Randomized", "Breast", "Cancer", "Prevention", "Trial", "of", "Low", "-", "Dose", "Tamoxifen", "and", "Fenretinide", "in", "Premenopausal", "Women", ".", "Menopausal", "symptoms", "are", "the", "main", "reason", "for", "withdrawal", "in", "tamoxifen", "prevention", "trials", ".", "Here", ",", "we", "present", "Menopause", "Quality", "of", "Life", "(", "MenQoL", ")", "assessment", "within", "a", "randomized", "2", "×", "2", "phase", "II", "clinical", "trial", "of", "low", "-", "dose", "tamoxifen", "and", "the", "synthetic", "retinoid", "fenretinide", ".", "A", "total", "of", "235", "premenopausal", "women", "at", "higher", "risk", "for", "breast", "cancer", "were", "randomized", "to", "either", "tamoxifen", "5", "mg", "daily", ",", "fenretinide", "200", "mg", "daily", ",", "their", "combination", ",", "or", "placebo", ".", "Climacteric", "symptoms", "were", "investigated", "using", "the", "MenQoL", "questionnaire", "which", "was", "self", "-", "administered", "at", "each", "visit", "for", "2", "years", "of", "treatment", "and", "for", "1", "year", "of", "follow", "-", "up", ".", "CYP", "2", "D", "6", "was", "genotyped", "in", "subjects", "taking", "tamoxifen", "to", "study", "the", "association", "with", "menopausal", "symptoms", ".", "The", "MenQoL", "effect", "size", "analysis", "showed", "no", "statistically", "significant", "difference", "among", "the", "four", "treatment", "arms", "for", "all", "four", "domains", "(", "vasomotor", ",", "physical", ",", "psychosocial", ",", "and", "sexual", ")", ".", "Vasomotor", "symptoms", "only", "slightly", "increased", "under", "tamoxifen", ",", "with", "a", "score", "at", "year", "two", "of", "1.45", ",", "1.21", ",", "0.58", ",", "and", "1.17", "in", "the", "combined", ",", "tamoxifen", ",", "fenretinide", ",", "and", "placebo", "arms", ",", "respectively", ".", "Compared", "with", "the", "slow", "metabolizers", ",", "a", "higher", "percentage", "of", "subjects", "with", "CYP", "2", "D", "6", "extensive", "metabolizer", "genotype", "complained", "of", "a", "≥", "3", "score", "in", "the", "vasomotor", ",", "psychosocial", ",", "and", "sexual", "domain", "in", "the", "tamoxifen", "arms", "(", "P", "value", "=", "0.01", ",", "0.007", ",", "and", "0.007", ",", "respectively", ")", ".", "QoL", "in", "premenopausal", "or", "perimenopausal", "women", "was", "not", "significantly", "worsened", "by", "low", "-", "dose", "tamoxifen", "or", "fenretinide", ".", "Our", "findings", "suggest", "that", "a", "low", "dose", "of", "tamoxifen", "may", "increase", "its", "acceptability", "for", "breast", "cancer", "prevention", "." ]
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971
[ "Carvedilol", "for", "Prevention", "of", "Chemotherapy", "-", "Related", "Cardiotoxicity", ":", "The", "CECCY", "Trial", ".", "Anthracycline", "(", "ANT", ")", "chemotherapy", "is", "associated", "with", "cardiotoxicity", ".", "Prevention", "with", "β", "-", "blockers", "remains", "controversial", ".", "This", "prospective", ",", "randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "study", "sought", "to", "evaluate", "the", "role", "of", "carvedilol", "in", "preventing", "ANT", "cardiotoxicity", ".", "The", "authors", "randomized", "200", "patients", "with", "HER", "2", "-", "negative", "breast", "cancer", "tumor", "status", "and", "normal", "left", "ventricular", "ejection", "fraction", "(", "LVEF", ")", "referred", "for", "ANT", "(", "240", "mg", "/", "m", "2", ")", "to", "receive", "carvedilol", "or", "placebo", "until", "chemotherapy", "completion", ".", "The", "primary", "endpoint", "was", "prevention", "of", "a", "≥", "10", "%", "reduction", "in", "LVEF", "at", "6", "months", ".", "Secondary", "outcomes", "were", "effects", "of", "carvedilol", "on", "troponin", "I", ",", "B", "-", "type", "natriuretic", "peptide", ",", "and", "diastolic", "dysfunction", ".", "Primary", "endpoint", "occurred", "in", "14", "patients", "(", "14.5", "%", ")", "in", "the", "carvedilol", "group", "and", "13", "patients", "(", "13.5", "%", ")", "in", "the", "placebo", "group", "(", "p", "=", "1.0", ")", ".", "No", "differences", "in", "changes", "of", "LVEF", "or", "B", "-", "type", "natriuretic", "peptide", "were", "noted", "between", "groups", ".", "A", "significant", "difference", "existed", "between", "groups", "in", "troponin", "I", "levels", "over", "time", ",", "with", "lower", "levels", "in", "the", "carvedilol", "group", "(", "p", "=", "0.003", ")", ".", "Additionally", ",", "a", "lower", "incidence", "of", "diastolic", "dysfunction", "was", "noted", "in", "the", "carvedilol", "group", "(", "p", "=", "0.039", ")", ".", "A", "nonsignificant", "trend", "toward", "a", "less", "-", "pronounced", "increase", "in", "LV", "end", "-", "diastolic", "diameter", "during", "the", "follow", "-", "up", "was", "noted", "in", "the", "carvedilol", "group", "(", "44.1", "±", "3.64", "mm", "to", "45.2", "±", "3.2", "mm", "vs.", "44.9", "±", "3.6", "mm", "to", "46.4", "±", "4.0", "mm", ";", "p", "=", "0.057", ")", ".", "In", "this", "largest", "clinical", "trial", "of", "β", "-", "blockers", "for", "prevention", "of", "cardiotoxicity", "under", "contemporary", "ANT", "dosage", ",", "the", "authors", "noted", "a", "13.5", "%", "to", "14.5", "%", "incidence", "of", "cardiotoxicity", ".", "In", "this", "scenario", ",", "carvedilol", "had", "no", "impact", "on", "the", "incidence", "of", "early", "onset", "of", "LVEF", "reduction", ".", "However", ",", "the", "use", "of", "carvedilol", "resulted", "in", "a", "significant", "reduction", "in", "troponin", "levels", "and", "diastolic", "dysfunction", ".", "(", "Carvedilol", "Effect", "in", "Preventing", "Chemotherapy", "-", "Induced", "Cardiotoxicity", "[", "CECCY", "]", ";", "NCT", "01724450", ")", "." ]
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972
