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705
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706
[ "Effects", "of", "exercise", "on", "sleep", "problems", "in", "breast", "cancer", "patients", "receiving", "radiotherapy", ":", "a", "randomized", "clinical", "trial", ".", "Sleep", "problems", "frequently", "affect", "breast", "cancer", "patients", "during", "and", "after", "treatment", "and", "reduce", "their", "quality", "of", "life", ".", "Treatment", "strategies", "are", "mostly", "unknown", ".", "Thus", ",", "we", "assessed", "within", "a", "randomized", "controlled", "trial", "whether", "a", "12", "-week", "exercise", "program", "starting", "with", "the", "radiotherapy", "influences", "sleep", "trajectories", ".", "Sleep", "quality", "and", "problems", "were", "assessed", "via", "self", "-", "report", "in", "160", "breast", "cancer", "patients", "before", ",", "during", ",", "and", "2", ",", "6", ",", "and", "12", "months", "after", "participation", "in", "a", "trial", "investigating", "resistance", "exercise", "versus", "a", "relaxation", "control", "group", "concomitant", "with", "radiotherapy", ".", "As", "additional", "comparison", "group", ",", "25", "age", "-", "matched", "healthy", "women", "exercised", "and", "followed", "identical", "study", "procedures", ".", "Ordinal", "logistic", "regression", "analyses", "were", "used", ".", "The", "exercise", "intervention", "significantly", "decreased", "sleep", "problems", "compared", "to", "the", "relaxation", "control", "group", "(", "scale", ":", "0", "-", "100", ",", "with", "between", "-", "group", "mean", "differences", "of", "-", "10.2", "(", "p", "=", "0.03", ")", "from", "baseline", "to", "the", "end", "of", "radiotherapy", "and", "-", "10.9", "(", "p", "=", "0.005", ")", "to", "the", "end", "of", "the", "intervention", ")", ",", "with", "sleep", "problems", "decreasing", "in", "the", "exercise", "group", "and", "increasing", "in", "the", "control", "group", ".", "At", "12", "months", ",", "differences", "were", "still", "observed", "but", "statistically", "non", "-", "significant", "(", "mean", "difference", "=", "-", "5.9", ",", "p", "=", "0.20", ")", ".", "Further", "adjustment", "for", "potential", "confounders", "did", "not", "change", "the", "results", ".", "Several", "determinants", "of", "sleep", "problems", "at", "baseline", "were", "identified", ",", "e.g.", ",", "previous", "chemotherapy", "and", "higher", "body", "mass", "index", ".", "Our", "randomized", "exercise", "intervention", "trial", "confirmed", "results", "from", "earlier", "but", "mostly", "smaller", "studies", "that", "radiotherapy", "aggravates", "sleep", "problems", "in", "breast", "cancer", "patients", "and", "that", "exercise", "can", "ameliorate", "these", "effects", ".", "Considering", "that", "sleep", "quality", "can", "be", "a", "major", "predictor", "of", "quality", "of", "life", ",", "our", "findings", "are", "of", "substantial", "importance", "to", "many", "breast", "cancer", "patients", "." ]
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707
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708
[ "Preoperative", "breast", "MRI", "for", "early", "-", "stage", "breast", "cancer", ":", "effect", "on", "surgical", "and", "long", "-", "term", "outcomes", ".", "The", "purpose", "of", "this", "study", "was", "to", "evaluate", "the", "effect", "of", "the", "use", "of", "preoperative", "breast", "MRI", "on", "surgical", "and", "long", "-", "term", "outcomes", "among", "women", "with", "early", "-", "stage", "breast", "cancer", "undergoing", "breast", "conservation", "therapy", ".", "A", "retrospective", "review", "yielded", "the", "cases", "of", "174", "women", "with", "stage", "0", ",", "I", ",", "or", "II", "breast", "cancer", "who", "underwent", "preoperative", "MRI", "between", "2000", "and", "2004", ".", "A", "control", "group", "of", "174", "patients", "who", "did", "not", "undergo", "preoperative", "MRI", "before", "breast", "conservation", "therapy", "was", "matched", "by", "age", ",", "histopathologic", "finding", ",", "stage", ",", "and", "surgeon", ".", "Features", "compared", "included", "breast", "density", ",", "presence", "of", "mammographically", "occult", "disease", ",", "margin", "status", ",", "lymph", "node", "involvement", ",", "lymphovascular", "invasion", ",", "extensive", "intraductal", "component", ",", "hormone", "receptor", "status", ",", "and", "use", "of", "adjuvant", "therapy", ".", "Outcomes", ",", "including", "rates", "of", "reexcision", ",", "ipsilateral", "recurrence", ",", "and", "disease", "-", "free", "survival", ",", "were", "compared", "by", "Kaplan", "-", "Meier", "methods", "and", "the", "log", "-", "rank", "test", ".", "Patients", "referred", "for", "preoperative", "breast", "MRI", "were", "more", "likely", "to", "have", "extremely", "dense", "breasts", "(", "28", "%", "vs", "6", "%", ",", "p", "<", "0.0001", ")", "and", "mammographically", "occult", "cancer", "(", "24", "%", "vs", "9", "%", ",", "p", "=", "0.0003", ")", ".", "The", "two", "groups", "had", "identical", "rates", "of", "final", "negative", "margins", ",", "lymph", "node", "involvement", ",", "lymphovascular", "invasion", ",", "extensive", "intraductal", "component", "status", ",", "positive", "hormone", "receptor", "results", ",", "and", "systemic", "adjuvant", "therapy", ".", "Fewer", "patients", "in", "the", "preoperative", "MRI", "group", "needed", "reexcision", "(", "29", "%", "vs", "45", "%", ",", "p", "=", "0.02", ")", ".", "The", "median", "follow", "-", "up", "period", "after", "treatment", "was", "8", "years", ".", "There", "was", "no", "significant", "difference", "in", "locoregional", "recurrence", "(", "p", "=", "0.33", ")", "or", "disease", "-", "free", "survival", "(", "p", "=", "0.73", ")", "rates", "between", "the", "two", "groups", ".", "Reexcision", "rates", "among", "patients", "with", "early", "breast", "cancer", "undergoing", "conservation", "therapy", "were", "lower", "among", "women", "who", "underwent", "preoperative", "breast", "MRI", ".", "There", "was", "no", "statistically", "significant", "effect", "of", "the", "use", "of", "preoperative", "MRI", "on", "rates", "of", "locoregional", "recurrence", "or", "disease", "-", "free", "survival", "." ]
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709
[ "Optimizing", "expectations", "to", "prevent", "side", "effects", "and", "enhance", "quality", "of", "life", "in", "breast", "cancer", "patients", "undergoing", "endocrine", "therapy", ":", "study", "protocol", "of", "a", "randomized", "controlled", "trial", ".", "Adjuvant", "endocrine", "therapy", "can", "improve", "disease", "-", "free", "survival", "and", "time", "before", "recurrence", "in", "breast", "cancer", "patients", ".", "However", ",", "it", "is", "associated", "with", "considerable", "side", "effects", "that", "negatively", "affect", "patients", "'", "quality", "of", "life", "and", "cause", "non", "-", "adherence", ".", "The", "recently", "demonstrated", "effect", "of", "individual", "expectations", "on", "side", "-", "effect", "development", "(", "nocebo", "effect", ")", "suggests", "that", "psychological", "factors", "play", "a", "role", "in", "the", "prevention", "of", "side", "effects", ".", "The", "aim", "of", "this", "study", "is", "to", "evaluate", "cognitive", "-", "behavioral", "side", "-", "effect", "prevention", "training", "(", "SEPT", ")", "for", "breast", "cancer", "patients", ".", "This", "article", "describes", "the", "study", "protocol", "and", "applied", "research", "methods", ".", "In", "a", "randomized", "controlled", "trial", ",", "184", "female", "breast", "cancer", "patients", "are", "assigned", "to", "receive", "either", "SEPT", ",", "standard", "medical", "care", "or", "a", "manualized", "supportive", "therapy", "at", "the", "start", "of", "adjuvant", "endocrine", "treatment", ".", "SEPT", "consists", "of", "three", "sessions", "of", "cognitive", "-", "behavioral", "training", "including", "psychoeducation", "to", "provide", "a", "realistic", "view", "of", "endocrine", "therapy", ",", "imagination", "-", "training", "to", "integrate", "positive", "aspects", "of", "medication", "into", "daily", "life", ",", "and", "side", "-", "effect", "management", "to", "enhance", "expectations", "about", "coping", "ability", ".", "Side", "effects", "three", "months", "after", "the", "start", "of", "endocrine", "therapy", "serve", "as", "primary", "outcomes", ".", "Secondary", "outcomes", "include", "quality", "of", "life", ",", "coping", "ability", "and", "patients", "'", "medication", "adherence", ".", "Patients", "'", "expectations", "(", "i.e.", ",", "expectations", "about", "side", "effects", ",", "coping", "ability", ",", "treatment", "and", "illness", ")", "are", "analyzed", "as", "mediators", ".", "The", "optimization", "of", "expectations", "might", "be", "a", "potential", "pathway", "in", "health", "care", "to", "improve", "patients", "'", "quality", "of", "life", "during", "long", "-", "term", "medication", "intake", ".", "The", "results", "will", "provide", "implications", "for", "a", "possible", "integration", "of", "evidence", "-", "based", "prevention", "training", "into", "clinical", "practice", ".", "ClinicalTrials.gov", ",", "(", "NCT", "01741883", ")", "." ]
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710
[ "L", "-", "Thyroxine", "intake", "as", "a", "potential", "risk", "factor", "for", "the", "development", "of", "fatigue", "in", "breast", "cancer", "patients", "undergoing", "chemotherapy", ".", "L", "-", "Thyroxine", "is", "one", "of", "the", "most", "commonly", "prescribed", "drugs", "and", "accordingly", "used", "by", "many", "breast", "cancer", "patients", "with", "thyroid", "disorders", ".", "Hence", ",", "potential", "interactions", "of", "chemotherapy", "with", "L", "-", "thyroxine", ",", "possibly", "contributing", "to", "fatigue", ",", "would", "be", "of", "high", "clinical", "relevance", ".", "Therefore", ",", "we", "investigated", "fatigue", "and", "underlying", "pathways", "in", "L", "-", "thyroxine", "-", "using", "breast", "cancer", "patients", "during", "chemotherapy", ".", "Thyroid", "-", "stimulating", "hormone", "(", "TSH", ")", ",", "L", "-", "triiodothyronine", "(", "T", "3", ")", ",", "and", "diurnal", "salivary", "cortisol", "patterns", "were", "analyzed", "in", "breast", "cancer", "patients", "in", "the", "beginning", "and", "at", "the", "end", "of", "adjuvant", "chemotherapy", "within", "the", "control", "group", "(", "n", "=", "41", ")", "of", "a", "randomized", "exercise", "intervention", "trial", ".", "Additionally", ",", "relationships", "in", "the", "exercising", "group", "(", "n", "=", "45", ")", "as", "well", "as", "in", "healthy", "women", "(", "n", "=", "25", ")", "were", "explored", ".", "Regression", "and", "mediation", "analyses", "were", "performed", ".", "L", "-", "Thyroxine", "use", "was", "significantly", "associated", "with", "lower", "TSH", "(", "median", "=", "0.33", "mU", "/", "l", ",", "interquartile", "range", "=", "(", "0.15", "-", "0.48", ")", ")", ",", "whereas", "patients", "not", "using", "L", "-", "thyroxine", "had", "TSH", "comparable", "to", "healthy", "women", "(", "0.51", "mU", "/", "l", "(", "0.37", "-", "0.74", ")", ")", ".", "T", "3", "significantly", "declined", "during", "chemotherapy", "in", "L", "-", "thyroxine", "users", "but", "not", "in", "non", "-", "users", ".", "However", ",", "the", "group", "difference", "failed", "statistical", "significance", ".", "L", "-", "Thyroxine", "treatment", "was", "significantly", "associated", "with", "increased", "physical", "fatigue", "during", "chemotherapy", "(", "p", "=", "0.004", ")", "in", "the", "non", "-", "exercising", "group", ".", "This", "association", "appeared", "to", "be", "partly", "mediated", "by", "TSH", ".", "Further", ",", "TSH", "appeared", "to", "affect", "fatigue", "partly", "via", "increased", "cortisol", "levels", ".", "In", "the", "exercise", "group", ",", "there", "was", "no", "significant", "association", "between", "L", "-", "thyroxine", "and", "fatigue", ".", "L", "-", "Thyroxine", "treatment", "during", "chemotherapy", "might", "result", "in", "hormonal", "dysregulations", "that", "can", "contribute", "to", "increased", "physical", "fatigue", ".", "Therefore", ",", "breast", "cancer", "patients", "on", "L", "-", "thyroxine", "treatment", "may", "need", "special", "monitoring", "of", "their", "thyroid", "levels", "and", "of", "fatigue", "during", "chemotherapy", "and", "should", "be", "encouraged", "to", "exercise", ".", "ClinicalTrials.gov", "NCT", "01106820", "." ]
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711
[ "The", "use", "of", "Ginkgo", "biloba", "for", "the", "prevention", "of", "chemotherapy", "-", "related", "cognitive", "dysfunction", "in", "women", "receiving", "adjuvant", "treatment", "for", "breast", "cancer", ",", "N", "00", "C", "9", ".", "Patients", "undergoing", "treatment", "for", "cancer", "often", "report", "problems", "with", "their", "cognitive", "function", ",", "which", "is", "an", "essential", "component", "of", "health", "-", "related", "quality", "of", "life", ".", "Pursuant", "to", "this", ",", "a", "two", "-", "arm", "randomized", ",", "placebo", "-", "controlled", ",", "double", "-", "blind", ",", "phase", "III", "clinical", "trial", "was", "conducted", "to", "evaluate", "Ginkgo", "biloba", "(", "EGB", "761", ")", "for", "the", "prevention", "of", "chemotherapy", "-", "related", "cognitive", "dysfunction", "in", "patients", "with", "breast", "cancer", ".", "Previously", "chemotherapy", "naïve", "women", "about", "to", "receive", "adjuvant", "chemotherapy", "for", "breast", "cancer", "were", "randomized", "to", "receive", "60", "mg", "of", "EGB", "761", "or", "a", "matching", "placebo", "twice", "daily", ".", "The", "study", "agent", "was", "to", "begin", "before", "their", "second", "cycle", "of", "chemotherapy", "and", "to", "be", "taken", "throughout", "chemotherapy", "and", "1", "month", "beyond", "completion", ".", "The", "primary", "measure", "for", "cognitive", "function", "was", "the", "High", "Sensitivity", "Cognitive", "Screen", "(", "HSCS", ")", ",", "with", "a", "secondary", "measure", "being", "the", "Trail", "Making", "Tests", "(", "TMT", ")", "A", "and", "B", ".", "Subjective", "assessment", "of", "cognitive", "function", "was", "evaluated", "by", "the", "cognitive", "subscale", "of", "the", "Perceived", "Health", "Scale", "(", "PHS", ")", "and", "the", "Profile", "of", "Mood", "States", "(", "POMS", ")", ".", "Data", "were", "collected", "at", "baseline", "and", "at", "intervals", "throughout", "and", "after", "chemotherapy", ",", "up", "to", "24", "months", "after", "completion", "of", "adjuvant", "treatment", ".", "The", "primary", "statistical", "analysis", "included", "normalized", "area", "under", "the", "curve", "(", "AUC", ")", "comparisons", "of", "the", "HSCS", ",", "between", "the", "arms", ".", "Secondary", "analyses", "included", "evaluation", "of", "the", "other", "measures", "of", "cognition", "as", "well", "as", "correlational", "analyses", "between", "self", "-", "report", "and", "cognitive", "testing", ".", "One", "hundred", "and", "sixty", "-", "six", "women", "provided", "evaluable", "data", ".", "There", "were", "no", "significant", "differences", "in", "AUC", "up", "to", "12", "months", "on", "the", "HSCS", "between", "arms", "at", "the", "end", "of", "chemotherapy", "or", "at", "any", "other", "time", "point", "after", "adjuvant", "treatment", ".", "There", "were", "also", "no", "significant", "differences", "in", "TMT", "A", "or", "B", "at", "any", "data", "point", ".", "Perceived", "cognitive", "functions", ",", "as", "measured", "by", "the", "PHS", "and", "confusion", "/", "bewilderment", "subscale", "of", "the", "POMS", ",", "were", "not", "different", "between", "arms", "at", "the", "end", "of", "chemotherapy", ".", "There", "was", "also", "little", "correlation", "between", "self", "-", "reported", "cognition", "and", "cognitive", "testing", ".", "No", "differences", "were", "observed", "in", "toxicities", "per", "Common", "Terminology", "Criteria", "for", "Adverse", "Events", "(", "CTCAE", ")", "assessment", "between", "Ginkgo", "biloba", "and", "placebo", "throughout", "the", "study", ";", "however", ",", "after", "chemotherapy", ",", "the", "placebo", "group", "reported", "worse", "nausea", "(", "p", "=", ".", "05", ")", ".", "This", "study", "did", "not", "provide", "any", "support", "for", "the", "notion", "that", "Ginkgo", "biloba", ",", "at", "a", "dose", "of", "60", "mg", "twice", "a", "day", ",", "can", "help", "prevent", "cognitive", "changes", "from", "chemotherapy", ".", "These", "analyses", "do", "provide", "data", "to", "further", "support", "the", "low", "associations", "between", "patients", "'", "self", "-", "report", "of", "cognition", "and", "cognitive", "performance", ",", "based", "on", "more", "formal", "testing", "." ]
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712
[ "Epirubicin", "and", "docetaxel", "with", "or", "without", "capecitabine", "as", "neoadjuvant", "treatment", "for", "early", "breast", "cancer", ":", "final", "results", "of", "a", "randomized", "phase", "III", "study", "(", "ABCSG-", "24", ")", ".", "This", "randomized", "phase", "III", "trial", "compared", "pathologic", "complete", "response", "(", "pCR", ")", "rates", "of", "early", "breast", "cancer", "(", "EBC", ")", "following", "neoadjuvant", "epirubicin", "-", "docetaxel", "(", "ED", ")", "±capecitabine", "(", "C", ")", ",", "and", "evaluated", "the", "addition", "of", "trastuzumab", "in", "HER", "2", "-", "positive", "tumors", ".", "Patients", "with", "invasive", "breast", "cancer", "(", "except", "T", "4", "d", ")", "were", "randomly", "assigned", "to", "receive", "six", "3", "-weekly", "cycles", "of", "ED", "(", "both", "75", "mg", "/", "m", "2", ")", "±C", "(", "1000", "mg", "/", "m", "2", ",", "twice", "daily", ",", "days", "1", "-", "14", ")", ".", "Patients", "with", "HER", "2", "-", "positive", "disease", "were", "further", "randomized", "to", "receive", "trastuzumab", "(", "8", "mg", "/", "kg", ",", "then", "6", "mg", "/", "kg", "every", "3", "weeks", ")", "or", "not", ".", "Primary", "end", "point", ":", "pCR", "rate", "at", "the", "time", "of", "surgery", ".", "Five", "hundred", "thirty", "-", "six", "patients", "were", "randomized", "to", "ED", "(", "n=", "266", ")", "or", "EDC", "(", "n=", "270", ")", ";", "93", "patients", "were", "further", "randomized", "to", "trastuzumab", "(", "n=", "44", ")", "or", "not", "(", "n=", "49", ")", ".", "pCR", "rate", "was", "significantly", "increased", "with", "EDC", "(", "23.0", "%", "versus", "15.4", "%", "ED", ",", "P=", "0.027", ")", ",", "and", "nonsignificantly", "further", "increased", "with", "trastuzumab", "(", "38.6", "%", "EDC", "versus", "26.5", "%", "ED", ",", "P=", "0.212", ")", ".", "Rates", "of", "axillary", "node", "involvement", "at", "surgery", "and", "breast", "conservation", "were", "improved", "with", "EDC", "versus", "ED", ",", "but", "not", "significantly", ";", "the", "addition", "of", "trastuzumab", "had", "no", "further", "impact", ".", "Hormone", "receptor", "status", ",", "tumor", "size", ",", "grade", ",", "and", "C", "(", "all", "P≤", "0.035", ")", "were", "independent", "prognostic", "factors", "for", "pCR", ".", "Trastuzumab", "added", "to", "ED±C", "significantly", "increased", "the", "number", "of", "serious", "adverse", "events", "(", "35", "versus", "18", ";", "P=", "0.020", ")", ",", "mainly", "due", "to", "infusion", "-", "related", "reactions", ".", "These", "findings", "show", "that", "the", "integration", "of", "C", "into", "a", "neoadjuvant", "taxane-", "/", "anthracycline", "-", "based", "regimen", "is", "a", "feasible", ",", "safe", ",", "and", "effective", "treatment", "option", ",", "with", "incorporation", "of", "trastuzumab", "in", "HER", "2", "-", "positive", "disease", ".", "NCT", "00309556", ",", "www.clinicaltrials.gov", "." ]
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713
[ "The", "Effects", "of", "Mind", "Subtraction", "Meditation", "on", "Breast", "Cancer", "Survivors", "'", "Psychological", "and", "Spiritual", "Well", "-", "being", "and", "Sleep", "Quality", ":", "A", "Randomized", "Controlled", "Trial", "in", "South", "Korea", ".", "Most", "breast", "cancer", "survivors", "experience", "psychological", "and", "spiritual", "distress", ",", "including", "depression", ",", "anxiety", ",", "perceived", "stress", ",", "and", "loss", "of", "meaningfulness", "in", "life", ".", "This", "distress", "can", "negatively", "impact", "physical", "health", ",", "quality", "of", "life", ",", "and", "quality", "of", "sleep", ".", "The", "aim", "of", "this", "study", "was", "to", "compare", "and", "examine", "the", "effectiveness", "of", "mind", "subtraction", "meditation", "(", "MSM", ")", "and", "a", "self", "-", "management", "education", "(", "SME", ")", "group", "on", "breast", "cancer", "survivors", ".", "A", "randomized", "controlled", "trial", "was", "conducted", "with", "South", "Korean", "female", "breast", "cancer", "survivors", "(", "stages", "I", "-", "III", ")", ".", "Self", "-", "reported", "questionnaires", "were", "administered", "to", "both", "MSM", "group", "(", "n", "=", "22", ")", "and", "SME", "group", "(", "n", "=", "24", ")", "to", "measure", "psychological", "and", "spiritual", "well", "-", "being", ",", "as", "well", "as", "quality", "of", "sleep", ".", "Compared", "with", "the", "SME", "group", ",", "the", "MSM", "group", "reported", "a", "significant", "decrease", "in", "depression", "(", "P", "=", ".", "034", ")", ",", "anxiety", "(", "P", "=", ".", "036", ")", ",", "and", "perceived", "stress", "(", "P", "=", ".", "009", ")", "and", "an", "increase", "in", "quality", "of", "life", "(", "P", "<", ".", "001", ")", ",", "satisfaction", "with", "life", "(", "P", "<", ".", "001", ")", ",", "posttraumatic", "growth", "(", "P", "=", ".", "007", ")", ",", "and", "quality", "of", "sleep", "(", "P", "=", ".", "010", ")", ".", "Mind", "subtraction", "meditation", "may", "have", "positive", "therapeutic", "effects", "among", "breast", "cancer", "survivors", ".", "This", "meditation", "program", "may", "be", "useful", "to", "manage", "psychological", "and", "spiritual", "distress", ",", "as", "well", "as", "improve", "quality", "of", "life", "and", "sleep", ",", "in", "clinical", "settings", "among", "breast", "cancer", "survivors", ".", "This", "study", "demonstrated", "the", "clinical", "effectiveness", "and", "the", "feasibility", "of", "applying", "the", "MSM", "method", "to", "breast", "cancer", "survivors", ".", "The", "participants", "had", "a", "high", "attendance", "rate", "in", "the", "program", ",", "which", "speaks", "to", "the", "likelihood", "of", "the", "applicability", "of", "the", "meditation", "program", "on", "an", "outpatient", "basis", "." ]
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714
