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[ "EduCan", "trial", ":", "study", "protocol", "for", "a", "randomised", "controlled", "trial", "on", "the", "effectiveness", "of", "pain", "neuroscience", "education", "after", "breast", "cancer", "surgery", "on", "pain", ",", "physical", ",", "emotional", "and", "work", "-", "related", "functioning", ".", "Over", "the", "past", "decades", ",", "awareness", "on", "the", "importance", "of", "educational", "interventions", "in", "cancer", "pain", "management", "has", "increased", ".", "However", ",", "education", "is", "often", "restricted", "to", "biomedical", "pain", "management", "instructions", ".", "A", "more", "modern", "educational", "approach", ",", "also", "known", "as", "pain", "neuroscience", "education", "(", "PNE", ")", ",", "explains", "pain", "from", "a", "biopsychosocial", "perspective", ".", "We", "hypothesise", "that", "this", "more", "comprehensive", "educational", "approach", "in", "the", "early", "treatment", "phase", "of", "breast", "cancer", "will", "lead", "to", "more", "beneficial", "effects", "for", "cancer", "pain", "management", ".", "Therefore", ",", "the", "aim", "of", "the", "present", "study", "is", "to", "investigate", "the", "effectiveness", "of", "this", "PNE", "intervention", ",", "in", "addition", "to", "best", "evidence", "physical", "therapy", "modalities", "for", "treatment", "and", "prevention", "of", "pain", ",", "physical", ",", "emotional", "and", "work", "-", "related", "functioning", "after", "breast", "cancer", "surgery", ",", "compared", "with", "a", "traditional", "biomedical", "educational", "intervention", ".", "A", "double", "-", "blinded", "randomised", "controlled", "trial", "has", "been", "started", "in", "November", "2017", "at", "the", "University", "Hospitals", "of", "Leuven", ".", "Immediately", "after", "breast", "cancer", "surgery", ",", "all", "participants", "(", "n=", "184", ")", "receive", "a", "12", "-week", "intensive", "standard", "physical", "therapy", "programme", ".", "They", "receive", "three", "additional", "refresher", "sessions", "at", "6", ",", "8", "and", "12", "months", "postsurgery", ".", "In", "addition", ",", "participants", "receive", "three", "educational", "sessions", "during", "the", "first", "-", "month", "postsurgery", "and", "three", "'", "booster", "sessions", "'", "at", "6", ",", "8", "and", "12", "months", "postsurgery", ".", "In", "the", "intervention", "group", ",", "the", "content", "of", "the", "education", "sessions", "is", "based", "on", "the", "modern", "PNE", "approach", ".", "Whereas", "in", "the", "control", "group", ",", "the", "education", "is", "based", "on", "the", "traditional", "biomedical", "approach", ".", "The", "primary", "outcome", "parameter", "is", "pain", "-", "related", "disability", "1", "year", "after", "surgery", ".", "Secondary", "outcomes", "related", "to", "other", "dimensions", "of", "pain", ",", "physical", ",", "emotional", "and", "work", "-", "related", "functioning", "at", "1", "-week", ",", "4", ",", "6", ",", "8", ",", "12", "and", "18", "months", "postsurgery", ".", "The", "study", "will", "be", "conducted", "in", "accordance", "with", "the", "Declaration", "of", "Helsinki", ".", "This", "protocol", "has", "been", "approved", "by", "the", "ethical", "committee", "of", "the", "University", "Hospitals", "of", "Leuven", ".", "Results", "will", "be", "disseminated", "via", "peer", "-", "reviewed", "scientific", "journals", "and", "presentations", "at", "congresses", ".", "NCT", "03351075", "." ]
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101
[ "Omission", "of", "fentanyl", "during", "sevoflurane", "anesthesia", "decreases", "the", "incidences", "of", "postoperative", "nausea", "and", "vomiting", "and", "accelerates", "postanesthesia", "recovery", "in", "major", "breast", "cancer", "surgery", ".", "Our", "purpose", "was", "to", "investigate", "the", "effect", "of", "omission", "of", "fentanyl", "during", "sevoflurane", "anesthesia", "on", "the", "incidences", "of", "postoperative", "nausea", "and", "vomiting", "and", "on", "postanesthesia", "recovery", "in", "female", "patients", "undergoing", "major", "breast", "cancer", "surgery", ".", "Female", "patients", "(", "American", "Society", "of", "Anesthesiologists", "[", "ASA", "]", "physical", "status", "[", "PS", "]", "class", "I", "-", "II", ";", "age", ",", "28", "-", "84", "years", ")", "undergoing", "major", "breast", "cancer", "surgery", "were", "randomized", "to", "one", "of", "two", "anesthesia", "maintenance", "groups", ":", "sevoflurane", "-", "fentanyl", "anesthesia", "(", "SF", ";", "n", "=", "25", ")", "or", "fentanyl", "-", "free", "sevoflurane", "anesthesia", "(", "S", ";", "n", "=", "26", ")", ".", "All", "patients", "were", "administered", "with", "propofol", "2", "mg", "x", "kg", "(", "-", "1", ")", "intravenously", "for", "anesthesia", "induction", ",", "a", "laryngeal", "mask", "airway", "was", "placed", ",", "and", "they", "received", "rectal", "diclofenac", "and", "local", "infiltration", "anesthesia", ".", "Anesthesia", "was", "maintained", "with", "sevoflurane", "in", "oxygen", "-", "air", "and", "they", "breathed", "spontaneously", ".", "The", "patients", "in", "group", "SF", "received", "fentanyl", "0.1", "mg", "intravenously", "and", "those", "in", "group", "S", "received", "normal", "saline", "during", "anesthesia", ".", "Group", "SF", "revealed", "higher", "incidences", "of", "postoperative", "nausea", "(", "68", "%", "vs", "27", "%", ")", "and", "vomiting", "(", "32", "%", "vs", "8", "%", ")", "in", "the", "first", "24", "postoperative", "hours", "than", "group", "S", ".", "The", "median", "(", "25", "th-", "75", "th", "percentile", ")", "length", "of", "time", "from", "postanesthesia", "care", "unit", "(", "PACU", ")", "admission", "to", "ambulation", "was", "significantly", "longer", "in", "group", "SF", "(", "n", "=", "23", ")", "at", "195", "min", "(", "158", "-", "219", "min", ")", ",", "than", "in", "group", "S", ",", "at", "141", "min", "(", "101", "-", "175", "min", ")", ".", "Two", "patients", "in", "group", "SF", "could", "not", "walk", "during", "the", "PACU", "stay", ".", "Omission", "of", "fentanyl", "during", "sevoflurane", "anesthesia", ",", "combined", "with", "diclofenac", "and", "local", "infiltration", "anesthesia", ",", "decreases", "the", "incidences", "of", "postoperative", "nausea", "and", "vomiting", "and", "accelerates", "postanesthesia", "recovery", "in", "patients", "undergoing", "major", "breast", "cancer", "surgery", "." ]
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102
[ "Prospective", "randomized", "trial", "of", "paravertebral", "block", "for", "patients", "undergoing", "breast", "cancer", "surgery", ".", "The", "goal", "of", "the", "current", "study", "was", "to", "evaluate", "the", "effect", "of", "regional", "anesthesia", "using", "paravertebral", "block", "(", "PVB", ")", "on", "postoperative", "pain", "after", "breast", "surgery", ".", "Patients", "undergoing", "unilateral", "breast", "surgery", "without", "reconstruction", "were", "randomized", "to", "general", "anesthesia", "(", "GA", ")", "only", "or", "PVB", "with", "GA", "and", "pain", "scores", "assessed", ".", "Eighty", "patients", "were", "randomized", "(", "41", "to", "GA", "and", "39", "to", "PVB", "with", "GA", ")", ".", "Operative", "times", "were", "not", "significantly", "different", "between", "groups", ".", "Pain", "scores", "were", "lower", "after", "PVB", "compared", "to", "GA", "at", "1", "hour", "(", "1", "vs", "3", ",", "P", "=", ".", "006", ")", "and", "3", "hours", "(", "0", "vs", "2", ",", "P", "=", ".", "001", ")", "but", "not", "at", "later", "time", "points", ".", "The", "overall", "worst", "pain", "experienced", "was", "lower", "with", "PVB", "(", "3", "vs", "5", ",", "P", "=", ".", "02", ")", ".", "More", "patients", "were", "pain", "-", "free", "in", "the", "PVB", "group", "at", "1", "hour", "(", "44", "%", "vs", "17", "%", ",", "P", "=", ".", "014", ")", "and", "3", "hours", "(", "54", "%", "vs", "17", "%", ",", "P", "=", ".", "005", ")", "postoperatively", ".", "PVB", "significantly", "decreases", "postoperative", "pain", "up", "to", "3", "hours", "after", "breast", "cancer", "surgery", "." ]
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103
[ "Weight", "Lifting", "and", "Physical", "Function", "Among", "Survivors", "of", "Breast", "Cancer", ":", "A", "Post", "Hoc", "Analysis", "of", "a", "Randomized", "Controlled", "Trial", ".", "Survivors", "of", "breast", "cancer", "may", "experience", "deterioration", "of", "physical", "function", ".", "This", "is", "important", "because", "poor", "physical", "function", "may", "be", "associated", "with", "premature", "mortality", ",", "injurious", "falls", ",", "bone", "fracture", ",", "and", "disability", ".", "We", "conducted", "a", "post", "hoc", "analysis", "to", "explore", "the", "potential", "efficacy", "of", "slowly", "progressive", "weight", "lifting", "to", "reduce", "the", "incidence", "of", "physical", "function", "deterioration", "among", "survivors", "of", "breast", "cancer", ".", "Between", "October", "2005", "and", "August", "2008", ",", "we", "conducted", "a", "single", "-", "blind", ",", "12", "-month", ",", "randomized", "controlled", "trial", "of", "twice", "-", "per", "-", "week", "slowly", "progressive", "weight", "lifting", "or", "standard", "care", "among", "295", "survivors", "of", "nonmetastatic", "breast", "cancer", ".", "In", "this", "post", "hoc", "analysis", "of", "data", "from", "the", "Physical", "Activity", "and", "Lymphedema", "Trial", ",", "we", "examined", "incident", "deterioration", "of", "physical", "function", "after", "12", "months", ",", "defined", "as", "a", "≥", "10", "-point", "decrease", "in", "the", "physical", "function", "subscale", "of", "the", "Medical", "Outcomes", "Short", "-", "Form", "36", "-item", "questionnaire", ".", "The", "proportion", "of", "participants", "who", "experienced", "incident", "physical", "function", "deterioration", "after", "12", "months", "was", "16.3", "%", "(", "24", "/", "147", ")", "in", "the", "control", "group", "and", "8.1", "%", "(", "12", "/", "148", ")", "in", "the", "weight", "lifting", "group", "(", "relative", "risk", ",", "0.49", ";", "95", "%", "CI", ",", "0.25", "to", "0.96", ";", "P", "=", ".", "04", ")", ".", "No", "serious", "or", "unexpected", "adverse", "events", "occurred", "that", "were", "related", "to", "weight", "lifting", ".", "Slowly", "progressive", "weight", "lifting", "compared", "with", "standard", "care", "reduced", "the", "incidence", "of", "physical", "function", "deterioration", "among", "survivors", "of", "breast", "cancer", ".", "These", "data", "are", "hypothesis", "generating", ".", "Future", "studies", "should", "directly", "compare", "the", "efficacy", "of", "weight", "lifting", "with", "other", "modalities", "of", "exercise", ",", "such", "as", "brisk", "walking", ",", "to", "appropriately", "inform", "the", "development", "of", "a", "confirmatory", "study", "designed", "to", "preserve", "physical", "function", "among", "survivors", "of", "breast", "cancer", "." ]
