Datasets:

Stardrums

/

pico-breast-cancer

like 2

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[ "A", "Randomized", "Multicenter", "Phase", "II", "Study", "of", "Docosahexaenoic", "Acid", "in", "Patients", "with", "a", "History", "of", "Breast", "Cancer", ",", "Premalignant", "Lesions", ",", "or", "Benign", "Breast", "Disease", ".", "Obesity", ",", "a", "cause", "of", "subclinical", "inflammation", ",", "is", "a", "risk", "factor", "for", "the", "development", "of", "postmenopausal", "breast", "cancer", "and", "is", "associated", "with", "poorer", "cancer", "outcomes", ".", "Docosahexaenoic", "acid", "(", "DHA", ")", ",", "an", "omega-", "3", "fatty", "acid", ",", "possesses", "anti", "-", "inflammatory", "properties", ".", "We", "hypothesized", "that", "treatment", "with", "DHA", "would", "reduce", "the", "expression", "of", "proinflammatory", "genes", "and", "aromatase", ",", "the", "rate", "-", "limiting", "enzyme", "for", "estrogen", "biosynthesis", ",", "in", "benign", "breast", "tissue", "of", "overweight", "/", "obese", "women", ".", "A", "randomized", ",", "placebo", "-", "controlled", ",", "double", "-", "blind", "phase", "II", "study", "of", "DHA", "given", "for", "12", "weeks", "to", "overweight", "/", "obese", "women", "with", "a", "history", "of", "stage", "I", "-", "III", "breast", "cancer", ",", "DCIS", "/", "LCIS", ",", "Paget", "'s", "disease", ",", "or", "proliferative", "benign", "breast", "disease", "was", "carried", "out", ".", "In", "this", "placebo", "controlled", "trial", ",", "the", "primary", "objective", "was", "to", "determine", "whether", "DHA", "(", "1", ",", "000", "mg", "by", "mouth", "twice", "daily", ")", "reduced", "breast", "tissue", "levels", "of", "TNFα", ".", "Secondary", "objectives", "included", "evaluation", "of", "the", "effect", "of", "DHA", "on", "breast", "tissue", "levels", "of", "COX-", "2", ",", "IL", "1", "β", ",", "aromatase", ",", "white", "adipose", "tissue", "inflammation", ",", "and", "gene", "expression", "by", "RNA", "-", "seq", ".", "Red", "blood", "cell", "fatty", "acid", "levels", "were", "measured", "to", "assess", "compliance", ".", "From", "July", "2013", "to", "November", "2015", ",", "64", "participants", "were", "randomized", "and", "treated", "on", "trial", "(", "32", "women", "per", "arm", ")", ".", "Increased", "levels", "of", "omega-", "3", "fatty", "acids", "in", "red", "blood", "cells", "were", "detected", "following", "treatment", "with", "DHA", "(", "P", "<", "0.001", ")", "but", "not", "placebo", ".", "Treatment", "with", "DHA", "did", "not", "alter", "levels", "of", "TNFα", "(", "P", "=", "0.71", ")", ",", "or", "other", "biomarkers", "including", "the", "transcriptome", "in", "breast", "samples", ".", "Treatment", "with", "DHA", "was", "overall", "well", "-", "tolerated", ".", "Although", "compliance", "was", "confirmed", ",", "we", "did", "not", "observe", "changes", "in", "the", "levels", "of", "prespecified", "biomarkers", "in", "the", "breast", "after", "treatment", "with", "DHA", "when", "compared", "with", "placebo", ".", "Cancer", "Prev", "Res", ";", "11", "(", "4", ")", ";", "203", "-", "14", ".", "©", "2018", "AACRSee", "related", "editorial", "by", "Fabian", "and", "Kimler", ",", "p.", "187", "." ]