[ "A", "clinical", "study", "on", "the", "use", "of", "Huaier", "granules", "in", "post", "-", "surgical", "treatment", "of", "triple", "-", "negative", "breast", "cancer", ".", "In", "recent", "years", ",", "traditional", "Chinese", "medicine", "(", "TCM", ")", "has", "been", "developing", "rapidly", "in", "cancer", "treatment", ".", "Huaier", "is", "a", "widely", "used", "fungus", "by", "TCM", "to", "treat", "different", "kinds", "of", "cancers", ".", "Its", "good", "efficacy", "in", "prevention", "of", "tumor", "recurrence", "and", "metastasis", "has", "been", "proven", "by", "a", "large", "number", "of", "clinical", "studies", ".", "In", "order", "to", "further", "investigate", "the", "efficacy", "and", "safety", "of", "Huaier", "granules", "in", "post", "-", "surgical", "therapy", "for", "stage", "I", "-", "III", "triple", "-", "negative", "breast", "cancer", "(", "TNBC", ")", "patients", ",", "we", "performed", "a", "case", "-", "control", "clinical", "study", "to", "observe", "its", "effects", "on", "the", "post", "-", "surgical", "safety", "and", "survival", "rates", "of", "these", "patients", ".", "Two", "hundred", "and", "one", "TNBC", "patients", "underwent", "modified", "radical", "mastectomy", "were", "selected", ",", "they", "were", "admitted", "to", "our", "hospital", "between", "October", "2010", "to", "September", "2014", ".", "The", "patients", "were", "randomly", "allocated", "to", "the", "experimental", "group", "(", "101", "cases", ")", "or", "the", "control", "group", "(", "100", "cases", ")", ".", "Patients", "in", "the", "experimental", "group", "were", "treated", "with", "Huaier", "granules", ",", "by", "orally", "taking", "20", "g", "each", "time", "with", "3", "times", "a", "day", ".", "Medication", "was", "started", "during", "chemotherapy", "or", "at", "the", "time", "in", "6", "or", "18", "months", "after", "it", ".", "The", "control", "group", "did", "not", "receive", "any", "TCM", "preparations", "during", "this", "process", ".", "The", "disease", "-", "free", "survival", "(", "DFS", ")", "and", "overall", "survival", "(", "OS", ")", "were", "measured", "as", "the", "main", "outcome", ".", "The", "median", "follow", "-", "up", "time", "was", "46", "months", ".", "For", "the", "100", "patients", "in", "control", "group", ",", "5", "-year", "DFS", "and", "OS", "was", "82", "%", "and", "86", "%", "respectively", ",", "while", "87.1", "%", "and", "90.1", "%", "for", "the", "101", "patients", "in", "the", "experimental", "group", ".", "The", "difference", "was", "not", "statistically", "significant", ".", "However", ",", "stage", "III", "patients", "in", "the", "control", "group", "showed", "a", "5", "-year", "DFS", "of", "53.8", "%", "and", "OS", "of", "65.4", "%", ",", "which", "were", "significantly", "lower", "than", "that", "of", "stage", "III", "patients", "in", "the", "experimental", "group", "as", "81.3", "%", "and", "87.5", "%", ".", "In", "the", "experimental", "group", ",", "10", "patients", "with", "6", "-month", "medication", "showed", "disease", "progression", ",", "whereas", "only", "3", "patients", "with", "18", "-month", "medication", "showed", "disease", "progression", ".", "This", "difference", "was", "statistically", "significant", "as", "well", ".", "Huaier", "granules", "could", "play", "an", "important", "role", "in", "post", "-", "surgical", "adjuvant", "therapy", "of", "TNBC", "patients", ",", "specially", "by", "effectively", "increasing", "the", "DFS", "and", "OS", "of", "breast", "cancer", "patients", "at", "middle", "to", "advanced", "stage", "." ]
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715
[ "Effect", "of", "preoperative", "short", "course", "famotidine", "on", "TILs", "and", "survival", "in", "breast", "cancer", ".", "Histamine", "receptor", "antagonists", "have", "been", "shown", "to", "induce", "tumor", "-", "infiltrating", "lymphocytes", "(", "TILs", ")", "in", "colonic", "cancers", "and", "improve", "survival", ".", "The", "role", "of", "histamine", "receptor", "anatagonists", "in", "breast", "cancer", "is", "unclarified", ".", "To", "evaluate", "the", "role", "of", "histamine", "receptor", "antagonists", "in", "inducing", "(", "TILs", ")", "in", "breast", "cancer", ".", "Forty", "-", "five", "patients", "with", "operable", "breast", "cancers", "(", "25", "cases", "who", "received", "preoperative", "famotidine", "and", "20", "controls", ")", "were", "studied", "for", "the", "effect", "of", "famotidine", "in", "inducing", "TILs", "and", "survival", "in", "breast", "cancer", ".", "Significant", "TILs", "were", "seen", "in", "75", "%", "(", "18", "/", "24", ")", "of", "cases", "as", "opposed", "to", "35", "%", "(", "7", "/", "20", ")", "controls", ".", "In", "logistic", "regression", "analysis", "the", "only", "variable", "found", "to", "be", "predictive", "of", "TILs", "was", "famotidine", ",", "odds", "ratio", "7.324", "(", "1.693", "-", "31.686", ")", "P=", "0.008", ".", "In", "Cox", "'s", "regression", "presence", "of", "TILs", "was", "favorably", "associated", "with", "improved", "disease", "free", "survival", "at", "a", "median", "follow", "up", "of", "35.56", "months", ".", "The", "hazard", "ratio", "for", "disease", "relapse", "was", "3.327", "(", "1.174", "-", "9.426", ")", "P=", "0.024", "in", "TIL", "negative", "as", "compared", "to", "TIL", "positive", "patients", ".", "Famotidine", "use", "alone", "was", "not", "significant", "in", "the", "original", "model", ",", "however", ",", "on", "incorporation", "of", "quadrant", "of", "involvement", "in", "addition", "to", "other", "established", "prognostic", "factors", "in", "the", "above", "multivariate", "model", ",", "it", "assumed", "borderline", "significance", "with", "a", "hazard", "ratio", "for", "disease", "free", "survival", "3.404", "(", "1.005", "-", "11.531", ",", "P=", "0.049", ")", ".", "Preoperative", "short", "course", "famotidine", "induces", "TILs", "in", "breast", "cancer", ".", "Patients", "with", "TILs", "demonstrable", "in", "tumor", "specimens", "had", "an", "improved", "disease", "free", "survival", ".", "Famotidine", "may", "improve", "disease", "free", "survival", "in", "breast", "cancer", "and", "these", "findings", "need", "validation", "in", "larger", "population", "subsets", "." ]
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716
[ "Pentoxifylline", "and", "vitamin", "E", "treatment", "for", "prevention", "of", "radiation", "-", "induced", "side", "-", "effects", "in", "women", "with", "breast", "cancer", ":", "a", "phase", "two", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "randomised", "clinical", "trial", "(", "Ptx-", "5", ")", ".", "A", "previous", "study", "has", "shown", "that", "pentoxifylline", "in", "combination", "with", "vitamin", "E", "can", "reverse", "radiation", "-", "induced", "fibrosis", ".", "The", "aim", "of", "the", "present", "study", "is", "to", "investigate", "if", "the", "same", "drugs", "could", "prevent", "radiation", "-", "induced", "side", "-", "effects", "in", "women", "with", "breast", "cancer", ".", "A", "randomised", ",", "placebo", "-", "controlled", ",", "double", "-", "blind", ",", "parallel", "group", "trial", "was", "performed", ".", "Women", "with", "breast", "cancer", "were", "treated", "for", "12", "months", "with", "400", "mg", "pentoxifylline", "t.i.d", ".", "or", "placebo", ",", "in", "combination", "with", "100", "mg", "vitamin", "E", "t.i.d", ".", ",", "starting", "1", "-", "3", "months", "after", "the", "completion", "of", "radiotherapy", ".", "The", "primary", "end", "-", "point", "was", "passive", "abduction", "of", "the", "shoulder", ",", "and", "the", "secondary", "end", "-", "point", "was", "difference", "in", "arm", "volumes", ".", "The", "trial", "is", "registered", "on", "the", "ISRCTN", ".", "org", "website", ",", "number", "ISRCTN", "39143623", ".", "83", "patients", "were", "included", "in", "the", "study", ";", "42", "in", "the", "pentoxifylline+vitamin", "E", "group", "and", "41", "in", "the", "placebo+vitamin", "E", "group", ".", "Both", "treatments", "were", "generally", "well", "tolerated", ".", "Seven", "patients", "were", "withdrawn", "from", "the", "treatment", "due", "to", "disease", "progression", ";", "four", "in", "the", "pentoxifylline", "group", "and", "three", "in", "the", "placebo", "group", ".", "At", "inclusion", ",", "patients", "had", "impaired", "passive", "abduction", "of", "the", "shoulder", ".", "During", "treatment", ",", "both", "the", "groups", "improved", "significantly", ".", "Median", "improvement", "from", "baseline", "was", "3.7", "degrees", "(", "p=", "0.0035", ")", "on", "pentoxifylline", "and", "was", "9.4", "degrees", "(", "p=", "0.0041", ")", "in", "the", "placebo", "group", ",", "but", "no", "difference", "between", "the", "groups", "was", "detected", "(", "p=", "0.20", ")", ".", "Arm", "volumes", "increased", "over", "time", "in", "the", "placebo", "group", "(", "1.04", "%", ")", ",", "but", "not", "on", "pentoxifylline", "(", "0.50", "%", ")", ",", "and", "differed", "significantly", "between", "the", "groups", "(", "p=", "0.0172", ")", ".", "The", "combination", "of", "pentoxifylline", "and", "vitamin", "E", "was", "safe", "and", "may", "be", "used", "for", "the", "prevention", "of", "some", "radiation", "-", "induced", "side", "-", "effects", "." ]
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717
[ "Effects", "of", "Nia", "exercise", "in", "women", "receiving", "radiation", "therapy", "for", "breast", "cancer", ".", "To", "compare", "a", "12", "-week", "nontraditional", "exercise", "Nia", "program", "practiced", "at", "home", "to", "usual", "care", "on", "fatigue", ",", "quality", "of", "life", "(", "QOL", ")", ",", "aerobic", "capacity", ",", "and", "shoulder", "flexibility", "in", "women", "with", "breast", "cancer", "undergoing", "radiation", "therapy", ".", "Randomized", "clinical", "trial", ".", "Large", "community", "-", "based", "hospital", "in", "the", "midwestern", "United", "States", ".", "41", "women", "with", "stage", "I", ",", "II", ",", "or", "III", "breast", "cancer", "starting", "radiation", "therapy", ".", "22", "women", "were", "randomized", "to", "the", "Nia", "group", "and", "19", "to", "the", "usual", "care", "group", ".", "Those", "in", "the", "Nia", "group", "were", "instructed", "to", "practice", "Nia", "20", "-", "60", "minutes", "three", "times", "per", "week", "for", "12", "weeks", ".", "Those", "in", "the", "usual", "care", "group", "were", "instructed", "to", "continue", "normal", "activities", ".", "Fatigue", ",", "QOL", ",", "aerobic", "capacity", ",", "and", "shoulder", "flexibility", ".", "Controlling", "for", "baseline", "scores", ",", "change", "over", "time", "between", "groups", "was", "significantly", "different", "for", "the", "women", "who", "practiced", "Nia", "at", "least", "13", "times", "during", "the", "12", "-week", "period", ";", "those", "in", "the", "Nia", "intervention", "reported", "significantly", "less", "fatigue", "between", "weeks", "6", "and", "12", ",", "as", "compared", "to", "control", "group", "(", "p", "=", "0.05", ")", ".", "No", "statistical", "differences", "in", "QOL", ",", "aerobic", "capacity", ",", "or", "shoulder", "flexibility", "were", "found", ",", "but", "trends", "favoring", "Nia", "were", "identified", ".", "For", "women", "undergoing", "radiation", "therapy", "for", "breast", "cancer", ",", "Nia", "can", "help", "relieve", "fatigue", ".", "Additional", "research", "in", "arm", "and", "shoulder", "mobility", "and", "preservation", "also", "may", "be", "beneficial", ".", "Oncology", "nurses", "are", "in", "a", "unique", "position", "to", "offer", "suggestions", "to", "help", "manage", "fatigue", ",", "and", "Nia", "could", "be", "considered", "as", "part", "of", "a", "cancer", "survivorship", "program", ".", "Exercise", "is", "beneficial", "for", "women", "with", "breast", "cancer", ",", "and", "interest", "is", "growing", "in", "nontraditional", "exercise", "options", ".", "Nia", "can", "benefit", "women", "with", "breast", "cancer", "undergoing", "radiation", "therapy", "." ]
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718
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719
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720
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721
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723
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724
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725
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726
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728
[ "Surgery", "following", "neoadjuvant", "therapy", "in", "patients", "with", "HER", "2", "-", "positive", "locally", "advanced", "or", "inflammatory", "breast", "cancer", "participating", "in", "the", "NeOAdjuvant", "Herceptin", "(", "NOAH", ")", "study", ".", "To", "describe", "surgical", "outcomes", "in", "patients", "with", "HER", "2", "-", "positive", "locally", "advanced", "(", "LABC", ")", "or", "inflammatory", "breast", "cancer", "(", "IBC", ")", "participating", "in", "the", "NeOAdjuvant", "Herceptin", "(", "NOAH", ")", "study", "(", "ISRCTN", "86043495", ")", ".", "A", "total", "of", "235", "patients", "with", "HER", "2", "-", "positive", "disease", "were", "randomized", "to", "neoadjuvant", "trastuzumab", "plus", "chemotherapy", "(", "doxorubicin", "plus", "paclitaxel", ",", "followed", "by", "paclitaxel", ",", "followed", "by", "cyclophosphamide", ",", "methotrexate", "and", "fluorouracil", ")", "or", "neoadjuvant", "chemotherapy", "alone", ".", "Of", "these", "patients", ",", "228", "received", "their", "allocated", "treatment", "(", "115", "received", "trastuzumab", "plus", "chemotherapy", "and", "113", "received", "chemotherapy", "alone", ")", "and", "were", "potentially", "eligible", "for", "surgery", ".", "Mastectomy", "was", "required", "for", "all", "patients", "with", "IBC", "and", "was", "recommended", "for", "all", "patients", "with", "LABC", ".", "However", ",", "breast", "-", "conserving", "therapy", "could", "be", "considered", "for", "patients", "with", "peripheral", "neoplasms", "measuring", "≤", "4", "cm", "in", "diameter", "at", "diagnosis", ",", "with", "a", "favorable", "ratio", "of", "tumor", "to", "breast", "volume", ",", "or", "at", "the", "patient", "'s", "request", "if", "there", "had", "been", "a", "good", "response", "to", "treatment", ".", "As", "previously", "reported", ",", "the", "addition", "of", "trastuzumab", "to", "neoadjuvant", "chemotherapy", "improved", "the", "overall", ",", "complete", "and", "pathological", "complete", "response", "to", "therapy", "and", "significantly", "improved", "event", "-", "free", "survival", "(", "the", "primary", "endpoint", "of", "the", "study", ")", ".", "Trastuzumab", "also", "enabled", "more", "patients", "to", "have", "breast", "conserving", "surgery", "(", "BCS", ")", "(", "23", "%", "versus", "13", "%", "respectively", ")", "without", "an", "apparent", "detrimental", "effect", "on", "local", "disease", "control", "(", "no", "patient", "treated", "with", "trastuzumab", "plus", "chemotherapy", "had", "experienced", "a", "local", "recurrence", "after", "BCS", "at", "the", "time", "of", "analysis", ")", ".", "Although", "this", "was", "not", "an", "aim", "of", "the", "trial", ",", "neoadjuvant", "trastuzumab", "given", "concurrently", "with", "chemotherapy", "enabled", "23", "%", "of", "patients", "with", "HER", "2", "-", "positive", "LABC", "/", "IBC", "to", "avoid", "mastectomy", "(", "including", "a", "small", "number", "of", "patients", "with", "IBC", ")", "." ]
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729
[ "Results", "of", "the", "CONFIRM", "phase", "III", "trial", "comparing", "fulvestrant", "250", "mg", "with", "fulvestrant", "500", "mg", "in", "postmenopausal", "women", "with", "estrogen", "receptor", "-", "positive", "advanced", "breast", "cancer", ".", "We", "compared", "fulvestrant", "500", "mg", "regimen", "with", "the", "approved", "dose", "of", "fulvestrant", "250", "mg", "per", "month", "for", "treatment", "of", "postmenopausal", "women", "with", "estrogen", "receptor", "-", "positive", "advanced", "breast", "cancer", "who", "experienced", "progression", "after", "prior", "endocrine", "therapy", ".", "Comparison", "of", "Faslodex", "in", "Recurrent", "or", "Metastatic", "Breast", "Cancer", "(", "CONFIRM", ")", "is", "a", "double", "-", "blind", ",", "parallel", "-", "group", ",", "multicenter", ",", "phase", "III", "study", ".", "Patients", "were", "randomly", "assigned", "to", "fulvestrant", "500", "mg", "(", "500", "mg", "intramuscularly", "[", "IM", "]", "on", "day", "0", ",", "then", "500", "mg", "IM", "on", "days", "14", "and", "28", "and", "every", "28", "days", "thereafter", ")", "or", "250", "mg", "every", "28", "days", ".", "Primary", "end", "point", "was", "progression", "-", "free", "survival", "(", "PFS", ")", ".", "Secondary", "end", "points", "included", "objective", "response", "rate", ",", "clinical", "benefit", "rate", "(", "CBR", ")", ",", "duration", "of", "clinical", "benefit", "(", "DoCB", ")", ",", "overall", "survival", "(", "OS", ")", ",", "and", "quality", "of", "life", "(", "QOL", ")", ".", "PFS", "was", "significantly", "longer", "for", "fulvestrant", "500", "mg", "(", "n", "=", "362", ")", "than", "250", "mg", "(", "n", "=", "374", ")", "(", "hazard", "ratio", "[", "HR", "]", "=", "0.80", ";", "95", "%", "CI", ",", "0.68", "to", "0.94", ";", "P", "=", ".", "006", ")", ",", "corresponding", "to", "a", "20", "%", "reduction", "in", "risk", "of", "progression", ".", "Objective", "response", "rate", "was", "similar", "for", "fulvestrant", "500", "mg", "and", "250", "mg", "(", "9.1", "%", "v", "10.2", "%", ",", "respectively", ")", ".", "CBR", "was", "45.6", "%", "for", "fulvestrant", "500", "mg", "and", "39.6", "%", "for", "fulvestrant", "250", "mg", ".", "DoCB", "and", "OS", "were", "16.6", "and", "25.1", "months", ",", "respectively", ",", "for", "the", "500", "-mg", "group", ",", "whereas", "DoCB", "and", "OS", "were", "13.9", "and", "22.8", "months", ",", "respectively", ",", "in", "the", "250", "-mg", "group", ".", "Fulvestrant", "500", "mg", "was", "well", "tolerated", "with", "no", "dose", "-", "dependent", "adverse", "events", ".", "QOL", "was", "similar", "for", "both", "arms", ".", "Fulvestrant", "500", "mg", "was", "associated", "with", "a", "statistically", "significant", "increase", "in", "PFS", "and", "not", "associated", "with", "increased", "toxicity", ",", "corresponding", "to", "a", "clinically", "meaningful", "improvement", "in", "benefit", "versus", "risk", "compared", "with", "fulvestrant", "250", "mg", "." ]
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730
[ "Three", "-", "Arm", "Randomized", "Phase", "III", "Trial", ":", "Quality", "Aloe", "and", "Placebo", "Cream", "Versus", "Powder", "as", "Skin", "Treatment", "During", "Breast", "Cancer", "Radiation", "Therapy", ".", "The", "efficacy", "of", "aloe", "extract", "in", "reducing", "radiation", "-", "induced", "skin", "injury", "is", "controversial", ".", "The", "purpose", "of", "the", "present", "3", "-arm", "randomized", "trial", "was", "to", "test", "the", "efficacy", "of", "quality", "-", "tested", "aloe", "extract", "in", "reducing", "the", "severity", "of", "radiation", "-", "induced", "skin", "injury", "and", ",", "secondarily", ",", "to", "examine", "the", "effect", "of", "a", "moist", "cream", "versus", "a", "dry", "powder", "skin", "care", "regimen", ".", "A", "total", "of", "248", "patients", "with", "breast", "cancer", "were", "randomized", "to", "powder", ",", "aloe", "cream", ",", "or", "placebo", "cream", ".", "Acute", "skin", "toxicity", "was", "scored", "weekly", "and", "after", "treatment", "at", "weeks", "1", ",", "2", ",", "and", "4", "using", "a", "modified", "10", "-point", "Catterall", "scale", ".", "The", "patients", "scored", "their", "symptom", "severity", "using", "a", "6", "-point", "Likert", "scale", "and", "kept", "an", "acute", "phase", "diary", ".", "The", "aloe", "formulation", "did", "not", "reduce", "acute", "skin", "toxicity", "or", "symptom", "severity", ".", "Patients", "with", "a", "greater", "body", "mass", "index", "were", "more", "likely", "to", "develop", "acute", "skin", "toxicity", ".", "A", "similar", "pattern", "of", "increased", "skin", "reaction", "toxicity", "occurred", "with", "both", "study", "creams", "compared", "with", "the", "dry", "powder", "regimen", ".", "No", "evidence", "was", "found", "to", "support", "prophylactic", "application", "of", "quality", "aloe", "extract", "or", "cream", "to", "improve", "the", "symptoms", "or", "reduce", "the", "skin", "reaction", "severity", ".", "Our", "results", "support", "a", "dry", "skin", "care", "regimen", "of", "powder", "during", "radiation", "therapy", "." ]
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731
[ "Effect", "of", "Dietary", "Flaxseed", "Intake", "on", "Circulating", "Sex", "Hormone", "Levels", "among", "Postmenopausal", "Women", ":", "A", "Randomized", "Controlled", "Intervention", "Trial", ".", "Lignan", "intake", ",", "and", "its", "richest", "food", "source", ",", "flaxseed", ",", "have", "been", "associated", "with", "reduced", "breast", "cancer", "risk", ".", "Endogenous", "sex", "hormones", ",", "such", "as", "estrogens", ",", "play", "a", "role", "in", "breast", "cancer", "development", ",", "and", "lignans", "may", "alter", "these", "sex", "hormone", "levels", ".", "To", "assess", "the", "effect", "of", "flaxseed", "on", "circulating", "sex", "hormones", ",", "a", "randomized", "controlled", "trial", "was", "conducted", "among", "99", "postmenopausal", "women", "in", "Toronto", ",", "Canada", ".", "The", "intervention", "arm", "consumed", "2", "tablespoons", "(", "15", "g", ")", "of", "ground", "flaxseed", "daily", "for", "7", "weeks", ";", "the", "control", "arm", "maintained", "usual", "diet", ".", "Baseline", "and", "week", "7", "concentrations", "of", "14", "serum", "sex", "hormones", "were", "measured", "using", "liquid", "chromatography", "-", "tandem", "mass", "spectrometry", "(", "LC", "-", "MS", "/", "MS", ")", "and", "immunoassay", ",", "and", "serum", "enterolignans", "(", "lignan", "biomarker", ")", "using", "LC", "-", "MS", "/", "MS", ".", "Intervention", "effects", "on", "sex", "hormone", "levels", "were", "assessed", "using", "analysis", "of", "covariance", ".", "Serum", "enterolignans", "increased", "among", "the", "flaxseed", "arm", "(", "+", "516", "%", ")", ".", "Women", "consuming", "flaxseed", "(", "vs.", "controls", ")", "had", "increased", "serum", "2", "-hydroxyestrone", "[", "treatment", "effect", "ratio", "(", "TER", ")", "=", "1.54", ";", "95", "%", "CI", ":", "1.18", "-", "2.00", "]", "and", "2", ":", "16", "α", "-", "hydroxyestrone", "ratio", "(", "TER", "=", "1.54", ";", "95", "%", "CI", ":", "1.15", "-", "2.06", ")", ";", "effects", "on", "other", "hormones", "were", "not", "statistically", "significant", ".", "Within", "the", "flaxseed", "arm", ",", "change", "in", "enterolignan", "level", "was", "positively", "correlated", "with", "changes", "in", "2", "-hydroxyestrone", "and", "2", ":", "16", "α", "-", "hydroxyestrone", "ratio", ",", "and", "negatively", "with", "prolactin", ".", "Findings", "suggest", "flaxseed", "affects", "certain", "circulating", "sex", "hormone", "levels", "with", "possible", "implications", "for", "future", "breast", "cancer", "prevention", "research", "." ]
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732