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104
[ "A", "randomized", "controlled", "Phase", "II", "trial", "of", "vinorelbine", "plus", "capecitabine", "versus", "docetaxel", "plus", "capecitabine", "in", "anthracycline", "-", "pretreated", "women", "with", "metastatic", "breast", "cancer", ".", "Previous", "studies", "have", "shown", "that", "vinorelbine", "/", "capecitabine", "(", "NX", ")", "and", "docetaxel", "/", "capecitabine", "(", "TX", ")", "chemotherapy", "has", "a", "certain", "effect", "in", "advanced", "breast", "cancer", ".", "However", ",", "there", "are", "few", "clinical", "studies", "directly", "comparing", "TX", "and", "NX", "regimen", "chemotherapy", ",", "especially", "in", "patients", "with", "advanced", "breast", "cancer", "previously", "treated", "with", "anthracycline", "and", "taxane", ".", "The", "purpose", "of", "this", "Phase", "II", "study", "was", "to", "compare", "survival", "and", "side", "effects", "between", "patients", "with", "anthracycline-", "and", "taxane", "-", "resistant", "advanced", "breast", "cancer", "treated", "with", "NX", "and", "those", "treated", "with", "TX", "chemotherapy", ".", "From", "February", "2012", "to", "March", "2014", ",", "a", "total", "number", "of", "97", "patients", "were", "randomly", "assigned", "to", "NX", "(", "n", "=", "55", ")", "or", "TX", "(", "n", "=", "42", ")", ".", "Baseline", "characteristics", "were", "relatively", "well", "-", "balanced", "in", "the", "two", "treatment", "arms", ".", "The", "clinical", "trial", "registration", "number", "(", "clincaltrials", ".", "gov", ")", "is", "NCT", "01635465", ".", "After", "a", "median", "follow", "-", "up", "of", "46.0", "months", ",", "there", "was", "no", "significant", "difference", "between", "the", "NX", "and", "TX", "arms", "in", "objective", "response", "rate", "(", "17.9", "%", "vs.", "21.1", "%", ";", "P", "=", "0.686", ")", "and", "progression", "-", "free", "survival", "(", "6", "months", "vs.", "7", "months", ";", "P", "=", "0.560", ")", ".", "The", "overall", "survival", "period", "of", "the", "TX", "arm", "was", "longer", "than", "that", "of", "the", "NX", "arm", "(", "32", "months", "vs.", "27", "months", ")", "but", "without", "statistical", "significance", ".", "Both", "regimens", "were", "well", "-", "tolerated", ".", "The", "main", "toxicities", "were", "neutropenia", ",", "leukopenia", ",", "and", "anemia", ".", "In", "the", "TX", "arm", ",", "hand", "-", "foot", "syndrome", "occurred", "more", "frequently", "than", "in", "the", "NX", "arm", "(", "P", "<", "0.01", ")", ",", "but", "frequencies", "of", "other", "minor", "adverse", "effects", "were", "similar", "between", "the", "two", "arms", ".", "NX", "and", "TX", "regimens", "are", "both", "alternative", "treatments", "for", "patients", "with", "anthracycline-", "and", "taxane", "-", "resistant", "advanced", "breast", "cancer", ",", "but", "the", "safety", "profile", "was", "more", "favorable", "and", "manageable", "with", "the", "NX", "regimen", ".", "ClinicalTrials", ".", "gov", "NCT", "01635465", ".", "Registered", "09", "July", "2012", "." ]
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105
[ "Multicenter", "phase", "II", "randomized", "trial", "evaluating", "antiangiogenic", "therapy", "with", "sunitinib", "as", "consolidation", "after", "objective", "response", "to", "taxane", "chemotherapy", "in", "women", "with", "HER", "2", "-", "negative", "metastatic", "breast", "cancer", ".", "The", "aim", "of", "this", "study", "is", "to", "test", "the", "hypothesis", "that", "antiangiogenic", "treatment", "with", "sunitinib", "consolidation", "can", "prolong", "remissions", "induced", "by", "taxane", "-", "based", "chemotherapy", "in", "women", "with", "metastatic", "breast", "cancer", ".", "The", "method", "involves", "a", "two", "-", "arm", "open", "-", "label", "(", "2", ":1", "randomization", ")", "multicenter", ",", "randomized", "phase", "II", "trial", "evaluating", "the", "efficacy", "of", "sunitinib", "(", "arm", "A", ")", "versus", "no", "therapy", "(", "arm", "B", ")", "in", "patients", "with", "HER-", "2", "-", "negative", "metastatic", "breast", "cancer", "who", "achieved", "an", "objective", "response", "to", "taxane", "-", "based", "chemotherapy", ".", "The", "results", "of", "this", "study", "indicates", "that", "the", "primary", "endpoint", "of", "progression", "-", "free", "survival", "(", "PFS", ")", ">", "or", "=", "5", "months", "was", "achieved", "in", "10", "of", "36", "patients", "(", "28", "%", ")", "in", "arm", "A", "and", "4", "of", "19", "patients", "(", "21", "%", ")", "in", "arm", "B", ".", "The", "median", "PFS", "was", "2.8", "and", "3.1", "months", ",", "respectively", ".", "A", "protocol", "amendment", "to", "the", "sunitinib", "dosing", "schedule", "was", "made", "because", "53", "%", "(", "17", "/", "32", ")", "of", "patients", "treated", "at", "a", "starting", "dose", "of", "50", "mg", "(", "4", "weeks", "on", "/", "2", "weeks", "off", ")", "required", "dose", "reduction", ".", "Changing", "the", "starting", "dose", "to", "sunitinib", "37.5", "mg", "continuously", "resulted", "in", "dose", "reductions", "in", "44", "%", "(", "7", "/", "16", ")", "of", "patients", ".", "Grades", "III", "-", "IV", "toxicity", "occurred", "in", "69", "%", "of", "patients", "in", "arm", "A", "(", "fatigue", "31", "%", ",", "musculoskeletal", "pain", "11", "%", ",", "neutropenia", "and", "thrombopenia", "8", "%", ")", "and", "11", "%", "in", "arm", "B", ".", "The", "proof", "-", "of", "-", "principle", "study", "does", "not", "confirm", "the", "hypothesis", "that", "sunitinib", "consolidation", "therapy", "can", "lead", "to", "a", "predefined", "clinically", "relevant", "proportion", "of", "patients", "with", "PFS", "of", ">", "or", "=", "5", "months", "after", "an", "objective", "response", "to", "taxanes", ".", "Furthermore", ",", "toxicity", "was", "significant", "." ]
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106
[ "Dressing", "Wear", "Time", "after", "Breast", "Reconstruction", ":", "A", "Randomized", "Clinical", "Trial", ".", "The", "evidence", "to", "support", "dressing", "standards", "for", "breast", "surgery", "wounds", "is", "empiric", "and", "scarce", ".", "This", "two", "-", "arm", "randomized", "clinical", "trial", "was", "designed", "to", "assess", "the", "effect", "of", "dressing", "wear", "time", "on", "surgical", "site", "infection", "(", "SSI", ")", "rates", ",", "skin", "colonization", "and", "patient", "perceptions", ".", "A", "total", "of", "200", "breast", "cancer", "patients", "undergoing", "breast", "reconstruction", "were", "prospectively", "enrolled", ".", "Patients", "were", "randomly", "allocated", "to", "group", "I", "(", "dressing", "removed", "on", "the", "first", "postoperative", "day", ",", "n", "=", "100", ")", "or", "group", "II", "(", "dressing", "removed", "on", "the", "sixth", "postoperative", "day", ",", "n", "=", "100", ")", ".", "SSIs", "were", "defined", "and", "classified", "according", "to", "criteria", "from", "the", "Centers", "for", "Disease", "Control", "and", "Prevention", ".", "Samples", "collected", "before", "placing", "the", "dressing", "and", "after", "1", "day", "(", "group", "I", ")", "and", "6", "days", "(", "both", "groups", ")", "were", "cultured", "for", "skin", "colonization", "assessments", ".", "Patients", "preferences", "and", "perceptions", "with", "regard", "to", "safety", ",", "comfort", "and", "convenience", "were", "recorded", "and", "analyzed", ".", "A", "total", "of", "186", "patients", "completed", "the", "follow", "-", "up", ".", "The", "global", "SSI", "rate", "was", "4.5", "%", ".", "Six", "patients", "in", "group", "I", "and", "three", "in", "group", "II", "had", "SSI", "(", "p", "=", "0.497", ")", ".", "Before", "dressing", ",", "the", "groups", "were", "similar", "with", "regard", "to", "skin", "colonization", ".", "At", "the", "sixth", "day", ",", "there", "was", "a", "higher", "colonization", "by", "coagulase", "-", "negative", "staphylococci", "in", "group", "I", "(", "p", "<", "0.0001", ")", ".", "Patients", "preferred", "to", "keep", "dressing", "for", "six", "days", "(", "p", "<", "0.0001", ")", ",", "and", "considered", "this", "a", "safer", "choice", "(", "p", "<", "0.05", ")", ".", "Despite", "group", "I", "had", "a", "higher", "skin", "colonization", "by", "coagulase", "-", "negative", "staphylococci", "on", "the", "sixth", "postoperative", "day", ",", "there", "was", "no", "difference", "in", "SSI", "rates", ".", "Patients", "preferred", "keeping", "dressing", "for", "six", "days", "and", "considered", "it", "a", "safer", "choice", ".", "ClinicalTrials.gov", "NCT", "01148823", "." ]
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107