[ "Twenty", "-", "year", "follow", "-", "up", "of", "a", "randomized", "study", "comparing", "breast", "-", "conserving", "surgery", "with", "radical", "mastectomy", "for", "early", "breast", "cancer", ".", "We", "conducted", "20", "years", "of", "follow", "-", "up", "of", "women", "enrolled", "in", "a", "randomized", "trial", "to", "compare", "the", "efficacy", "of", "radical", "(", "Halsted", ")", "mastectomy", "with", "that", "of", "breast", "-", "conserving", "surgery", ".", "From", "1973", "to", "1980", ",", "701", "women", "with", "breast", "cancers", "measuring", "no", "more", "than", "2", "cm", "in", "diameter", "were", "randomly", "assigned", "to", "undergo", "radical", "mastectomy", "(", "349", "patients", ")", "or", "breast", "-", "conserving", "surgery", "(", "quadrantectomy", ")", "followed", "by", "radiotherapy", "to", "the", "ipsilateral", "mammary", "tissue", "(", "352", "patients", ")", ".", "After", "1976", ",", "patients", "in", "both", "groups", "who", "had", "positive", "axillary", "nodes", "also", "received", "adjuvant", "chemotherapy", "with", "cyclophosphamide", ",", "methotrexate", ",", "and", "fluorouracil", ".", "Thirty", "women", "in", "the", "group", "that", "underwent", "breast", "-", "conserving", "therapy", "had", "a", "recurrence", "of", "tumor", "in", "the", "same", "breast", ",", "whereas", "eight", "women", "in", "the", "radical", "-", "mastectomy", "group", "had", "local", "recurrences", "(", "P", "<", "0.001", ")", ".", "The", "crude", "cumulative", "incidence", "of", "these", "events", "was", "8.8", "percent", "and", "2.3", "percent", ",", "respectively", ",", "after", "20", "years", ".", "In", "contrast", ",", "there", "was", "no", "significant", "difference", "between", "the", "two", "groups", "in", "the", "rates", "of", "contralateral", "-", "breast", "carcinomas", ",", "distant", "metastases", ",", "or", "second", "primary", "cancers", ".", "After", "a", "median", "follow", "-", "up", "of", "20", "years", ",", "the", "rate", "of", "death", "from", "all", "causes", "was", "41.7", "percent", "in", "the", "group", "that", "underwent", "breast", "-", "conserving", "surgery", "and", "41.2", "percent", "in", "the", "radical", "-", "mastectomy", "group", "(", "P=", "1.0", ")", ".", "The", "respective", "rates", "of", "death", "from", "breast", "cancer", "were", "26.1", "percent", "and", "24.3", "percent", "(", "P=", "0.8", ")", ".", "The", "long", "-", "term", "survival", "rate", "among", "women", "who", "undergo", "breast", "-", "conserving", "surgery", "is", "the", "same", "as", "that", "among", "women", "who", "undergo", "radical", "mastectomy", ".", "Breast", "-", "conserving", "surgery", "is", "therefore", "the", "treatment", "of", "choice", "for", "women", "with", "relatively", "small", "breast", "cancers", "." ]
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973
[ "Identification", "and", "Preservation", "of", "Arm", "Lymphatic", "System", "in", "Axillary", "Dissection", "for", "Breast", "Cancer", "to", "Reduce", "Arm", "Lymphedema", "Events", ":", "A", "Randomized", "Clinical", "Trial", ".", "Controversy", "in", "axillary", "reverse", "mapping", "in", "axillary", "lymph", "node", "dissection", "(", "ALND", ")", "possibly", "results", "from", "incomplete", "recognition", "of", "the", "arm", "lymphatic", "system", "(", "ALS", ")", "and", "its", "compromise", "to", "oncological", "safety", ".", "The", "iDEntification", "and", "Preservation", "of", "ARm", "lymphaTic", "system", "(", "DEPART", ")", "technique", "facilitates", "complete", "identification", "of", "ALS", ";", "therefore", ",", "its", "use", "may", "decrease", "the", "occurrence", "of", "arm", "lymphedema", ".", "This", "study", "aimed", "to", "examine", "the", "arm", "lymphedema", "rate", ",", "locoregional", "recurrence", ",", "and", "feasibility", "to", "perform", "DEPART", "in", "ALND", ".", "Patients", "from", "February", "2013", "to", "October", "2017", "from", "two", "tertiary", "referral", "centers", "were", "randomly", "assigned", "to", "two", "groups", ".", "In", "the", "study", "group", ",", "indocyanine", "green", "and", "methylene", "blue", "(", "MB", ")", "were", "utilized", "to", "identify", "arm", "sentinel", "nodes", ",", "and", "0.1", "ml", "MB", "was", "injected", "into", "the", "arm", "sentinel", "nodes", "to", "reveal", "the", "subsequent", "-", "echelon", "nodes", "and", "lymphatics", ".", "Gross", "arm", "lymph", "nodes", "were", "examined", "by", "intraoperative", "partial", "frozen", "section", "and", "were", "removed", "if", "positive", ".", "Arm", "lymphedema", ",", "local", "recurrence", ",", "regional", "recurrence", ",", "and", "distant", "metastasis", "were", "recorded", "at", "different", "follow", "-", "up", "examinations", ".", "Arm", "sentinel", "nodes", "were", "identified", "in", "573", "(", "83.2", "%", ")", "patients", ".", "Subsequent", "-", "echelon", "nodes", "and", "lymphatics", "were", "visualized", "in", "558", "(", "97.4", "%", ")", "patients", ".", "Metastatic", "arm", "nodes", "were", "identified", "in", "38", "(", "6.8", "%", ")", "patients", ".", "The", "arm", "lymphedema", "rate", "was", "3.3", "%", "(", "18", "/", "543", ")", "in", "the", "study", "group", "versus", "15.3", "%", "(", "99", "/", "648", ")", "in", "the", "control", "group", "(", "p", "<", "0.001", ")", "after", "37", "-month", "median", "follow", "-", "up", ".", "Regional", "recurrence", "showed", "no", "difference", "between", "the", "two", "groups", "(", "1.4", "%", "and", "1.2", "%", ",", "respectively", ")", "(", "p", "=", "0.392", ")", ".", "DEPART", "can", "benefit", "breast", "cancer", "patients", "who", "undergo", "ALND", ",", "reducing", "the", "arm", "lymphedema", "rate", "without", "adversely", "affecting", "the", "morbidity", "of", "regional", "recurrence", "." ]
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974
[ "Treatment", "patterns", "and", "clinical", "outcomes", "among", "patients", "receiving", "palbociclib", "in", "combination", "with", "an", "aromatase", "inhibitor", "or", "fulvestrant", "for", "HR+", "/", "HER", "2", "-", "negative", "advanced", "/", "metastatic", "breast", "cancer", "in", "real", "-", "world", "settings", "in", "the", "US", ":", "Results", "from", "the", "IRIS", "study", ".", "Palbociclib", "is", "a", "selective", "cyclin", "-", "dependent", "kinase", "(", "CDK", ")", "4", "/", "6", "inhibitor", "approved", "for", "use", "in", "postmenopausal", "women", "with", "hormone", "receptor", "-", "positive", ",", "human", "epidermal", "growth", "factor", "2", "-negative", "(", "HR+", "/", "HER", "2", "-", ")", "advanced", "/", "metastatic", "breast", "cancer", "(", "ABC", "/", "MBC", ")", ".", "Palbociclib", "has", "proven", "benefits", "in", "phase", "III", "placebo", "-", "controlled", "studies", ";", "however", ",", "real", "-", "world", "outcome", "data", "are", "lacking", ".", "The", "Ibrance", "Real", "World", "Insights", "(", "IRIS", ")", "study", "evaluated", "palbociclib", "use", "in", "patients", "with", "HR+", "/", "HER", "2", "-", "ABC", "/", "MBC", "in", "the", "real", "-", "world", "setting", "in", "the", "US", ",", "Argentina", ",", "and", "Germany", ".", "Here", "we", "describe", "results", "for", "the", "US", "patient", "subgroup", ".", "IRIS", "was", "a", "retrospective", "medical", "chart", "review", "study", "of", "patients", "with", "confirmed", "HR+", "/", "HER", "2", "-", "ABC", "/", "MBC", "who", "received", "palbociclib", "with", "either", "an", "aromatase", "inhibitor", "(", "AI", ")", "as", "initial", "endocrine", "-", "based", "therapy", "in", "postmenopausal", "women", "or", "fulvestrant", "-", "based", "therapy", "in", "women", "with", "disease", "progression", "following", "endocrine", "therapy", ".", "Physicians", "extracted", "data", "from", "patient", "medical", "records", "for", "≤", "16", "sequential", "patients", "each", ".", "Outcomes", "included", "progression", "-", "free", "and", "survival", "rates", ".", "Records", "were", "extracted", "for", "652", "patients", ":", "360", "(", "55.2", "%", ")", "treated", "with", "palbociclib", "+", "AI", "and", "292", "(", "44.8", "%", ")", "treated", "with", "palbociclib", "+", "fulvestrant", ".", "The", "12", "-month", "progression", "-", "free", "rate", "was", "84.1", "%", "for", "patients", "treated", "with", "palbociclib", "+", "AI", "and", "79.8", "%", "for", "those", "treated", "with", "palbociclib", "+", "fulvestrant", ";", "12", "-month", "survival", "rates", "were", "95.1", "%", "for", "palbociclib", "+", "AI", "and", "87.9", "%", "for", "palbociclib", "+", "fulvestrant", ".", "In", "this", "first", "real", "-", "world", "assessment", "of", "clinical", "outcomes", "in", "US", "patients", "with", "HR+", "/", "HER-", "ABC", "/", "MBC", ",", "treatment", "with", "palbociclib", "in", "combination", "with", "AI", "or", "fulvestrant", "demonstrated", "favorable", "effectiveness", "in", "terms", "of", "progression", "-", "free", "and", "survival", "rates", ".", "Ongoing", "studies", "are", "needed", "to", "deliver", "mature", "clinical", "outcome", "data", "beyond", "12", "/", "24", "months", "in", "the", "real", "-", "world", "setting", "." ]
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975
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976
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977
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978
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979
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980
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981
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982
[ "Preventing", "weight", "gain", "in", "African", "American", "breast", "cancer", "survivors", "using", "smart", "scales", "and", "activity", "trackers", ":", "a", "randomized", "controlled", "pilot", "study", ".", "This", "study", "evaluated", "the", "feasibility", "and", "preliminary", "efficacy", "of", "two", "6", "-month", ",", "self", "-", "regulation", "interventions", "that", "focused", "on", "daily", "self", "-", "weighing", "(", "DSW", ")", "and", "used", "objective", "monitoring", "and", "tailored", "feedback", "about", "weight", "(", "±activity", ")", ",", "to", "prevent", "weight", "gain", "among", "African", "American", "breast", "cancer", "survivors", ".", "Participants", "(", "n", "=", "35", ")", "were", "randomized", "to", "an", "intervention", "+", "activity", "monitoring", "(", "INT+", ")", ",", "intervention", "(", "INT", ")", ",", "or", "control", "(", "CON", ")", "group", ".", "Interventions", "included", "a", "wireless", "scale", "(", "±activity", "tracker", ")", "that", "transmitted", "objective", "data", "to", "a", "mobile", "app", "/", "website", ",", "emailed", "lessons", ",", "and", "tailored", "feedback", "based", "on", "objective", "weight", "(", "±activity", "data", ")", ".", "Participants", "completed", "in", "-", "person", "and", "online", "assessments", "at", "baseline", ",", "3", "months", ",", "and", "6", "months", ".", "Ninety", "-", "four", "percent", "of", "participants", "completed", "assessments", "at", "3", "months", ",", "and", "97", "%", "at", "6", "months", ".", "Median", "(", "IQR", ")", "weight", "change", "after", "6", "months", "was", "-", "0.9", "%", "(", "-", "4.4", "-", "0.1", ")", "in", "the", "INT+", "(", "p", "=", "0.075", ";", "p", "=", "0.067", "vs.", "CON", ")", "and", "-", "0.2", "%", "(", "-", "4.2", "-", "1.3", ")", "in", "the", "INT", "groups", "(", "p", "=", "0.463", ";", "p", "=", "0.357", "vs.", "CON", ")", ",", "versus", "a", "0.2", "%", "(", "-", "0.7", "-", "1.7", ")", "gain", "in", "the", "CON", "group", ".", "The", "proportion", "of", "INT+", ",", "INT", ",", "and", "CON", "participants", "that", "were", "at", "or", "below", "baseline", "weight", "was", "72.7", ",", "53.8", ",", "and", "45.5", "%", ",", "respectively", "(", "effect", "sizes", "d", "=", "0.64", ",", "d", "=", "0.18", ")", ".", "Most", "INT+", "participants", "weighed", "and", "wore", "trackers", "≥", "5", "days", "/", "week", "(", "INT+", ",", "81.9", "%", "vs.", "INT", ",", "38.5", "%", "vs.", "CON", ",", "0", "%", ";", "p", "<", "0.0005", ";", "INT+", ",", "72.7", "%", ")", ".", "Both", "intervention", "groups", "perceived", "DSW", "as", "positive", ",", "and", "100", "%", "would", "recommend", "the", "program", "to", "other", "breast", "cancer", "survivors", ".", "An", "intervention", "focused", "on", "DSW", "as", "a", "self", "-", "monitoring", "strategy", "shows", "promise", "for", "preventing", "weight", "gain", "in", "breast", "cancer", "survivors", ".", "Daily", "self", "-", "monitoring", "of", "weight", "and", "activity", "may", "be", "a", "feasible", "and", "accessible", "approach", "to", "promote", "weight", "gain", "prevention", "in", "breast", "cancer", "survivors", ".", "ClinicalTrials.gov", ",", "NCT", "02030353", "." ]
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983
[ "De", "-", "escalation", "strategies", "in", "HER", "2", "-", "positive", "early", "breast", "cancer", "(", "EBC", ")", ":", "final", "analysis", "of", "the", "WSG", "-", "ADAPT", "HER", "2", "+", "/", "HR-", "phase", "II", "trial", ":", "efficacy", ",", "safety", ",", "and", "predictive", "markers", "for", "12", "weeks", "of", "neoadjuvant", "dual", "blockade", "with", "trastuzumab", "and", "pertuzumab", "±", "weekly", "paclitaxel", ".", "Response", "rates", "in", "HER", "2", "-", "overexpressing", "EBC", "treated", "with", "neoadjuvant", "chemotherapy", "and", "trastuzumab", "(", "T", ")", "have", "been", "improved", "by", "addition", "of", "pertuzumab", "(", "P", ")", ".", "The", "prospective", ",", "phase", "II", ",", "neoadjuvant", "WSG", "-", "ADAPT", "HER", "2", "+", "/", "HR-", "trial", "assessed", "whether", "patients", "with", "strong", "early", "response", "to", "dual", "blockade", "alone", "might", "achieve", "pathological", "complete", "response", "(", "pCR", ")", "comparable", "to", "that", "of", "patients", "receiving", "dual", "blockade", "and", "chemotherapy", ".", "Female", "patients", "with", "HER", "2", "+", "/", "HR-", "EBC", "(", "M", "0", ")", "were", "randomized", "(", "5", ":", "2", ")", "to", "12", "weeks", "of", "T", "+", "P", "±", "weekly", "paclitaxel", "(", "pac", ")", "at", "80", "mg", "/", "m", "2", ".", "Early", "response", "was", "defined", "as", "proliferation", "decrease", "≥", "30", "%", "of", "Ki-", "67", "(", "versus", "baseline", ")", "or", "low", "cellularity", "(", "<", "500", "invasive", "tumor", "cells", ")", "in", "the", "3", "-week", "biopsy", ".", "The", "trial", "was", "designed", "to", "test", "non", "-", "inferiority", "for", "pCR", "in", "early", "responding", "patients", "of", "the", "T", "+", "P", "arm", "versus", "all", "chemotherapy", "-", "treated", "patients", ".", "From", "February", "2014", "to", "December", "2015", ",", "160", "patients", "were", "screened", ",", "92", "were", "randomized", "to", "T", "+", "P", "and", "42", "to", "T", "+", "P+pac", ".", "Baseline", "characteristics", "were", "well", "balanced", "(", "median", "age", "54", "versus", "51.5", "years", ",", "cT", "2", "51.1", "versus", "52.4", "%", ",", "cN", "0", "54.3", "versus", "61.9", "%", ")", ";", "91.3", "%", "of", "patients", "completed", "T", "+", "P", "per", "protocol", "and", "92.9", "%", "T", "+", "P+pac", ".", "The", "pCR", "rate", "in", "the", "T", "+", "P+pac", "arm", "was", "90.5", "%", ",", "compared", "with", "36.3", "%", "in", "the", "T", "+", "P", "arm", "as", "a", "whole", ".", "In", "the", "T", "+", "P", "arm", ",", "24", "/", "92", "were", "classified", "as", "non", "-", "responders", ",", "and", "their", "pCR", "rate", "was", "only", "8.3", "%", "compared", "with", "44.7", "%", "in", "responders", "(", "38", "/", "92", ")", "and", "42.9", "%", "in", "patients", "with", "unclassified", "early", "response", "(", "30", "/", "92", ")", ".", "No", "new", "safety", "signals", "were", "observed", "in", "the", "study", "population", ".", "Addition", "of", "taxane", "monotherapy", "to", "dual", "HER", "2", "blockade", "in", "a", "12", "-week", "neoadjuvant", "setting", "substantially", "increases", "pCR", "rates", "in", "HER", "2", "+", "/", "HR-", "EBC", "compared", "with", "dual", "blockade", "alone", ",", "even", "within", "early", "responders", "to", "dual", "blockade", ".", "Early", "non", "-", "response", "under", "dual", "blockade", "strongly", "predicts", "failure", "to", "achieve", "pCR", "." ]
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984
[ "Radioguided", "localization", "of", "nonpalpable", "breast", "cancer", "lesions", ":", "randomized", "comparison", "with", "wire", "localization", "in", "patients", "undergoing", "conservative", "surgery", "and", "sentinel", "node", "biopsy", ".", "The", "aim", "of", "this", "investigation", "was", "to", "determine", "whether", "radioguided", "occult", "lesion", "localization", "and", "routine", "wire", "localization", "differ", "in", "respect", "to", "the", "effectiveness", "of", "complete", "excision", "of", "nonpalpable", "breast", "cancer", "lesions", ".", "This", "prospective", "randomized", "study", "included", "patients", "with", "breast", "cancer", "scheduled", "for", "conservative", "tumor", "excision", "and", "sentinel", "node", "biopsy", ".", "Patients", "were", "randomized", "to", "either", "radioguided", "localization", "or", "wire", "localization", ".", "Comparative", "radiologic", ",", "surgical", ",", "and", "pathologic", "data", "were", "collected", "and", "analyzed", "to", "establish", "the", "duration", ",", "ease", "of", "use", ",", "and", "accuracy", "of", "the", "two", "techniques", "for", "occult", "lesion", "localization", ".", "The", "effectiveness", "of", "sentinel", "node", "biopsy", "also", "was", "assessed", ".", "One", "radiologist", "and", "two", "surgeons", "participated", "in", "the", "study", ".", "Among", "134", "patients", ",", "68", "were", "treated", "with", "wire", "localization", "and", "66", "with", "radioguided", "localization", ".", "The", "mean", "duration", "of", "radiologic", "localization", "was", "significantly", "shorter", "for", "radioguided", "localization", "(", "p", "<", "0.001", ")", ".", "No", "statistical", "differences", "were", "found", "for", "the", "other", "parameters", "studied", ".", "Radiography", "of", "the", "surgical", "specimen", "showed", "100", "%", "lesion", "excision", "with", "both", "techniques", ".", "Complete", "tumor", "excision", "with", "tumor", "-", "free", "margins", "was", "achieved", "in", "89.4", "%", "of", "patients", "who", "underwent", "radioguided", "localization", "group", "and", "82.4", "%", "of", "patients", "who", "underwent", "wire", "localization", ".", "Pathologic", "examination", "showed", "the", "excised", "tissue", "volume", "was", "slightly", "larger", "(", "p", "=", "0.371", ")", "and", "lesion", "concentricity", "slightly", "less", "(", "p", "=", "0.730", ")", "with", "radioguided", "localization", ".", "The", "sentinel", "node", "detection", "rate", "was", "91", "%", "with", "radioguided", "localization", "and", "84", "%", "with", "wire", "localization", ".", "The", "radioguided", "technique", "is", "as", "effective", "as", "the", "standard", "wire", "technique", "for", "localization", "and", "excision", "of", "nonpalpable", "breast", "cancer", "lesions", "and", "is", "somewhat", "faster", "and", "simpler", "to", "perform", "than", "wire", "localization", "." ]
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985
[ "Hydrosorb", "®", "versus", "control", "(", "water", "based", "spray", ")", "in", "the", "management", "of", "radio", "-", "induced", "skin", "toxicity", ":", "Results", "of", "multicentre", "controlled", "randomized", "trial", ".", "To", "report", "the", "efficacy", "of", "Hydrosorb", "®", "versus", "control", "(", "water", "based", "spray", ")", "as", "topical", "treatment", "of", "grade", "1", "-", "2", "radiodermatitis", "in", "patients", "(", "pts", ")", "treated", "for", "early", "stage", "breast", "cancer", "(", "BC", ")", "with", "normo", "fractionated", "radiotherapy", "(", "RT", ")", ".", "BC", "pts", "were", "randomized", "to", "receive", "either", "Hydrosorb", "®", "(", "A", ")", "or", "water", "based", "spray", "(", "B", ")", ".", "The", "primary", "endpoint", "was", "local", "treatment", "failure", "defined", "as", "interruption", "of", "RT", "because", "of", "skin", "radiotoxicity", "or", "change", "of", "local", "care", "because", "of", "skin", "alteration", ".", "Secondary", "endpoints", "were", ":", "evaluation", "of", "skin", "colorimetry", ",", "pain", ",", "quality", "of", "life", ".", "Two", "-", "hundred", "seventy", "-", "eight", "pts", "were", "enrolled", ".", "There", "were", "186", "successfully", "treated", "pts", ".", "There", "were", "60", "\"", "failures", "\"", "in", "the", "Hydrosorb", "®", "arm", ",", "and", "62", "in", "the", "control", "arm", "(", "p=", "0.72", ")", ",", "but", "mostly", "without", "interruption", "of", "the", "RT", ".", "Twenty", "-", "four", "pts", "stopped", "RT", "for", "local", "care", ".", "The", "average", "absolute", "reduction", "of", "colorimetric", "levels", "between", "day", "28", "and", "day", "0", "was", "4", "in", "the", "Hydrosorb", "®", ",", "and", "4.2", "in", "the", "water", "spray", "groups", ",", "respectively", "(", "p=", "0.36", ")", ".", "Forty", "-", "eight", "patients", "in", "the", "Hydrosorb", "®", "arm", "had", "a", "VAS", ">", "2", "versus", "51", "pts", "in", "the", "placebo", "arm", ",", "i.e.", "34", "%", "and", "38", "%", ",", "respectively", "(", "p=", "0.45", ")", ".", "A", "significant", "reduction", "of", "pain", "was", "observed", "on", "D", "7", "and", "D", "21", "in", "the", "Hydrosorb", "®", "arm", ".", "The", "present", "study", "showed", "no", "significant", "difference", "between", "Hydrosorb", "®", "and", "simple", "water", "spray", "in", "the", "treatment", "of", "acute", "radio", "-", "induced", "dermatitis", "even", "if", "there", "was", "a", "trend", "to", "an", "improvement", "in", "pain", "at", "the", "first", "weeks", "after", "the", "treatment", ".", "Systematic", "prevention", "measures", "and", "modern", "breast", "cancer", "radiotherapy", "techniques", "now", "allow", "excellent", "tolerability", ",", "but", "the", "place", "of", "topical", "treatment", "to", "optimize", "this", "tolerability", "has", "yet", "to", "be", "defined", ".", "It", "seems", "that", "the", "most", "important", "part", "of", "the", "skin", "care", "is", "the", "prevention", "of", "skin", "reactions", "using", "new", "adapted", "techniques", ",", "as", "well", "as", "strict", "hygiene", "." ]
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986
[ "\"", "Tumour", "marker", "guided", "\"", "salvage", "treatment", "prolongs", "survival", "of", "breast", "cancer", "patients", ":", "final", "report", "of", "a", "7", "-year", "study", ".", "Randomised", "trials", "on", "breast", "cancer", "showed", "no", "significant", "benefit", "from", "post", "-", "operative", "follow", "-", "up", "with", "clinical", "and/or", "conventional", "radiological", "means", ".", "We", "hypothesised", "that", "carcinoembryonic", "antigen", "(", "CEA", ")", ",", "tissue", "polipeptyde", "antigen", "(", "TPA", ")", ",", "breast", "cancer", "associated", "antigen", "115", "D", "8", "/", "DF", "3", "(", "CA", "15.3", ")", "tumour", "marker", "panel", "is", "sensitive", "enough", "for", "significantly", "anticipating", "salvage", "treatment", "and", "prolonging", "survival", "of", "relapsing", "breast", "cancer", "patients", ".", "From", "October", "1981", "to", "May", "1999", ",", "68", "(", "62", "%", ")", "of", "109", "patients", "with", "distant", "metastases", "were", "recruited", ".", "Thirty", "-", "six", "(", "53", "%", ")", "received", "salvage", "treatment", "at", "the", "time", "of", "significant", "increase", "in", "one", "or", "more", "components", "of", "CEA", "-", "TPA", "-", "CA", "15.3", "tumour", "marker", "panel", "and", "negative", "instrumental", "examinations", "(", "\"", "tumour", "marker", "guided", "\"", "treatment", ")", "and", "32", "(", "47", "%", ")", "were", "treated", "only", "after", "radiological", "confirmation", "of", "metastases", "(", "conventional", "treatment", ")", ".", "The", "prognostic", "factors", "of", "the", "two", "groups", "did", "not", "show", "any", "statistically", "significant", "difference", ".", "The", "time", "from", "one", "or", "more", "tumour", "marker", "increase", "to", "clear", "clinical", "and/or", "radiological", "signs", "of", "distant", "metastases", "(", "lead", "time", ")", "was", "significantly", "prolonged", "in", "the", "36", "patients", "with", "\"", "tumour", "marker", "guided", "\"", "treatment", "(", "17.3", "+", "/-", "13.1", "vs.", "2.9", "+", "/-", "2.9", "months", ",", "P", "<", "0.001", ",", "Wilcoxon", "test", ")", "as", "well", "as", "the", "survival", "curves", "from", "salvage", "therapy", "and", "from", "mastectomy", "(", "the", "proportion", "of", "survivors", "was", ":", "at", "36", "months", "from", "salvage", "therapy", "28", "%", "vs.", "9", "%", ",", "P", "=", "0.0094", ";", "at", "84", "months", "from", "mastectomy", "42", "%", "vs.", "19", "%", ",", "P", "=", "0.0017", ")", ".", "The", "multivariate", "Cox", "analysis", "showed", "that", "time", "from", "mastectomy", "to", "tumour", "marker", "increase", "and", "\"", "tumour", "marker", "guided", "\"", "salvage", "treatment", "were", "the", "only", "significantly", "different", "variables", "(", "P", "=", "0.00001", "and", "0.005", ",", "respectively", ")", ".", "These", "data", "point", "out", "that", "\"", "tumour", "marker", "guided", "\"", "salvage", "treatment", "significantly", "prolongs", "disease", "-", "free", "and", "overall", "survivals", "of", "relapsing", "responsive", "patients", "." ]
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987
[ "Decision", "aid", "on", "breast", "cancer", "screening", "reduces", "attendance", "rate", ":", "results", "of", "a", "large", "-", "scale", ",", "randomized", ",", "controlled", "study", "by", "the", "DECIDEO", "group", ".", "Controversies", "regarding", "the", "benefits", "of", "breast", "cancer", "screening", "programs", "have", "led", "to", "the", "promotion", "of", "new", "strategies", "taking", "into", "account", "individual", "preferences", ",", "such", "as", "decision", "aid", ".", "The", "aim", "of", "this", "study", "was", "to", "assess", "the", "impact", "of", "a", "decision", "aid", "leaflet", "on", "the", "participation", "of", "women", "invited", "to", "participate", "in", "a", "national", "breast", "cancer", "screening", "program", ".", "This", "Randomized", ",", "multicentre", ",", "controlled", "trial", ".", "Women", "aged", "50", "to", "74", "years", ",", "were", "randomly", "assigned", "to", "receive", "either", "a", "decision", "aid", "or", "the", "usual", "invitation", "letter", ".", "Primary", "outcome", "was", "the", "participation", "rate", "12", "months", "after", "the", "invitation", ".", "16", "000", "women", "were", "randomized", "and", "15", "844", "included", "in", "the", "modified", "intention", "-", "to", "-", "treat", "analysis", ".", "The", "participation", "rate", "in", "the", "intervention", "group", "was", "40.25", "%", "(", "3174", "/", "7885", "women", ")", "compared