[ "Protective", "effects", "of", "salidroside", "on", "epirubicin", "-", "induced", "early", "left", "ventricular", "regional", "systolic", "dysfunction", "in", "patients", "with", "breast", "cancer", ".", "Salidroside", "[", "2", "-", "(", "4", "-", "hydroxyphenyl", ")", "ethyl", "-", "β", "-", "D", "-", "glucopyranoside", "]", ",", "one", "of", "the", "most", "potent", "ingredients", "extracted", "from", "the", "plant", "Rhodiola", "rosea", "L", ".", ",", "has", "been", "shown", "to", "have", "a", "cardiovascular", "protective", "effect", "as", "an", "antioxidant", ",", "and", "early", "treatment", "of", "epirubicin", "-", "induced", "cardiotoxicity", "has", "been", "the", "focus", "of", "clinical", "chemotherapy", "in", "patients", "with", "breast", "cancer", ".", "However", ",", "the", "cardioprotective", "effects", "of", "salidroside", "on", "epirubicin", "-", "induced", "cardiotoxicity", ",", "especially", "early", "left", "ventricular", "regional", "systolic", "dysfunction", ",", "have", "to", "date", "been", "sparsely", "investigated", ".", "The", "aim", "of", "this", "study", "was", "to", "investigate", "the", "protective", "effects", "of", "salidroside", "in", "preventing", "early", "left", "ventricular", "regional", "systolic", "dysfunction", "induced", "by", "epirubicin", ".", "Sixty", "patients", "with", "histologically", "confirmed", "breast", "cancer", "were", "enrolled", ".", "Eligible", "patients", "were", "randomized", "to", "receive", "salidroside", "(", "600", "mg", "/", "day", ";", "n", "=", "30", ")", "or", "placebo", "(", "n", "=", "30", ")", "starting", "1", "week", "before", "chemotherapy", ".", "Patients", "were", "investigated", "by", "means", "of", "echocardiography", "and", "strain", "rate", "(", "SR", ")", "imaging", ".", "We", "also", "measured", "plasma", "concentrations", "of", "reactive", "oxygen", "species", "(", "ROS", ")", ".", "All", "parameters", "were", "assessed", "at", "baseline", "and", "7", "days", "after", "each", "new", "epirubicin", "dose", "of", "100", "mg", "/", "m", "2", ".", "A", "decline", "of", "the", "SR", "peak", "was", "observed", "at", "an", "epirubicin", "dose", "of", "200", "mg", "/", "m", "2", ",", "with", "no", "significant", "differences", "between", "salidroside", "and", "placebo", "(", "1.35", "±", "0.36", "vs", "1.42", "±", "0.49", "/second", ")", ".", "At", "growing", "cumulative", "doses", "of", "epirubicin", ",", "the", "SR", "normalized", "only", "with", "salidroside", ",", "showing", "a", "significant", "difference", "in", "comparison", "with", "placebo", "at", "epirubicin", "doses", "of", "300", "mg", "/", "m", "2", "(", "1.67", "±", "0.43", "vs", "1.32", "±", "0.53", "/second", ",", "p", "<", "0.05", ")", "and", "400", "mg", "/", "m", "2", "(", "1.68", "±", "0.29", "vs", "1.40", "±", "0.23", "/second", ",", "p", "<", "0.05", ")", ".", "Moreover", ",", "a", "significant", "increase", "in", "plasma", "concentrations", "of", "ROS", "was", "found", "with", "placebo", ",", "but", "they", "remained", "unchanged", "with", "salidroside", ".", "Salidroside", "can", "provide", "a", "protective", "effect", "on", "epirubicin", "-", "induced", "early", "left", "ventricular", "regional", "systolic", "dysfunction", "in", "patients", "with", "breast", "cancer", "." ]
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733
[ "External", "beam", "accelerated", "partial", "breast", "irradiation", "versus", "whole", "breast", "irradiation", "after", "breast", "conserving", "surgery", "in", "women", "with", "ductal", "carcinoma", "in", "situ", "and", "node", "-", "negative", "breast", "cancer", "(", "RAPID", ")", ":", "a", "randomised", "controlled", "trial", ".", "Whole", "breast", "irradiation", "delivered", "once", "per", "day", "over", "3", "-", "5", "weeks", "after", "breast", "conserving", "surgery", "reduces", "local", "recurrence", "with", "good", "cosmetic", "results", ".", "Accelerated", "partial", "breast", "irradiation", "(", "APBI", ")", "delivered", "over", "1", "week", "to", "the", "tumour", "bed", "was", "developed", "to", "provide", "a", "more", "convenient", "treatment", ".", "In", "this", "trial", ",", "we", "investigated", "if", "external", "beam", "APBI", "was", "non", "-", "inferior", "to", "whole", "breast", "irradiation", ".", "We", "did", "this", "multicentre", ",", "randomised", 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")", ",", "analysed", "by", "intention", "to", "treat", ".", "The", "trial", "was", "designed", "on", "the", "basis", "of", "an", "expected", "5", "year", "IBTR", "rate", "of", "1", "·", "5", "%", "in", "the", "whole", "breast", "irradiation", "group", "with", "85", "%", "power", "to", "exclude", "a", "1", "·", "5", "%", "increase", "in", "the", "APBI", "group", ";", "non", "-", "inferiority", "was", "shown", "if", "the", "upper", "limit", "of", "the", "two", "-", "sided", "90", "%", "CI", "for", "the", "IBTR", "hazard", "ratio", "(", "HR", ")", "was", "less", "than", "2", "·", "02", ".", "This", "trial", "is", "registered", "with", "ClinicalTrials.gov", ",", "NCT", "00282035", ".", "Between", "Feb", "7", ",", "2006", ",", "and", "July", "15", ",", "2011", ",", "we", "enrolled", "2135", "women", ".", "1070", "were", "randomly", "assigned", "to", "receive", "APBI", "and", "1065", "were", "assigned", "to", "receive", "whole", "breast", "irradiation", ".", "Six", "patients", "in", "the", 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"adverse", "cosmesis", ",", "which", "might", "be", "related", "to", "the", "twice", "per", "day", "treatment", ".", "Other", "approaches", ",", "such", "as", "treatment", "once", "per", "day", ",", "might", "not", "adversely", "affect", "cosmesis", "and", "should", "be", "studied", ".", "Canadian", "Institutes", "for", "Health", "Research", "and", "Canadian", "Breast", "Cancer", "Research", "Alliance", "." ]
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734
[ "Dietary", "flaxseed", "alters", "tumor", "biological", "markers", "in", "postmenopausal", "breast", "cancer", ".", "Flaxseed", ",", "the", "richest", "source", "of", "mammalian", "lignan", "precursors", ",", "has", "previously", "been", "shown", "to", "reduce", "the", "growth", "of", "tumors", "in", "rats", ".", "This", "study", "examined", ",", "in", "a", "randomized", "double", "-", "blind", "placebo", "-", "controlled", "clinical", "trial", ",", "the", "effects", "of", "dietary", "flaxseed", "on", "tumor", "biological", "markers", "and", "urinary", "lignan", "excretion", "in", "postmenopausal", "patients", "with", "newly", "diagnosed", "breast", "cancer", ".", "Patients", "were", "randomized", "to", "daily", "intake", "of", "either", "a", "25", "g", "flaxseed", "-", "containing", "muffin", "(", "n", "=", "19", ")", "or", "a", "control", "(", "placebo", ")", "muffin", "(", "n", "=", "13", ")", ".", "At", "the", "time", "of", "diagnosis", "and", "again", "at", "definitive", "surgery", ",", "tumor", "tissue", "was", "analyzed", "for", "the", "rate", "of", "tumor", "cell", "proliferation", "(", "Ki-", "67", "labeling", "index", ",", "primary", "end", "point", ")", ",", "apoptosis", ",", "c", "-", "erbB", "2", "expression", ",", "and", "estrogen", "and", "progesterone", "receptor", "levels", ".", "Twenty", "-", "four", "-", "hour", "urine", "samples", "were", "analyzed", "for", "lignans", ",", "and", "3", "-day", "diet", "records", "were", "evaluated", "for", "macronutrient", "and", "caloric", "intake", ".", "Mean", "treatment", "times", "were", "39", "and", "32", "days", "in", "the", "placebo", "and", "flaxseed", "groups", ",", "respectively", ".", "Reductions", "in", "Ki-", "67", "labeling", "index", "(", "34.2", "%", ";", "P", "=", "0.001", ")", "and", "in", "c", "-", "erbB", "2", "expression", "(", "71.0", "%", ";", "P", "=", "0.003", ")", "and", "an", "increase", "in", "apoptosis", "(", "30.7", "%", ";", "P", "=", "0.007", ")", "were", "observed", "in", "the", "flaxseed", ",", "but", "not", "in", "the", "placebo", "group", ".", "No", "significant", "differences", "in", "caloric", "and", "macronutrient", "intake", "were", "seen", "between", "groups", "and", "between", "pre-", "and", "posttreatment", "periods", ".", "A", "significant", "increase", "in", "mean", "urinary", "lignan", "excretion", "was", "observed", "in", "the", "flaxseed", "group", "(", "1", ",", "300", "%", ";", "P", "<", "0.01", ")", "compared", "with", "placebo", "controls", ".", "The", "total", "intake", "of", "flaxseed", "was", "correlated", "with", "changes", "in", "c", "-", "erbB", "2", "score", "(", "r", "=", "-", "0.373", ";", "P", "=", "0.036", ")", "and", "apoptotic", "index", "(", "r", "=", "0.495", ";", "P", "<", "0.004", ")", ".", "Dietary", "flaxseed", "has", "the", "potential", "to", "reduce", "tumor", "growth", "in", "patients", "with", "breast", "cancer", "." ]
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735
[ "Randomized", "controlled", "trial", "of", "supportive", "care", "interventions", "to", "manage", "psychological", "distress", "and", "symptoms", "in", "Latinas", "with", "breast", "cancer", "and", "their", "informal", "caregivers", ".", "Objective", ":", "The", "purpose", "of", "this", "study", "was", "to", "test", "two", "2", "-month", "psychosocial", "interventions", "(", "Telephone", "Interpersonal", "Counseling", "[", "TIPC", "]", "and", "Supportive", "Health", "Education", "[", "SHE", "]", ")", "to", "improve", "quality", "of", "life", "(", "QOL", ")", "outcomes", "for", "Latinas", "with", "breast", "cancer", "and", "their", "informal", "caregivers", ".", "Methods", ":", "Two", "hundred", "and", "forty", "-", "one", "Latinas", "with", "breast", "cancer", "and", "their", "caregivers", "were", "assessed", "at", "baseline", ",", "immediately", "after", "the", "2", "-month", "intervention", ",", "at", "4", "and", "6", "months", "after", "baseline", ".", "QOL", "outcomes", "were", "psychological", "distress", ",", "symptoms", "and", "social", "support", ".", "Results", ":", "Linear", "mixed", "effects", "models", "showed", "that", "for", "cancer", "survivors", "at", "2", "months", ",", "TIPC", "produced", "lower", "adjusted", "mean", "depression", "scores", "compared", "to", "SHE", ".", "At", "4", "months", ",", "SHE", "had", "reduced", "total", "number", "of", "symptoms", ",", "global", "symptom", "distress", ",", "and", "social", "isolation", "compared", "to", "TIPC", ".", "Only", "total", "number", "of", "symptoms", "was", "lower", "in", "SHE", "than", "in", "TIPC", "at", "6", "months", ".", "Among", "caregivers", "at", "2", "months", ",", "total", "number", "of", "symptoms", ",", "global", "symptom", "distress", ",", "and", "anxiety", "were", "lower", ",", "and", "self", "-", "efficacy", "for", "symptom", "management", "was", "higher", "in", "SHE", "compared", "to", "TIPC", ".", "Caregiver", "depression", "was", "lower", "in", "TIPC", "compared", "to", "SHE", "at", "4", "months", ".", "Conclusions", ":", "These", "telephone", "delivered", "interventions", "improved", "different", "outcomes", ".", "TIPC", "demonstrated", "superior", "benefits", "for", "depression", "management", "and", "SHE", "was", "more", "successful", "in", "anxiety", "and", "cancer", "-", "related", "symptom", "management", "." ]
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736
[ "Site", "of", "primary", "tumor", "has", "a", "prognostic", "role", "in", "operable", "breast", "cancer", ":", "the", "international", "breast", "cancer", "study", "group", "experience", ".", "Cancer", "presenting", "at", "the", "medial", "site", "of", "the", "breast", "may", "have", "a", "worse", "prognosis", "compared", "with", "tumors", "located", "in", "external", "quadrants", ".", "For", "medial", "tumors", ",", "axillary", "lymph", "node", "staging", "may", "not", "accurately", "reflect", "the", "metastatic", "potential", "of", "the", "disease", ".", "Eight", "-", "thousand", "four", "-", "hundred", "twenty", "-", "two", "patients", "randomly", "assigned", "to", "International", "Breast", "Cancer", "Study", "Group", "clinical", "trials", "between", "1978", "and", "1999", "were", "classified", "as", "medial", "site", "(", "1", ",", "622", ";", "19", "%", ")", "or", "lateral", ",", "central", ",", "and", "other", "sites", "(", "6", ",", "800", ";", "81", "%", ")", ".", "Median", "follow", "-", "up", "was", "11", "years", ".", "A", "statistically", "significant", "difference", "was", "observed", "for", "patients", "with", "medial", "tumors", "versus", "those", "with", "nonmedial", "tumors", "in", "disease", "-", "free", "survival", "(", "DFS", ";", "10", "-year", "DFS", ",", "46", "%", "v", "48", "%", ";", "HR", ",", "1.10", ";", "95", "%", "CI", ",", "1.02", "to", "1.18", ";", "P", "=", ".", "01", ")", "and", "overall", "survival", "(", "10", "-year", "OS", "59", "%", "v", "61", "%", ";", "HR", ",", "1.09", ";", "1.01", "to", "1.19", ";", "P", "=", ".", "04", ")", ".", "This", "difference", "increased", "after", "adjustment", "for", "other", "prognostic", "factors", "(", "HR", ",", "1.22", ";", "95", "%", "CI", ",", "1.13", "to", "1.32", "for", "DFS", ";", "and", "HR", ",", "1.24", ";", "95", "%", "CI", ",", "1.14", "to", "1.35", "for", "OS", ";", "both", "P", "=", ".", "0001", ")", ".", "The", "risk", "of", "relapse", "for", "patients", "with", "medial", "presentation", "was", "largest", "for", "the", "node", "-", "negative", "cohort", "and", "for", "patients", "with", "tumors", "larger", "than", "2", "cm", ".", "In", "the", "subgroup", "of", "2", ",", "931", "patients", "with", "negative", "axillary", "lymph", "nodes", ",", "10", "-year", "DFS", "was", "61", "%", "v", "67", "%", ",", "and", "OS", "was", "73", "%", "v", "80", "%", "for", "medial", "versus", "nonmedial", "sites", ",", "respectively", "(", "HR", "1.33", ";", "95", "%", "CI", ",", "1.15", "to", "1.54", ";", "P", "=", ".", "0001", "for", "DFS", ";", "and", "HR", "1.40", ";", "95", "%", "CI", ",", "1.17", "to", "1.67", ";", "P", "=", ".", "0003", "for", "OS", ")", ".", "Tumor", "site", "has", "a", "significant", "prognostic", "utility", ",", "especially", "for", "axillary", "lymph", "node", "-", "negative", "disease", ",", "that", "should", "be", "considered", "in", "therapeutic", "algorithms", ".", "New", "staging", "procedures", "such", "as", "biopsy", "of", "the", "sentinel", "internal", "mammary", "nodes", "or", "novel", "imaging", "methods", "should", "be", "further", "studied", "in", "patients", "with", "medial", "tumors", "." ]
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737
[ "Melatonin", "for", "Prevention", "of", "Breast", "Radiation", "Dermatitis", ":", "A", "Phase", "II", ",", "Prospective", ",", "Double", "-", "Blind", "Randomized", "Trial", ".", "Radiation", "-", "induced", "dermatitis", "is", "commonly", "seen", "during", "radiotherapy", "for", "breast", "cancer", ".", "Melatonin", "-", "based", "creams", "have", "shown", "a", "protective", "effect", "against", "ultraviolet", "-", "induced", "erythema", "and", "a", "radioprotective", "effect", "in", "rats", ".", "To", "evaluate", "the", "efficacy", "of", "melatonin", "-", "containing", "cream", "in", "minimizing", "acute", "radiation", "dermatitis", ".", "In", "this", "phase", "II", ",", "prospective", ",", "randomized", ",", "placebo", "-", "controlled", "double", "-", "blind", "study", ",", "patients", "who", "underwent", "breast", "-", "conserving", "surgery", "for", "stage", "0", "-", "2", "breast", "cancer", "were", "randomly", "allocated", "to", "melatonin", "emulsion", "(", "26", "women", ")", "or", "placebo", "(", "21", "women", ")", "for", "twice", "daily", "use", "during", "radiation", "treatment", "and", "2", "weeks", "following", "the", "end", "of", "radiotherapy", ".", "All", "women", "received", "50", "Gy", "whole", "breast", "radiation", "therapy", "with", "2", "Gy", "/", "fx", "using", "computed", "tomography", "-", "based", "3", "D", "planning", ".", "Patients", "were", "examined", "and", "completed", "a", "detailed", "questionnaire", "weekly", "and", "2", "weeks", "following", "the", "end", "of", "treatment", ".", "The", "occurrence", "of", "grade", "1", "/", "2", "acute", "radiation", "dermatitis", "was", "significantly", "lower", "(", "59", "%", "vs.", "90", "%", ",", "P", "=", "0.038", ")", "in", "the", "melatonin", "group", ".", "Women", "older", "than", "50", "had", "significantly", "less", "dermatitis", "than", "younger", "patients", "(", "56", "%", "vs.", "100", "%", ",", "P", "=", "0.021", ")", ".", "The", "maximal", "radiation", "dermatitis", "in", "the", "study", "group", "was", "grade", "2", "in", "15", "%", "of", "the", "treated", "patients", ".", "Patients", "treated", "with", "melatonin", "-", "containing", "emulsion", "experienced", "significantly", "reduced", "radiation", "dermatitis", "compared", "to", "patients", "receiving", "placebo", "." ]
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738
[ "\"", "Promoting", "Early", "Presentation", "\"", "intervention", "sustains", "increased", "breast", "cancer", "awareness", "in", "older", "women", "for", "three", "years", ":", "A", "randomized", "controlled", "trial", ".", "Objective", "In", "a", "randomized", "controlled", "trial", ",", "the", "Promoting", "Early", "Presentation", "intervention", "increased", "older", "women", "'s", "breast", "cancer", "awareness", "after", "two", "years", ".", "We", "investigated", "whether", "this", "increase", "was", "sustained", "at", "three", "years", ",", "and", "the", "effect", "on", "breast", "screening", "self", "-", "referral", ".", "Methods", "We", "randomly", "allocated", "867", "women", "attending", "their", "final", "invited", "breast", "screening", "appointment", "to", "the", "Promoting", "Early", "Presentation", "intervention", "or", "usual", "care", ".", "We", "examined", "breast", "cancer", "awareness", "after", "three", "years", "and", "breast", "screening", "self", "-", "referrals", "after", "four", "years", ".", "Results", "Women", "in", "the", "Promoting", "Early", "Presentation", "intervention", "arm", "had", "higher", "breast", "cancer", "awareness", "at", "three", "years", "than", "the", "usual", "care", "arm", "(", "odds", "ratio", ":", "10.4", ";", "95", "%", "confidence", "interval", ":", "3.1", "to", "34.8", ")", ".", "There", "were", "no", "differences", "in", "proportions", "self", "-", "referring", "for", "breast", "screening", "between", "arms", ",", "but", "statistical", "power", "was", "limited", ".", "Conclusion", "The", "Promoting", "Early", "Presentation", "intervention", "has", "a", "sustained", "effect", "on", "breast", "cancer", "awareness", "in", "older", "women", ".", "The", "effect", "on", "self", "-", "referral", "for", "breast", "screening", "is", "unclear", "." ]
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739
[ "[", "Clinical", "value", "of", "combined", "therapy", "with", "188", "Re", "-", "HEDP", "and", "pamidronate", "in", "breast", "cancer", "with", "bone", "metastasis", "]", ".", "To", "evaluate", "the", "clinical", "therapeutic", "value", "of", "(", "188", ")", "Re", "-", "HEDP", "combined", "with", "pamidronate", "in", "breast", "cancer", "with", "bone", "metastasis", ".", "Forty", "-", "eight", "patients", "with", "breast", "cancer", "with", "multi", "-", "bone", "metastases", "were", "randomly", "divided", "into", "three", "groups", ":", "15", "patients", "received", "(", "188", ")", "Re", "-", "HEDP", "(", "group", "A", ")", ",", "15", "patients", "received", "pamidronate", "(", "group", "B", ")", "and", "18", "patients", "were", "treated", "by", "(", "188", ")", "Re", "-", "HEDP", "plus", "pamidronate", "(", "group", "C", ")", ".", "The", "overall", "pain", "relief", "rate", "was", "73.3", "%", ",", "80.0", "%", ",", "100.0", "%", "in", "groups", "A", ",", "B", "and", "C", ".", "The", "response", "rate", "of", "bone", "metastasis", "was", "40.0", "%", ",", "33.3", "%", ",", "66.7", "%", "in", "groups", "A", ",", "B", "and", "C", "respectively", ".", "The", "therapeutic", "effect", "of", "group", "C", "was", "better", "than", "those", "of", "groups", "A", "and", "B", "(", "P", "<", "0.05", ")", ",", "without", "any", "significance", "in", "the", "difference", "(", "P", ">", "0.05", ")", ".", "The", "therapeutic", "effect", "of", "(", "188", ")", "Re", "-", "HEDP", "combined", "with", "pamidronate", "for", "breast", "cancer", "with", "bone", "metastasis", "is", "remarkable", "in", "bone", "pain", "relief", "and", "bone", "metastasis", "control", ",", "which", "is", "better", "than", "either", "(", "188", ")", "Re", "-", "HEDP", "or", "pamidronate", "alone", "." ]
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740
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741
[ "Overall", "survival", "results", "from", "the", "randomized", "phase", "2", "study", "of", "palbociclib", "in", "combination", "with", "letrozole", "versus", "letrozole", "alone", "for", "first", "-", "line", "treatment", "of", "ER+", "/", "HER", "2", "-", "advanced", "breast", "cancer", "(", "PALOMA-", "1", ",", "TRIO-", "18", ")", ".", "Palbociclib", "is", "a", "cyclin", "-", "dependent", "kinase", "4", "/", "6", "(", "CDK", "4", "/", "6", ")", "inhibitor", ",", "approved", "in", "combination", "with", "endocrine", "therapy", "for", "the", "treatment", "of", "women", "and", "men", "with", "hormone", "receptor", "-", "positive", ",", "human", "epidermal", "growth", "factor", "receptor", "2", "-negative", "advanced", "breast", "cancer", "(", "HR+", "/", "HER", "2", "-", "ABC", ")", ".", "In", "the", "phase", "2", ",", "open", "-", "label", ",", "PALOMA-", "1", "trial", ",", "palbociclib", "plus", "letrozole", "significantly", "prolonged", "progression", "-", "free", "survival", "(", "PFS", ")", "versus", "letrozole", "alone", "(", "hazard", "ratio", ",", "0.488", ";", "95", "%", "CI", "0.319", "‒", "0.748", ";", "P", "=", "0.0004", ";", "median", "PFS", ",", "20.2", "vs", "10.2", "months", ",", "respectively", ")", "in", "postmenopausal", "women", "with", "estrogen", "receptor", "-", "positive", "(", "ER+", ")", "/", "HER", "2", "-", "ABC", ".", "Here", ",", "we", "present", "the", "final", "overall", "survival", "(", "OS", ")", "and", "updated", "safety", "results", ".", "Postmenopausal", "women", "with", "ER+", "/", "HER", "2", "-", "ABC", "were", "randomized", "1", ":1", "to", "receive", "either", "palbociclib", "(", "125", "mg", "/", "day", ",", "3", "/", "1", "schedule", ")", "plus", "letrozole", "(", "2.5", "mg", "/", "day", ",", "continuous", ")", "or", "letrozole", "alone", "(", "2.5", "mg", "/", "day", ",", "continuous", ")", ".", "The", "primary", "endpoint", "was", "investigator", "-", "assessed", "PFS", ";", "secondary", "endpoints", "included", "OS", "and", "safety", ".", "A", "total", "of", "165", "patients", "were", "randomized", ".", "At", "the", "data", "cutoff", "date", "of", "December", "30", ",", "2016", "(", "median", "duration", "of", "follow", "-", "up", ",", "64.7", "months", ")", ",", "the", "stratified", "hazard", "ratio", "for", "OS", "was", "0.897", "(", "95", "%", "CI", "0.623", "-", "1.294", ";", "P", "=", "0.281", ")", ";", "median", "OS", "in", "the", "palbociclib", "plus", "letrozole", "and", "letrozole", "alone", "arms", "was", "37.5", "and", "34.5", "months", ",", "respectively", ".", "The", "median", "time", "from", "randomization", "to", "first", "subsequent", "chemotherapy", "use", "was", "longer", "with", "palbociclib", "plus", "letrozole", "than", "letrozole", "alone", "(", "26.7", "and", "17.7", "months", ",", "respectively", ")", ".", "The", "most", "frequently", "reported", "adverse", "event", "in", "the", "palbociclib", "plus", "letrozole", "arm", "was", "neutropenia", "(", "any", "grade", ",", "75", "%", ";", "grade", "3", "or", "4", ",", "59", "%", ")", ".", "Palbociclib", "plus", "letrozole", "treatment", "led", "to", "a", "numerical", "but", "not", "statistically", "significant", "improvement", "in", "median", "OS", ".", "Pfizer", "Inc", "(", "NCT", "00721409", ")", "." ]