[ "Tamoxifen", "plus", "tegafur", "-", "uracil", "(", "TUFT", ")", "versus", "tamoxifen", "plus", "Adriamycin", "(", "doxorubicin", ")", "and", "cyclophosphamide", "(", "ACT", ")", "as", "adjuvant", "therapy", "to", "treat", "node", "-", "positive", "premenopausal", "breast", "cancer", "(", "PreMBC", ")", ":", "results", "of", "Japan", "Clinical", "Oncology", "Group", "Study", "9404", ".", "A", "prospective", "randomized", "clinical", "trial", "was", "conducted", "to", "evaluate", "the", "efficacy", "of", "tamoxifen", "plus", "doxorubicin", "and", "cyclophosphamide", "compared", "to", "tamoxifen", "plus", "tegafur", "-", "uracil", "as", "an", "adjuvant", "therapy", "to", "treat", "node", "-", "positive", "premenopausal", "breast", "cancer", "(", "PreMBC", ")", ".", "Eligibility", "criteria", "included", "pathologically", "node", "-", "positive", "(", "n", "=", "1", "-", "9", ")", "preMBC", "with", "curative", "resection", ",", "in", "stages", "I", "-", "IIIA", ".", "Patients", "were", "randomized", "to", "receive", "either", "tamoxifen", "20", "mg", "/", "day", "plus", "tegafur", "-", "uracil", "400", "mg", "/", "day", "(", "TU", ")", "for", "2", "years", "or", "six", "courses", "of", "a", "28", "-day", "cycle", "of", "doxorubicin", "40", "mg", "/", "m", "(", "2", ")", "plus", "cyclophosphamide", "500", "mg", "/", "m", "(", "2", ")", "on", "day", "1", "along", "with", "tamoxifen", "(", "ACT", ")", "given", "for", "2", "years", "as", "adjuvant", "therapy", ".", "Primary", "endpoint", "was", "overall", "survival", "(", "OS", ")", ",", "and", "secondary", "endpoint", "was", "recurrence", "-", "free", "survival", "(", "RFS", ")", ".", "In", "total", ",", "169", "patients", "were", "recruited", "(", "TU", "arm", "87", ",", "ACT", "arm", "82", ")", "between", "October", "1994", "and", "September", "1999", ".", "The", "HR", "for", "OS", "was", "0.76", "(", "95", "%", "CI", "0.35", ",", "1.66", ",", "log", "-", "rank", "p", "=", "0.49", ")", "and", "that", "for", "RFS", "was", "0.77", "(", "95", "%", "CI", "0.44", ",", "1.36", ",", "log", "-", "rank", "p", "=", "0.37", ")", ",", "with", "ACT", "resulting", "in", "a", "better", "HR", ".", "The", "5", "-year", "OS", "was", "79.7", "%", "for", "patients", "in", "the", "TU", "arm", "and", "83", "%", "for", "those", "in", "the", "ACT", "arm", ".", "The", "5", "-year", "RFS", "was", "66.1", "%", "for", "patients", "in", "the", "TU", "arm", "and", "70.6", "%", "for", "those", "in", "the", "ACT", "arm", ".", "A", "higher", "proportion", "of", "patients", "in", "the", "ACT", "arm", "experienced", "grade", "3", "leucopenia", "(", "0", "%", "in", "the", "TU", "arm", ",", "4", "%", "in", "the", "ACT", "arm", ")", ".", "There", "were", "no", "significant", "differences", "in", "the", "efficacy", "of", "TU", "and", "ACT", "as", "adjuvant", "therapy", "." ]
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108
[ "Dressing", "wear", "time", "after", "breast", "reconstruction", ":", "study", "protocol", "for", "a", "randomized", "controlled", "trial", ".", "One", "of", "the", "major", "risk", "variables", "for", "surgical", "site", "infection", "is", "wound", "management", ".", "Understanding", "infection", "risk", "factors", "for", "breast", "operations", "is", "essential", "in", "order", "to", "develop", "infection", "-", "prevention", "strategies", "and", "improve", "surgical", "outcomes", ".", "The", "aim", "of", "this", "trial", "is", "to", "assess", "the", "influence", "of", "dressing", "wear", "time", "on", "surgical", "site", "infection", "rates", "and", "skin", "colonization", ".", "Patients", "'", "perception", "at", "self", "-", "assessment", "will", "also", "be", "analyzed", ".", "This", "is", "a", "two", "-", "arm", "randomized", "controlled", "trial", ".", "Two", "hundred", "breast", "cancer", "patients", "undergoing", "immediate", "or", "delayed", "breast", "reconstruction", "will", "be", "prospectively", "enrolled", ".", "Patients", "will", "be", "randomly", "allocated", "to", "group", "I", "(", "dressing", "removed", "on", "postoperative", "day", "one", ")", "or", "group", "II", "(", "dressing", "removed", "on", "postoperative", "day", "six", ")", ".", "Surgical", "site", "infections", "will", "be", "defined", "by", "standard", "criteria", "from", "the", "Centers", "for", "Disease", "Control", "and", "Prevention", "(", "CDC", ")", ".", "Skin", "colonization", "will", "be", "assessed", "by", "culture", "of", "samples", "collected", "at", "predefined", "time", "points", ".", "Patients", "will", "score", "dressing", "wear", "time", "with", "regard", "to", "safety", ",", "comfort", "and", "convenience", ".", "The", "evidence", "to", "support", "dressing", "standards", "for", "breast", "surgery", "wounds", "is", "empiric", "and", "scarce", ".", "CDC", "recommends", "protecting", ",", "with", "a", "sterile", "dressing", "for", "24", "to", "48", "hours", "postoperatively", ",", "a", "primarily", "closed", "incision", ",", "but", "there", "is", "no", "recommendation", "to", "cover", "this", "kind", "of", "incision", "beyond", "48", "hours", ",", "or", "on", "the", "appropriate", "time", "to", "shower", "or", "bathe", "with", "an", "uncovered", "incision", ".", "The", "results", "of", "the", "ongoing", "trial", "may", "support", "standard", "recommendations", "regarding", "dressing", "wear", "time", "after", "breast", "reconstruction", ".", "ClinicalTrials.gov", "identifier", ":", "http:", "/", "/", "NCT", "01148823", "." ]
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109
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110
[ "Sentinel", "lymph", "node", "biopsy", "in", "patients", "with", "multifocal", "breast", "cancer", ".", "Multifocal", "or", "multicentric", "breast", "cancer", "has", "been", "suggested", "as", "a", "contraindication", "for", "sentinel", "node", "biopsy", "(", "SNB", ")", ".", "However", ",", "recent", "studies", "have", "demonstrated", "that", "all", "quadrants", "of", "the", "breast", "drain", "through", "common", "afferent", "channels", "to", "a", "common", "axillary", "sentinel", "node", ".", "This", "should", "mean", "that", "the", "presence", "of", "multifocal", "tumour", "should", "not", "affect", "the", "lymphatic", "drainage", ".", "The", "purpose", "of", "this", "study", "was", "to", "evaluate", "the", "feasibility", "and", "accuracy", "of", "SNB", "in", "patients", "with", "multifocal", "breast", "cancer", "using", "a", "peritumoural", "injection", "technique", "for", "sentinel", "lymph", "node", "(", "SN", ")", "mapping", ".", "In", "the", "ALMANAC", "multicentre", "trial", "validation", "phase", ",", "we", "took", "SNB", "samples", "from", "842", "patients", "with", "node", "negative", ",", "invasive", "breast", "cancer", "with", "use", "of", "a", "blue", "dye", "and", "radiolabelled", "colloid", "mapping", "technique", "at", "the", "peritumoural", "injection", "site", ".", "All", "patients", "underwent", "standard", "axillary", "treatment", "after", "SNB", ".", "Seventy", "-", "five", "of", "the", "842", "patients", "had", "multifocal", "lesions", "on", "final", "histopathologic", "examination", ".", "The", "following", "analysis", "is", "focused", "on", "patients", "with", "multifocal", "lesions", ".", "A", "mean", "number", "of", "2.4", "SNs", "were", "identified", "in", "71", "of", "75", "patients", "(", "identification", "rate", ":", "94.7", "%", ")", ".", "Thirty", "-", "one", "patients", "had", "a", "positive", "SN", ",", "40", "a", "negative", "SN", ".", "Standard", "axillary", "treatment", "confirmed", "the", "SN", "to", "be", "negative", "in", "37", "of", "40", "patients", ",", "whereas", "three", "patients", "revealed", "positive", "non", "-", "sentinel", "lymph", "nodes", "(", "false", "-", "negative", "rate", ":", "8.8", "%", ")", ".", "Overall", "SN", "biopsy", "accurately", "predicted", "axillary", "lymph", "node", "status", "in", "68", "of", "71", "patients", "(", "95.8", "%", ")", ".", "SNB", "accurately", "staged", "the", "axilla", "in", "multifocal", "breast", "cancer", "and", "may", "become", "an", "alternative", "to", "complete", "axillary", "lymph", "node", "dissection", "in", "node", "negative", "patients", "with", "multifocal", "breast", "cancer", "." ]
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111
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"in", "the", "post", "-", "treatment", "period", ".", "IBIS", "-", "II", "is", "an", "international", ",", "randomised", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "trial", ".", "Postmenopausal", "women", "at", "increased", "risk", "of", "developing", "breast", "cancer", "were", "recruited", "and", "were", "randomly", "assigned", "(", "1", ":1", ")", "to", "either", "anastrozole", "(", "1", "mg", "per", "day", ",", "oral", ")", "or", "matching", "placebo", "daily", "for", "5", "years", ".", "After", "treatment", "completion", ",", "women", "were", "followed", "on", "a", "yearly", "basis", "to", "collect", "data", "on", "breast", "cancer", "incidence", ",", "death", ",", "other", "cancers", ",", "and", "major", "adverse", "events", "(", "cardiovascular", "events", "and", "fractures", ")", ".", "The", "primary", "outcome", "was", "all", "breast", "cancer", ".", "3864", "women", "were", "recruited", "between", "Feb", "2", ",", "2003", ",", "and", "Jan", "31", ",", "2012", ".", "1920", "women", "were", "randomly", "assigned", "to", "5", "years", "anastrozole", "and", "1944", "to", "placebo", ".", "After", "a", "median", "follow", "-", "up", "of", "131", "months", "(", "IQR", "105", "-", "156", ")", ",", "a", "49", "%", "reduction", "in", "breast", "cancer", "was", "observed", "for", "anastrozole", "(", "85", "vs", "165", "cases", ",", "hazard", "ratio", "[", "HR", "]", "0", "·", "51", ",", "95", "%", "CI", "0", "·", "39", "-", "0", "·", "66", ",", "p", "<", "0", "·", "0001", ")", ".", "The", "reduction", "was", "larger", "in", "the", "first", "5", "years", "(", "35", "vs", "89", ",", "0", "·", "39", ",", "0", "·", "27", "-", "0", "·", "58", ",", "p", "<", "0", "·", "0001", ")", ",", "but", "still", "significant", "after", "5", "years", "(", "50", "vs", "76", "new", "cases", ",", "0", "·", "64", ",", "0", "·", "45", "-", "0", "·", "91", ",", "p=", "0", "·", "014", ")", ",", "and", "not", "significantly", "different", "from", "the", "first", "5", "years", "(", "p=", "0", "·", "087", ")", ".", "Invasive", "oestrogen", "receptor", "-", "positive", "breast", "cancer", "was", "reduced", "by", "54", "%", "(", "HR", "0", "·", "46", ",", "95", "%", "CI", "0", "·", "33", "-", "0", "·", "65", ",", "p", "<", "0", "·", "0001", ")", ",", "with", "a", "continued", "significant", "effect", "in", "the", "period", "after", "treatment", ".", "A", "59", "%", "reduction", "in", "ductal", "carcinoma", "in", "situ", "was", "observed", "(", "0", "·", "41", ",", "0", "·", "22", "-", "0", "·", "79", ",", "p=", "0", "·", "0081", ")", ",", "especially", "in", "participants", "known", "to", "be", "oestrogen", "receptor", "-", "positive", "(", "0", "·", "22", ",", "0", "·", "78", "-", "0", "·", "65", ",", "p", "<", "0", "·", "0001", ")", ".", "No", "significant", "difference", "in", "deaths", "was", "observed", "overall", "(", "69", "vs", "70", ",", "HR", "0", "·", "96", ",", "95", "%", "CI", "0", "·", "69", "-", "1", "·", "34", ",", "p=", "0", "·", "82", 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"National", "Health", "and", "Medical", "Research", "Council", "Australia", ",", "Breast", "Cancer", "Research", "Foundation", ",", "Sanofi", "Aventis", ",", "and", "AstraZeneca", "." ]