", "with", "42.13", "%", "(", "3353", "/", "7959", ")", "in", "the", "control", "group", "(", "p", "=", "0.02", ")", ".", "Previous", "attendance", "for", "screening", "(", "RR", "=", "6.24", ";", "[", "95", "%", "IC", ":", "5.75", "-", "6.77", "]", ";", "p", "<", "0.0001", ")", "and", "medium", "household", "income", "(", "RR", "=", "1.05", ";", "[", "95", "%", "IC", ":", "1.01", "-", "1.09", "]", ";", "p", "=", "0.0074", ")", "were", "independently", "associated", "with", "attendance", "for", "screening", ".", "This", "large", "-", "scale", "study", "demonstrates", "that", "the", "decision", "aid", "reduced", "the", "participation", "rate", ".", "The", "decision", "aid", "activate", "the", "decision", "making", "process", "of", "women", "toward", "non", "-", "attendance", "to", "screening", ".", "These", "results", "show", "the", "importance", "of", "promoting", "informed", "patient", "choices", ",", "especially", "when", "those", "choices", "can", "not", "be", "anticipated", "." ]
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988
[ "The", "cyclin", "-", "dependent", "kinase", "4", "/", "6", "inhibitor", "palbociclib", "in", "combination", "with", "letrozole", "versus", "letrozole", "alone", "as", "first", "-", "line", "treatment", "of", "oestrogen", "receptor", "-", "positive", ",", "HER", "2", "-", "negative", ",", "advanced", "breast", "cancer", "(", "PALOMA-", "1", "/", "TRIO-", "18", ")", ":", "a", "randomised", "phase", "2", "study", ".", "Palbociclib", "(", "PD-", "0332991", ")", "is", "an", "oral", ",", "small", "-", "molecule", "inhibitor", "of", "cyclin", "-", "dependent", "kinases", "(", "CDKs", ")", "4", "and", "6", "with", "preclinical", "evidence", "of", "growth", "-", "inhibitory", "activity", "in", "oestrogen", "receptor", "-", "positive", "breast", "cancer", "cells", "and", "synergy", "with", "anti", "-", "oestrogens", ".", "We", "aimed", "to", "assess", "the", "safety", "and", "efficacy", "of", "palbociclib", "in", "combination", "with", "letrozole", "as", "first", "-", "line", "treatment", "of", "patients", "with", "advanced", ",", "oestrogen", "receptor", "-", "positive", ",", "HER", "2", "-", "negative", "breast", "cancer", ".", "In", "this", "open", "-", "label", ",", "randomised", "phase", "2", "study", ",", "postmenopausal", "women", "with", "advanced", "oestrogen", "receptor", "-", "positive", "and", "HER", "2", "-", "negative", "breast", "cancer", "who", "had", "not", "received", "any", "systemic", "treatment", "for", "their", "advanced", "disease", "were", "eligible", "to", "participate", ".", "Patients", "were", "enrolled", "in", "two", "separate", "cohorts", "that", "accrued", "sequentially", ":", "in", "cohort", "1", ",", "patients", "were", "enrolled", "on", "the", "basis", "of", "their", "oestrogen", "receptor", "-", "positive", "and", "HER", "2", "-", "negative", "biomarker", "status", "alone", ",", "whereas", "in", "cohort", "2", "they", "were", "also", "required", "to", "have", "cancers", "with", "amplification", "of", "cyclin", "D", "1", "(", "CCND", "1", ")", ",", "loss", "of", "p", "16", "(", "INK", "4", "A", "or", "CDKN", "2", "A", ")", ",", "or", "both", ".", "In", "both", "cohorts", ",", "patients", "were", "randomly", "assigned", "1", ":1", "via", "an", "interactive", "web", "-", "based", "randomisation", "system", ",", "stratified", "by", "disease", "site", "and", "disease", "-", "free", "interval", ",", "to", "receive", "continuous", "oral", "letrozole", "2.5", "mg", "daily", "or", "continuous", "oral", "letrozole", "2.5", "mg", "daily", "plus", "oral", "palbociclib", "125", "mg", ",", "given", "once", "daily", "for", "3", "weeks", "followed", "by", "1", "week", "off", "over", "28", "-day", "cycles", ".", "The", "primary", "endpoint", "was", "investigator", "-", "assessed", "progression", "-", "free", "survival", "in", "the", "intention", "-", "to", "-", "treat", "population", ".", "Accrual", "to", "cohort", "2", "was", "stopped", "after", "an", "unplanned", "interim", "analysis", "of", "cohort", "1", "and", "the", "statistical", "analysis", "plan", "for", "the", "primary", "endpoint", "was", "amended", "to", "a", "combined", "analysis", "of", "cohorts", "1", "and", "2", "(", "instead", "of", "cohort", "2", "alone", ")", ".", "The", "study", "is", "ongoing", "but", "closed", "to", "accrual", ";", "these", "are", "the", "results", "of", "the", "final", "analysis", "of", "progression", "-", "free", "survival", ".", "The", "study", "is", "registered", "with", "the", "ClinicalTrials", ".", "gov", ",", "number", "NCT", "00721409", ".", "Between", "Dec", "22", ",", "2009", ",", "and", "May", "12", ",", "2012", ",", "we", "randomly", "assigned", "165", "patients", ",", "84", "to", "palbociclib", "plus", "letrozole", "and", "81", "to", "letrozole", "alone", ".", "At", "the", "time", "of", "the", "final", "analysis", "for", "progression", "-", "free", "survival", "(", "median", "follow", "-", "up", "29.6", "months", "[", "95", "%", "CI", "27.9", "-", "36.0", "]", "for", "the", "palbociclib", "plus", "letrozole", "group", "and", "27.9", "months", "[", "25.5", "-", "31.1", "]", "for", "the", "letrozole", "group", ")", ",", "41", "progression", "-", "free", "survival", "events", "had", "occurred", "in", "the", "palbociclib", "plus", "letrozole", "group", "and", "59", "in", "the", "letrozole", "group", ".", "Median", "progression", "-", "free", "survival", "was", "10.2", "months", "(", "95", "%", "CI", "5.7", "-", "12.6", ")", "for", "the", "letrozole", "group", "and", "20.2", "months", "(", "13.8", "-", "27.5", ")", "for", "the", "palbociclib", "plus", "letrozole", "group", "(", "HR", "0.488", ",", "95", "%", "CI", "0.319", "-", "0.748", ";", "one", "-", "sided", "p=", "0.0004", ")", ".", "In", "cohort", "1", "(", "n=", "66", ")", ",", "median", "progression", "-", "free", "survival", "was", "5.7", "months", "(", "2.6", "-", "10.5", ")", "for", "the", "letrozole", "group", "and", "26.1", "months", "(", "11.2", "-not", "estimable", ")", "for", "the", "palbociclib", "plus", "letrozole", "group", "(", "HR", "0.299", ",", "0.156", "-", "0.572", ";", "one", "-", "sided", "p", "<", "0.0001", ")", ";", "in", "cohort", "2", "(", "n=", "99", ")", ",", "median", "progression", "-", "free", "survival", "was", "11.1", "months", "(", "7.1", "-", "16.4", ")", "for", "the", "letrozole", "group", "and", "18.1", "months", "(", "13.1", "-", "27.5", ")", "for", "the", "palbociclib", "plus", "letrozole", "group", "(", "HR", "0.508", ",", "0.303", "-", "0.853", ";", "one", "-", "sided", "p=", "0.0046", ")", ".", "Grade", "3", "-", "4", "neutropenia", "was", "reported", "in", "45", "(", "54", "%", ")", "of", "83", "patients", "in", "the", "palbociclib", "plus", "letrozole", "group", "versus", "one", "(", "1", "%", ")", "of", "77", "patients", "in", "the", "letrozole", "group", ",", "leucopenia", "in", "16", "(", "19", "%", ")", "versus", "none", ",", "and", "fatigue", "in", "four", "(", "4", "%", ")", "versus", "one", "(", "1", "%", ")", ".", "Serious", "adverse", "events", 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992