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742
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743
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744
[ "Effect", "of", "Metformin", "on", "Breast", "Ductal", "Carcinoma", "In", "Situ", "Proliferation", "in", "a", "Randomized", "Presurgical", "Trial", ".", "Metformin", "is", "associated", "with", "lower", "breast", "cancer", "risk", "in", "epidemiologic", "studies", "and", "showed", "decreased", "proliferation", "in", "HER", "2", "-", "positive", "breast", "cancer", "in", "a", "presurgical", "trial", ".", "To", "provide", "insight", "into", "its", "preventive", "potential", ",", "we", "measured", "proliferation", "by", "Ki-", "67", "labeling", "index", "(", "LI", ")", "of", "intraepithelial", "lesions", "surrounding", "breast", "cancer", ".", "We", "randomly", "assigned", "200", "nondiabetic", "patients", "diagnosed", "with", "invasive", "breast", "cancer", "in", "core", "biopsies", "to", "metformin", ",", "1", ",", "700", "mg", "or", "placebo", "once", "daily", "for", "28", "days", "before", "surgery", ".", "Upon", "surgery", ",", "five", "to", "seven", "specimens", "of", "cancer", "adjacent", "(", "≤", "1", "cm", ")", "and", "distant", "(", ">", "1", "cm", ")", "tissue", "were", "screened", "for", "LCIS", ",", "ductal", "carcinoma", "in", "situ", "(", "DCIS", ")", ",", "and", "ductal", "hyperplasia", "(", "DH", ")", ".", "The", "prevalence", "of", "LCIS", ",", "DCIS", ",", "and", "DH", "was", "4.5", "%", "(", "9", "/", "200", ")", ",", "67", "%", "(", "133", "/", "200", ")", ",", "and", "35", "%", "(", "69", "/", "200", ")", ",", "respectively", ".", "Overall", ",", "metformin", "did", "not", "affect", "Ki-", "67", "LI", "in", "premalignant", "disorders", ".", "The", "median", "posttreatment", "Ki-", "67", "LI", "(", "IQR", ")", "in", "the", "metformin", "and", "placebo", "arm", "was", ",", "respectively", ",", "15", "%", "(", "5", "-", "15", ")", "versus", "5", "%", "(", "4", "-", "6", ")", "in", "LCIS", "(", "P", "=", "0.1", ")", ",", "12", "%", "(", "8", "-", "20", ")", "versus", "10", "%", "(", "7", "-", "24", ")", "in", "DCIS", "(", "P", "=", "0.9", ")", ",", "and", "3", "%", "(", "1", "-", "4", ")", "versus", "3", "%", "(", "1", "-", "4", ")", "in", "DH", "(", "P", "=", "0.5", ")", ".", "However", ",", "posttreatment", "Ki-", "67", "in", "HER", "2", "-", "positive", "DCIS", "lesions", "was", "significantly", "lower", "in", "women", "randomized", "to", "metformin", "especially", "when", "ER", "was", "coexpressed", ":", "22", "%", "(", "11", "-", "32", ")", "versus", "35", "%", "(", "30", "-", "40", ")", "in", "HER", "2", "-", "positive", "DCIS", "(", "n", "=", "22", ",", "P", "=", ".", "06", ")", ";", "12", "%", "(", "7", "-", "18", ")", "versus", "32", "%", "(", "27", "-", "42", ")", "in", "ER", "-", "positive", "/", "HER", "2", "-", "positive", "DCIS", "(", "n", "=", "15", ",", "P", "=", ".", "004", ")", ".", "Eight", "of", "22", "(", "36", "%", ")", "HER", "2", "-", "positive", "DCIS", "were", "adjacent", "to", "HER", "2", "-", "negative", "invasive", "breast", "cancer", ".", "In", "tissue", "samples", "obtained", "following", "4", "weeks", "of", "study", "drug", ",", "proliferation", "was", "lower", "in", "HER", "2", "-", "positive", "DCIS", "for", "women", "randomized", "to", "metformin", "versus", "placebo", ".", "An", "adjuvant", "trial", "incorporating", "metformin", "in", "HER", "2", "-", "positive", "DCIS", "is", "warranted", "." ]
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745
[ "Exploring", "the", "Feasibility", "of", "a", "Broad", "-", "Reach", "Physical", "Activity", "Behavior", "Change", "Intervention", "for", "Women", "Receiving", "Chemotherapy", "for", "Breast", "Cancer", ":", "A", "Randomized", "Trial", ".", "Facilitating", "healthy", "levels", "of", "physical", "activity", "(", "PA", ")", "during", "chemotherapy", "is", "important", "for", "the", "psychosocial", "and", "physical", "health", "of", "breast", "cancer", "survivors", ".", "The", "primary", "objective", "of", "this", "feasibility", "study", "was", "to", "examine", "the", "effects", "of", "a", "broad", "-", "reach", "PA", "behavior", "change", "intervention", "among", "women", "with", "breast", "cancer", "receiving", "adjuvant", "chemotherapy", ".", "Breast", "cancer", "patients", "receiving", "adjuvant", "chemotherapy", "(", "N", "=", "95", ")", "were", "randomly", "assigned", "to", "receive", "a", "PA", "resource", "kit", "consisting", "of", "tailored", "print", "materials", "and", "a", "step", "pedometer", "(", "intervention", ")", "or", "a", "standard", "public", "health", "PA", "recommendation", "(", "standard", "recommendation", ")", ".", "The", "primary", "outcome", "was", "daily", "pedometer", "steps", ".", "Secondary", "outcomes", "were", "self", "-", "reported", "light", ",", "moderate", ",", "and", "vigorous", "intensity", "PA", ",", "total", "moderate", "-", "to", "-", "vigorous", "PA", ",", "and", "sedentary", "time", ".", "Assessments", "were", "conducted", "before", "and", "after", "adjuvant", "chemotherapy", ".", "Attrition", "was", "19", "%", "(", "17", "of", "95", ")", ".", "Intervention", "patients", "wore", "their", "step", "pedometer", "for", "85", "days", "(", "range", ",", "35", "-", "144", "days", ";", "SD", "=", "26.4", ")", "for", "a", "95", "%", "adherence", "rate", ".", "Analyses", "of", "covariance", "suggested", "that", "the", "intervention", "was", "not", "statistically", "superior", "to", "standard", "recommendation", "for", "daily", "average", "pedometer", "steps", "(", "-", "771", ";", "95", "%", "CI", "=", "-", "2024", "to", "482", ";", "P", "=", "0.22", ")", ",", "total", "MVPA", "minutes", "(", "-", "4", ";", "95", "%", "CI", "=", "-", "62", "to", "570", ";", "P", "=", "0.90", ")", ",", "or", "sedentary", "time", "(", "+", "160", ";", "95", "%", "CI", "=", "-", "186", "to", "506", ";", "P", "=", "0.42", ")", ".", "This", "broach", "-", "reach", "and", "low", "intensive", "intervention", "was", "not", "more", "effective", "for", "promoting", "PA", "in", "breast", "cancer", "patients", "receiving", "chemotherapy", "than", "providing", "the", "standard", "public", "health", "guidelines", "for", "PA", ".", "Achieving", "physical", "activity", "behavior", "change", "during", "adjuvant", "breast", "cancer", "chemotherapy", "may", "require", "some", "level", "of", "supervised", "physical", "activity", "or", "more", "intensive", "(", "e.g.", ",", "face", "-", "to", "-", "face", ",", "supervised", ")", "interventions", "." ]
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746
[ "A", "randomized", "comparison", "of", "sentinel", "-", "node", "biopsy", "with", "routine", "axillary", "dissection", "in", "breast", "cancer", ".", "Although", "numerous", "studies", "have", "shown", "that", "the", "status", "of", "the", "sentinel", "node", "is", "an", "accurate", "predictor", "of", "the", "status", "of", "the", "axillary", "nodes", "in", "breast", "cancer", ",", "the", "efficacy", "and", "safety", "of", "sentinel", "-", "node", "biopsy", "require", "validation", ".", "From", "March", "1998", "to", "December", "1999", ",", "we", "randomly", "assigned", "516", "patients", "with", "primary", "breast", "cancer", "in", "whom", "the", "tumor", "was", "less", "than", "or", "equal", "to", "2", "cm", "in", "diameter", "either", "to", "sentinel", "-", "node", "biopsy", "and", "total", "axillary", "dissection", "(", "the", "axillary", "-", "dissection", "group", ")", "or", "to", "sentinel", "-", "node", "biopsy", "followed", "by", "axillary", "dissection", "only", "if", "the", "sentinel", "node", "contained", "metastases", "(", "the", "sentinel", "-", "node", "group", ")", ".", "The", "number", "of", "sentinel", "nodes", "found", "was", "the", "same", "in", "the", "two", "groups", ".", "A", "sentinel", "node", "was", "positive", "in", "83", "of", "the", "257", "patients", "in", "the", "axillary", "-", "dissection", "group", "(", "32.3", "percent", ")", ",", "and", "in", "92", "of", "the", "259", "patients", "in", "the", "sentinel", "-", "node", "group", "(", "35.5", "percent", ")", ".", "In", "the", "axillary", "-", "dissection", "group", ",", "the", "overall", "accuracy", "of", "the", "sentinel", "-", "node", "status", "was", "96.9", "percent", ",", "the", "sensitivity", "91.2", "percent", ",", "and", "the", "specificity", "100", "percent", ".", "There", "was", "less", "pain", "and", "better", "arm", "mobility", "in", "the", "patients", "who", "underwent", "sentinel", "-", "node", "biopsy", "only", "than", "in", "those", "who", "also", "underwent", "axillary", "dissection", ".", "There", "were", "15", "events", "associated", "with", "breast", "cancer", "in", "the", "axillary", "-", "dissection", "group", "and", "10", "such", "events", "in", "the", "sentinel", "-", "node", "group", ".", "Among", "the", "167", "patients", "who", "did", "not", "undergo", "axillary", "dissection", ",", "there", "were", "no", "cases", "of", "overt", "axillary", "metastasis", "during", "follow", "-", "up", ".", "Sentinel", "-", "node", "biopsy", "is", "a", "safe", "and", "accurate", "method", "of", "screening", "the", "axillary", "nodes", "for", "metastasis", "in", "women", "with", "a", "small", "breast", "cancer", "." ]
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747
[ "Acupuncture", "relieves", "menopausal", "discomfort", "in", "breast", "cancer", "patients", ":", "a", "prospective", ",", "double", "blinded", ",", "randomized", "study", ".", "This", "study", "evaluates", "the", "effect", "of", "acupuncture", "on", "hot", "flashes", "and", "disturbed", "night", "sleep", "in", "patients", "treated", "for", "breast", "cancer", ".", "The", "effect", "of", "acupuncture", "was", "tested", "against", "a", "sham", "-", "acupuncture", "group", "and", "a", "no", "-", "treatment", "control", "group", ".", "Plasma", "estradiol", "was", "measured", "to", "rule", "out", "this", "as", "cause", "of", "effect", ".", "Side", "effects", "of", "the", "treatment", "were", "registered", ".", "We", "randomized", "94", "women", "into", "the", "study", ":", "31", "had", "acupuncture", ",", "29", "had", "sham", "acupuncture", "and", "34", "had", "no", "treatment", ".", "In", "the", "acupuncture", "group", ",", "16", "patients", "(", "52", "%", ")", "experienced", "a", "significant", "effect", "on", "hot", "flashes", "compared", "with", "seven", "patients", "(", "24", "%", ")", "in", "the", "sham", "group", "(", "p", "<", "0.05", ")", ".", "The", "effect", "came", "after", "the", "second", "acupuncture", "session", "and", "lasted", "for", "at", "least", "12", "weeks", "after", "last", "treatment", ".", "A", "statistically", "significant", "positive", "effect", "was", "seen", "on", "sleep", "in", "the", "acupuncture", "group", "compared", "with", "the", "sham", "-", "acupuncture", "and", "no", "-", "treatment", "groups", ".", "The", "effect", "was", "not", "correlated", "with", "increased", "levels", "of", "plasma", "estradiol", ".", "No", "side", "effects", "of", "acupuncture", "were", "registered", ".", "We", "find", "that", "acupuncture", "significantly", "relieves", "hot", "flashes", "and", "sleep", "disturbances", "and", "is", "a", "good", "and", "safe", "treatment", "in", "women", "treated", "for", "breast", "cancer", "." ]
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748
[ "Amisulpride", "prevents", "nausea", "and", "vomiting", "associated", "with", "highly", "emetogenic", "chemotherapy", ":", "a", "randomised", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", ",", "dose", "-", "ranging", "trial", ".", "Chemotherapy", "-", "induced", "nausea", "and", "vomiting", "(", "CINV", ")", "remain", "significant", "clinical", "problems", ",", "especially", "in", "the", "delayed", "phase", "(", "24", "-", "120", "h", "after", "chemotherapy", ")", ".", "Amisulpride", "is", "a", "dopamine", "D", "2", "/", "D", "3", "-", "receptor", "antagonist", "previously", "shown", "to", "be", "an", "effective", "intravenous", "antiemetic", ".", "We", "conducted", "a", "randomised", ",", "double", "-", "blind", "study", "to", "characterise", "the", "dose", "response", "of", "oral", "amisulpride", "in", "delayed", "phase", "CINV", ".", "Chemotherapy", "-", "naïve", "patients", "receiving", "cisplatin", "≥", "70", "mg", "/", "m", "2", "or", "an", "anthracycline", "-", "cyclophosphamide", "regimen", "for", "breast", "cancer", "received", ",", "on", "day", "1", ",", "20", "mg", "amisulpride", "and", "8", "-", "16", "mg", "ondansetron", "intravenously", "followed", ",", "once", "daily", "on", "days", "2", "-", "4", ",", "by", "10", ",", "20", "or", "40", "mg", "oral", "amisulpride", "or", "placebo", ".", "A", "control", "group", "receiving", "standard", "three", "-", "drug", "prophylaxis", "was", "enrolled", "for", "assay", "sensitivity", "purposes", ".", "The", "primary", "endpoint", "was", "complete", "response", "(", "CR", ")", ",", "defined", "as", "no", "emesis", "or", "rescue", "medication", "use", ",", "in", "the", "delayed", "phase", ".", "Three", "hundred", "eighteen", "subjects", "were", "evaluable", "per", "protocol", ".", "CR", "rate", "(", "24", "-", "120", "h", ")", "was", "20", "%", "with", "placebo", "and", "46", "%", "with", "10", "mg", "amisulpride", "(", "p", "=", "0.006", "after", "multiplicity", "adjustment", ")", ";", "in", "the", "three", "-", "drug", "control", "group", ",", "it", "was", "59", "%", ".", "Emesis", ",", "nausea", "and", "0", "-", "120", "-", "h", "CR", "rate", "were", "significantly", "improved", "with", "10", "mg", "amisulpride", "compared", "to", "placebo", ".", "Higher", "doses", "of", "amisulpride", "were", "not", "more", "effective", "than", "10", "mg", ".", "In", "patients", "with", "acute", "phase", "CR", ",", "delayed", "phase", "CR", "rate", "was", "44", "%", "for", "placebo", ",", "75", "%", "for", "10", "mg", "amisulpride", "(", "p", "=", "0.022", ")", "and", "70", "%", "for", "the", "3", "-drug", "control", ".", "No", "significant", "differences", "were", "seen", "between", "groups", "in", "safety", "parameters", ".", "Amisulpride", "10", "mg", "orally", "is", "safe", "and", "superior", "to", "placebo", "at", "preventing", "delayed", "CINV", "caused", "by", "highly", "emetogenic", "chemotherapy", ".", "NCT", "01857232", "." ]
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749
[ "Augmentation", "of", "venlafaxine", "and", "selective", "serotonin", "reuptake", "inhibitors", "with", "zolpidem", "improves", "sleep", "and", "quality", "of", "life", "in", "breast", "cancer", "patients", "with", "hot", "flashes", ":", "a", "randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "trial", ".", "Hot", "flashes", "are", "a", "major", "quality", "-", "of", "-", "life", "issue", "for", "breast", "cancer", "survivors", ",", "interrupting", "sleep", ",", "reducing", "quality", "of", "life", ",", "and", "diminishing", "treatment", "adherence", "to", "adjuvant", "endocrine", "therapies", ".", "Serotonin", "-", "norepinephrine", "reuptake", "inhibitors", "(", "SNRIs", ")", "and", "selective", "serotonin", "reuptake", "inhibitors", "(", "SSRIs", ")", "are", "used", "widely", "but", "are", "only", "partially", "effective", "for", "hot", "flashes", ".", "Alternative", "strategies", "are", "needed", ".", "We", "hypothesized", "that", "augmentation", "of", "SSRI", "/", "SNRI", "therapy", "with", "hypnotic", "agents", "would", "optimize", "hot", "flash", "therapy", "by", "improving", "sleep", "and", "quality", "of", "life", ".", "Women", "with", "breast", "cancer", "or", "at", "high", "risk", "for", "developing", "the", "disease", "who", "had", "hot", "flashes", "in", "association", "with", "nocturnal", "awakenings", "were", "randomized", "to", "double", "-", "blinded", "treatment", "with", "zolpidem", "10", "mg", "or", "placebo", "for", "5", "weeks", ".", "SSRI", "/", "SNRI", "nonusers", "(", "81", "%", ")", "started", "venlafaxine", "XR", "75", "mg", "/", "day", "concurrently", ",", "whereas", "SSRI", "/", "SNRI", "users", "continued", "that", "therapy", ".", "We", "compared", "the", "proportion", "of", "responders", ",", "defined", "as", "study", "completers", "with", "improved", "subjective", "sleep", "quality", "(", "Pittsburgh", "Sleep", "Quality", "Index", ")", "and/or", "objectively", "assessed", "wake", "time", "after", "sleep", "onset", "on", "actigraphy", ",", "between", "groups", ".", "Of", "53", "women", "(", "aged", "51", "±", "8", "y", ")", "randomized", "to", "zolpidem", "augmentation", "(", "n", "=", "25", ")", "or", "placebo", "augmentation", "(", "n", "=", "28", ")", ",", "38", "completed", "the", "protocol", "(", "57", "%", "on", "placebo", ",", "88", "%", "on", "zolpidem", ")", ".", "More", "women", "augmented", "with", "zolpidem", "than", "placebo", "were", "responders", "on", "the", "sleep", "outcome", "(", "40", "%", "vs", "14", "%", ";", "P", "=", "0.035", ")", ".", "Quality", "of", "life", "improved", "more", "with", "zolpidem", "than", "with", "placebo", "(", "P", "=", "0.01", ")", ".", "Treatment", "effects", "on", "hot", "flashes", "and", "mood", "did", "not", "differ", "between", "groups", ".", "Augmentation", "of", "SSRI", "/", "SNRI", "with", "zolpidem", "improves", "sleep", "and", "quality", "of", "life", "in", "breast", "cancer", "survivors", "with", "hot", "flashes", "and", "associated", "sleep", "disturbance", ".", "Adding", "a", "hypnotic", "agent", "to", "an", "SSRI", "/", "SNRI", "helps", "women", "to", "sleep", "through", "nighttime", "hot", "flashes", ".", "Treatments", "targeting", "sleep", "may", "be", "an", "important", "supplemental", "strategy", "to", "optimize", "well", "-", "being", "." ]
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750
[ "Denosumab", "compared", "with", "zoledronic", "acid", "for", "the", "treatment", "of", "bone", "metastases", "in", "patients", "with", "advanced", "breast", "cancer", ":", "a", "randomized", ",", "double", "-", "blind", "study", ".", "This", "randomized", "study", "compared", "denosumab", ",", "a", "fully", "human", "monoclonal", "antibody", "against", "receptor", "activator", "of", "nuclear", "factor", "κ", "B", "(", "RANK", ")", "ligand", ",", "with", "zoledronic", "acid", "in", "delaying", "or", "preventing", "skeletal", "-", "related", "events", "(", "SREs", ")", "in", "patients", "with", "breast", "cancer", "with", "bone", "metastases", ".", "Patients", "were", "randomly", "assigned", "to", "receive", "either", "subcutaneous", "denosumab", "120", "mg", "and", "intravenous", "placebo", "(", "n", "=", "1", ",", "026", ")", "or", "intravenous", "zoledronic", "acid", "4", "mg", "adjusted", "for", "creatinine", "clearance", "and", "subcutaneous", "placebo", "(", "n", "=", "1", ",", "020", ")", "every", "4", "weeks", ".", "All", "patients", "were", "strongly", "recommended", "to", "take", "daily", "calcium", "and", "vitamin", "D", "supplements", ".", "The", "primary", "end", "point", "was", "time", "to", "first", "on", "-", "study", "SRE", "(", "defined", "as", "pathologic", "fracture", ",", "radiation", "or", "surgery", "to", "bone", ",", "or", "spinal", "cord", "compression", ")", ".", "Denosumab", "was", "superior", "to", "zoledronic", "acid", "in", "delaying", "time", "to", "first", "on", "-", "study", "SRE", "(", "hazard", "ratio", ",", "0.82", ";", "95", "%", "CI", ",", "0.71", "to", "0.95", ";", "P", "=", ".", "01", "superiority", ")", "and", "time", "to", "first", "and", "subsequent", "(", "multiple", ")", "on", "-", "study", "SREs", "(", "rate", "ratio", ",", "0.77", ";", "95", "%", "CI", ",", "0.66", "to", "0.89", ";", "P", "=", ".", "001", ")", ".", "Reduction", "in", "bone", "turnover", "markers", "was", "greater", "with", "denosumab", ".", "Overall", "survival", ",", "disease", "progression", ",", "and", "rates", "of", "adverse", "events", "(", "AEs", ")", "and", "serious", "AEs", "were", "similar", "between", "groups", ".", "An", "excess", "of", "renal", "AEs", "and", "acute", "-", "phase", "reactions", "occurred", "with", "zoledronic", "acid", ";", "hypocalcemia", "occurred", "more", "frequently", "with", "denosumab", ".", "Osteonecrosis", "of", "the", "jaw", "occurred", "infrequently", "(", "2.0", "%", ",", "denosumab", ";", "1.4", "%", ",", "zoledronic", "acid", ";", "P", "=", ".", "39", ")", ".", "Denosumab", "was", "superior", "to", "zoledronic", "acid", "in", "delaying", "or", "preventing", "SREs", "in", "patients", "with", "breast", "cancer", "metastatic", "to", "bone", "and", "was", "generally", "well", "tolerated", ".", "With", "the", "convenience", "of", "a", "subcutaneous", "injection", "and", "no", "requirement", "for", "renal", "monitoring", ",", "denosumab", "represents", "a", "potential", "treatment", "option", "for", "patients", "with", "bone", "metastases", "." ]
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751
[ "Venlafaxine", "is", "superior", "to", "clonidine", "as", "treatment", "of", "hot", "flashes", "in", "breast", "cancer", "patients", "--", "a", "double", "-", "blind", ",", "randomized", "study", ".", "Classical", "hormone", "replacement", "therapy", "for", "hot", "flashes", "is", "contraindicated", "in", "breast", "cancer", "especially", "in", "endocrine", "responsive", "disease", ".", "In", "a", "double", "-", "blind", ",", "randomized", "phase", "III", "study", ",", "breast", "cancer", "patients", "suffering", "from", "hot", "flashes", "at", "least", "twice", "a", "day", ",", "who", "were", "not", "taking", "any", "medication", "against", "hypertension", "and", "depression", "received", "either", "clonidine", "0.075", "mg", "twice", "a", "day", "or", "venlafaxine", "37.5", "mg", "twice", "a", "day", "for", "4", "weeks", ".", "The", "primary", "end", "point", "was", "defined", "as", "the", "frequency", "of", "hot", "flashes", "after", "4", "weeks", "of", "treatment", ".", "A", "self", "-", "reported", "1", "-week", "hot", "flash", "and", "other", "symptom", "questionnaire", "were", "kept", "before", "the", "start", "of", "treatment", "until", "the", "end", "of", "treatment", "course", ".", "From", "April", "2002", "to", "October", "2004", ",", "80", "patients", "were", "recruited", "of", "whom", "64", "were", "assessable", "for", "efficacy", "analyses", ".", "Thirty", "-", "three", "received", "clonidine", "and", "31", "venlafaxine", ",", "nine", "patients", "stopped", "early", "because", "of", "side", "-", "effects", "and", "seven", "withdrew", "consent", ".", "At", "the", "end", "of", "treatment", "week", "4", ",", "the", "median", "hot", "flash", "frequency", "dropped", "by", "7.6", "hot", "flashes", "per", "day", "for", "patients", "receiving", "venlafaxine", "and", "4.85", "hot", "flashes", "per", "day", "for", "those", "receiving", "clonidine", "(", "P", "=", "0.025", ")", ".", "Venlafaxine", "is", "significantly", "more", "effective", "in", "reducing", "the", "frequency", "of", "hot", "flashes", "in", "breast", "cancer", "patients", "than", "clonidine", "." ]