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112
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113
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114
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115
[ "The", "Living", "Well", "after", "Breast", "Cancer", "™", "Pilot", "Trial", ":", "a", "weight", "loss", "intervention", "for", "women", "following", "treatment", "for", "breast", "cancer", ".", "Obesity", "is", "associated", "with", "poor", "prognosis", "and", "risk", "of", "treatment", "side", "-", "effects", "in", "breast", "cancer", "survivors", ".", "This", "pilot", "study", "assessed", "the", "feasibility", ",", "acceptability", ",", "safety", "and", "efficacy", "of", "a", "telephone", "-", "delivered", "weight", "loss", "intervention", ",", "among", "women", "(", "BMI", "25", "-", "40", "kg", "/", "m", "2", ")", "following", "treatment", "for", "stage", "I", "-", "III", "breast", "cancer", ",", "on", "weight", "loss", "(", "primary", "outcome", ")", ",", "quality", "of", "life", "and", "treatment", "-", "related", "side", "-", "effects", "(", "vs", "usual", "care", ")", ".", "Ninety", "women", "(", "mean", "±", "SD", "age", ":", "55.3", "±", "8.7", "years", ";", "BMI", ":", "31.0", "±", "4.3", "kg", "/", "m", "2", ";", "15.9", "±", "2.9", "months", "postdiagnosis", ")", ",", "recruited", "from", "a", "state", "-", "based", "cancer", "registry", ",", "were", "randomized", "to", "a", "weight", "loss", "(", "diet", "and", "physical", "activity", ")", "intervention", "(", "n", "=", "45", ")", "or", "usual", "care", "(", "n", "=", "45", ")", ".", "Data", "collected", "at", "baseline", "and", "6", "months", "included", "weight", ",", "body", "composition", ",", "quality", "of", "life", ",", "fatigue", "and", "body", "image", ".", "Acceptability", "and", "satisfaction", "were", "assessed", "in", "intervention", "participants", ".", "Oncologists", "provided", "consent", "to", "contact", "82.6", "%", "of", "patients", ",", "with", "84.1", "%", "of", "those", "women", "contacted", "and", "eligible", "consenting", "to", "participate", ".", "Compared", "with", "usual", "care", ",", "mean", "weight", "loss", "was", "significantly", "greater", "in", "the", "intervention", "arm", "(", "-", "3.1", "kg", "[", "95", "%", "CI", ",", "-", "5.4", "to", "-", "0.7", "]", ";", "-", "3.7", "%", "baseline", "weight", "[", "95", "%", "CI", ",", "-", "6.6", "to", "-", "0.9", "]", ")", ",", "as", "were", "reductions", "in", "fat", "mass", "(", "-", "2.1", "kg", "[", "95", "%", "CI", ",", "-", "4.2", "to", "-", "0.1", "]", ")", "and", "waist", "circumference", "(", "-", "4.0", "cm", "[", "95", "%", "CI", ",", "-", "6.6", "to", "-", "1.3", "]", ")", ".", "No", "other", "statistically", "significant", "intervention", "effects", "were", "observed", ".", "Participants", "were", "highly", "satisfied", "with", "the", "intervention", "overall", "and", "it", "is", "timing", "in", "relation", "to", "diagnosis", "/", "treatment", ".", "One", "reported", "adverse", "event", "(", "musculoskeletal", "injury", ")", "was", "attributable", "to", "the", "intervention", ".", "This", "weight", "loss", "intervention", "was", "feasible", ",", "acceptable", ",", "safe", "and", "effective", "for", "women", "1", "-", "2", "years", "after", "a", "breast", "cancer", "diagnosis", ".", "The", "effect", "of", "weight", "loss", "on", "quality", "of", "life", "and", "treatment", "-", "related", "side", "-", "effects", "should", "be", "examined", "further", "in", "fully", "-", "powered", "studies", "." ]
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116
[ "Multidisciplinary", "Approach", "to", "Novel", "Therapies", "in", "Cardio", "-", "Oncology", "Research", "(", "MANTICORE", "101", "-Breast", ")", ":", "A", "Randomized", "Trial", "for", "the", "Prevention", "of", "Trastuzumab", "-", "Associated", "Cardiotoxicity", ".", "Purpose", "The", "primary", "toxicity", "of", "trastuzumab", "therapy", "for", "human", "epidermal", "growth", "factor", "receptor", "2", "-overexpressing", "(", "HER", "2", "-", "positive", ")", "breast", "cancer", "is", "dose", "-", "independent", "cardiac", "dysfunction", ".", "Angiotensin", "-", "converting", "enzyme", "inhibitors", "and", "β", "-", "blockers", "are", "recommended", "first", "-", "line", "agents", "for", "heart", "failure", ".", "We", "hypothesized", "that", "angiotensin", "-", "converting", "enzyme", "inhibitors", "and", "β", "-", "blockers", "could", "prevent", "trastuzumab", "-", "related", "cardiotoxicity", ".", "Patients", "and", "Methods", "In", "this", "double", "-", "blinded", ",", "placebo", "-", "controlled", "trial", ",", "patients", "with", "HER", "2", "-", "positive", "early", "breast", "cancer", "were", "randomly", "assigned", "to", "receive", "treatment", "with", "perindopril", ",", "bisoprolol", ",", "or", "placebo", "(", "1", ":1", ":1", ")", "for", "the", "duration", "of", "trastuzumab", "adjuvant", "therapy", ".", "Patients", "underwent", "cardiac", "magnetic", "resonance", "imaging", "at", "baseline", "and", "post", "-", "cycle", "17", "for", "the", "determination", "of", "left", "ventricular", "volumes", "and", "left", "ventricular", "ejection", "fraction", "(", "LVEF", ")", ".", "Cardiotoxicity", "was", "evaluated", "as", "the", "change", "in", "indexed", "left", "ventricular", "end", "diastolic", "volume", "and", "LVEF", ".", "Results", "Thirty", "-", "three", "patients", "received", "perindopril", ",", "31", "received", "bisoprolol", ",", "and", "30", "received", "placebo", ".", "Baseline", "demographic", ",", "cancer", ",", "and", "cardiovascular", "profiles", "were", "similar", "between", "groups", ".", "Study", "drugs", "were", "well", "tolerated", "with", "no", "serious", "adverse", "events", ".", "After", "17", "cycles", "of", "trastuzumab", ",", "indexed", "left", "ventricular", "end", "diastolic", "volume", "increased", "in", "patients", "treated", "with", "perindopril", "(", "+", "7", "±", "14", "mL", "/", "m", "2", ")", ",", "bisoprolol", "(", "+", "8", "mL", "±", "9", "mL", "/", "m", "2", ")", ",", "and", "placebo", "(", "+", "4", "±", "11", "mL", "/", "m", "2", ";", "P", "=", ".", "36", ")", ".", "In", "secondary", "analyses", ",", "trastuzumab", "-", "mediated", "decline", "in", "LVEF", "was", "attenuated", "in", "bisoprolol", "-", "treated", "patients", "(", "-", "1", "±", "5", "%", ")", "relative", "to", "the", "perindopril", "(", "-", "3", "±", "4", "%", ")", "and", "placebo", "(", "-", "5", "±", "5", "%", ")", "groups", "(", "P", "=", ".", "001", ")", ".", "Perindopril", "and", "bisoprolol", "use", "were", "independent", "predictors", "of", "maintained", "LVEF", "on", "multivariable", "analysis", ".", "Conclusion", "Perindopril", "and", "bisoprolol", "were", "well", "tolerated", "in", "patients", "with", "HER", "2", "-", "positive", "early", "breast", "cancer", "who", "received", "trastuzumab", "and", "protected", "against", "cancer", "therapy", "-", "related", "declines", "in", "LVEF", ";", "however", ",", "trastuzumab", "-", "mediated", "left", "ventricular", "remodeling", "-", "the", "primary", "outcome", "-", "was", "not", "prevented", "by", "these", "pharmacotherapies", "." ]
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117
[ "Indocyanine", "green", "fluorescence", "-", "guided", "lumpectomy", "of", "nonpalpable", "breast", "cancer", "versus", "wire", "-", "guided", "excision", ":", "A", "randomized", "clinical", "trial", ".", "The", "use", "of", "wire", "localization", "(", "WL", ")", "for", "excisions", "of", "nonpalpable", "breast", "cancer", "(", "NBC", ")", "has", "several", "disadvantages", ".", "The", "purpose", "of", "this", "study", "was", "to", "evaluate", "the", "use", "of", "indocyanine", "green", "-", "guided", "nonpalpable", "breast", "cancer", "lesion", "localization", "(", "INBCL", ")", "and", "to", "compare", "it", "with", "WL", ".", "A", "total", "of", "62", "patients", "with", "a", "preoperative", "histological", "diagnosis", "of", "NBC", "lesions", "that", "could", "be", "visualized", "with", "ultrasound", "and", "mammography", "were", "randomized", "to", "INBCL", "or", "WL", ".", "Patients", "with", "preoperatively", "diagnosed", "primary", "ductal", "carcinoma", "in", "situ", "and", "multifocal", "disease", "were", "excluded", "from", "the", "study", ".", "Significance", "was", "considered", "at", "P", "<", "0.05", ".", "Of", "all", "62", "excision", ",", "32", "(", "51.6", "%", ")", "were", "guided", "by", "INBCL", "and", "30", "(", "48.4", "%", ")", "by", "WL", ".", "Both", "techniques", "resulted", "in", "100", "%", "retrieval", "of", "the", "lesions", ".", "The", "rate", "of", "clear", "margins", "was", "significantly", "higher", "in", "the", "INBCL", "group", "(", "87.5", "%", ";", "28", "/", "32", ")", "compared", "to", "the", "WL", "(", "63.3", "%", ",", "19", "/", "30", ")", "(", "P", "=", "0.026", ")", ",", "reducing", "the", "requirement", "of", "re", "-", "excision", ".", "When", "results", "of", "the", "excised", "tissue", "are", "taken", "into", "account", ",", "the", "mean", "volume", "of", "the", "INBCL", "specimen", "was", "56", "cm", "3", "less", "than", "that", "of", "the", "WL", "group", ",", "although", "this", "was", "not", "significantly", "different", "(", "P", "=", "0.058", ")", ".", "INBCL", "for", "NBCs", "was", "more", "accurate", "than", "WL", ",", "because", "it", "optimized", "the", "surgeon", "'s", "ability", "to", "obtain", "clear", "margins", ".", "A", "smaller", "volume", "of", "the", "tissue", "may", "be", "excised", "by", "using", "INBCL", "technique", ".", "Therefore", "INBCL", "is", "an", "attractive", "alternative", "to", "WL", "." ]
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118