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[ "Intravenous", "pamidronate", "versus", "oral", "and", "intravenous", "clodronate", "in", "bone", "metastatic", "breast", "cancer", ":", "a", "randomized", ",", "open", "-", "label", ",", "non", "-", "inferiority", "Phase", "III", "trial", ".", "Patients", "with", "metastasized", "breast", "cancer", "often", "suffer", "from", "discomfort", "caused", "by", "metastatic", "bone", "disease", ".", "Thus", ",", "osteoprotection", "is", "an", "important", "part", "of", "therapy", "in", "breast", "cancer", "metastasized", "to", "bone", ",", "and", "bisphosphonates", "(", "BPs", ")", "are", "a", "major", "therapeutic", "option", ".", "In", "this", "study", ",", "our", "objectives", "were", "to", "compare", "the", "side", "effects", "of", "oral", "versus", "intravenous", "BP", "treatment", "and", "to", "assess", "their", "clinical", "effectiveness", ".", "In", "this", "prospective", "randomized", ",", "open", "-", "label", ",", "non", "-", "inferiority", "trial", ",", "we", "enrolled", "breast", "cancer", "patients", "with", "at", "least", "one", "bone", "metastasis", "and", "an", "Eastern", "Cooperative", "Oncology", "Group", "performance", "status", "of", "0", "-", "2", ".", "Patients", "were", "randomly", "assigned", "to", "one", "of", "the", "three", "treatment", "groups", ":", "A", ",", "60", "mg", "pamidronate", "intravenously", "q", "3", "w", ";", "B", "-", "iv", ",", "900", "mg", "clodronate", "intravenously", "q", "3", "w", ";", "and", "B", "-", "o", ",", "2", ",", "400", "mg", "oral", "clodronate", "daily", ".", "Assessments", "were", "performed", "at", "baseline", "and", "every", "3", "months", "thereafter", ".", "Between", "1995", "and", "1999", ",", "321", "patients", "with", "confirmed", "bone", "metastases", "from", "breast", "cancer", "were", "included", "in", "the", "study", ".", "At", "first", "follow", "-", "up", ",", "gastrointestinal", "(", "GI", ")", "tract", "side", "effects", "were", "most", "common", ",", "and", "adverse", "effects", "on", "the", "GI", "tract", "were", "more", "frequent", "in", "the", "oral", "treatment", "group", "(", "P=", "0.002", "and", "P", "<", "0.001", ",", "respectively", ")", ".", "There", "were", "no", "statistically", "significant", "differences", "among", "the", "treatment", "cohorts", "for", "other", "documented", "side", "effects", "(", "skin", ",", "serum", "electrolytes", ",", "urinary", "tract", ",", "immune", "system", ",", "and", "others", ")", ".", "No", "significant", "differences", "in", "clinical", "effectiveness", "of", "BP", "treatment", ",", "as", "assessed", "by", "pain", "score", ",", "were", "detected", "among", "the", "groups", ";", "however", ",", "pathologic", "fractures", "were", "more", "effectively", "prevented", "by", "intravenous", "than", "oral", "BP", "administration", "(", "P=", "0.03", ")", ".", "Noncompliance", "rates", "were", "similar", "among", "the", "study", "cohorts", ".", "We", "conclude", "that", "oral", "BP", "treatment", "is", "significantly", "associated", "with", "higher", "rates", "of", "adverse", "GI", "side", "effects", ".", "Additionally", ",", "our", "data", "indicate", "that", "intravenous", "BP", "administration", "is", "more", "effective", "than", "oral", "treatment", "in", "prevention", "of", "pathologic", "fractures", ";", "hence", ",", "oral", "administration", "should", "be", "considered", "with", "caution", "." ]