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752
[ "Effects", "of", "exercise", "during", "adjuvant", "chemotherapy", "on", "breast", "cancer", "outcomes", ".", "Observational", "studies", "suggest", "that", "physical", "activity", "after", "a", "breast", "cancer", "diagnosis", "is", "associated", "with", "improved", "cancer", "outcomes", ";", "however", ",", "no", "randomized", "data", "are", "available", ".", "Here", ",", "we", "report", "an", "exploratory", "follow", "-", "up", "of", "cancer", "outcomes", "from", "the", "Supervised", "Trial", "of", "Aerobic", "versus", "Resistance", "Training", "(", "START", ")", ".", "The", "START", "was", "a", "Canadian", "multicenter", "trial", "that", "randomized", "242", "breast", "cancer", "patients", "between", "2003", "and", "2005", "to", "usual", "care", "(", "n", "=", "82", ")", ",", "supervised", "aerobic", "(", "n", "=", "78", ")", ",", "or", "resistance", "(", "n", "=", "82", ")", "exercise", "during", "chemotherapy", ".", "The", "primary", "end", "point", "for", "this", "exploratory", "analysis", "was", "disease", "-", "free", "survival", "(", "DFS", ")", ".", "Secondary", "end", "points", "were", "overall", "survival", ",", "distant", "DFS", ",", "and", "recurrence", "-", "free", "interval", ".", "The", "two", "exercise", "arms", "were", "combined", "for", "analysis", "(", "n", "=", "160", ")", ",", "and", "selected", "subgroups", "were", "explored", ".", "After", "a", "median", "follow", "-", "up", "of", "89", "months", ",", "there", "were", "25", "/", "160", "(", "15.6", "%", ")", "DFS", "events", "in", "the", "exercise", "groups", "and", "18", "/", "82", "(", "22.0", "%", ")", "in", "the", "control", "group", ".", "Eight", "-", "year", "DFS", "was", "82.7", "%", "for", "the", "exercise", "groups", "compared", "with", "75.6", "%", "for", "the", "control", "group", "(", "HR", ",", "0.68", ";", "95", "%", "confidence", "interval", "(", "CI", ")", ",", "0.37", "-", "1.24", ";", "log", "-", "rank", ",", "P", "=", "0.21", ")", ".", "Slightly", "stronger", "effects", "were", "observed", "for", "overall", "survival", "(", "HR", ",", "0.60", ";", "95", "%", "CI", ",", "0.27", "-", "1.33", ";", "log", "-", "rank", ",", "P", "=", "0.21", ")", ",", "distant", "DFS", "(", "HR", ",", "0.62", ";", "95", "%", "CI", ",", "0.32", "-", "1.19", ";", "log", "-", "rank", ",", "P", "=", "0.15", ")", ",", "and", "recurrence", "-", "free", "interval", "(", "HR", ",", "0.58", ";", "95", "%", "CI", ",", "0.30", "-", "1.11", ";", "Gray", "test", ",", "P", "=", "0.095", ")", ".", "Subgroup", "analyses", "suggested", "potentially", "stronger", "exercise", "effects", "on", "DFS", "for", "women", "who", "were", "overweight", "/", "obese", "(", "HR", ",", "0.59", ";", "95", "%", "CI", ",", "0.27", "-", "1.27", ")", ",", "had", "stage", "II", "/", "III", "cancer", "(", "HR", ",", "0.61", ";", "95", "%", "CI", ",", "0.31", "-", "1.20", ")", ",", "estrogen", "receptor", "-", "positive", "tumors", "(", "HR", ",", "0.58", ";", "95", "%", "CI", ",", "0.26", "-", "1.29", ")", ",", "human", "epidermal", "growth", "factor", "receptor", "2", "-positive", "tumors", "(", "HR", ",", "0.21", ";", "95", "%", "CI", ",", "0.04", "-", "1.02", ")", ",", "received", "taxane", "-", "based", "chemotherapies", "(", "HR", ",", "0.46", ";", "95", "%", "CI", ",", "0.19", "-", "1.15", ")", ",", "and", "≥", "85", "%", "of", "their", "planned", "chemotherapy", "(", "HR", ",", "0.50", ";", "95", "%", "CI", ",", "0.25", "-", "1.01", ")", ".", "This", "exploratory", "follow", "-", "up", "of", "the", "START", "provides", "the", "first", "randomized", "data", "to", "suggest", "that", "adding", "exercise", "to", "standard", "chemotherapy", "may", "improve", "breast", "cancer", "outcomes", ".", "A", "definitive", "phase", "III", "trial", "is", "warranted", "." ]
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753
[ "A", "multi", "-", "centre", "randomised", "trial", "comparing", "ultrasound", "vs", "mammography", "for", "screening", "breast", "cancer", "in", "high", "-", "risk", "Chinese", "women", ".", "Chinese", "women", "tend", "to", "have", "small", "and", "dense", "breasts", "and", "ultrasound", "is", "a", "common", "method", "for", "breast", "cancer", "screening", "in", "China", ".", "However", ",", "its", "efficacy", "and", "cost", "comparing", "with", "mammography", "has", "not", "been", "evaluated", "in", "randomised", "trials", ".", "At", "14", "breast", "centres", "across", "China", "during", "2008", "-", "2010", ",", "13", "339", "high", "-", "risk", "women", "aged", "30", "-", "65", "years", "were", "randomised", "to", "be", "screened", "by", "mammography", "alone", ",", "ultrasound", "alone", ",", "or", "by", "both", "methods", "at", "enrollment", "and", "1", "-year", "follow", "-", "up", ".", "A", "total", "of", "12", "519", "and", "8692", "women", "underwent", "the", "initial", "and", "second", "screenings", ",", "respectively", ".", "Among", "the", "30", "cancers", "(", "of", "which", "15", "were", "stage", "0", "/I", ")", "detected", ",", "5", "(", "0.72", "/", "1000", ")", "were", "in", "the", "mammography", "group", ",", "11", "(", "1.51", "/", "1000", ")", "in", "the", "ultrasound", "group", ",", "and", "14", "(", "2.02", "/", "1000", ")", "in", "the", "combined", "group", "(", "P=", "0.12", ")", ".", "In", "the", "combined", "group", ",", "ultrasound", "detected", "all", "the", "14", "cancers", ",", "whereas", "mammography", "detected", "8", ",", "making", "ultrasound", "more", "sensitive", "(", "100", "vs", "57.1", "%", ",", "P=", "0.04", ")", "with", "a", "better", "diagnostic", "accuracy", "(", "0.999", "vs", "0.766", ",", "P=", "0.01", ")", ".", "There", "was", "no", "difference", "between", "mammography", "and", "ultrasound", "in", "specificity", "(", "100", "vs", "99.9", "%", ",", "P=", "0.51", ")", "and", "positive", "predictive", "value", "(", "72.7", "vs", "70.0", "%", ";", "P=", "0.87", ")", ".", "To", "detect", "one", "cancer", ",", "the", "costs", "of", "ultrasound", ",", "mammography", ",", "and", "combined", "modality", "were", "$", "7876", ",", "$", "45", "253", ",", "and", "$", "21", "599", ",", "respectively", ".", "Ultrasound", "is", "superior", "to", "mammography", "for", "breast", "cancer", "screening", "in", "high", "-", "risk", "Chinese", "women", "." ]
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754
[ "Effect", "of", "β", "-", "glucan", "on", "drain", "fluid", "and", "amount", "of", "drainage", "following", "modified", "radical", "mastectomy", ".", "To", "reduce", "the", "seroma", "formation", "following", "mastectomy", "and", "axillary", "dissection", ",", "many", "different", "techniques", "and", "drugs", "have", "been", "investigated", ".", "The", "aim", "of", "this", "study", "is", "to", "evaluate", "the", "effects", "of", "oral", "β", "-", "glucan", "on", "drain", "fluid", "and", "efficacy", "of", "daily", "drainage", "and", "drain", "removal", "day", "in", "mastectomy", "patients", ".", "One", "hundred", "and", "thirty", "breast", "cancer", "patients", "of", "Ankara", "Oncology", "Training", "and", "Research", "Hospital", "were", "divided", "into", "2", "groups", "by", "consecutive", "randomization", "(", "n", "=", "65", "each", ")", ".", "β", "-", "glucan", "10", "mg", "capsules", "were", "administered", "to", "Group", "1", "twice", "a", "day", "for", "10", "days", ".", "Group", "2", "took", "placebos", "in", "the", "same", "manner", ".", "Age", ",", "menarche", "age", ",", "menopause", ",", "parity", ",", "history", "of", "oral", "contraceptives", ",", "comorbidities", ",", "postoperative", "daily", "drainage", "volumes", "and", "drain", "removal", "days", "were", "recorded", "and", "compared", ".", "Seroma", "samples", "during", "the", "first", "and", "second", "day", "of", "drainage", "were", "taken", "for", "analysis", "of", "Interleukin-", "6", "(", "IL-", "6", ")", "and", "Tumor", "Necrosis", "Factor", "(", "TNF", "-", "α", ")", ".", "There", "was", "no", "difference", "between", "groups", "in", "terms", "of", "age", ",", "menarche", "age", ",", "menopause", "period", ",", "parity", ",", "oral", "contraceptive", "use", "and", "comorbidities", ".", "Group", "1", "showed", "significantly", "lower", "daily", "drainage", "volumes", "between", "days", "2", "and", "8", ".", "Mean", "drain", "removal", "day", "was", "7.16", "±", "1.72", "in", "Group", "1", "and", "8.59", "±", "2.27", "in", "Group", "2", ".", "The", "difference", "was", "significant", "(", "p", "<", "0.001", ")", ".", "TNF", "-", "α", "and", "IL-", "6", "levels", "on", "days", "1", "and", "2", "in", "Group", "1", "were", "significantly", "lower", "(", "p", "<", "0.001", ")", ".", "In", "addition", ",", "β", "-", "glucan", "significantly", "shortened", "the", "number", "of", "days", "required", "for", "the", "drain", "removal", "in", "patients", "who", "have", "comorbidities", "(", "p", "=", "0.018", ")", ".", "The", "earliest", "removal", "was", "in", "patients", "without", "comorbidity", "and", "who", "received", "β", "-", "glucan", "(", "p", "=", "0.002", ")", ".", "β", "-", "glucan", "decreased", "drain", "discharges", "after", "mastectomy", ".", "The", "drains", "were", "removed", "earlier", "in", "β", "-", "glucan", "administered", "patients", "." ]
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755
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756
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757
[ "Continued", "Treatment", "Effect", "of", "Zoledronic", "Acid", "Dosing", "Every", "12", "vs", "4", "Weeks", "in", "Women", "With", "Breast", "Cancer", "Metastatic", "to", "Bone", ":", "The", "OPTIMIZE-", "2", "Randomized", "Clinical", "Trial", ".", "Zoledronic", "acid", ",", "a", "potent", "bisphosphonate", ",", "is", "commonly", "administered", "to", "patients", "with", "bone", "metastases", "to", "reduce", "the", "risk", "of", "skeletal", "-", "related", "events", "(", "SREs", ")", ".", "However", ",", "there", "have", "been", "concerns", "regarding", "its", "long", "-", "term", "monthly", "administration", ".", "To", "examine", "whether", "zoledronic", "acid", "every", "12", "weeks", "was", "noninferior", "to", "zoledronic", "acid", "every", "4", "weeks", "in", "patients", "with", "metastatic", "breast", "cancer", "that", "involved", "the", "bone", "who", "had", "previously", "received", "a", "standard", "dosing", "regimen", "of", "zoledronic", "acid", "and/or", "pamidronate", 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758
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759
[ "Influence", "of", "zoledronic", "acid", "on", "disseminated", "tumor", "cells", "in", "primary", "breast", "cancer", "patients", ".", "The", "presence", "of", "disseminated", "tumor", "cells", "(", "DTCs", ")", "in", "bone", "marrow", "of", "patients", "with", "early", "breast", "cancer", "(", "EBC", ")", "has", "been", "correlated", "with", "increased", "risk", "of", "metastatic", "disease", "or", "locoregional", "relapse", ".", "Zoledronic", "acid", "(", "ZOL", ")", "treatment", "has", "reduced", "DTCs", "in", "the", "bone", "marrow", "of", "patients", "with", "EBC", "in", "several", "studies", ".", "This", "controlled", "study", "sought", "to", "confirm", "these", "observations", ".", "Patients", "with", "EBC", "and", "DTC", "-", "positive", "bone", "marrow", "were", "randomized", "(", "N", "=", "96", ")", "to", "treatment", "with", "ZOL", "plus", "adjuvant", "systemic", "therapy", "or", "adjuvant", "systemic", "therapy", "alone", ".", "The", "change", "in", "DTC", "numbers", "at", "12", "months", "versus", "baseline", "was", "measured", ".", "DTC", "-", "positive", "patients", "treated", "with", "ZOL", "were", "more", "likely", "to", "become", "DTC", "-", "negative", "after", "12", "months", "of", "treatment", "compared", "with", "the", "controls", "(", "67", "%", "versus", "35", "%", ";", "P", "=", "0.009", ")", ".", "At", "12", "months", ",", "DTC", "counts", "decreased", "to", "a", "mean", "of", "0.5", "±", "0.8", "DTCs", "in", "the", "ZOL", "group", "and", "to", "0.9", "±", "0.8", "DTCs", "in", "the", "control", "group", ".", "In", "addition", ",", "ZOL", "was", "generally", "well", "tolerated", ".", "Treatment", "with", "ZOL", "improves", "elimination", "of", "DTCs", ".", "Further", "studies", "are", "needed", "to", "determine", "whether", "the", "reduction", "in", "DTCs", "by", "ZOL", "provides", "clinical", "benefit", "." ]
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760
[ "Propolis", "in", "the", "prevention", "of", "oral", "mucositis", "in", "breast", "cancer", "patients", "receiving", "adjuvant", "chemotherapy", ":", "A", "pilot", "randomised", "controlled", "trial", ".", "Chemo", "-", "induced", "oral", "mucositis", "(", "OM", ")", "is", "associated", "with", "significant", "symptoms", ",", "treatment", "delays", "and", "increased", "costs", ".", "This", "pilot", "randomised", "controlled", "trial", "aimed", "at", "evaluating", "the", "safety", ",", "tolerability", "and", "compliance", "with", "propolis", "in", "breast", "cancer", "patients", "receiving", "doxorubicin", "and", "cyclophosphamide", ",", "testing", "preliminary", "clinical", "efficacy", "of", "propolis", "in", "the", "prevention", "of", "OM", ",", "and", "prospectively", "evaluating", "the", "incidence", "of", "OM", ".", "Sixty", "patients", "were", "randomised", "to", "receive", "either", "a", "dry", "extract", "of", "propolis", "with", "8", "%", "-", "12", "%", "of", "galangin", "plus", "mouth", "rinsing", "with", "sodium", "bicarbonate", "(", "experimental", "arm", ")", ",", "or", "mouth", "rinsing", "with", "sodium", "bicarbonate", "(", "control", "arm", ")", ".", "OM", "was", "evaluated", "with", "the", "NCI", "-", "CTCAE", "v", "4.0", "after", "5", ",", "10", ",", "15", "and", "21", "days", "of", "treatment", ".", "Compliance", "with", ",", "tolerability", "of", "propolis", "and", "adverse", "events", "were", "recorded", ".", "The", "incidence", "of", "OM", "was", "also", "prospectively", "evaluated", "for", "6", "months", ".", "Two", "patients", "(", "6.7", "%", ")", "manifested", "a", "suspected", "skin", "reaction", "to", "propolis", ".", "No", "patient", "in", "the", "experimental", "arm", "developed", "OM", ">", "G", "1", ",", "while", "in", "the", "control", "arm", "OM", ">", "G", "1", "was", "16.7", "%", "(", "p", "=", ".", "02", ")", ".", "The", "incidence", "of", "OM", "≥", "G", "1", "at", "the", "end", "of", "cycles", "2", "-", "8", "was", "higher", "at", "the", "second", "(", "25", "%", ")", "and", "fifth", "cycles", "(", "45.8", "%", ")", ".", "Propolis", "plus", "bicarbonate", "was", "safe", ",", "well", "tolerated", "and", "promisingly", "effective", "in", "the", "prevention", "of", "OM", "in", "patients", "with", "breast", "cancer", "." ]
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761
[ "Trastuzumab", "plus", "anastrozole", "versus", "anastrozole", "alone", "for", "the", "treatment", "of", "postmenopausal", "women", "with", "human", "epidermal", "growth", "factor", "receptor", "2", "-positive", ",", "hormone", "receptor", "-", "positive", "metastatic", "breast", "cancer", ":", "results", "from", "the", "randomized", "phase", "III", "TAnDEM", "study", ".", "TAnDEM", "is", "the", "first", "randomized", "phase", "III", "study", "to", "combine", "a", "hormonal", "agent", "and", "trastuzumab", "without", "chemotherapy", "as", "treatment", "for", "human", "epidermal", "growth", "factor", "receptor", "2", "(", "HER", "2", ")", "/", "hormone", "receptor", "-", "copositive", "metastatic", "breast", "cancer", "(", "MBC", ")", ".", "Postmenopausal", "women", "with", "HER", "2", "/", "hormone", "receptor", "-", "copositive", "MBC", "were", "randomly", "assigned", "to", "anastrozole", "(", "1", "mg", "/", "d", "orally", ")", "with", "or", "without", "trastuzumab", "(", "4", "mg", "/", "kg", "intravenous", "infusion", "on", "day", "1", ",", "then", "2", "mg", "/", "kg", "every", "week", ")", "until", "progression", ".", "The", "primary", "end", "point", "was", "progression", "-", "free", "survival", "(", "PFS", ")", "in", "the", "intent", "-", "to", "-", "treat", "population", ".", "Results", "Overall", ",", "103", "patients", "received", "trastuzumab", "plus", "anastrozole", ";", "104", "received", "anastrozole", "alone", ".", "Patients", "in", "the", "trastuzumab", "plus", "anastrozole", "arm", "experienced", "significant", "improvements", "in", "PFS", "compared", "with", "patients", "receiving", "anastrozole", "alone", "(", "hazard", "ratio", "=", "0.63", ";", "95", "%", "CI", ",", "0.47", "to", "0.84", ";", "median", "PFS", ",", "4.8", "v", "2.4", "months", ";", "log", "-", "rank", "P", "=", ".", "0016", ")", ".", "In", "patients", "with", "centrally", "confirmed", "hormone", "receptor", "positivity", "(", "n", "=", "150", ")", ",", "median", "PFS", "was", "5.6", "and", "3.8", "months", "in", "the", "trastuzumab", "plus", "anastrozole", "and", "anastrozole", "alone", "arms", ",", "respectively", "(", "log", "-", "rank", "P", "=", ".", "006", ")", ".", "Overall", "survival", "in", "the", "overall", "and", "centrally", "confirmed", "hormone", "receptor", "-", "positive", "populations", "showed", "no", "statistically", "significant", "treatment", "difference", ";", "however", ",", "70", "%", "of", "patients", "in", "the", "anastrozole", "alone", "arm", "crossed", "over", "to", "receive", "trastuzumab", "after", "progression", "on", "anastrozole", "alone", ".", "Incidence", "of", "grade", "3", "and", "4", "adverse", "events", "was", "23", "%", "and", "5", "%", ",", "respectively", ",", "in", "the", "trastuzumab", "plus", "anastrozole", "arm", ",", "and", "15", "%", "and", "1", "%", ",", "respectively", ",", "in", "the", "anastrozole", "alone", "arm", ";", "one", "patient", "in", "the", "combination", "arm", "experienced", "New", "York", "Heart", "Association", "class", "II", "congestive", "heart", "failure", ".", "Trastuzumab", "plus", "anastrozole", "improves", "outcomes", "for", "patients", "with", "HER", "2", "/", "hormone", "receptor", "-", "copositive", "MBC", "compared", "with", "anastrozole", "alone", ",", "although", "adverse", "events", "and", "serious", "adverse", "events", "were", "more", "frequent", "with", "the", "combination", "." ]
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762
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763
[ "A", "randomized", "study", "of", "olanzapine", "-", "containing", "versus", "standard", "antiemetic", "regimens", "for", "the", "prevention", "of", "chemotherapy", "-", "induced", "nausea", "and", "vomiting", "in", "Chinese", "breast", "cancer", "patients", ".", "Chemotherapy", "-", "induced", "nausea", "and", "vomiting", "(", "CINV", ")", "are", "distressing", "symptoms", ".", "This", "randomized", "study", "evaluated", "the", "antiemetic", "efficacies", "of", "standard", "antiemetic", "regimen", "with", "/", "without", "olanzapine", ".", "Eligible", "patients", "were", "chemotherapy", "-", "naive", "Chinese", "breast", "cancer", "patients", "who", "were", "planned", "for", "(", "neo", ")", "adjuvant", "doxorubicin", "/", "cyclophosphamide", ".", "Antiemetic", "regimen", "for", "all", "studied", "population", "included", "aprepitant", ",", "ondansetron", "and", "dexamethasone", ";", "patients", "were", "randomized", "to", "Olanzapine", "(", "with", "olanzapine", ")", "or", "Standard", "arms", "(", "without", "olanzapine", ")", ".", "Patients", "filled", "in", "self", "-", "reported", "diaries", "and", "completed", "visual", "analogue", "scales", "for", "nausea", ",", "as", "well", "as", "Functional", "Living", "Index", "-", "Emesis", "questionnaires", ".", "Blood", "profiles", "including", "fasting", "glucose", "and", "lipids", "were", "monitored", ".", "120", "patients", "were", "randomized", ".", "In", "Cycle", "1", "doxorubicin", "/", "cyclophosphamide", ",", "the", "Olanzapine", "arm", "had", "significantly", "higher", "rates", "of", "\"", "Complete", "Response", "\"", "than", "the", "Standard", "arm", ":", "65.0", "%", "vs", "38.3", "%", "in", "the", "overall", "period", "(", "p", "=", "0.0035", ")", ",", "70.0", "%", "vs", "51.7", "%", "in", "the", "acute", "period", "(", "p", "=", "0.0397", ")", "and", "92.9", "%", "vs", "74.2", "%", "in", "the", "delayed", "period", "(", "p", "=", "0.0254", ")", ".", "Olanzapine", "arm", "also", "had", "significantly", "higher", "rates", "of", "\"", "No", "significant", "nausea", "\"", "and", "\"", "No", "nausea", "\"", "during", "all", "3", "time", "-", "frames", "and", "better", "QOL", ".", "Similar", "findings", "were", "also", "revealed", "throughout", "multiple", "cycles", ".", "Pre", "-", "study", "abnormalities", "in", "glucose", "and", "lipids", "occurred", "in", "39.7", "%", "and", "34.2", "%", "of", "the", "studied", "population", "respectively", ";", "there", "were", "no", "differences", "in", "these", "parameters", "between", "the", "two", "arms", "at", "end", "-", "of", "-", "study", "assessment", ".", "The", "addition", "of", "olanzapine", "to", "standard", "aprepitant", "-", "based", "antiemetic", "regimen", "provides", "clinically", "meaningful", "improvement", "in", "controlling", "CINV", ".", "This", "was", "associated", "with", "a", "positive", "impact", "on", "QOL", "and", "tolerable", "toxicity", "profiles", "among", "Chinese", "breast", "cancer", "patients", "receiving", "doxorubicin", "/", "cyclophosphamide", "chemotherapy", ".", "Further", "studies", "on", "metabolic", "profiles", "of", "breast", "cancer", "patients", "are", "warranted", "." ]
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764
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765
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766
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"with", "electrons", ".", "Italian", "Association", "for", "Cancer", "Research", ",", "Jacqueline", "Seroussi", "Memorial", "Foundation", "for", "Cancer", "Research", ",", "and", "Umberto", "Veronesi", "Foundation", "." ]
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767
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768
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769
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770
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771
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773
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774