[ "Anthracycline", "-", "induced", "cardiotoxicity", "prevention", "with", "angiotensin", "-", "converting", "enzyme", "inhibitor", "ramipril", "in", "women", "with", "low", "-", "risk", "breast", "cancer", ":", "results", "of", "a", "prospective", "randomized", "study", ".", "Anthracycline‑induced", "cardiotoxicity", "(", "AIC", ")", "remains", "the", "main", "long‑term", "irreversible", "side", "effect", "in", "malignancy", "survivors", ".", "Cardiotoxicity", "prevention", "is", "one", "of", "the", "most", "reasonable", "approaches", ".", "In", "this", "prospective", "randomized", "open‑label", "study", ",", "we", "aimed", "to", "verify", "whether", "ramipril", "protects", "from", "early‑onset", "AIC", "in", "women", "with", "breast", "cancer", "(", "BC", ")", ".", "We", "analyzed", "data", "from", "96", "women", "(", "median", "age", ",", "47", "years", ")", "with", "BC", "after", "breast", "surgery", ",", "without", "significant", "cardiovascular", "diseases", ",", "who", "were", "eligible", "for", "adjuvant", "anthracyclines", ".", "They", "were", "randomized", "to", "a", "ramipril", "or", "control", "arm", ".", "Cardiotoxicity", "was", "estimated", "with", "repeat", "echocardiography", "and", "themeasurement", "of", "troponin", "I", "and", "N‑terminal", "fragment", "of", "the", "prohormone", "brain", "natriuretic", "peptide", "(", "NT‑proBNP", ")", "levels", "over", "1", "‑year", "follow‑up", ".", "Anthracycline‑induced", "cardiotoxicity", "was", "defined", "as", "a", "decrease", "in", "left", "ventricular", "ejection", "fraction", "(", "LVEF", ")", ",", "elevated", "biomarker", "levels", ",", "and/or", "occurrence", "of", "heart", "failure", "(", "HF", ")", "or", "cardiac", "death", ".", "A", "decrease", "in", "LVEF", "above", "10", "‑percent", "points", "occurred", "in", "6.3", "%", "of", "ramipril", "patients", "and", "18.5", "%", "ofcontrols", "(", "P", "=", "0.15", ")", ".", "No", "cases", "of", "HF", ",", "cardiac", "death", ",", "or", "LVEF", "decline", "below", "50", "%", "were", "reported", ".", "The", "percentage", "of", "patients", "with", "elevated", "NT‑proBNP", "levels", "increased", "with", "time", "in", "controls", "(", "P", "=", "0.003", ")", "and", "remained", "unchanged", "in", "the", "ramipril", "arm", ".", "At", "the", "end", "of", "follow‑up", ",", "an", "increase", "in", "NT‑proBNP", "levels", "was", "more", "common", "and", "decline", "was", "less", "common", "in", "the", "control", "than", "ramipril", "arm", "(", "P", "=", "0.01", ")", ".", "No", "significant", "differences", "in", "troponin", "levels", "were", "found", "between", "the", "study", "arms", ".", "Ramipril", "was", "well", "tolerated", "in", "normotensive", "women", ".", "In", "relatively", "young", "women", "with", "BC", "without", "serious", "comorbidities", ",", "who", "received", "anthracyclines", ",", "1", "‑year", "treatment", "with", "ramipril", "exerts", "potentially", "protective", "effects", "on", "cardiotoxicity", "assessed", "with", "NT‑proBNP", "levels", "." ]
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119
[ "Neratinib", "after", "trastuzumab", "-", "based", "adjuvant", "therapy", "in", "patients", "from", "Asia", "with", "early", "stage", "HER", "2", "-", "positive", "breast", "cancer", ".", "Aim", ":", "To", "evaluate", "the", "efficacy", "and", "safety", "of", "neratinib", "as", "extended", "adjuvant", "therapy", "in", "patients", "from", "Asia", "based", "on", "exploratory", "analyses", "of", "the", "Phase", "III", "ExteNET", "trial", ".", "Patients", "&", "methods", ":", "A", "total", "of", "2840", "women", "with", "early", "stage", "HER", "2", "-", "positive", "breast", "cancer", "were", "randomly", "assigned", "to", "neratinib", "240", "mg", "/", "day", "or", "placebo", "for", "1", "year", "after", "trastuzumab", "-", "based", "adjuvant", "therapy", ".", "Results", ":", "A", "total", "of", "341", "patients", "were", "from", "Asia", "(", "neratinib", ",", "n", "=", "165", ";", "placebo", ",", "n", "=", "176", ")", ".", "2", "-year", "invasive", "disease", "-", "free", "survival", "rates", "were", "92.8", "and", "90.8", "%", "with", "neratinib", "and", "placebo", ",", "respectively", "(", "HR", ":", "0.70", ";", "95", "%", "CI", ":", "0.31", "-", "1.55", ")", ",", "and", "5", "-year", "rates", "were", "91.9", "and", "87.2", "%", ",", "respectively", "(", "HR", ":", "0.57", ";", "95", "%", "CI", ":", "0.27", "-", "1.13", ")", ".", "Diarrhea", "was", "the", "most", "common", "adverse", "event", "with", "neratinib", ".", "Conclusion", ":", "Extended", "adjuvant", "therapy", "with", "neratinib", "reduces", "disease", "recurrences", "in", "Asian", "women", "with", "HER", "2", "-", "positive", "breast", "cancer", ".", "Trial", "registration", ":", "Clinicaltrials", ".", "gov", "NCT", "00878709", "." ]
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126
[ "A", "pilot", "study", "of", "minocycline", "for", "the", "prevention", "of", "paclitaxel", "-", "associated", "neuropathy", ":", "ACCRU", "study", "RU", "221408", "I", ".", "Paclitaxel", "is", "associated", "with", "both", "an", "acute", "pain", "syndrome", "(", "P", "-", "APS", ")", "and", "chronic", "chemotherapy", "-", "induced", "peripheral", "neuropathy", "(", "CIPN", ")", ".", "Given", "that", "extensive", "animal", "data", "suggest", "that", "minocycline", "may", "prevent", "chemotherapy", "-", "induced", "neurotoxicity", ",", "the", "purpose", "of", "this", "pilot", "study", "was", "to", "investigate", "the", "efficacy", "of", "minocycline", "for", "the", "prevention", "of", "CIPN", "and", "the", "P", "-", "APS", ".", "Patients", "with", "breast", "cancer", "were", "enrolled", "prior", "to", "initiating", "neoadjuvant", "or", "adjuvant", "weekly", "paclitaxel", "for", "12", "weeks", "and", "were", "randomized", "to", "receive", "minocycline", "200", "mg", "on", "day", "1", "followed", "by", "100", "mg", "twice", "daily", "or", "a", "matching", "placebo", ".", "Patients", "completed", "(", "1", ")", "an", "acute", "pain", "syndrome", "questionnaire", "daily", "during", "chemotherapy", "to", "measure", "P", "-", "APS", "and", "(", "2", ")", "the", "EORTC", "QLQ", "-", "CIPN", "20", "questionnaire", "at", "baseline", ",", "prior", "to", "each", "dose", "of", "paclitaxel", ",", "and", "monthly", "for", "6", "months", "post", "treatment", ",", "to", "measure", "CIPN", ".", "Forty", "-", "seven", "patients", "were", "randomized", ".", "There", "were", "no", "remarkable", "differences", "noted", "between", "the", "minocycline", "and", "placebo", "groups", "for", "the", "overall", "sensory", "neuropathy", "score", "of", "the", "EORTC", "QLQ", "-", "CIPN", "20", "or", "its", "individual", "components", ",", "which", "evaluate", "tingling", ",", "numbness", "and", "shooting", "/", "burning", "pain", "in", "hands", "and", "feet", ".", "However", ",", "patients", "taking", "minocycline", "had", "a", "significant", "reduction", "in", "the", "daily", "average", "pain", "score", "attributed", "to", "P", "-", "APS", "(", "p", "=", "0.02", ")", ".", "Not", "only", "were", "no", "increased", "toxicities", "reported", "with", "minocycline", ",", "but", "there", "was", "a", "significant", "reduction", "in", "fatigue", "(", "p", "=", "0.02", ")", ".", "Results", "of", "this", "pilot", "study", "do", "not", "support", "the", "use", "of", "minocycline", "to", "prevent", "CIPN", ",", "but", "suggest", "that", "it", "may", "reduce", "P", "-", "APS", "and", "decrease", "fatigue", ";", "further", "study", "of", "the", "impact", "of", "this", "agent", "on", "those", "endpoints", "may", "be", "warranted", "." ]
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127
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128
[ "Outcomes", "of", "Japanese", "breast", "cancer", "patients", "treated", "with", "pre", "-", "operative", "and", "post", "-", "operative", "anastrozole", "or", "tamoxifen", ".", "The", "present", "study", "examined", "long", "-", "term", "efficacy", "outcomes", "in", "a", "subgroup", "of", "postmenopausal", ",", "estrogen", "receptor", "-", "positive", "Japanese", "breast", "cancer", "patients", "from", "the", "Pre", "-", "Operative", "\"", "Arimidex", "\"", "Compared", "with", "Tamoxifen", "trial", ",", "following", "pre", "-", "operative", "(", "3", "months", ")", "and", "post", "-", "operative", "(", "5", "years", ")", "adjuvant", "treatment", "with", "either", "anastrozole", "or", "tamoxifen", ".", "Patients", "with", "large", ",", "potentially", "operable", ",", "locally", "-", "advanced", "breast", "cancer", "were", "randomized", "to", "receive", "anastrozole", "(", "1", "mg", "/", "day", ")", "plus", "tamoxifen", "placebo", "or", "tamoxifen", "(", "20", "mg", "/", "day", ")", "plus", "anastrozole", "placebo", "pre", "-", "operatively", ".", "After", "surgery", "at", "3", "months", ",", "patients", "continued", "on", "the", "same", "study", "medication", "as", "adjuvant", "therapy", "for", "up", "to", "5", "years", "or", "until", "recurrence", ",", "intolerable", "toxicity", "or", "withdrawal", "of", "patient", "consent", ".", "Recurrence", "-", "free", "survival", "and", "overall", "survival", "were", "measured", "from", "the", "date", "of", "randomization", "to", "the", "date", "of", "recurrence", "or", "death", ",", "whichever", "occurred", "first", ".", "Patients", "were", "monitored", "for", "adverse", "events", "throughout", "the", "study", "period", "and", "up", "to", "30", "days", "following", "administration", "of", "the", "last", "study", "medication", ".", "During", "post", "-", "operative", "adjuvant", "therapy", ",", "4", "/", "48", "(", "8", "%", ")", "anastrozole", "and", "25", "/", "49", "(", "51", "%", ")", "tamoxifen", "patients", "experienced", "recurrence", ".", "There", "was", "a", "significant", "difference", "in", "recurrence", "-", "free", "survival", "between", "the", "two", "groups", "(", "hazard", "ratio", "0.14", ";", "95", "%", "confidence", "interval", "0.05", "-", "0.41", ";", "P", "=", "0.0003", ")", ".", "There", "was", "a", "significant", "increase", "in", "overall", "survival", "with", "anastrozole", "(", "0.21", ";", "0.05", "-", "0.96", ";", "P", "=", "0.0436", ")", "and", "there", "were", "2", "/", "48", "(", "4", "%", ")", "and", "10", "/", "49", "(", "20", "%", ")", "deaths", "with", "anastrozole", "and", "tamoxifen", ",", "respectively", ".", "Most", "patients", "responding", "to", "pre", "-", "operative", "therapy", "remained", "recurrence", "-", "free", ".", "Sequential", "pre", "-", "operative", "/", "post", "-", "operative", "treatment", "with", "anastrozole", "resulted", "in", "lower", "recurrence", "and", "death", "rates", ",", "compared", "with", "tamoxifen", "." ]
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129