[ "Paclitaxel", "improves", "the", "prognosis", "in", "estrogen", "receptor", "negative", "inflammatory", "breast", "cancer", ":", "the", "M", ".", "D", ".", "Anderson", "Cancer", "Center", "experience", ".", "The", "treatment", "of", "inflammatory", "breast", "cancer", "includes", "preoperative", "anthracycline", "-", "based", "chemotherapy", ",", "surgery", ",", "and", "radiation", "therapy", ".", "In", "the", "past", "few", "years", ",", "taxanes", ",", "mainly", "paclitaxel", ",", "have", "been", "frequently", "used", "for", "preoperative", "chemotherapy", ",", "usually", "in", "sequence", "with", "anthracyclines", ".", "The", "purpose", "of", "this", "retrospective", "analysis", "was", "to", "determine", "how", "adding", "paclitaxel", "to", "anthracycline", "-", "based", "regimens", "affects", "prognosis", ".", "A", "total", "of", "240", "patients", "treated", "in", "6", "consecutive", "trials", "between", "1973", "and", "2000", "were", "included", "in", "the", "analysis", ".", "Group", "1", "(", "N", "=", "178", ")", "consisted", "of", "patients", "treated", "in", "the", "first", "4", "trials", "(", "1973", "-", "1993", ")", "with", "FAC", "(", "5", "-fluorouracil", "/", "doxorubicin", "/", "cyclophosphamide", ")", "based", "regimens", ".", "Group", "2", "(", "N", "=", "62", ")", "consisted", "of", "patients", "treated", "in", "the", "last", "2", "trials", "(", "1994", "-", "2000", ")", "with", "FAC", "followed", "by", "paclitaxel", "given", "every", "3", "weeks", "or", "given", "in", "a", "high", "-", "dose", "weekly", "schedule", ".", "The", "2", "groups", "differed", "with", "respect", "to", "median", "follow", "-", "up", "durations", ",", "which", "were", "148", "months", "(", "range", ",", "85", "-", "283", "months", ")", "in", "group", "1", "and", "45", "months", "(", "range", ",", "21", "-", "99", "months", ")", "in", "group", "2", ".", "Estrogen", "receptor", "(", "ER", ")", "status", "was", "negative", "in", "58", "cases", "(", "33", "%", ")", "in", "group", "1", "and", "40", "cases", "(", "65", "%", ")", "in", "group", "2", ".", "There", "was", "no", "difference", "in", "median", "age", "between", "the", "groups", ".", "The", "objective", "response", "rates", "(", "complete", "and", "partial", ")", "were", "similar", "(", "group", "1", ",", "74", "%", ";", "group", "2", ",", "82", "%", ")", ".", "The", "median", "overall", "survival", "(", "OS", ")", "and", "progression", "-", "free", "survival", "(", "PFS", ")", "were", "better", "in", "the", "patients", "treated", "with", "paclitaxel", ",", "and", "these", "differences", "reached", "statistical", "significance", "in", "the", "patients", "with", "ER", "-", "negative", "disease", "(", "median", "OS", ":", "group", "1", ",", "32", "months", ";", "group", "2", ",", "54", "months", ";", "P", "=", "0.03", ";", "median", "PFS", ":", "group", "1", ",", "18", "months", ";", "group", "2", ",", "27", "months", ";", "P", "=", "0.04", ")", ".", "It", "may", "be", "concluded", "that", "the", "addition", "of", "paclitaxel", "to", "anthracycline", "-", "based", "therapy", "resulted", "in", "a", "statistically", "significant", "improvement", "in", "outcome", "in", "patients", "with", "ER", "-", "negative", "inflammatory", "breast", "cancer", "." ]
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993
[ "Phase", "III", "randomized", "trial", "of", "Calendula", "officinalis", "compared", "with", "trolamine", "for", "the", "prevention", "of", "acute", "dermatitis", "during", "irradiation", "for", "breast", "cancer", ".", "The", "effectiveness", "of", "nonsteroid", "topical", "agents", "for", "the", "prevention", "of", "acute", "dermatitis", "during", "adjuvant", "radiotherapy", "for", "breast", "carcinoma", "has", "not", "been", "demonstrated", ".", "The", "goal", "of", "this", "study", "was", "to", "compare", "the", "effectiveness", "of", "calendula", "(", "Pommade", "au", "Calendula", "par", "Digestion", ";", "Boiron", "Ltd", ",", "Levallois", "-", "Perret", ",", "France", ")", "with", "that", "of", "trolamine", "(", "Biafine", ";", "Genmedix", "Ltd", ",", "France", ")", ",", "which", "is", "considered", "in", "many", "institutions", "to", "be", "the", "reference", "topical", "agent", ".", "Between", "July", "1999", "and", "June", "2001", ",", "254", "patients", "who", "had", "been", "operated", "on", "for", "breast", "cancer", "and", "who", "were", "to", "receive", "postoperative", "radiation", "therapy", "were", "randomly", "allocated", "to", "application", "of", "either", "trolamine", "(", "128", "patients", ")", "or", "calendula", "(", "126", "patients", ")", "on", "the", "irradiated", "fields", "after", "each", "session", ".", "The", "primary", "end", "point", "was", "the", "occurrence", "of", "acute", "dermatitis", "of", "grade", "2", "or", "higher", ".", "Prognostic", "factors", ",", "including", "treatment", "modalities", "and", "patient", "characteristics", ",", "were", "also", "investigated", ".", "Secondary", "end", "points", "were", "the", "occurrence", "of", "pain", ",", "the", "quantity", "of", "topical", "agent", "used", ",", "and", "patient", "satisfaction", ".", "The", "occurrence", "of", "acute", "dermatitis", "of", "grade", "2", "or", "higher", "was", "significantly", "lower", "(", "41", "%", "v", "63", "%", ";", "P", "<", ".", "001", ")", "with", "the", "use", "of", "calendula", "than", "with", "trolamine", ".", "Moreover", ",", "patients", "receiving", "calendula", "had", "less", "frequent", "interruption", "of", "radiotherapy", "and", "significantly", "reduced", "radiation", "-", "induced", "pain", ".", "Calendula", "was", "considered", "to", "be", "more", "difficult", "to", "apply", ",", "but", "self", "-", "assessed", "satisfaction", "was", "greater", ".", "Body", "mass", "index", "and", "adjuvant", "chemotherapy", "before", "radiotherapy", "after", "lumpectomy", "were", "significant", "prognostic", "factors", "for", "acute", "dermatitis", ".", "Calendula", "is", "highly", "effective", "for", "the", "prevention", "of", "acute", "dermatitis", "of", "grade", "2", "or", "higher", "and", "should", "be", "proposed", "for", "patients", "undergoing", "postoperative", "irradiation", "for", "breast", "cancer", "." ]