[ "Polychemotherapy", "for", "early", "breast", "cancer", ":", "results", "from", "the", "international", "adjuvant", "breast", "cancer", "chemotherapy", "randomized", "trial", ".", "Survival", "of", "patients", "with", "early", "-", "stage", "breast", "cancer", "is", "improved", "following", "treatment", "with", "single", "-", "modality", "tamoxifen", ",", "ovarian", "ablation", "or", "suppression", ",", "or", "chemotherapy", ".", "The", "Adjuvant", "Breast", "Cancer", "Trials", "were", "designed", "to", "ascertain", "any", "additional", "benefits", "of", "combined", "treatment", ".", "The", "Adjuvant", "Breast", "Cancer", "Chemotherapy", "Trial", "was", "a", "randomized", "phase", "III", "trial", "in", "which", "patients", "with", "early", "-", "stage", "breast", "cancer", "who", "were", "receiving", "prolonged", "(", "5", "years", ")", "tamoxifen", "treatment", ",", "with", "or", "without", "ovarian", "ablation", "or", "suppression", ",", "were", "randomly", "assigned", "to", "standard", "chemotherapy", "versus", "none", ".", "Trial", "endpoints", "included", "relapse", "-", "free", "and", "overall", "survival", ".", "Hazard", "ratios", "(", "HRs", ")", "were", "derived", "from", "Cox", "models", ",", "and", "all", "statistical", "tests", "were", "two", "-", "sided", ".", "Between", "1992", "and", "2000", ",", "1991", "patients", "between", "the", "ages", "of", "26", "and", "81", "years", "were", "randomly", "assigned", "(", "987", "to", "chemotherapy", ",", "1004", "to", "no", "chemotherapy", ")", "from", "106", "UK", "and", "16", "non", "-", "UK", "centers", ".", "Nine", "hundred", "seven", "(", "92", "%", ")", "patients", "received", "chemotherapy", "as", "allocated", "(", "87", "%", "received", "cyclophosphamide", ",", "methotrexate", ",", "and", "5", "-fluorouracil", ";", "11", "%", "received", "anthracycline", "-", "containing", "regimens", ")", ".", "A", "total", "of", "244", "of", "the", "619", "premenopausal", "patients", "received", "elective", "ovarian", "ablation", "or", "suppression", ".", "Chemotherapy", "improved", "relapse", "-", "free", "survival", "(", "relapse", "in", "the", "chemotherapy", "group", "versus", "no", "-", "chemotherapy", "group", ",", "298", "events", "versus", "332", "events", ",", "HR", "=", "0.86", ",", "95", "%", "confidence", "interval", "[", "CI", "]", "=", "0.73", "to", "1.01", ";", "P", "=", ".", "06", ")", "and", "overall", "survival", "(", "death", "from", "any", "cause", "in", "the", "chemotherapy", "group", "versus", "no", "-", "chemotherapy", "group", ",", "243", "events", "versus", "282", "events", ",", "HR", "=", "0.83", ",", "95", "%", "CI", "=", "0.70", "to", "0.99", ";", "P", "=", ".", "03", ")", "after", "adjustment", "for", "nodal", "status", ",", "estrogen", "receptor", "status", ",", "and", "age", ".", "Subgroup", "analyses", "showed", "that", "the", "benefit", "of", "chemotherapy", "was", "greatest", "in", "younger", "women", "(", "<", "50", "years", ")", "and", "in", "particular", "for", "premenopausal", "women", "not", "receiving", "ovarian", "ablation", "or", "suppression", ".", "Modest", "yet", "sustainable", "benefits", "for", "chemoendocrine", "therapy", "occur", "in", "women", "with", "breast", "cancer", ".", "However", ",", "the", "full", "impact", "on", "overall", "survival", "may", "not", "emerge", "for", "several", "years", "." ]
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775
[ "Lumpectomy", "plus", "tamoxifen", "or", "anastrozole", "with", "or", "without", "whole", "breast", "irradiation", "in", "women", "with", "favorable", "early", "breast", "cancer", ".", "In", "women", "with", "favorable", "early", "breast", "cancer", "treated", "by", "lumpectomy", "plus", "tamoxifen", "or", "anastrazole", ",", "it", "remains", "unclear", "whether", "whole", "breast", "radiotherapy", "is", "beneficial", ".", "Between", "January", "1996", "and", "June", "2004", ",", "the", "Austrian", "Breast", "and", "Colorectal", "Cancer", "Study", "Group", "(", "ABCSG", ")", "randomly", "assigned", "869", "women", "to", "receive", "breast", "radiotherapy", "+", "/-", "boost", "(", "n", "=", "414", ")", "or", "not", "(", "n", "=", "417", ")", "after", "breast", "-", "conserving", "surgery", "(", "ABCSG", "Study", "8", "A", ")", ".", "Favorable", "early", "breast", "cancer", "was", "specified", "as", "tumor", "size", "<3", "cm", ",", "Grading", "1", "or", "2", ",", "negative", "lymph", "nodes", ",", "positive", "estrogen", "and/or", "progesterone", "receptor", "status", ",", "and", "manageable", "by", "breast", "-", "conserving", "surgery", ".", "Breast", "radiotherapy", "was", "performed", "after", "lumpectomy", "with", "2", "tangential", "opposed", "breast", "fields", "with", "mean", "50", "Gy", ",", "plus", "boost", "in", "71", "%", "of", "patients", "with", "mean", "10", "Gy", ",", "in", "a", "median", "of", "6", "weeks", ".", "The", "primary", "endpoint", "was", "local", "relapse", "-", "free", "survival", ";", "further", "endpoints", "were", "contralateral", "breast", "cancer", ",", "distant", "metastases", ",", "and", "disease", "-", "free", "and", "overall", "survival", ".", "The", "median", "follow", "-", "up", "was", "53.8", "months", ".", "The", "mean", "age", "was", "66", "years", ".", "Overall", ",", "there", "were", "21", "local", "relapses", ",", "with", "2", "relapses", "in", "the", "radiotherapy", "group", "(", "5", "-y", "rate", "0.4", "%", ")", "vs.", "19", "in", "the", "no", "-", "radiotherapy", "group", "(", "5.1", "%", ")", ",", "respectively", "(", "p", "=", "0.0001", ",", "hazard", "ratio", "10.2", ")", ".", "Overall", "relapses", "occurred", "in", "30", "patients", ",", "with", "7", "events", "in", "the", "radiotherapy", "group", "(", "5", "-y", "rate", "2.1", "%", ")", "vs.", "23", "events", "in", "the", "no", "-", "radiotherapy", "group", "(", "6.1", "%", ")", "(", "p", "=", "0.002", ",", "hazard", "ratio", "3.5", ")", ".", "No", "significant", "differences", "were", "found", "for", "distant", "metastases", "and", "overall", "survival", ".", "Breast", "radiotherapy", "+", "/-", "boost", "in", "women", "with", "favorable", "early", "breast", "cancer", "after", "lumpectomy", "combined", "with", "tamoxifen", "/", "anastrazole", "leads", "to", "a", "significant", "reduction", "in", "local", "and", "overall", "relapse", "." ]
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776
[ "Six", "versus", "12", "months", "of", "adjuvant", "trastuzumab", "in", "combination", "with", "dose", "-", "dense", "chemotherapy", "for", "women", "with", "HER", "2", "-", "positive", "breast", "cancer", ":", "a", "multicenter", "randomized", "study", "by", "the", "Hellenic", "Oncology", "Research", "Group", "(", "HORG", ")", ".", "Adjuvant", "trastuzumab", "in", "combination", "with", "chemotherapy", "improves", "survival", "of", "women", "with", "HER", "2", "-", "positive", "early", "breast", "cancer", ".", "In", "this", "study", ",", "we", "compared", "12", "versus", "6", "months", "of", "adjuvant", "trastuzumab", ".", "Axillary", "node", "-", "positive", "or", "high", "-", "risk", "node", "-", "negative", "women", "with", "HER", "2", "-", "positive", "early", "breast", "cancer", "were", "randomized", "to", "receive", "12", "or", "6", "months", "of", "adjuvant", "trastuzumab", "concurrently", "with", "dose", "-", "dense", ",", "granulocyte", "colony", "-", "stimulating", "factor", "(", "G", "-", "CSF", ")", "-supported", "docetaxel", "(", "75", "mg", "/", "m", "(", "2", ")", "every", "14", "days", "for", "four", "cycles", ")", ".", "All", "patients", "received", "upfront", "dose", "-", "dense", ",", "G", "-", "CSF", "-", "supported", "FEC", "(", "5", "-fluorouracil", "700", "mg", "/", "m", "(", "2", ")", ",", "epirubicin", "75", "mg", "/", "m", "(", "2", ")", ",", "cyclophosphamide", "700", "mg", "/", "m", "(", "2", ")", "every", "14", "days", "for", "four", "cycles", ")", ".", "Randomization", "was", "carried", "out", "before", "commence", "of", "chemotherapy", ".", "The", "primary", "end", "point", "was", "the", "3", "-year", "disease", "-", "free", "survival", "(", "DFS", ")", ".", "A", "total", "of", "481", "patients", "were", "randomized", "to", "receive", "12", "months", "(", "n", "=", "241", ")", "or", "6", "months", "(", "n", "=", "240", ")", "of", "adjuvant", "trastuzumab", ".", "Chemotherapy", "was", "completed", "in", "99", "%", "and", "98", "%", "of", "patients", ",", "while", "trastuzumab", "therapy", "in", "100", "%", "and", "96", "%", "of", "patients", "in", "the", "12", "-", "and", "6", "-month", "groups", ",", "respectively", ".", "After", "47", "and", "51", "months", "of", "median", "follow", "-", "up", ",", "there", "were", "17", "(", "7.1", "%", ")", "and", "28", "(", "11.7", "%", ")", "disease", "relapses", "in", "the", "12", "-", "and", "6", "-month", "groups", "(", "P", "=", "0.08", ")", ".", "The", "3", "-year", "DFS", "was", "95.7", "%", "versus", "93.3", "%", "in", "favor", "of", "the", "12", "-month", "treatment", "group", "(", "hazard", "ratio", "=", "1.57", ";", "95", "%", "confidence", "interval", "0.86", "-", "2.10", ";", "P", "=", "0.137", ")", ".", "There", "was", "no", "difference", "in", "terms", "of", "overall", "survival", "and", "cardiac", "toxicity", "between", "the", "two", "groups", ".", "Our", "study", "failed", "to", "show", "noninferiority", "for", "the", "6", "-month", "arm", ".", "The", "results", "further", "support", "the", "current", "standard", "of", "care", "that", "is", "administration", "of", "adjuvant", "trastuzumab", "for", "12", "months", "." ]
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777
[ "Secondary", "leukemia", "after", "epirubicin", "-", "based", "adjuvant", "chemotherapy", "in", "operable", "breast", "cancer", "patients", ":", "16", "years", "experience", "of", "the", "French", "Adjuvant", "Study", "Group", ".", "The", "purpose", "of", "this", "study", "was", "to", "evaluate", "incidence", "and", "risk", "factors", "of", "secondary", "leukemia", "after", "adjuvant", "epirubicin", "-", "based", "chemotherapy", "in", "breast", "cancer", "patients", ".", "Among", "eight", "French", "Adjuvant", "Study", "Group", "trials", ",", "3653", "patients", "were", "assessable", ":", "2603", "received", "epirubicin", ";", "682", "received", "hormonotherapy", ";", "and", "368", "had", "no", "systemic", "treatment", ".", "Chemotherapy", "was", "FEC", "regimen", "in", "85", "%", "of", "cases", "(", "fluorouracil", "500", "mg", "/", "m", "2", ",", "epirubicin", "50", ",", "75", "or", "100", "mg", "/", "m", "2", ",", "cyclophosphamide", "500", "mg", "/", "m", "2", ",", "three", "or", "six", "cycles", ")", ".", "Epirubicin", "cumulative", "dose", "was", "<", "300", "mg", "/", "m", "2", "in", "1045", "patients", ";", "300", "-", "600", "mg", "/", "m", "2", "in", "1187", ";", "and", ">", "or", "=", "600", "mg", "/", "m", "2", "in", "286", ",", "followed", "by", "radiotherapy", "in", "96", "%", "of", "cases", ".", "The", "median", "follow", "-", "up", "was", "104", "months", ".", "Eight", "cases", "of", "leukemia", "occurred", "in", "epirubicin", "-", "exposed", "patients", "and", "one", "in", "non", "-", "exposed", "patients", ".", "After", "9", "years", ",", "the", "risk", "of", "developing", "a", "leukemia", "was", "0.34", "%", "(", "95", "%", "confidence", "interval", "0.11", "-", "0.57", ")", "in", "epirubicin", "-", "exposed", "patients", ".", "In", "patients", "receiving", "chemotherapy", ",", "leukemia", "subtypes", "were", ":", "AML", "2", "(", "two", ")", ",", "AML", "3", "(", "one", ")", ",", "AML", "4", "(", "three", ")", "and", "ALL", "(", "two", ")", ".", "None", "of", "the", "classically", "recognized", "risk", "factors", "was", "significantly", "correlated", "with", "the", "occurrence", "of", "a", "leukemia", ".", "Irrespective", "of", "the", "dose", ",", "the", "incidence", "of", "secondary", "leukemia", "after", "adjuvant", "epirubicin", "-", "based", "chemotherapy", "was", "low", ".", "After", "a", "long", "follow", "-", "up", ",", "the", "benefit", "/", "risk", "ratio", "for", "early", "breast", "cancer", "patients", "remained", "in", "favor", "of", "epirubicin", "-", "based", "adjuvant", "chemotherapy", ":", "eight", "cases", "(", "0.31", "%", ")", "occurred", ",", "and", "in", "some", "of", "them", ",", "treatment", "causality", "could", "be", "debatable", "." ]
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778
[ "Betamethasone", "in", "prevention", "of", "postoperative", "nausea", "and", "vomiting", "following", "breast", "surgery", ".", "To", "investigate", "whether", "betamethasone", "decreases", "the", "incidence", "of", "postoperative", "nausea", "/", "vomiting", "(", "PONV", ")", "and", "reduces", "postoperative", "pain", "following", "partial", "mastectomy", ".", "Prospective", "randomized", ",", "double", "-", "blinded", "study", ".", "Operating", "room", "and", "Postanesthesia", "Care", "Unit", "of", "a", "university", "hospital", ".", "80", "ASA", "physical", "status", "1", "and", "2", "women", "scheduled", "for", "elective", "breast", "cancer", "surgery", ".", "Patients", "were", "randomly", "allocated", "to", "two", "groups", "in", "double", "-", "blinded", "fashion", ":", "Group", "B", "(", "betamethasone", ";", "37", "pts", ")", "and", "Group", "C", "(", "control", ";", "38", "pts", ")", ".", "Group", "B", "received", "8", "mg", "of", "betamethasone", "intravenously", "before", "the", "start", "of", "surgery", ".", "The", "rate", "of", "PONV", "and", "pain", "were", "recorded", "using", "a", "numeric", "rating", "scale", "(", "NRS", ";", "0", "-", "10", ")", ",", "as", "well", "as", "rescue", "doses", "of", "antiemetics", "(", "ondansetron", ")", "and", "analgesics", "(", "ketobemidone", ")", ".", "There", "was", "a", "significant", "lower", "incidence", "of", "postoperative", "nausea", "(", "PON", ")", "scoring", "NRS", "≥", "1", "in", "Group", "B", "in", "the", "4", "to", "12", "-hour", "period", "compared", "with", "Group", "C", "(", "P", "=", "0.02", ")", ".", "The", "cumulative", "incidence", "of", "PON", "was", "57", "%", "in", "Group", "B", "versus", "68", "%", "in", "Group", "C", "(", "P", "=", "0.27", ")", ".", "The", "overall", "incidence", "of", "postoperative", "vomiting", "(", "POV", ")", "was", "18", "%", "and", "20", "%", "in", "Groups", "B", "and", "C", ",", "respectively", ".", "Postoperative", "pain", "was", "reduced", "by", "40", "%", "in", "Group", "B", "in", "the", "4", "to", "12", "-hour", "period", ",", "but", "the", "mean", "dose", "of", "postoperative", "rescue", "analgesic", "did", "not", "differ", "between", "the", "groups", ".", "Preoperative", "betamethasone", "reduces", "the", "severity", "of", "PONV", "and", "pain", "in", "patients", "undergoing", "elective", "breast", "surgery", "." ]
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779
[ "Effectiveness", "of", "biosimilar", "filgrastim", "vs.", "original", "granulocyte", "colony", "-", "stimulating", "factors", "in", "febrile", "neutropenia", "prevention", "in", "breast", "cancer", "patients", ".", "The", "purpose", "of", "this", "study", "is", "to", "describe", "the", "effectiveness", "of", "biosimilar", "filgrastim", "and", "original", "granulocyte", "colony", "-", "stimulating", "factors", "(", "G", "-", "CSFs", ")", ",", "lenograstim", "and", "pegfilgrastim", ",", "in", "febrile", "neutropenia", "(", "FN", ")", "prevention", "in", "breast", "cancer", "patients", "receiving", "docetaxel", "/", "doxorubicin", "/", "cyclophosphamide", "(", "TAC", ")", "as", "adjuvant", "/", "neoadjuvant", "treatment", "and", "to", "analyze", "their", "treatment", "patterns", ".", "A", "pharmacoepidemiology", "cohort", "study", "was", "developed", "in", "a", "university", "hospital", "(", "with", "23", "healthcare", "centers", ")", "with", "retrospective", "data", "collection", "(", "2012", "-", "2014", ")", ".", "Effectiveness", "of", "G", "-", "CSFs", "was", "assessed", "by", "the", "FN", "incidence", ".", "Other", "parameters", "analyzed", "were", "as", "follows", ":", "moderate", "and", "severe", "neutropenia", "incidence", ",", "neutropenia", "-", "related", "hospitalizations", ",", "dosage", ",", "and", "duration", ".", "Data", "was", "analyzed", "using", "each", "cycle", "as", "a", "unit", "of", "analysis", ".", "We", "identified", "98", "patients", "representing", "518", "chemotherapy", "cycles", ",", "215", "with", "original", "G", "-", "CSFs", "(", "35", "lenograstim", "and", "180", "pegfilgrastim", ")", "and", "303", "with", "biosimilar", "filgrastim", ".", "The", "FN", "incidence", "was", "similar", "in", "both", "groups", "(", "3.7", "%", "original", "vs.", "3.3", "%", "biosimilar", ";", "p", "=", "0.79", ")", ".", "No", "statistically", "significant", "differences", "were", "found", "in", "moderate", "and", "severe", "neutropenia", "incidence", "(", "4.7", "vs.", "6.3", "%", ";", "p", "=", "0.43", ")", "or", "neutropenia", "-", "related", "hospitalizations", "(", "3.3", "vs.", "3.6", "%", ";", "p", "=", "0.19", ")", ".", "When", "the", "three", "drugs", "were", "evaluated", "separately", ",", "a", "higher", "FN", "incidence", "was", "observed", "with", "lenograstim", "than", "with", "pegfilgratim", "or", "biosimilar", "(", "p", "=", "0.024", ")", ".", "The", "dosage", "and", "duration", "of", "biosimilar", "were", "lower", "than", "lenograstim", "(", "4.9", "vs.", "5.7", "μg", "/", "kg", "/", "day", ";", "5", "vs.", "7", "days", ";", "p", "<", "0.001", ")", ".", "An", "abbreviated", "5", "-day", "course", "of", "biosimilar", "filgrastim", "provided", "optimal", "primary", "prophylaxis", "against", "FN", "post", "-", "chemotherapy", "TAC", "in", "patients", "with", "breast", "cancer", ".", "The", "clinical", "relevance", "of", "the", "highest", "FN", "incidence", "in", "the", "lenograstim", "cohort", "needs", "further", "attention", "." ]
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780
[ "Randomized", "clinical", "trial", "comparing", "blue", "dye", "with", "combined", "dye", "and", "isotope", "for", "sentinel", "lymph", "node", "biopsy", "in", "breast", "cancer", ".", "Use", "of", "blue", "dye", "alone", "as", "a", "marker", "for", "sentinel", "lymph", "node", "(", "SLN", ")", "biopsy", "is", "effective", ",", "but", "combining", "it", "with", "isotope", "marking", "can", "improve", "the", "success", "rate", ".", "Use", "of", "the", "isotope", "adds", "extra", "cost", "and", "there", "are", "potential", "radiation", "hazards", ".", "The", "two", "techniques", "were", "compared", "in", "a", "randomized", "trial", ".", "Women", "with", "early", "breast", "cancer", "(", "less", "than", "3", "cm", ")", "and", "no", "palpable", "axillary", "nodes", "were", "recruited", ".", "Women", "older", "than", "70", "years", "with", "multicentric", "cancers", "or", "previous", "surgery", "to", "the", "breast", "or", "axilla", "were", "excluded", ".", "Patients", "were", "randomized", "to", "either", "blue", "dye", "alone", "or", "combined", "mapping", "for", "SLN", "biopsy", ".", "All", "women", "had", "a", "level", "I", "and", "II", "axillary", "dissection", "after", "the", "SLN", "biopsy", ".", "A", "total", "of", "123", "patients", "were", "recruited", ",", "of", "whom", "five", "were", "excluded", "from", "analysis", ".", "Blue", "dye", "alone", "was", "used", "in", "57", "women", "and", "61", "had", "combined", "mapping", ".", "Baseline", "demographic", "data", "were", "similar", "in", "the", "two", "cohorts", ".", "The", "success", "rate", "of", "SLN", "biopsy", "was", "higher", "with", "combined", "mapping", "than", "with", "blue", "dye", "alone", "(", "100", "versus", "86", "per", "cent", ";", "P", "=", "0.002", ")", ".", "The", "accuracy", "and", "false", "-", "negative", "rate", "were", "similar", "(", "accuracy", "100", "per", "cent", "for", "combined", "mapping", "versus", "98", "per", "cent", "for", "blue", "dye", ";", "false", "-", "negative", "rate", "0", "versus", "5", "per", "cent", ")", ".", "Combined", "mapping", "was", "superior", "to", "blue", "dye", "alone", "in", "identification", "of", "the", "SLN", ",", "but", "accuracy", "and", "false", "-", "negative", "rates", "were", "similar", "." ]
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781
[ "Randomized", ",", "self", "-", "controlled", ",", "prospective", "assessment", "of", "the", "efficacy", "of", "mometasone", "furoate", "local", "application", "in", "reducing", "acute", "radiation", "dermatitis", "in", "patients", "with", "head", "and", "neck", "squamous", "cell", "carcinomas", ".", "Acute", "radiation", "dermatitis", "(", "ARD", ")", "is", "a", "common", "adverse", "effect", "in", "patients", "undergoing", "radiotherapy", ".", "Mometasone", "furoate", "cream", "(", "MMF", ")", "was", "reported", "to", "significantly", "reduce", "ARD", ",", "especially", "in", "breast", "cancer", ".", "Clinically", ",", "ARD", "is", "more", "critical", "and", "more", "difficult", "to", "prevent", "in", "patients", "with", "head", "and", "neck", "squamous", "cell", "carcinoma", "(", "HNSCC", ")", "than", "in", "those", "with", "breast", "cancer", ",", "because", "a", "higher", "dose", "of", "radiotherapy", "is", "required", "in", "HNSCC", "cases", ".", "The", "aim", "of", "this", "study", "was", "to", "evaluate", "the", "effect", "of", "MMF", "local", "application", "on", "radiation", "dermatitis", "in", "patients", "with", "HNSCC", ".", "HNSCC", "patients", "scheduled", "for", "bilateral", "radical", "radiotherapy", "to", "the", "neck", "with", "identical", "radiation", "doses", "were", "enrolled", ".", "One", "side", "of", "the", "neck", "skin", "(", "test", "groups", ")", "of", "the", "patients", "were", "randomized", "to", "apply", "a", "thin", "layer", "of", "MMF", "once", "a", "day", "from", "the", "date", "of", "first", "radiotherapy", "until", "either", "2", "weeks", "after", "end", "of", "radiotherapy", "or", "until", "the", "test", "side", "skin", "developed", "ARD", "lesions", ",", "while", "the", "other", "side", "of", "neck", "(", "control", "groups", ")", "did", "n't", "apply", "any", "medication", ".", "The", "severity", "of", "ARD", "was", "evaluated", "weekly", "by", "using", "the", "modified", "radiation", "therapy", "oncology", "group", "score", ",", "pain", "intensity", ",", "and", "itch", "stages", ".", "Forty", "-", "one", "patients", "(", "82", "targets", ")", "were", "analyzed", ".", "There", "was", "a", "significant", "difference", "between", "the", "ARD", "scores", "on", "the", "test", "side", "and", "the", "control", "side", ".", "MMF", "reduced", "the", "stages", "of", "ARD", "when", "the", "radiotherapy", "dose", "was", "<", "6000", "cGY", "(", "P", "=", ".", "01", ")", "but", "showed", "no", "improvement", "when", "the", "dose", "was", "≥", "6000", "cGY", "(", "P", "=", ".", "699", ")", ".", "Compared", "to", "the", "control", "side", ",", "local", "application", "of", "MMF", "significantly", "reduced", "the", "itch", "and", "pain", "scores", "of", "the", "test", "side", "skin", "regardless", "of", "the", "radiotherapy", "dose", "and", "ARD", "stage", "(", "P", "<", ".", "001", ")", "during", "radiotherapy", ".", "This", "study", "showed", "that", "MMF", "inunction", "after", "high", "-", "dose", "radiotherapy", "(", ">", "50", "Gy", ")", "can", "prevent", "ARD", ",", "especially", "when", "the", "radiation", "dose", "is", "<", "6000", "cGY", "." ]
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782