[ "Effect", "of", "tamoxifen", "on", "venous", "thromboembolic", "events", "in", "a", "breast", "cancer", "prevention", "trial", ".", "Tamoxifen", ",", "a", "selective", "estrogen", "-", "receptor", "modulator", ",", "increases", "venous", "thromboembolic", "events", "(", "VTE", ")", ",", "but", "the", "factors", "explaining", "this", "risk", "are", "unclear", ".", "Atherosclerosis", "may", "induce", "VTE", ",", "or", "the", "2", "conditions", "may", "share", "common", "risk", "factors", ".", "We", "assessed", "the", "effect", "of", "tamoxifen", "on", "VTE", "in", "a", "breast", "cancer", "prevention", "trial", "and", "studied", "its", "association", "with", "risk", "factors", "for", "VTE", ".", "The", "incidence", "of", "VTE", "was", "studied", "in", "5408", "hysterectomized", "women", "randomly", "assigned", "to", "tamoxifen", "20", "mg", "/", "d", "or", "placebo", "for", "5", "years", ".", "There", "were", "28", "VTEs", "on", "placebo", "and", "44", "on", "tamoxifen", "therapy", "(", "hazard", "ratio", "[", "HR]=", "1.63", ";", "95", "%", "confidence", "interval", "[", "CI", "]", ",", "1.02", "to", "2.63", ")", ",", "80", "%", "of", "which", "were", "superficial", "phlebitis", ",", "accounting", "for", "all", "of", "the", "excess", "due", "to", "tamoxifen", "within", "18", "months", "from", "randomization", ".", "Compared", "with", "placebo", ",", "the", "risk", "of", "VTE", "on", "tamoxifen", "was", "higher", "in", "women", "aged", "55", "years", "or", "older", ",", "women", "with", "a", "body", "mass", "index", ">", "or", "=", "25", "kg", "/", "m", "2", ",", "elevated", "blood", "pressure", ",", "total", "cholesterol", ">", "or", "=", "250", "mg", "/", "dL", ",", "current", "smoking", ",", "and", "a", "family", "history", "of", "coronary", "heart", "disease", "(", "CHD", ")", ".", "Of", "the", "685", "women", "with", "a", "CHD", "risk", "score", ">", "or", "=", "5", "who", "entered", "the", "trial", ",", "1", "in", "the", "placebo", "arm", "and", "13", "in", "the", "tamoxifen", "arm", "developed", "VTE", "(", "log", "-", "rank", "P=", "0.0013", ")", ".", "In", "multivariate", "regression", "analysis", ",", "age", ">", "or", "=", "60", "years", ",", "height", ">", "or", "=", "165", "cm", ",", "and", "diastolic", "blood", "pressure", ">", "or", "=", "90", "mm", "Hg", "had", "independent", "detrimental", "effects", "on", "VTE", "risk", "during", "tamoxifen", "therapy", ",", "whereas", "transdermal", "estrogen", "therapy", "concomitant", "with", "tamoxifen", "was", "not", "associated", "with", "any", "excess", "of", "VTE", "(", "HR=", "0.64", ";", "95", "%", "CI", ",", "0.23", "to", "1.82", ")", ".", "Women", "with", "conventional", "risk", "factors", "for", "atherosclerosis", "have", "a", "higher", "risk", "of", "VTE", "during", "tamoxifen", "therapy", ".", "This", "information", "should", "be", "incorporated", "into", "counseling", "women", "on", "its", "risk", "-", "benefit", "ratio", ",", "particularly", "in", "the", "prevention", "setting", "." ]
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[ "Effect", "of", "Rosuvastatin", "in", "Preventing", "Chemotherapy", "-", "Induced", "Cardiotoxicity", "in", "Women", "With", "Breast", "Cancer", ":", "A", "Randomized", ",", "Single", "-", "Blind", ",", "Placebo", "-", "Controlled", "Trial", ".", "Chemotherapy", "-", "induced", "cardiotoxicity", "is", "a", "major", "and", "leading", "cause", "of", "death", "in", "breast", "cancer", "survivors", ".", "It", "can", "present", "decades", "after", "chemotherapy", "and", "can", "manifest", "in", "different", "ways", ";", "some", "chemotherapeutic", "agents", "have", "a", "powerful", "dose", "-", "dependent", "relationship", "with", "cardiotoxicity", ".", "The", "aim", "of", "this", "study", "was", "to", "investigate", "the", "effect", "of", "rosuvastatin", "on", "preventing", "chemotherapy", "-", "induced", "cardiotoxicity", "in", "patients", "with", "breast", "cancer", ".", "Our", "study", "was", "a", "randomized", ",", "single", "-", "blind", ",", "placebo", "-", "controlled", "trial", "that", "involved", "89", "women", "with", "newly", "diagnosed", "breast", "cancer", "who", "were", "scheduled", "to", "receive", "chemotherapy", ".", "Patients", "were", "randomly", "assigned", "to", "receive", "rosuvastatin", "or", "a", "placebo", "in", "a", "1", ":1", "ratio", "for", "6", "months", ".", "Echocardiography", ",", "using", "2", "-dimensional", "(", "2", "D", ")", "Doppler", ",", "tissue", "Doppler", ",", "and", "speckle", "-", "tracking", "methods", ",", "was", "used", "to", "determine", "the", "absolute", "changes", "in", "the", "left", "ventricular", "systolic", "ejection", "fraction", "(", "LVEF", ")", ",", "left", "ventricular", "end", "-", "diastolic", "volume", "(", "LVEDV", ")", ",", "left", "ventricular", "end", "-", "systolic", "volume", "(", "LVESV", ")", ",", "left", "atrial", "(", "LA", ")", "diameter", ",", "transmitral", "Doppler", "early", "diastolic", "velocity", "(", "E", "wave", ")", ",", "tissue", "Doppler", "early", "diastolic", "(", "e", "'", ")", "and", "peak", "systolic", "(", "s", "'", ")", "mitral", "annular", "velocities", ",", "E", "/", "e", "'", "ratio", ",", "and", "global", "longitudinal", "systolic", "strain", ".", "The", "LVEF", "was", "significantly", "reduced", "in", "the", "placebo", "group", "at", "the", "end", "of", "the", "study", "when", "compared", "with", "the", "baseline", "value", ".", "However", ",", "there", "was", "no", "significant", "difference", "in", "the", "LVEF", "in", "the", "intervention", "group", "(", "intergroup", "P", "=", ".", "012", ")", ".", "Furthermore", ",", "compared", "with", "the", "intervention", "group", "at", "the", "end", "of", "the", "study", ",", "there", "was", "a", "significant", "increase", "in", "the", "4", "-", "and", "2", "-chamber", "LVESV", ",", "LA", "diameter", ",", "and", "E", "/", "e", "'", "ratio", "in", "the", "placebo", "group", "(", "intergroup", "P", "=", ".", "019", ",", "P", "=", ".", "024", ",", "P", "<", ".", "001", ",", "and", "P", "=", ".", "021", ",", "respectively", ")", "and", "a", "significant", "decrease", "in", "the", "e", "'", "and", "s", "'", "velocities", "in", "the", "placebo", "group", "(", "intergroup", "P", "<", ".", "001", "and", "P", "<", ".", "006", ",", "respectively", ")", ".", "The", "present", "study", "showed", "that", "the", "prophylactic", "use", "of", "rosuvastatin", "may", "prevent", "the", "development", "of", "chemotherapy", "-", "induced", "cardiotoxicity", "." ]
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142
[ "A", "randomized", ",", "double", "-", "blinded", "placebo", "-", "controlled", "clinical", "trial", "of", "the", "routine", "use", "of", "preoperative", "antibiotic", "prophylaxis", "in", "modified", "radical", "mastectomy", ".", "The", "effectiveness", "of", "antibiotic", "prophylaxis", "for", "prevention", "of", "surgical", "site", "infection", "(", "SSI", ")", "following", "specific", "types", "of", "breast", "cancer", "surgery", "remains", "uncertain", ".", "This", "study", "assessed", "the", "effectiveness", "of", "prophylaxis", "in", "modified", "radical", "mastectomy", "(", "MRM", ")", ".", "Women", "undergoing", "MRM", "for", "breast", "cancer", "were", "recruited", ".", "Women", "were", "excluded", "who", "had", "diabetes", "mellitus", ",", "severe", "malnutrition", "or", "known", "allergy", "to", "cephalosporins", ";", "were", "receiving", "corticosteroid", "therapy", "or", "were", "treated", "with", "antibiotics", "within", "one", "week", "prior", "to", "surgery", ";", "were", "scheduled", "for", "simultaneous", "breast", "reconstruction", "or", "bilateral", "oophorectomy", ";", "had", "existing", "local", "infection", ".", "Participants", "were", "randomized", "to", "receive", "either", "intravenous", "cefazolin", "1", "g", "or", "placebo", "within", "30", "min", "prior", "to", "skin", "incision", ".", "Standard", "skin", "preparation", "and", "operative", "technique", "for", "MRM", "were", "carried", "out", ".", "Wounds", "were", "assessed", "for", "SSI", "and", "other", "complications", "weekly", "for", "30", "days", ".", "A", "total", "of", "254", "women", "were", "recruited", ".", "Age", ",", "clinical", "stage", ",", "prior", "chemotherapy", ",", "and", "operative", "time", "were", "similar", "for", "antibiotic", "and", "placebo", "groups", ".", "The", "overall", "incidence", "of", "SSI", "was", "14.2", "%", ".", "There", "were", "no", "significant", "differences", "in", "the", "infection", "rate", "over", "the", "30", "-day", "follow", "-", "up", "period", "between", "the", "placebo", "and", "antibiotic", "groups", "(", "15", "%", "vs", "13.4", "%", ";", "p", "=", "0.719", ")", "or", "at", "each", "week", ".", "The", "majority", "of", "SSI", "were", "either", "cellulitis", "or", "superficial", "infection", "for", "both", "groups", ".", "There", "were", "no", "significant", "differences", "between", "groups", "in", "treatments", "required", "for", "SSI", ",", "incidence", "of", "hematoma", "or", "seroma", ".", "The", "findings", "of", "this", "study", ",", "alone", "and", "when", "meta", "-", "analyzed", "with", "data", "from", "studies", "in", "similar", "surgical", "populations", ",", "do", "not", "support", "the", "use", "of", "antibiotic", "prophylaxis", "in", "MRM", "." ]
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143