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[ "Cediranib", "in", "combination", "with", "fulvestrant", "in", "hormone", "-", "sensitive", "metastatic", "breast", "cancer", ":", "a", "randomized", "Phase", "II", "study", ".", "Hormone", "receptor", "-", "positive", "breast", "cancer", "is", "treated", "with", "estrogen", "inhibitors", ".", "Fulvestrant", "(", "FASLODEX", "™", ")", ",", "an", "estrogen", "receptor", "(", "ER", ")", "antagonist", "with", "no", "known", "agonist", "effects", ",", "competitively", "binds", ",", "blocks", "and", "degrades", "the", "ER", ".", "Vascular", "endothelial", "growth", "factor", "(", "VEGF", ")", "may", "mediate", "resistance", "to", "ER", "antagonists", ".", "Cediranib", "is", "a", "highly", "potent", "VEGF", "signaling", "inhibitor", "with", "activity", "against", "all", "three", "VEGF", "receptors", ".", "This", "randomized", "Phase", "II", "study", "evaluated", "cediranib", "plus", "fulvestrant", ".", "Postmenopausal", "women", "with", "hormone", "-", "sensitive", "metastatic", "breast", "cancer", "were", "eligible", ".", "The", "primary", "endpoint", "was", "progression", "-", "free", "survival", "(", "PFS", ")", ".", "Secondary", "endpoints", "included", "objective", "response", "rate", "(", "ORR", ")", ",", "duration", "of", "response", ",", "clinical", "benefit", "rate", "(", "CBR", ")", ",", "safety", "/", "tolerability", "and", "pharmacokinetics", "(", "PK", ")", ".", "Patients", "received", "cediranib", "45", "mg", "/", "day", "(", "n=", "31", ")", "or", "placebo", "(", "n=", "31", ")", "both", "plus", "fulvestrant", ".", "Demographic", "/", "baseline", "characteristics", "were", "well", "balanced", ".", "Patients", "treated", "with", "cediranib", "had", "a", "numerical", "advantage", "in", "PFS", "(", "hazard", "ratio=", "0.867", ",", "P=", "0.669", ";", "median", "223", "vs.", "112", "days", ",", "respectively", ")", "and", "ORR", "(", "22", "vs.", "8", "%", ",", "respectively", ")", "vs.", "placebo", ",", "although", "not", "statistically", "significant", ".", "CBR", "was", "42", "%", "in", "both", "arms", ".", "The", "most", "common", "adverse", "events", "(", "AEs", ")", "in", "the", "cediranib", "arm", "were", "diarrhea", "(", "68", "%", ")", ",", "fatigue", "(", "61", "%", ")", "and", "hypertension", "(", "55", "%", ")", ".", "The", "incidence", "of", "grade", "≥", "3", "AEs", "(", "68", "%", "vs.", "32", "%", ")", ",", "serious", "AEs", "(", "48", "%", "vs.", "13", "%", ")", ",", "discontinuation", "AEs", "(", "39", "%", "vs.", "10", "%", ")", ",", "and", "cediranib", "dose", "reductions", "/", "interruptions", "(", "74", "%", "vs.", "32", "%", ")", "were", "higher", "in", "the", "cediranib", "arm", ".", "There", "was", "no", "evidence", "of", "a", "clinically", "relevant", "effect", "of", "cediranib", "on", "fulvestrant", "PK", ".", "Cediranib", "plus", "fulvestrant", "may", "demonstrate", "clinical", "activity", "in", "this", "population", ",", "but", "cediranib", "45", "mg", "was", "not", "sufficiently", "well", "tolerated", ".", "Investigation", "of", "lower", "doses", "of", "cediranib", "plus", "hormonal", "/", "chemotherapy", "could", "be", "considered", "." ]

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"cancer", "and", "randomly", "allocated", "them", "oral", "anastrozole", "(", "1", "mg", "/", "day", ")", "or", "matched", "placebo", ".", "1410", "(", "36", "%", ")", "postmenopausal", "women", "were", "then", "enrolled", "in", "a", "bone", "substudy", "and", "stratified", "at", "baseline", "according", "to", "their", "lowest", "baseline", "T", "score", "at", "spine", "or", "femoral", "neck", "(", "stratum", "I", ":", "T", "score", "at", "least", "-", "1", "·", "0", ";", "stratum", "II", ":", "T", "score", "at", "least", "-", "2", "·", "5", "but", "less", "than", "-", "1", "·", "0", ";", "stratum", "III", ":", "T", "score", "less", "than", "-", "2", "·", "5", "but", "greater", "than", "-", "4", "·", "0", ")", ".", "Women", "in", "stratum", "I", "were", "monitored", "only", ";", "women", "in", "stratum", "III", "were", "all", "given", "risedronate", "(", "35", "mg", "/", "week", ")", ".", "Women", "in", "stratum", "II", "were", "randomly", "assigned", "(", "1", ":1", ")", "to", "risedronate", "(", "35", "mg", "/", "week", ")", "or", "matched", "placebo", "by", "use", "of", "a", "block", "randomisation", "schedule", "via", "a", "web", "-", "based", "programme", ".", "The", "primary", "outcome", "of", "this", "per", "-", "protocol", "analysis", "(", "done", "with", "all", "women", "with", "a", "baseline", "and", "3", "year", "DXA", "assessment", ")", "was", "the", "effect", "of", "risedronate", "versus", "placebo", "for", "osteopenic", "women", "in", "stratum", "II", "randomly", "allocated", "to", "anastrozole", "(", "1", "mg", "/", "day", ")", ".", "Secondary", "outcomes", "included", "effect", "of", "anastrozole", "(", "1", "mg", "/", "day", ")", "on", "BMD", "in", "women", "not", "receiving", "risedronate", "(", "strata", "I", "and", "II", ")", "and", "in", "osteoporotic", "women", "who", "were", "all", "treated", "with", "risedronate", "(", "stratum", "III", ")", ".", "The", "trial", "is", "ongoing", ",", "but", "no", "longer", "recruiting", ".", "This", 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