[ "Evaluation", "of", "Lymphedema", "Prevention", "Protocol", "on", "Quality", "of", "Life", "among", "Breast", "Cancer", "Patients", "with", "Mastectomy", ".", "Lymphedema", "is", "a", "widespread", "complication", "after", "surgery", "or", "radiation", "therapy", "due", "to", "the", "damage", "and", "obstruction", "of", "the", "lymphatic", "vessels", ".", "A", "study", "was", "conducted", "to", "assess", "the", "effectiveness", "of", "lymphedema", "prevention", "protocol", "on", "quality", "of", "life", "among", "breast", "cancer", "patients", "with", "mastectomy", "at", "a", "selected", "hospital", "in", "Tamil", "Nadu", ".", "Objectives", "of", "the", "study", "were", "to", "identify", "the", "effect", "of", "lymphedema", "prevention", "protocol", "on", "lymphedema", "occurrence", "and", "quality", "of", "life", ".", "A", "quantitative", "research", "approach", "of", "quasi", "experimental", "non", "-", "equivalent", "with", "control", "group", "before", "-after", "design", "(", "Non", "randomized", ")", "was", "used", ".", "The", "investigator", "had", "included", "120", "participants", "by", "using", "purposive", "sampling", "technique", "which", "included", "60", "each", "in", "study", "and", "comparison", "group", ".", "Pre", "test", "was", "done", "before", "the", "intervention", "of", "lymphedema", "prevention", "protocol", "to", "both", "comparison", "and", "study", "group", "participants", ".", "Lymphedema", "prevention", "protocol", "was", "implemented", "for", "study", "group", "whereas", "comparison", "group", "received", "routine", "care", ".", "Post", "tests", "1", ",", "2", ",", "3", ",", "and", "4", "were", "done", "by", "using", "the", "structured", "questionnaire", "at", "10", "th", "day", ",", "30", "th", ",", "60", "th", "and", "90", "th", "post", "operative", "day", "respectively", ".", "Subjects", "'", "responses", "were", "coded", "and", "statistically", "analyzed", "by", "using", "descriptive", "and", "inferential", "statistics", ".", "The", "comparison", "of", "quality", "of", "life", "between", "study", "and", "comparison", "group", "over", "a", "period", "of", "time", "were", "statistically", "significant", "at", "p", "<", "0.001", "whereas", "lymphedema", "occurrence", "was", "significant", "at", "p", "<", "0.01", ".", "The", "early", "execution", "of", "preventive", "measures", "of", "lymphedema", "prevents", "the", "lymphedema", "occurrence", "and", "promotes", "the", "quality", "of", "life", "among", "patients", "undergone", "mastectomy", "." ]
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783
[ "Phase", "III", "double", "-", "blind", ",", "placebo", "-", "controlled", ",", "prospective", "randomized", "trial", "of", "adjuvant", "tamoxifen", "vs.", "tamoxifen", "and", "fenretinide", "in", "postmenopausal", "women", "with", "positive", "receptors", "(", "EB", "193", ")", ":", "an", "intergroup", "trial", "coordinated", "by", "the", "Eastern", "Cooperative", "Oncology", "Group", ".", "Fenretinide", "and", "tamoxifen", "have", "additive", "antitumor", "effects", "preclinically", ".", "We", "performed", "a", "randomized", ",", "placebo", "-", "controlled", ",", "double", "-", "blind", "adjuvant", "trial", "in", "breast", "cancer", "patients", "treated", "for", "5", "years", "with", "tamoxifen", ",", "with", "or", "without", "fenretinide", ".", "Between", "October", "1995", "and", "October", "1999", ",", "426", "postmenopausal", "women", "with", "hormone", "receptor", "-", "positive", "breast", "cancer", "were", "randomized", ".", "Patients", "were", "monitored", "for", "efficacy", "and", "toxicity", ".", "Four", "hundred", "and", "nineteen", "patients", "were", "evaluable", ".", "The", "study", "was", "terminated", "early", "due", "to", "slow", "accrual", ".", "There", "were", "no", "significant", "differences", "between", "treatment", "groups", "in", "DFS", ",", "TTR", "or", "survival", ".", "More", "patients", "stopped", "treatment", "early", "on", "the", "fenretinide", "arm", "than", "on", "placebo", "(", "P", "=", "0.02", ")", ".", "Grade", "3", "/", "4", "toxicities", ",", "including", "visual", "problems", "and", "musculoskeletal", "complaints", "were", "more", "common", "in", "patients", "receiving", "fenretinide", "(", "P", "=", "0.007", ")", ".", "A", "Night", "Blindness", "Questionnaire", "was", "used", "to", "monitor", "nyctalopia", ",", "which", "was", "slightly", ",", "but", "not", "significantly", ",", "more", "common", "on", "fenretinide", ".", "In", "this", "underpowered", "study", ",", "no", "significant", "difference", "was", "observed", "in", "efficacy", "between", "treatment", "groups", ".", "This", "trial", "provides", "important", "toxicity", "information", "about", "fenretinide", ",", "a", "retinoid", "that", "has", "been", "used", "in", "the", "prevention", "setting", ",", "because", "it", "is", "the", "only", "placebo", "-", "controlled", ",", "double", "-", "blind", "randomized", "study", "ever", "performed", "." ]
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784
[ "Cisplatin", "plus", "oral", "etoposide", "(", "EoP", ")", "combination", "is", "more", "effective", "than", "paclitaxel", "in", "patients", "with", "advanced", "breast", "cancer", "pretreated", "with", "anthracyclines", ":", "a", "randomised", "phase", "III", "trial", "of", "Turkish", "Oncology", "Group", ".", "Our", "objective", "was", "to", "determine", "whether", "oral", "etoposide", "and", "cisplatin", "combination", "(", "EoP", ")", "is", "superior", "to", "paclitaxel", "in", "the", "treatment", "of", "advanced", "breast", "cancer", "(", "ABC", ")", "patients", "pretreated", "with", "anthracyclines", ".", "From", "December", "1997", "to", "August", "2003", ",", "201", "patients", "were", "randomised", ",", "100", "to", "EoP", "and", "101", "to", "paclitaxel", "arms", ".", "Four", "patients", "in", "each", "arm", "were", "ineligible", ".", "The", "doses", "of", "etoposide", "and", "cisplatin", "were", "50", "mg", "p.o", ".", "twice", "a", "day", "for", "7", "days", "and", "70", "mg", "m", "(", "-", "2", ")", "intravenously", "(", "i.", "v.", ")", "on", "day", "1", ",", "respectively", ",", "and", "it", "was", "175", "mg", "m", "(", "-", "2", ")", "on", "day", "1", "for", "paclitaxel", ".", "Both", "treatments", "were", "repeated", "every", "3", "weeks", ".", "A", "median", "of", "four", "cycles", "of", "study", "treatment", "was", "given", "in", "both", "arms", ".", "The", "response", "rate", "obtained", "in", "the", "EoP", "arm", "was", "significantly", "higher", "(", "36.3", "vs", "22.2", "%", ";", "P=", "0.038", ")", ".", "Median", "response", "duration", "was", "longer", "for", "the", "EoP", "arm", "(", "7", "vs", "4", "months", ")", "(", "P=", "0.132", ")", ".", "Also", ",", "time", "to", "progression", "was", "significantly", "in", "favour", "of", "the", "EoP", "arm", "(", "5.5", "vs", "3.9", "months", ";", "P=", "0.003", ")", ".", "Median", "overall", "survival", "was", "again", "significantly", "longer", "in", "the", "EoP", "arm", "(", "14", "vs", "9.5", "months", ";", "P=", "0.039", ")", ".", "Toxicity", "profile", "of", "both", "groups", "was", "similar", ".", "Two", "patients", "in", "each", "arm", "were", "lost", "due", "to", "febrile", "neutropenia", ".", "The", "observed", "activity", "and", "acceptable", "toxicity", "of", "EoP", "endorses", "the", "employment", "of", "this", "combination", "in", "the", "treatment", "of", "ABC", "following", "anthracyclines", "." ]
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785
[ "A", "cluster", "-", "randomized", "trial", "of", "a", "primary", "care", "informatics", "-", "based", "system", "for", "breast", "cancer", "screening", ".", "Information", "technology", "offers", "the", "promise", ",", "as", "yet", "unfulfilled", ",", "of", "delivering", "efficient", ",", "evidence", "-", "based", "health", "care", ".", "To", "evaluate", "whether", "a", "primary", "care", "network", "-", "based", "informatics", "intervention", "can", "improve", "breast", "cancer", "screening", "rates", ".", "Cluster", "-", "randomized", "controlled", "trial", "of", "12", "primary", "care", "practices", "conducted", "from", "March", "20", ",", "2007", "to", "March", "19", ",", "2008", ".", "Women", "42", "-", "69", "years", "old", "with", "no", "record", "of", "a", "mammogram", "in", "the", "prior", "2", "years", ".", "In", "intervention", "practices", ",", "a", "population", "-", "based", "informatics", "system", "was", "implemented", "that", ":", "connected", "overdue", "patients", "to", "appropriate", "care", "providers", ",", "presented", "providers", "with", "a", "Web", "-", "based", "list", "of", "their", "overdue", "patients", "in", "a", "non", "-", "visit", "-", "based", "setting", ",", "and", "enabled", "\"", "one", "-", "click", "\"", "mammography", "ordering", "or", "documented", "deferral", "reasons", ".", "Patients", "selected", "for", "mammography", "received", "automatically", "generated", "letters", "and", "follow", "-", "up", "phone", "calls", ".", "All", "practices", "had", "electronic", "health", "record", "reminders", "about", "breast", "cancer", "screening", "available", "during", "clinical", "encounters", ".", "The", "primary", "outcome", "was", "the", "proportion", "of", "overdue", "women", "undergoing", "mammography", "at", "1", "-year", "follow", "-", "up", ".", "Baseline", "mammography", "rates", "in", "intervention", "and", "control", "practices", "did", "not", "differ", "(", "79.5", "%", "vs", "79.3", "%", ",", "p", "=", "0.73", ")", ".", "Among", "3", ",", "054", "women", "in", "intervention", "practices", "and", "3", ",", "676", "women", "in", "control", "practices", "overdue", "for", "mammograms", ",", "intervention", "patients", "were", "somewhat", "younger", ",", "more", "likely", "to", "be", "non", "-", "Hispanic", "white", ",", "and", "have", "health", "insurance", ".", "Most", "intervention", "providers", "used", "the", "system", "(", "65", "of", "70", "providers", ",", "92.9", "%", ")", ".", "Action", "was", "taken", "for", "2", ",", "652", "(", "86.8", "%", ")", "intervention", "patients", "[", "2", ",", "274", "(", "74.5", "%", ")", "contacted", "and", "378", "(", "12.4", "%", ")", "deferred", "]", ".", "After", "1", "year", ",", "mammography", "rates", "were", "significantly", "higher", "in", "the", "intervention", "arm", "(", "31.4", "%", "vs", "23.3", "%", "in", "control", "arm", ",", "p", "<", "0.001", "after", "adjustment", "for", "baseline", "differences", ";", "8.1", "%", "absolute", "difference", ",", "95", "%", "CI", "5.1", "-", "11.2", "%", ")", ".", "All", "demographic", "subgroups", "benefited", "from", "the", "intervention", ".", "Intervention", "patients", "completed", "screening", "sooner", "than", "control", "patients", "(", "p", "<", "0.001", ")", ".", "A", "novel", "population", "-", "based", "informatics", "system", "functioning", "as", "part", "of", "a", "non", "-", "visit", "-", "based", "care", "model", "increased", "mammography", "screening", "rates", "in", "intervention", "practices", ".", "ClinicalTrials", ".", "gov", ";", "NCT", "00462891", "." ]
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786
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787
[ "Breast", "density", "changes", "in", "a", "randomized", "controlled", "trial", "evaluating", "bazedoxifene", "/", "conjugated", "estrogens", ".", "Breast", "density", "is", "associated", "with", "an", "increased", "risk", "of", "breast", "cancer", ".", "This", "study", "assessed", "changes", "in", "mammographic", "breast", "density", "after", "24", "months", "of", "treatment", "with", "bazedoxifene", "(", "BZA", ")", "/", "conjugated", "estrogens", "(", "CE", ")", "in", "postmenopausal", "women", ".", "This", "was", "an", "ancillary", "study", "in", "a", "subset", "of", "nonhysterectomized", "postmenopausal", "women", "enrolled", "in", "a", "randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", ",", "and", "active", "-", "controlled", "phase", "3", "study", ".", "Treatments", "evaluated", "were", "BZA", "20", "mg", "/", "CE", "0.45", "mg", ",", "BZA", "20", "mg", "/", "CE", "0.625", "mg", ",", "raloxifene", "60", "mg", ",", "and", "placebo", ".", "Women", "who", "were", "eligible", "for", "participation", "in", "the", "ancillary", "study", "must", "have", "completed", "24", "months", "of", "treatment", "and", "have", "mammograms", "at", "baseline", "and", "24", "months", ".", "The", "left", "craniocaudal", "views", "from", "each", "mammogram", "pair", "were", "digitized", "and", "analyzed", "by", "a", "radiologist", "who", "was", "blinded", "to", "treatment", "arm", "and", "mammogram", "date", ".", "The", "percent", "breast", "density", "was", "determined", "using", "validated", "software", ".", "Mammogram", "pairs", "were", "obtained", "from", "507", "evaluable", "participants", "(", "mean", "age", "range", ",", "55.2", "-", "56.3", "y", ")", ".", "The", "mean", "changes", "(", "95", "%", "CI", ")", "in", "mammographic", "breast", "density", "from", "baseline", "to", "24", "months", "were", "comparable", "among", "groups", "(", "-", "0.39", "%", "[", "-", "0.69", "to", "-", "0.08", "]", ",", "-", "0.05", "%", "[", "-", "0.38", "to", "0.27", "]", ",", "-", "0.23", "%", "[", "-", "0.54", "to", "0.08", "]", ",", "and", "-", "0.42", "%", "[", "-", "0.72", "to", "-", "0.11", "]", "for", "BZA", "20", "mg", "/", "CE", "0.45", "mg", ",", "BZA", "20", "mg", "/", "CE", "0.625", "mg", ",", "raloxifene", "60", "mg", ",", "and", "placebo", ",", "respectively", ")", ".", "These", "reductions", "from", "baseline", "were", "statistically", "significant", "for", "BZA", "20", "mg", "/", "CE", "0.45", "mg", "and", "placebo", ".", "The", "effect", "of", "both", "BZA", "/", "CE", "doses", "on", "breast", "density", "was", "generally", "consistent", "among", "subgroups", "based", "on", "age", ",", "body", "mass", "index", ",", "and", "years", "since", "menopause", ".", "Treatment", "with", "BZA", "20", "mg", "/", "CE", "0.45", "mg", "or", "BZA", "20", "mg", "/", "CE", "0.625", "mg", "for", "24", "months", "did", "not", "affect", "mammographic", "breast", "density", "in", "this", "population", "of", "postmenopausal", "women", "." ]
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788
[ "Topical", "atorvastatin", "1", "%", "for", "prevention", "of", "skin", "toxicity", "in", "patients", "receiving", "radiation", "therapy", "for", "breast", "cancer", ":", "a", "randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "trial", ".", "The", "purpose", "of", "this", "randomized", ",", "placebo", "-", "controlled", ",", "double", "-", "blind", "study", "was", "to", "investigate", "the", "preventive", "effect", "of", "topical", "administration", "of", "atorvastatin", "(", "ATV", ")", "on", "the", "acute", "radiation", "-", "induced", "skin", "toxicity", "in", "patients", "with", "breast", "cancer", ".", "Seventy", "breast", "cancer", "patients", "were", "randomly", "assigned", "to", "use", "topical", "ATV", "1", "%", "or", "placebo", "gels", "during", "radiotherapy", "twice", "daily", ".", "Radiation", "-", "induced", "dermatitis", "was", "classified", "according", "to", "the", "radiation", "therapy", "oncology", "group", "(", "RTOG", ")", "criteria", ",", "as", "well", "as", "pain", "and", "itching", "were", "scored", "according", "to", "VAS", "(", "visual", "analogue", "scale", ")", "for", "6", "Â", "weeks", "of", "treatment", ".", "Topical", "administration", "of", "ATV", "gel", "during", "radiotherapy", "reduced", "significantly", "radiation", "-", "induced", "breast", "swelling", ",", "itching", ",", "and", "pain", "in", "breast", "cancer", "patients", "by", "factors", "of", "1.8", ",", "1.7", ",", "and", "1.5", ",", "respectively", ".", "ATV", "reduced", "the", "redness", "caused", "by", "radiotherapy", "in", "patients", "as", "compared", "with", "placebo", ";", "however", ",", "this", "difference", "was", "statistically", "not", "significant", ".", "ATV", "was", "able", "to", "reduce", "significantly", "itching", ",", "breast", "edema", ",", "and", "pain", "in", "patients", "during", "radiotherapy", "." ]
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789
[ "Preoperative", "FLAC", "/", "granulocyte", "-", "colony", "-", "stimulating", "factor", "chemotherapy", "for", "stage", "II", "breast", "cancer", ":", "a", "prospective", "randomized", "trial", ".", "Preoperative", "chemotherapy", "for", "stage", "II", "breast", "cancer", "may", "reduce", "locoregional", "tumors", "and", "provides", "initial", "treatment", "for", "systemic", "micrometastases", ".", "We", "conducted", "a", "prospective", ",", "randomized", "trial", "to", "evaluate", "the", "ability", "of", "intensive", "preoperative", "chemotherapy", "to", "enhance", "the", "outcome", "of", "this", "approach", ".", "Patients", "with", "clinical", "stage", "II", "breast", "cancer", "(", "T", "2", "N", "0", ",", "T", "1", "N", "1", ",", "and", "T", "2", "N", "1", ")", "were", "prospectively", "randomized", "to", "receive", "either", "preoperative", "or", "postoperative", "chemotherapy", "with", "five", "21", "-day", "cycles", "of", "fluorouracil", ",", "leucovorin", "calcium", ",", "doxorubicin", ",", "and", "cyclophosphamide", "(", "FLAC", ")", "/", "granulocyte", "-", "colony", "-", "stimulating", "factor", ".", "Local", "therapy", "consisted", "of", "modified", "radical", "mastectomy", "or", "segmentectomy", "/", "axillary", "dissection", "/", "breast", "radiotherapy", ",", "according", "to", "patient", "preference", ".", "Fifty", "-", "three", "women", "were", "randomized", "(", "26", "preoperative", "chemotherapy", "and", "27", "postoperative", "chemotherapy", ")", ".", "The", "objective", "clinical", "response", "rate", "of", "the", "primary", "tumor", "to", "preoperative", "chemotherapy", "was", "80", "%", ",", "and", "the", "pathologic", "complete", "response", "rate", "was", "20", "%", ".", "Preoperative", "chemotherapy", "reduced", "the", "overall", "incidence", "and", "number", "of", "axillary", "lymph", "node", "metastases", ".", "There", "was", "no", "difference", "in", "the", "use", "of", "breast", "-", "conserving", "local", "therapy", "between", "the", "two", "treatment", "arms", ".", "There", "were", "20", "local", "/", "regional", "or", "distant", "recurrences", "(", "9", "preoperative", "and", "11", "postoperative", ")", ".", "There", "was", "no", "difference", "in", "the", "overall", "or", "disease", "-", "free", "survival", "between", "the", "preoperative", "and", "postoperative", "chemotherapy", "arms", ".", "Preoperative", "FLAC", "/", "granulocyte", "-", "colony", "-", "stimulating", "factor", "chemotherapy", "was", "effective", "against", "local", "/", "regional", "tumors", "in", "stage", "II", "breast", "cancer", "but", "was", "otherwise", "comparable", "to", "postoperative", "chemotherapy", "." ]
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790
[ "A", "randomized", ",", "double", "-", "blind", ",", "active", "control", ",", "multicenter", ",", "dose", "-", "finding", "study", "of", "lipegfilgrastim", "(", "XM", "22", ")", "in", "breast", "cancer", "patients", "receiving", "myelosuppressive", "therapy", ".", "This", "dose", "-", "ranging", "study", "was", "conducted", "to", "identify", "the", "optimal", "fixed", "dose", "of", "lipegfilgrastim", "compared", "with", "pegfilgrastim", "6.0", "mg", "for", "the", "provision", "of", "neutrophil", "support", "during", "myelosuppressive", "chemotherapy", "in", "patients", "with", "breast", "cancer", ".", "A", "phase", "2", "study", "was", "conducted", "in", "which", "208", "chemotherapy", "-", "naive", "patients", "were", "randomized", "to", "receive", "lipegfilgrastim", "3.0", ",", "4.5", ",", "or", "6.0", "mg", "or", "pegfilgrastim", "6.0", "mg", ".", "Study", "drugs", "were", "administered", "as", "a", "single", "subcutaneous", "injection", "on", "day", "2", "of", "each", "chemotherapy", "cycle", "(", "doxorubicin", "/", "docetaxel", "on", "day", "1", "for", "four", "3", "-week", "cycles", ")", ".", "The", "primary", "outcome", "measure", "was", "duration", "of", "severe", "neutropenia", "(", "DSN", ")", "in", "cycle", "1", ".", "Patients", "treated", "with", "lipegfilgrastim", "experienced", "shorter", "DSN", "in", "cycle", "1", "with", "higher", "doses", ".", "The", "mean", "DSN", "was", "0.76", "days", "in", "the", "lipegfilgrastim", "6.0", "-mg", "group", "and", "0.87", "days", "in", "the", "pegfilgrastim", "6.0", "-mg", "group", ",", "with", "no", "significant", "differences", "between", "treatment", "groups", ".", "Treatment", "with", "lipegfilgrastim", "6.0", "mg", "was", "consistently", "associated", "with", "a", "higher", "absolute", "neutrophil", "count", "(", "ANC", ")", "at", "nadir", ",", "shorter", "ANC", "recovery", "time", ",", "and", "a", "similar", "safety", "and", "tolerability", "profile", "compared", "with", "pegfilgrastim", ".", "This", "phase", "2", "study", "demonstrated", "that", "lipegfilgrastim", "6.0", "mg", "is", "the", "optimal", "dose", "for", "patients", "with", "breast", "cancer", "and", "provides", "neutrophil", "support", "that", "is", "at", "least", "equivalent", "to", "the", "standard", "6.0", "-mg", "fixed", "dose", "of", "pegfilgrastim", "." ]
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791
[ "Safety", "results", "from", "a", "phase", "III", "study", "(", "TURANDOT", "trial", "by", "CECOG", ")", "of", "first", "-", "line", "bevacizumab", "in", "combination", "with", "capecitabine", "or", "paclitaxel", "for", "HER-", "2", "-", "negative", "locally", "recurrent", "or", "metastatic", "breast", "cancer", ".", "We", "report", "safety", "data", "from", "a", "randomised", ",", "phase", "III", "study", "(", "CECOG", "/", "BC", ".", "1", ".", "3.005", ")", "evaluating", "first", "-", "line", "bevacizumab", "plus", "paclitaxel", "or", "capecitabine", "for", "locally", "recurrent", "or", "metastatic", "breast", "cancer", ".", "Patients", "aged", "≥", "18", "years", "with", "human", "epidermal", "growth", "factor", "receptor-", "2", "-", "negative", "breast", "adenocarcinoma", "were", "randomised", "to", "Arm", "A", ":", "bevacizumab", "10", "mg", "/", "kg", "days", "1", "and", "15", ";", "paclitaxel", "90", "mg", "/", "m", "(", "2", ")", "days", "1", ",", "8", ",", "and", "15", ",", "every", "4", "weeks", ";", "or", "Arm", "B", ":", "bevacizumab", "15", "mg", "/", "kg", "day", "1", ";", "capecitabine", "1000", "mg", "/", "m", "(", "2", ")", "b.i.d", ".", ",", "days", "1", "-", "14", ",", "every", "3", "weeks", ",", "until", "disease", "progression", ",", "unacceptable", "toxicity", "or", "consent", "withdrawal", ".", "A", "post", "hoc", "interim", "safety", "analysis", "included", "561", "patients", "(", "Arm", "A", ":", "284", ",", "Arm", "B", ":", "277", ")", ".", "The", "regimens", "demonstrated", "similar", "frequencies", "of", "all", "-", "grade", "and", "serious", "adverse", "events", "(", "SAEs", ")", ",", "but", "different", "safety", "profiles", ".", "Treatment", "-", "related", "events", "occurred", "in", "85.2", "%", "(", "Arm", "A", ")", "and", "78.0", "%", "(", "Arm", "B", ")", "of", "patients", ".", "Fatigue", "was", "most", "common", "in", "Arm", "A", "(", "30.6", "%", "versus", "23.5", "%", "Arm", "B", ")", ",", "and", "hand", "-", "foot", "syndrome", "(", "HFS", ")", "most", "common", "in", "Arm", "B", "(", "49.5", "%", "versus", "2.5", "%", "Arm", "A", ")", ".", "Diarrhoea", "(", "Arm", "A", ":", "0.4", "%", ",", "Arm", "B", ":", "1.4", "%", ")", "and", "pulmonary", "embolism", "(", "Arm", "A", ":", "0.7", "%", ",", "Arm", "B", ":", "1.1", "%", ")", "were", "the", "most", "frequently", "reported", "SAEs", ".", "These", "findings", "are", "in", "-", "line", "with", "safety", "data", "for", "bevacizumab", "plus", "paclitaxel", "or", "capecitabine", ",", "reported", "in", "previous", "phase", "III", "trials", "." ]
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792