[ "Adherence", "to", "a", "long", "-", "term", "progressive", "resistance", "training", "program", ",", "combining", "supervised", "and", "home", "-", "based", "exercise", "for", "breast", "cancer", "patients", "during", "adjuvant", "treatment", ".", "Background", ":", "The", "purpose", "of", "the", "study", "was", "to", "examine", "adherence", "and", "identify", "patient-", "and", "treatment", "-", "related", "factors", "associated", "with", "adherence", "to", "a", "20", "-week", "combined", "supervised", "and", "home", "-", "based", "progressive", "resistance", "training", "program", "in", "women", "treated", "for", "breast", "cancer", ".", "Methodology", ":", "The", "study", "population", "consisted", "of", "the", "intervention", "group", "in", "a", "randomized", "clinical", "trial", "examining", "the", "effect", "of", "resistance", "exercise", "on", "lymphoedema", "prevention", "(", "n", "=", "82", ")", ".", "The", "full", "program", "lasted", "50", "weeks", ",", "with", "an", "initial", "20", "weeks", "combined", "supervised", "and", "home", "-", "based", "exercise", "followed", "by", "30", "weeks", "self", "-", "administered", "exercise", ".", "Information", "about", "attendance", "rates", "(", "supervised", "exercise", ")", "and", "exercise", "dairies", "(", "home", "-", "based", "exercise", ")", "in", "the", "first", "20", "weeks", "was", "available", "for", "74", "and", "62", "participants", ",", "respectively", ".", "Adherence", "was", "measured", "as", "numbers", "of", "exercise", "sessions", "performed", "divided", "by", "expected", "number", "of", "exercise", "sessions", "with", ">", "2", "/", "3", "categorized", "as", "high", "adherence", ".", "Age", "-", "adjusted", "odds", "ratios", "(", "OR", ")", "were", "used", "to", "assess", "the", "associations", "between", "patient-", "and", "treatment", "-", "related", "factors", "with", "adherence", ".", "Results", ":", "The", "number", "of", "participants", "with", "high", "adherence", "to", "supervised", "exercise", "decreased", "in", "the", "late", "period", "(", "from", "week", "11", "onward", ")", "compared", "to", "the", "early", "period", "(", "65", "%", "vs.", "48", "%", ")", "whereas", "the", "proportion", "of", "participants", "with", "high", "adherence", "to", "home", "-", "based", "exercise", "remained", "close", "to", "55", "%", ".", "The", "most", "prominent", "factor", "associated", "with", "high", "adherence", "to", "supervised", "exercise", "was", "neoadjuvant", "chemotherapy", "[", "OR", "7.09", ";", "95", "%", "confidence", "interval", "(", "CI", ")", ",", "1.12", "-", "44.62", "]", ".", "For", "home", "-", "based", "exercise", ",", "lower", "adherence", "was", "seen", "in", "obese", "participants", "(", "OR", "0.16", ";", "95", "%", "CI", ",", "0.04", "-", "0.65", ")", "and", "in", "participants", "with", "average", "or", "below", "average", "lower", "body", "muscle", "strength", "at", "baseline", "(", "OR", "0.12", ";", "95", "%", "CI", ",", "0.03", "-", "0.46", ")", ".", "Conclusion", ":", "The", "results", "of", "this", "study", "offer", "valuable", "information", "on", "factors", "associated", "with", "adherence", "to", "a", "program", "of", "supervised", "and", "home", "-", "based", "exercise", ".", "Interventions", "may", "be", "adapted", "to", "ensure", "higher", "adherence", "rates", "through", "supportive", "efforts", "targeted", "to", "women", "who", "are", "obese", ",", "have", "low", "muscle", "strength", "and", "who", "receive", "no", "or", "adjuvant", "chemotherapy", "(", "as", "opposed", "to", "neoadjuvant", "chemotherapy", ")", "during", "exercise", "." ]
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150
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151
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154
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155
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156
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157
[ "Evaluation", "of", "lecithinized", "human", "recombinant", "super", "oxide", "dismutase", "as", "cardioprotectant", "in", "anthracycline", "-", "treated", "breast", "cancer", "patients", ".", "Anthracycline", "-", "induced", "cardiotoxicity", "is", "(", "partly", ")", "mediated", "by", "free", "radical", "overload", ".", "A", "randomized", "study", "was", "performed", "in", "breast", "cancer", "patients", "to", "investigate", "whether", "free", "radical", "scavenger", "super", "oxide", "dismutase", "(", "SOD", ")", "protects", "against", "anthracycline", "-", "induced", "cardiotoxicity", "as", "measured", "by", "changes", "in", "echo", ",", "electrocardiography", "and", "an", "array", "of", "biomarkers", ".", "Eighty", "female", ",", "chemotherapy", "-", "naïve", "breast", "cancer", "patients", "(", "median", "age", "49", ",", "range", "24", "-", "67", "years", ")", "scheduled", "for", "four", "or", "five", "courses", "of", "adjuvant", "3", "weekly", "doxorubicin", "plus", "cyclophosphamide", "(", "AC", ")", "chemotherapy", ",", "were", "randomly", "assigned", "to", "receive", "80", "mg", "PC", "-", "SOD", "(", "human", "recombinant", "SOD", "bound", "to", "lecithin", ")", "or", "placebo", ",", "administered", "intravenously", "(", "i.v", ".", ")", "immediately", "prior", "to", "each", "AC", "course", ".", "The", "primary", "end", "point", "was", "protection", "against", "cardiac", "damage", "evaluated", "using", "echocardiography", ",", "QT", "assessments", "and", "a", "set", "of", "biochemical", "markers", "for", "myocardial", "function", ",", "oxidative", "stress", "and", "inflammation", ".", "Assessments", "were", "performed", "before", "and", "during", "each", "course", "of", "chemotherapy", ",", "and", "at", "1", ",", "4", "and", "9", "months", "after", "completion", "of", "the", "chemotherapy", "regimen", ".", "In", "all", "patients", "cardiac", "effects", "such", "as", "increases", "in", "NT", "-", "proBNP", "concentration", "and", "prolongation", "of", "the", "QTc", "interval", "were", "noticed", ".", "There", "were", "no", "differences", "between", "the", "PC", "-", "SOD", "and", "placebo", "-", "treated", "patients", "in", "systolic", "or", "diastolic", "cardiac", "function", "or", "for", "any", "other", "of", "the", "biomarkers", "used", "to", "assess", "the", "cardiac", "effects", "of", "anthracyclines", ".", "PC", "-", "SOD", "at", "a", "dose", "of", "80", "mg", "i.v", ".", "is", "not", "cardioprotective", "in", "patients", "with", "breast", "carcinoma", "treated", "with", "anthracyclines", "." ]
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158
[ "The", "clinical", "relevance", "of", "axillary", "reverse", "mapping", "(", "ARM", ")", ":", "study", "protocol", "for", "a", "randomized", "controlled", "trial", ".", "Axillary", "lymph", "node", "dissection", "(", "ALND", ")", "in", "patients", "with", "breast", "cancer", "has", "the", "potential", "to", "induce", "side", "-", "effects", ",", "including", "upper", "-", "limb", "lymphedema", ".", "Axillary", "reverse", "mapping", "(", "ARM", ")", "is", "a", "technique", "that", "enables", "discrimination", "of", "the", "lymphatic", "drainage", "of", "the", "breast", "from", "that", "of", "the", "upper", "limb", "in", "the", "axillary", "lymph", "node", "(", "LN", ")", "basin", ".", "If", "lymphedema", "is", "caused", "by", "removing", "these", "lymphatics", "and", "nodes", "in", "the", "upper", "limb", ",", "the", "possibility", "of", "identifying", "these", "lymphatics", "would", "enable", "surgeons", "to", "preserve", "them", ".", "The", "aim", "of", "this", "study", "is", "to", "determine", "the", "clinical", "relevance", "of", "selective", "axillary", "LN", "and", "lymphatic", "preservation", "by", "means", "of", "ARM", ".", "To", "minimize", "the", "risk", "of", "overlooking", "tumor", "-", "positive", "ARM", "nodes", "and", "the", "associated", "risk", "of", "undertreatment", ",", "we", "will", "only", "include", "patients", "with", "a", "tumor", "-", "positive", "sentinel", "lymph", "node", "(", "SLN", ")", ".", "Patients", "who", "are", "candidates", "for", "ALND", "because", "of", "a", "proven", "positive", "axillary", "LN", "at", "clinical", "examination", "can", "be", "included", "in", "a", "registration", "study", ".", "The", "study", "will", "enroll", "280", "patients", "diagnosed", "with", "SLN", "biopsy", "-", "proven", "metastasis", "of", "invasive", "breast", "cancer", "with", "an", "indication", "for", "a", "completion", "ALND", ".", "Patients", "will", "be", "randomized", "to", "undergo", "standard", "ALND", "or", "an", "ALND", "in", "which", "the", "ARM", "nodes", "and", "their", "corresponding", "lymphatics", "will", "be", "left", "in", "situ", ".", "Primary", "outcome", "is", "the", "presence", "of", "axillary", "surgery", "-", "related", "lymphedema", "at", "6", ",", "12", ",", "and", "24", "months", "post", "-", "operatively", ",", "measured", "by", "the", "water", "-", "displacement", "method", ".", "Secondary", "outcome", "measures", "include", "pain", ",", "paresthesia", ",", "numbness", ",", "and", "loss", "of", "shoulder", "mobility", ",", "quality", "of", "life", ",", "and", "axillary", "recurrence", "risk", ".", "The", "benefit", "of", "ALND", "in", "patients", "with", "a", "positive", "SLN", "is", "a", "subject", "of", "debate", ".", "For", "many", "patients", ",", "an", "ALND", "will", "remain", "the", "treatment", "of", "choice", ".", "This", "multicenter", "randomized", "trial", "will", "provide", "evidence", "of", "whether", "or", "not", "axillary", "LN", "preservation", "by", "means", "of", "ARM", "decreases", "the", "side", "-", "effects", "of", "an", "ALND", ".", "Enrolment", "of", "patients", "will", "start", "in", "April", "2013", "in", "five", "breast", "-", "cancer", "centers", "in", "the", "Netherlands", ",", "and", "is", "expected", "to", "conclude", "by", "April", "2016", ".", "TC", "3698", "." ]
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159
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160