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994
[ "Risk", "-", "adapted", "targeted", "intraoperative", "radiotherapy", "versus", "whole", "-", "breast", "radiotherapy", "for", "breast", "cancer", ":", "5", "-year", "results", "for", "local", "control", "and", "overall", "survival", "from", "the", "TARGIT", "-", "A", "randomised", "trial", ".", "The", "TARGIT", "-", "A", "trial", "compared", "risk", "-", "adapted", "radiotherapy", "using", "single", "-", "dose", "targeted", "intraoperative", "radiotherapy", "(", "TARGIT", ")", "versus", "fractionated", "external", "beam", "radiotherapy", "(", "EBRT", ")", "for", "breast", "cancer", ".", "We", "report", "5", "-year", "results", "for", "local", "recurrence", "and", "the", "first", "analysis", "of", "overall", "survival", ".", "TARGIT", "-", "A", "was", "a", "randomised", ",", "non", "-", "inferiority", "trial", ".", "Women", "aged", "45", "years", "and", "older", "with", "invasive", "ductal", "carcinoma", "were", "enrolled", "and", "randomly", "assigned", "in", "a", "1", ":1", "ratio", "to", "receive", "TARGIT", "or", "whole", "-", "breast", "EBRT", ",", "with", "blocks", "stratified", "by", "centre", "and", "by", "timing", "of", "delivery", "of", "targeted", "intraoperative", "radiotherapy", ":", "randomisation", "occurred", "either", "before", "lumpectomy", "(", "prepathology", "stratum", ",", "TARGIT", "concurrent", "with", "lumpectomy", ")", "or", "after", "lumpectomy", "(", "postpathology", "stratum", ",", "TARGIT", "given", "subsequently", "by", "reopening", "the", "wound", ")", ".", "Patients", "in", "the", "TARGIT", "group", "received", "supplemental", "EBRT", "(", "excluding", "a", "boost", ")", "if", "unforeseen", "adverse", "features", "were", "detected", "on", "final", "pathology", ",", "thus", "radiotherapy", "was", "risk", "-", "adapted", ".", "The", "primary", "outcome", "was", "absolute", "difference", "in", "local", "recurrence", "in", "the", "conserved", "breast", ",", "with", "a", "prespecified", "non", "-", "inferiority", "margin", "of", "2", "·", "5", "%", "at", "5", "years", ";", "prespecified", "analyses", "included", "outcomes", "as", "per", "timing", "of", "randomisation", "in", "relation", "to", "lumpectomy", ".", "Secondary", "outcomes", "included", "complications", "and", "mortality", ".", "This", "study", "is", "registered", "with", "ClinicalTrials.gov", ",", "number", "NCT", "00983684", ".", "Patients", "were", "enrolled", "at", "33", "centres", "in", "11", "countries", ",", "between", "March", "24", ",", "2000", ",", "and", "June", "25", ",", "2012", ".", "1721", "patients", "were", "randomised", "to", "TARGIT", "and", "1730", "to", "EBRT", ".", "Supplemental", "EBRT", "after", "TARGIT", "was", "necessary", "in", "15", "·", "2", "%", "[", "239", "of", "1571", "]", "of", "patients", "who", "received", "TARGIT", "(", "21", "·", "6", "%", "prepathology", ",", "3", "·", "6", "%", "postpathology", ")", ".", "3451", "patients", "had", "a", "median", "follow", "-", "up", "of", "2", "years", "and", "5", "months", "(", "IQR", "12", "-", "52", "months", ")", ",", "2020", "of", "4", "years", ",", "and", "1222", "of", "5", "years", ".", "The", "5", "-year", "risk", "for", "local", "recurrence", "in", "the", "conserved", "breast", "was", "3", "·", "3", "%", "(", "95", "%", "CI", "2", "·", "1", "-", "5", "·", "1", ")", "for", "TARGIT", "versus", "1", "·", "3", "%", "(", "0", "·", "7", "-", "2", "·", "5", ")", "for", "EBRT", "(", "p=", "0", "·", "042", ")", ".", "TARGIT", "concurrently", "with", "lumpectomy", "(", "prepathology", ",", "n=", "2298", ")", "had", "much", "the", "same", "results", "as", "EBRT", ":", "2", "·", "1", "%", "(", "1", "·", "1", "-", "4", "·", "2", ")", "versus", "1", "·", "1", "%", "(", "0", "·", "5", "-", "2", "·", "5", ";", "p=", "0", "·", "31", ")", ".", "With", "delayed", "TARGIT", "(", "postpathology", ",", "n=", "1153", ")", "the", "between", "-", "group", "difference", "was", "larger", "than", "2", "·", "5", "%", "(", "TARGIT", "5", "·", "4", "%", "[", "3", "·", "0", "-", "9", "·", "7", "]", "vs", "EBRT", "1", "·", "7", "%", "[", "0", "·", "6", "-", "4", "·", "9", "]", ";", "p=", "0", "·", "069", ")", ".", "Overall", ",", "breast", "cancer", "mortality", "was", "much", "the", "same", "between", "groups", "(", "2", "·", "6", "%", "[", "1", "·", "5", "-", "4", "·", "3", "]", "for", "TARGIT", "vs", "1", "·", "9", "%", "[", "1", "·", "1", "-", "3", "·", "2", "]", "for", "EBRT", ";", "p=", "0", "·", "56", ")", "but", "there", "were", "significantly", "fewer", "non", "-", "breast", "-", "cancer", "deaths", "with", "TARGIT", "(", "1", "·", "4", "%", "[", "0", "·", "8", "-", "2", "·", "5", "]", "vs", "3", "·", "5", "%", "[", "2", "·", "3", "-", "5", "·", "2", "]", ";", "p=", "0", "·", "0086", ")", ",", "attributable", "to", "fewer", "deaths", "from", "cardiovascular", "causes", "and", "other", "cancers", ".", "Overall", "mortality", "was", "3", "·", "9", "%", "(", "2", "·", "7", "-", "5", "·", "8", ")", "for", "TARGIT", "versus", "5", "·", "3", "%", "(", "3", "·", "9", "-", "7", "·", "3", ")", "for", "EBRT", "(", "p=", "0", "·", "099", ")", ".", "Wound", "-", "related", "complications", "were", "much", "the", "same", "between", "groups", "but", "grade", "3", "or", "4", "skin", "complications", "were", "significantly", "reduced", "with", "TARGIT", "(", "four", "of", "1720", "vs", "13", "of", "1731", ",", "p=", "0", "·", "029", ")", ".", "TARGIT", "concurrent", "with", "lumpectomy", "within", "a", "risk", "-", "adapted", "approach", "should", "be", "considered", "as", "an", "option", "for", "eligible", "patients", "with", "breast", "cancer", "carefully", "selected", "as", "per", "the", "TARGIT", "-", "A", "trial", "protocol", ",", "as", "an", "alternative", "to", "postoperative", "EBRT", ".", "University", "College", "London", "Hospitals", "(", "UCLH", ")", "/", "UCL", "Comprehensive", "Biomedical", "Research", "Centre", ",", "UCLH", "Charities", ",", "National", "Institute", "for", "Health", "Research", "Health", "Technology", "Assessment", "programme", ",", "Ninewells", "Cancer", "Campaign", ",", "National", "Health", "and", "Medical", "Research", "Council", ",", "and", "German", "Federal", "Ministry", "of", "Education", "and", "Research", "." ]
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995
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996
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997
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998
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