[ "Carvedilol", "Administration", "Can", "Prevent", "Doxorubicin", "-", "Induced", "Cardiotoxicity", ":", "A", "Double", "-", "Blind", "Randomized", "Trial", ".", "The", "aim", "of", "this", "study", "is", "to", "evaluate", "the", "preventive", "effects", "of", "carvedilol", "on", "doxorubicin", "-", "induced", "cardiotoxicity", ".", "In", "this", "trial", ",", "70", "female", "patients", "with", "breast", "cancer", "who", "were", "candidates", "to", "receive", "doxorubicin", "were", "enrolled", ",", "from", "which", "30", "were", "selected", "randomly", "to", "receive", "carvedilol", "6.25", "mg", "daily", "during", "chemotherapy", ",", "with", "the", "rest", "receiving", "placebo", "as", "the", "control", "group", ".", "Both", "groups", "were", "evaluated", "1", "week", "before", "and", "1", "week", "after", "chemotherapy", "by", "measuring", "the", "left", "ventricular", "ejection", "fraction", "and", "strain", "/", "strain", "rate", ".", "Data", "analysis", "showed", "that", "the", "case", "group", "presented", "no", "significant", "reduction", "in", "strain", "and", "strain", "-", "rate", "parameters", "after", "intervention", ",", "while", "there", "was", "a", "significant", "reduction", "in", "these", "parameters", "in", "the", "control", "group", "(", "all", "p", "values", "<", "0.001", ")", ".", "Also", ",", "the", "mean", "differences", "of", "strain", "parameters", "in", "the", "case", "group", "were", "significantly", "less", "than", "in", "the", "control", "group", "in", "all", "evaluated", "heart", "walls", "(", "basal", "septal", "strain", ",", "p", "=", "0.005", ",", "basal", "lateral", "strain", ",", "p", "=", "0.001", ",", "basal", "inferior", "strain", ",", "p", "<", "0.001", ",", "and", "basal", "anterior", "strain", ",", "p", "<", "0.001", ")", ";", "the", "same", "was", "true", "for", "the", "strain", "-", "rate", "parameters", "(", "the", "p", "values", "for", "basal", "septal", ",", "basal", "lateral", ",", "basal", "inferior", "and", "basal", "anterior", "strain", "rate", "were", "0.037", ",", "0.037", ",", "0.002", "and", "<", "0.001", ",", "respectively", ")", ".", "This", "study", "shows", "that", "carvedilol", "can", "prevent", "doxorubicin", "-", "induced", "cardiotoxicity", ".", "Whether", "this", "prophylaxis", "should", "be", "considered", "as", "the", "preferred", "method", "needs", "further", "investigation", "." ]
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793
[ "A", "randomized", ",", "prospective", "study", "of", "endometrial", "resection", "to", "prevent", "recurrent", "endometrial", "polyps", "in", "women", "with", "breast", "cancer", "receiving", "tamoxifen", ".", "To", "assess", "the", "role", "of", "endometrial", "resection", "in", "preventing", "recurrence", "of", "tamoxifen", "-", "associated", "endometrial", "polyps", "in", "women", "with", "breast", "cancer", ".", "Randomized", ",", "prospective", "study", "(", "Canadian", "Task", "Force", "classification", "I", ")", ".", "Tertiary", "university", "-", "affiliated", "medical", "center", ".", "Twenty", "consecutive", "women", "(", "age", "range", "43", "-", "61", "yrs", ")", ".", "Hysteroscopic", "removal", "of", "tamoxifen", "-", "associated", "endometrial", "polyps", "with", "or", "without", "simultaneous", "resection", "of", "the", "endometrium", ".", "Patients", "were", "randomized", "to", "undergo", "(", "10", "women", ")", "or", "not", "undergo", "(", "10", ")", "concomitant", "endometrial", "resection", ".", "They", "were", "followed", "for", "at", "least", "18", "months", "(", "range", "18", "-", "24", "mo", ")", ",", "including", "transvaginal", "ultrasonography", "every", "6", "months", "and", "hysteroscopy", "when", "endometrial", "irregularity", "was", "noted", ".", "The", "main", "outcome", "variable", "was", "recurrence", "of", "endometrial", "polyps", ";", "occurrence", "of", "uterine", "bleeding", "was", "also", "noted", ".", "In", "women", "who", "underwent", "endometrial", "resection", ",", "only", "one", "had", "a", "1", "x", "1", "-cm", "endometrial", "polyp", "diagnosed", "and", "removed", "during", "follow", "-", "up", ".", "Seven", "women", "remained", "amenorrheic", ",", "and", "three", "experienced", "spotting", "for", "a", "few", "days", "every", "month", ".", "In", "the", "control", "group", ",", "six", "women", "had", "recurrent", "endometrial", "polyps", "requiring", "hysteroscopic", "removal", "(", "two", "-", "tail", "Fisher", "'s", "exact", "test", "p", "<", "0.06", ")", ".", "Recurrence", "of", "endometrial", "polyps", ",", "one", "of", "the", "most", "common", "problems", "in", "patients", "with", "breast", "cancer", "receiving", "long", "-", "term", "treatment", "with", "tamoxifen", ",", "may", "be", "reduced", "by", "performing", "endometrial", "resection", "at", "the", "time", "of", "hysteroscopic", "removal", "of", "polyps", ".", "The", "possible", "risk", "of", "occult", "endometrial", "cancer", "is", "yet", "to", "be", "determined", ".", "(", "J", "Am", "Assoc", "Gynecol", "Laparosc", "6", "(", "3", ")", ":", "285", "-", "288", ",", "1999", ")" ]
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794
[ "Effect", "of", "Low", "-", "Intensity", "Physical", "Activity", "and", "Moderate-", "to", "High", "-", "Intensity", "Physical", "Exercise", "During", "Adjuvant", "Chemotherapy", "on", "Physical", "Fitness", ",", "Fatigue", ",", "and", "Chemotherapy", "Completion", "Rates", ":", "Results", "of", "the", "PACES", "Randomized", "Clinical", "Trial", ".", "We", "evaluated", "the", "effectiveness", "of", "a", "low", "-", "intensity", ",", "home", "-", "based", "physical", "activity", "program", "(", "Onco", "-", "Move", ")", "and", "a", "moderate-", "to", "high", "-", "intensity", ",", "combined", "supervised", "resistance", "and", "aerobic", "exercise", "program", "(", "OnTrack", ")", "versus", "usual", "care", "(", "UC", ")", "in", "maintaining", "or", "enhancing", "physical", "fitness", ",", "minimizing", "fatigue", ",", "enhancing", "health", "-", "related", "quality", "of", "life", ",", "and", "optimizing", "chemotherapy", "completion", "rates", "in", "patients", "undergoing", "adjuvant", "chemotherapy", "for", "breast", "cancer", ".", "We", "randomly", "assigned", "patients", "who", "were", "scheduled", "to", "undergo", "adjuvant", "chemotherapy", "(", "N", "=", "230", ")", "to", "Onco", "-", "Move", ",", "OnTrack", ",", "or", "UC", ".", "Performance", "-", "based", "and", "self", "-", "reported", "outcomes", "were", "assessed", "before", "random", "assignment", ",", "at", "the", "end", "of", "chemotherapy", ",", "and", "at", "the", "6", "-month", "follow", "-", "up", ".", "We", "used", "generalized", "estimating", "equations", "to", "compare", "the", "groups", "over", "time", ".", "Onco", "-", "Move", "and", "OnTrack", "resulted", "in", "less", "decline", "in", "cardiorespiratory", "fitness", "(", "P", "<", ".", "001", ")", ",", "better", "physical", "functioning", "(", "P", "≤", ".", "001", ")", ",", "less", "nausea", "and", "vomiting", "(", "P", "=", ".", "029", "and", ".", "031", ",", "respectively", ")", "and", "less", "pain", "(", "P", "=", ".", "003", "and", ".", "011", ",", "respectively", ")", "compared", "with", "UC", ".", "OnTrack", "also", "resulted", "in", "better", "outcomes", "for", "muscle", "strength", "(", "P", "=", ".", "002", ")", "and", "physical", "fatigue", "(", "P", "<", ".", "001", ")", ".", "At", "the", "6", "-month", "follow", "-", "up", ",", "most", "outcomes", "returned", "to", "baseline", "levels", "for", "all", "three", "groups", ".", "A", "smaller", "percentage", "of", "participants", "in", "OnTrack", "required", "chemotherapy", "dose", "adjustments", "than", "those", "in", "the", "UC", "or", "Onco", "-", "Move", "groups", "(", "P", "=", ".", "002", ")", ".", "Both", "intervention", "groups", "returned", "earlier", "(", "P", "=", ".", "012", ")", ",", "as", "well", "as", "for", "more", "hours", "per", "week", "(", "P", "=", ".", "014", ")", ",", "to", "work", "than", "the", "control", "group", ".", "A", "supervised", ",", "moderate-", "to", "high", "-", "intensity", ",", "combined", "resistance", "and", "aerobic", "exercise", "program", "is", "most", "effective", "for", "patients", "with", "breast", "cancer", "undergoing", "adjuvant", "chemotherapy", ".", "A", "home", "-", "based", ",", "low", "-", "intensity", "physical", "activity", "program", "represents", "a", "viable", "alternative", "for", "women", "who", "are", "unable", "or", "unwilling", "to", "follow", "the", "higher", "intensity", "program", "." ]
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795
[ "Adjuvant", "denosumab", "in", "breast", "cancer", "(", "ABCSG-", "18", ")", ":", "a", "multicentre", ",", "randomised", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "trial", ".", "Adjuvant", "endocrine", "therapy", "compromises", "bone", "health", "in", "patients", "with", "breast", "cancer", ",", "causing", "osteopenia", ",", "osteoporosis", ",", "and", "fractures", ".", "Antiresorptive", "treatments", "such", "as", "bisphosphonates", "prevent", "and", "counteract", "these", "side", "-", "effects", ".", "In", "this", "trial", ",", "we", "aimed", "to", "investigate", "the", "effects", "of", "the", "anti", "-", "RANK", "ligand", "antibody", "denosumab", "in", "postmenopausal", ",", "aromatase", "inhibitor", "-", "treated", "patients", "with", "early", "-", "stage", "hormone", "receptor", "-", "positive", "breast", "cancer", ".", "In", "this", "prospective", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", ",", "phase", "3", "trial", ",", "postmenopausal", "patients", "with", "early", "hormone", "receptor", "-", "positive", "breast", "cancer", "receiving", "treatment", "with", "aromatase", "inhibitors", "were", "randomly", "assigned", "in", "a", "1", ":1", "ratio", "to", "receive", "either", "denosumab", "60", "mg", "or", "placebo", "administered", "subcutaneously", "every", "6", "months", "in", "58", "trial", "centres", "in", "Austria", "and", "Sweden", ".", "Patients", "were", "assigned", "by", "an", "interactive", "voice", "response", "system", ".", "The", "randomisation", "schedule", "used", "a", "randomly", "permuted", "block", "design", "with", "block", "sizes", "2", "and", "4", ",", "stratified", "by", "type", "of", "hospital", "regarding", "Hologic", "device", "for", "DXA", "scans", ",", "previous", "aromatase", "inhibitor", "use", ",", "and", "baseline", "bone", "mineral", "density", ".", "Patients", ",", "treating", "physicians", ",", "investigators", ",", "data", "managers", ",", "and", "all", "study", "personnel", "were", "masked", "to", "treatment", "allocation", ".", "The", "primary", "endpoint", "was", "time", "from", "randomisation", "to", "first", "clinical", "fracture", ",", "analysed", "by", "intention", "to", "treat", ".", "As", "an", "additional", "sensitivity", "analysis", ",", "we", "also", "analysed", "the", "primary", "endpoint", "on", "the", "per", "-", "protocol", "population", ".", "Patients", "were", "treated", "until", "the", "prespecified", "number", "of", "247", "first", "clinical", "fractures", "was", "reached", ".", "This", "trial", "is", "ongoing", "(", "patients", "are", "in", "follow", "-", "up", ")", "and", "is", "registered", "with", "the", "European", "Clinical", "Trials", "Database", ",", "number", "2005", "-", "005275", "-", "15", ",", "and", "with", "ClinicalTrials.gov", ",", "number", "NCT", "00556374", ".", "Between", "Dec", "18", ",", "2006", ",", "and", "July", "22", ",", "2013", ",", "3425", "eligible", "patients", "were", "enrolled", "into", "the", "trial", ",", "of", "whom", "3420", "were", "randomly", "assigned", "to", "receive", "denosumab", "60", "mg", "(", "n=", "1711", ")", "or", "placebo", "(", "n=", "1709", ")", "subcutaneously", "every", "6", "months", ".", "Compared", "with", "the", "placebo", "group", ",", "patients", "in", "the", "denosumab", "group", "had", "a", "significantly", "delayed", "time", "to", "first", "clinical", "fracture", "(", "hazard", "ratio", "[", "HR", "]", "0", "·", "50", "[", "95", "%", "CI", "0", "·", "39", "-", "0", "·", "65", "]", ",", "p", "<", "0", "·", "0001", ")", ".", "The", "overall", "lower", "number", "of", "fractures", "in", "the", "denosumab", "group", "(", "92", ")", "than", "in", "the", "placebo", "group", "(", "176", ")", "was", "similar", "in", "all", "patient", "subgroups", ",", "including", "in", "patients", "with", "a", "bone", "mineral", "density", "T", "-", "score", "of", "-", "1", "or", "higher", "at", "baseline", "(", "n=", "1872", ",", "HR", "0", "·", "44", "[", "95", "%", "CI", "0", "·", "31", "-", "0", "·", "64", "]", ",", "p", "<", "0", "·", "0001", ")", "and", "in", "those", "with", "a", "bone", "mineral", "density", "T", "-", "score", "of", "less", "than", "-", "1", "already", "at", "baseline", "(", "n=", "1548", ",", "HR", "0", "·", "57", "[", "95", "%", "CI", "0", "·", "40", "-", "0", "·", "82", "]", ",", "p=", "0", "·", "002", ")", ".", "The", "patient", "incidence", "of", "adverse", "events", "in", "the", "safety", "analysis", "set", "(", "all", "patients", "who", "received", "at", "least", "one", "dose", "of", "study", "drug", ")", "did", "not", "differ", "between", "the", "denosumab", "group", "(", "1366", "events", ",", "80", "%", ")", "and", "the", "placebo", "group", "(", "1334", "events", ",", "79", "%", ")", ",", "nor", "did", "the", "numbers", "of", "serious", "adverse", "events", "(", "521", "vs", "511", "[", "30", "%", "in", "each", "group", "]", ")", ".", "The", "main", "adverse", "events", "were", "arthralgia", "and", "other", "aromatase", "-", "inhibitor", "related", "symptoms", ";", "no", "additional", "toxicity", "from", "the", "study", "drug", "was", "reported", ".", "Despite", "proactive", "adjudication", "of", "every", "potential", "osteonecrosis", "of", "the", "jaw", "by", "an", "international", "expert", "panel", ",", "no", "cases", "of", "osteonecrosis", "of", "the", "jaw", "were", "reported", ".", "93", "patients", "(", "3", "%", "of", "the", "full", "analysis", "set", ")", "died", "during", "the", "study", ",", "of", "which", "one", "death", "(", "in", "the", "denosumab", "group", ")", "was", "thought", "to", "be", "related", "to", "the", "study", "drug", ".", "Adjuvant", "denosumab", "60", "mg", "twice", "per", "year", "reduces", "the", "risk", "of", "clinical", "fractures", "in", "postmenopausal", "women", "with", "breast", "cancer", "receiving", "aromatase", "inhibitors", ",", "and", "can", "be", "administered", "without", "added", "toxicity", ".", "Since", "a", "main", "side", "-", "effect", "of", "adjuvant", "breast", "cancer", "treatment", "can", "be", "substantially", "reduced", "by", "the", "addition", "of", "denosumab", ",", "this", "treatment", "should", "be", "considered", "for", "clinical", "practice", ".", "Amgen", "." ]
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796
[ "Bisphosphonate", "treatment", "in", "primary", "breast", "cancer", ":", "results", "from", "a", "randomised", "comparison", "of", "oral", "pamidronate", "versus", "no", "pamidronate", "in", "patients", "with", "primary", "breast", "cancer", ".", "During", "the", "period", "from", "January", "1990", "to", "January", "1996", "a", "total", "of", "953", "patients", "with", "lymph", "node", "negative", "primary", "breast", "cancer", "were", "randomised", "to", "oral", "pamidronate", "(", "n=", "460", ")", "150", "mg", "twice", "daily", "for", "4", "years", "or", "no", "adjuvant", "pamidronate", "(", "n=", "493", ")", "in", "order", "to", "investigate", "whether", "oral", "pamidronate", "can", "prevent", "the", "occurrence", "of", "bone", "metastases", "and", "fractures", ".", "The", "patients", "received", "adjuvant", "chemotherapy", ",", "loco", "-", "regional", "radiation", "therapy", ",", "but", "no", "endocrine", "treatment", ".", "During", "the", "follow", "-", "up", "period", "the", "number", "of", "patients", "with", "pure", "bone", "metastases", "was", "35", "in", "the", "control", "group", "and", "31", "in", "the", "pamidronate", "group", ".", "The", "number", "of", "patients", "with", "a", "combination", "of", "bone", "and", "other", "distant", "metastases", "were", "22", "in", "the", "control", "group", "and", "20", "in", "the", "pamidronate", "group", ".", "The", "hazard", "rate", "ratio", "for", "recurrence", "in", "bone", "in", "the", "pamidronate", "group", "compared", "to", "the", "control", "group", "was", "1.03", "(", "95", "%", "confidence", "interval", "0.75", "-", "1.40", ")", "and", "p=", "0.86", ".", "No", "effect", "was", "observed", "on", "overall", "survival", ".", "In", "a", "small", "subgroup", "of", "27", "patients", "from", "the", "study", ",", "12", "of", "whom", "were", "treated", "with", "pamidronate", "a", "significant", "bone", "preserving", "effect", "was", "observed", "on", "bone", "mineral", "density", "in", "the", "lumbar", "spine", ",", "but", "not", "in", "the", "proximal", "femur", ".", "The", "results", "from", "the", "trial", "do", "not", "support", "a", "beneficial", "effect", "of", "oral", "pamidronate", "on", "the", "occurrence", "of", "bone", "metastases", "or", "fractures", "in", "patients", "with", "primary", "breast", "cancer", "receiving", "adjuvant", "chemotherapy", "." ]
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797
[ "Effects", "of", "Exercise", "and", "Cardiorespiratory", "Fitness", "on", "Estrogen", "Metabolism", "in", "Postmenopausal", "Women", ".", "Lowering", "endogenous", "estrogen", "levels", "is", "one", "mechanism", "whereby", "physical", "activity", "may", "lower", "postmenopausal", "breast", "cancer", "risk", ".", "Several", "prospective", "studies", "have", "suggested", "that", "increased", "2", "-hydroxylation", "of", "estrogens", "may", "also", "reduce", "postmenopausal", "breast", "cancer", "risk", ",", "but", "whether", "or", "not", "exercise", "alters", "estrogen", "metabolism", "through", "this", "mechanism", "is", "unclear", ".", "We", "measured", "total", "circulating", "concentrations", "of", "parent", "estrogens", "(", "estrone", "and", "estradiol", ")", "and", "13", "estrogen", "metabolites", ",", "including", "glucuronidated", ",", "sulfated", ",", "and", "unconjugated", "forms", ",", "by", "stable", "isotope", "dilution", "LC", "/", "MS", "-", "MS", "in", "153", "postmenopausal", "women", "randomized", "to", "12", "months", "of", "moderate", "-", "to", "-", "vigorous", "exercise", "and", "153", "controls", ".", "We", "also", "explored", "associations", "with", "cardiorespiratory", "fitness", "measured", "by", "treadmill", ".", "Although", "women", "randomized", "to", "exercise", "averaged", "178", "minutes", "/", "week", "of", "exercise", "over", "12", "months", ",", "their", "cardiorespiratory", "fitness", "was", "13", "%", "greater", "than", "controls", "at", "12", "months", "(", "P", "=", "0.0001", ")", ",", "and", "total", "estradiol", "was", "reduced", "by", "10", "%", "(", "P", "=", "0.04", ")", ";", "there", "were", "no", "statistically", "significant", "effects", "of", "exercise", "on", "circulating", "concentrations", "of", "estrogen", "metabolites", "in", "the", "2", "-", ",", "4", "-", ",", "or", "16", "-pathways", ",", "or", "on", "the", "2", "-pathway", "/", "parent", "estrogens", "ratio", ".", "However", ",", "we", "observed", "a", "statistically", "significant", "association", "between", "increased", "fitness", "and", "reduced", "concentration", "of", "2", "-pathway", "metabolites", "(", "P", "<", "0.05", ")", ".", "We", "found", "no", "evidence", "that", "12", "months", "of", "moderate", "-", "to", "-", "vigorous", "exercise", "or", "increased", "fitness", "changed", "estrogen", "metabolism", "in", "a", "way", "that", "might", "reduce", "breast", "cancer", "risk", ".", "The", "protective", "effect", "of", "exercise", "on", "postmenopausal", "breast", "cancer", "is", "unlikely", "to", "be", "mediated", "by", "changes", "in", "estrogen", "metabolism", "." ]
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798
[ "Phase", "II", "randomized", "study", "of", "trastuzumab", "emtansine", "versus", "trastuzumab", "plus", "docetaxel", "in", "patients", "with", "human", "epidermal", "growth", "factor", "receptor", "2", "-positive", "metastatic", "breast", "cancer", ".", "Trastuzumab", "emtansine", "(", "T", "-", "DM", "1", ")", ",", "an", "antibody", "-", "drug", "conjugate", "composed", "of", "the", "cytotoxic", "agent", "DM", "1", "conjugated", "to", "trastuzumab", "via", "a", "stable", "thioether", "linker", ",", "has", "shown", "clinical", "activity", "in", "single", "-", "arm", "studies", "enrolling", "patients", "with", "human", "epidermal", "growth", "factor", "receptor", "2", "(", "HER", "2", ")", "-positive", "metastatic", "breast", "cancer", "(", "MBC", ")", "whose", "disease", "had", "progressed", "on", "HER", "2", "-", "targeted", "therapy", "in", "the", "metastatic", "setting", ".", "Patients", "(", "N", "=", "137", ")", "with", "HER", "2", "-", "positive", "MBC", "or", "recurrent", "locally", "advanced", "breast", "cancer", "were", "randomly", "assigned", "to", "trastuzumab", "plus", "docetaxel", "(", "HT", ";", "n", "=", "70", ")", "or", "T", "-", "DM", "1", "(", "n", "=", "67", ")", "as", "first", "-", "line", "treatment", "until", "disease", "progression", "or", "unacceptable", "toxicity", ".", "Primary", "end", "points", "were", "investigator", "-", "assessed", "progression", "-", "free", "survival", "(", "PFS", ")", "and", "safety", ".", "Key", "secondary", "end", "points", "included", "overall", "survival", "(", "OS", ")", ",", "objective", "response", "rate", "(", "ORR", ")", ",", "duration", "of", "objective", "response", ",", "clinical", "benefit", "rate", ",", "and", "quality", "of", "life", ".", "Median", "PFS", "was", "9.2", "months", "with", "HT", "and", "14.2", "months", "with", "T", "-", "DM", "1", "(", "hazard", "ratio", ",", "0.59", ";", "95", "%", "CI", ",", "0.36", "to", "0.97", ")", ";", "median", "follow", "-", "up", "was", "approximately", "14", "months", "in", "both", "arms", ".", "ORR", "was", "58.0", "%", "(", "95", "%", "CI", ",", "45.5", "%", "to", "69.2", "%", ")", "with", "HT", "and", "64.2", "%", "(", "95", "%", "CI", ",", "51.8", "%", "to", "74.8", "%", ")", "with", "T", "-", "DM", "1", ".", "T", "-", "DM", "1", "had", "a", "favorable", "safety", "profile", "versus", "HT", ",", "with", "fewer", "grade", "≥", "3", "adverse", "events", "(", "AEs", ";", "46.4", "%", "v", "90.9", "%", ")", ",", "AEs", "leading", "to", "treatment", "discontinuations", "(", "7.2", "%", "v", "34.8", "%", ")", ",", "[", "corrected", "]", "and", "serious", "AEs", "(", "20.3", "%", "v", "25.8", "%", ")", ".", "Preliminary", "OS", "results", "were", "similar", "between", "treatment", "arms", ";", "median", "follow", "-", "up", "was", "approximately", "23", "months", "in", "both", "arms", ".", "In", "this", "randomized", "phase", "II", "study", ",", "first", "-", "line", "treatment", "with", "T", "-", "DM", "1", "for", "patients", "with", "HER", "2", "-", "positive", "MBC", "provided", "a", "significant", "improvement", "in", "PFS", ",", "with", "a", "favorable", "safety", "profile", ",", "versus", "HT", "." ]
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799
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