[ "Prevention", "of", "postmenopausal", "osteoporosis", "in", "Chinese", "women", ":", "a", "5", "-year", ",", "double", "-", "blind", ",", "randomized", ",", "parallel", "placebo", "-", "controlled", "study", ".", "To", "observe", "the", "effectiveness", "and", "safety", "of", "menopause", "-", "related", "hormone", "therapy", "(", "MHT", ")", "to", "prevent", "bone", "loss", "in", "Chinese", "women", "during", "the", "menopausal", "transition", "and", "early", "menopause", ",", "as", "well", "as", "to", "evaluate", "the", "effects", "of", "5", "-year", "MHT", "on", "overall", "health", "to", "add", "Level", "I", "evidence", "for", "the", "prevention", "of", "osteoporosis", "using", "MHT", ".", "This", "clinical", "study", "was", "a", "prospective", ",", "double", "-", "blind", ",", "randomized", ",", "parallel", "placebo", "-", "controlled", "study", ".", "Chinese", "women", "in", "the", "menopausal", "transition", "and", "early", "menopause", "were", "randomly", "allocated", "to", "the", "MHT", "group", "or", "the", "placebo", "group", ".", "All", "subjects", "received", "a", "5", "-year", "intervention", ".", "The", "effectiveness", "of", "MHT", "for", "bone", "mineral", "density", "(", "BMD", ")", "and", "bone", "metabolism", "and", "the", "safety", "of", "MHT", "in", "relation", "to", "glycolipid", "metabolism", ",", "breast", "cancer", ",", "and", "cardiovascular", "disease", "were", "studied", ".", "In", "the", "MHT", "group", ",", "women", "in", "both", "transition", "and", "early", "menopause", "showed", "a", "significant", "increase", "in", "lumbar", "and", "femoral", "neck", "BMD", "after", "the", "1", "st", "year", "of", "therapy", ";", "BMD", "tended", "to", "decrease", "in", "the", "3", "rd", "year", "but", "ultimately", "was", "sustained", "at", "stable", "levels", "that", "were", "near", "the", "baseline", "levels", ".", "In", "the", "placebo", "group", ",", "BMD", "decreased", "at", "both", "sites", ".", "Metabolism", "indexes", "and", "breast", "ultrasound", "examination", "findings", "did", "not", "differ", "significantly", "between", "the", "MHT", "and", "placebo", "groups", ".", "Three", "cases", "of", "breast", "cancer", "and", "three", "cases", "of", "cardiovascular", "disease", "were", "diagnosed", "during", "follow", "-", "up", ".", "One", "breast", "cancer", "case", "and", "two", "cardiovascular", "disease", "cases", "occurred", "in", "the", "MHT", "group", ".", "Five", "-", "year", "sequential", "therapy", "with", "estrogen", "and", "progesterone", "can", "increase", "or", "maintain", "the", "BMD", "of", "women", "in", "their", "menopausal", "transition", "and", "early", "menopause", ".", "This", "regimen", "had", "no", "negative", "effect", "on", "glycolipid", "metabolism", "and", "did", "not", "increase", "the", "risk", "of", "breast", "cancer", "or", "cardiovascular", "events", "." ]
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161
[ "Guided", "paravertebral", "blocks", "with", "versus", "without", "clonidine", "for", "women", "undergoing", "breast", "surgery", ":", "a", "prospective", "double", "-", "blinded", "randomized", "study", ".", "Paravertebral", "blocks", "(", "PVBs", ")", "have", "been", "introduced", "as", "an", "alternative", "to", "general", "anesthesia", "for", "breast", "cancer", "surgeries", ".", "The", "addition", "of", "clonidine", "as", "an", "adjuvant", "in", "PVBs", "may", "enhance", "quality", "and", "duration", "of", "analgesia", "and", "significantly", "reduce", "the", "consumption", "of", "analgesics", "after", "breast", "surgery", ".", "In", "this", "prospective", "randomized", "double", "-", "blind", "study", ",", "we", "assessed", "the", "significance", "of", "adding", "clonidine", "to", "the", "anesthetic", "mixture", "for", "women", "undergoing", "mastectomy", ".", "Sixty", "patients", "were", "randomized", "equally", "into", "2", "groups", ",", "both", "of", "which", "received", "PVB", "block", ",", "either", "with", "or", "without", "clonidine", ".", "Analgesic", "consumption", "was", "noted", "up", "to", "2", "weeks", "after", "the", "operation", ".", "A", "visual", "analog", "scale", "was", "used", "to", "assess", "pain", "postoperatively", "during", "the", "hospital", "stay", ",", "and", "a", "numeric", "rating", "scale", "was", "used", "when", "patients", "were", "discharged", ".", "Analgesic", "consumption", "was", "significantly", "lower", "in", "the", "clonidine", "group", "48", "hours", "postoperatively", "with", "95", "%", "confidence", "interval", "(", "CI", ")", "for", "the", "difference", "(", "-", "69.5", "%", "to", "-", "6.6", "%", ")", ".", "Pain", "scores", "at", "rest", "showed", "significant", "reduction", "in", "the", "clonidine", "group", "during", "the", "period", "from", "24", "to", "72", "hours", "postoperatively", "with", "95", "%", "CI", "for", "the", "ratios", "of", "2", "means", "(", "1.09", "-", "3.61", ")", ",", "(", "2.04", "-", "9.04", ")", ",", "and", "(", "2.54", "-", "16.55", ")", ",", "respectively", ",", "with", "shoulder", "movement", "at", "24", ",", "48", ",", "and", "72", "hours", "postoperatively", "95", "%", "CI", "for", "the", "ratio", "of", "2", "means", "(", "1.10", "-", "3.15", ")", ",", "(", "1.32", "-", "6.38", ")", ",", "and", "(", "1.33", "-", "8.42", ")", ",", "respectively", ".", "The", "time", "needed", "to", "resume", "daily", "activity", "was", "shorter", "in", "the", "clonidine", "group", "compared", "with", "the", "control", "group", "with", "95", "%", "CI", "for", "the", "ratio", "of", "2", "means", "(", "1.14", "-", "1.62", ")", ".", "The", "addition", "of", "clonidine", "enhanced", "the", "analgesic", "efficacy", "of", "PVB", "up", "to", "3", "days", "postoperatively", "for", "patients", "undergoing", "breast", "surgery", "." ]
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162
[ "Tamoxifen", "for", "prevention", "of", "breast", "cancer", ":", "extended", "long", "-", "term", "follow", "-", "up", "of", "the", "IBIS", "-", "I", "breast", "cancer", "prevention", "trial", ".", "Four", "previously", "published", "randomised", "clinical", "trials", "have", "shown", "that", "tamoxifen", "can", "reduce", "the", "risk", "of", "breast", "cancer", "in", "healthy", "women", "at", "increased", "risk", "of", "breast", "cancer", "in", "the", "first", "10", "years", "of", "follow", "-", "up", ".", "We", "report", "the", "long", "-", "term", "follow", "-", "up", "of", "the", "IBIS", "-", "I", "trial", ",", "in", "which", "the", "participants", "and", "investigators", "remain", "largely", "masked", "to", "treatment", "allocation", ".", "In", "the", "IBIS", "-", "I", "randomised", "controlled", "trial", ",", "premenopausal", "and", "postmenopausal", "women", "35", "-", "70", "years", "of", "age", "deemed", "to", "be", "at", "an", "increased", "risk", "of", "developing", "breast", "cancer", "were", "randomly", "assigned", "(", "1", ":1", ")", "to", "receive", "oral", "tamoxifen", "20", "mg", "daily", "or", "matching", "placebo", "for", "5", "years", ".", "Patients", "were", "randomly", "assigned", "to", "the", "two", "treatment", "groups", "by", "telephone", "or", "fax", "according", "to", "a", "block", "randomisation", "schedule", "(", "permuted", "block", "sizes", "of", "six", "or", "ten", ")", ".", "Patients", "and", "investigators", "were", "masked", "to", "treatment", "assignment", "by", "use", "of", "central", "randomisation", "and", "coded", "drug", "supply", ".", "The", "primary", "endpoint", "was", "the", "occurrence", "of", "breast", "cancer", "(", "invasive", "breast", "cancer", "and", "ductal", "carcinoma", "in", "situ", ")", ",", "analysed", "by", "intention", "to", "treat", ".", "Cox", "proportional", "hazard", "models", "were", "used", "to", "assess", "breast", "cancer", "occurrence", "and", "mortality", ".", "The", "trial", "is", "closed", "to", "recruitment", "and", "active", "treatment", "is", "completed", ",", "but", "long", "-", "term", "follow", "-", "up", "is", "ongoing", ".", "This", "trial", "is", "registered", "with", "controlledtrials.com", ",", "number", "ISRCTN", "91879928", ".", "Between", "April", "14", ",", "1992", ",", "and", "March", "30", ",", "2001", ",", "7154", "eligible", "women", "recruited", "from", "genetics", "clinics", "and", "breast", "care", "clinics", "in", "eight", "countries", "were", "enrolled", "into", "the", "IBIS", "-", "I", "trial", "and", "were", "randomly", "allocated", "to", "the", "two", "treatment", "groups", ":", "3579", "to", "tamoxifen", "and", "3575", "to", "placebo", ".", "After", "a", "median", "follow", "up", "of", "16.0", "years", "(", "IQR", "14.1", "-", "17.6", ")", ",", "601", "breast", "cancers", "have", "been", "reported", "(", "251", "[", "7.0", "%", "]", "in", "3579", "patients", "in", "the", "tamoxifen", "group", "vs", "350", "[", "9.8", "%", "]", "in", "3575", "women", "in", "the", "placebo", "group", ";", "hazard", "ratio", "[", "HR", "]", "0.71", "[", "95", "%", "CI", "0.60", "-", "0.83", "]", ",", "p", "<", "0.0001", ")", ".", "The", "risk", "of", "developing", "breast", "cancer", "was", "similar", "between", "years", "0", "-", "10", "(", "226", "[", "6.3", "%", "]", "in", "3575", "women", "in", "the", "placebo", "group", "vs", "163", "[", "4.6", "%", "]", "in", "3579", "women", "in", "the", "tamoxifen", "group", ";", "hazard", "ratio", "[", "HR", "]", "0.72", "[", "95", "%", "CI", "0.59", "-", "0.88", "]", ",", "p=", "0.001", ")", "and", "after", "10", "years", "(", "124", "[", "3.8", "%", "]", "in", "3295", "women", "vs", "88", "[", "2.6", "%", "]", "in", "3343", ",", "respectively", ";", "HR", "0.69", "[", "0.53", "-", "0.91", "]", ",", "p=", "0.009", ")", ".", "The", "greatest", "reduction", "in", "risk", "was", "seen", "in", "invasive", "oestrogen", "receptor", "-", "positive", "breast", "cancer", "(", "HR", "0.66", "[", "95", "%", "CI", "0.54", "-", "0.81", "]", ",", "p", "<", "0.0001", ")", "and", "ductal", "carcinoma", "in", "situ", "(", "0.65", "[", "0.43", "-", "1.00", "]", ",", "p=", "0.05", ")", ",", "but", "no", "effect", "was", "noted", "for", "invasive", "oestrogen", "receptor", "-", "negative", "breast", "cancer", "(", "HR", "1.05", "[", "95", "%", "CI", "0.71", "-", "1.57", "]", ",", "p=", "0.8", ")", ".", "These", "results", "show", "that", "tamoxifen", "offers", "a", "very", "long", "period", "of", "protection", "after", "treatment", "cessation", ",", "and", "thus", "substantially", "improves", "the", "benefit", "-", "to", "-", "harm", "ratio", "of", "the", "drug", "for", "breast", "cancer", "prevention", ".", "Cancer", "Research", "UK", "(", "UK", ")", "and", "the", "National", "Health", "and", "Medical", "Research", "Council", "(", "Australia", ")", "." ]
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163
[ "A", "Comparison", "of", "Fentanyl", "and", "Flurbiprofen", "Axetil", "on", "Serum", "VEGF", "-", "C", ",", "TNF", "-", "α", ",", "and", "IL-", "1", "ß", "Concentrations", "in", "Women", "Undergoing", "Surgery", "for", "Breast", "Cancer", ".", "Vascular", "endothelial", "growth", "factor", "-", "C", "(", "VEGF", "-", "C", ")", ",", "tumor", "necrosis", "factor", "-", "α", "(", "TNF", "-", "α", ")", ",", "and", "interleukin-", "1", "ß", "(", "IL-", "1", "ß", ")", "have", "been", "shown", "to", "be", "associated", "with", "the", "recurrence", "and", "metastasis", "of", "breast", "cancer", "after", "surgery", ".", "This", "study", "tested", "the", "hypothesis", "that", "patients", "undergoing", "surgery", "for", "breast", "cancer", ",", "who", "received", "postoperative", "analgesia", "with", "flurbiprofen", "axetil", "combined", "with", "small", "doses", "of", "fentanyl", "(", "FA", ")", ",", "exhibited", "reduced", "levels", "of", "VEGF", "-", "C", ",", "TNF", "-", "α", ",", "and", "IL-", "1", "ß", "compared", "with", "those", "patients", "receiving", "fentanyl", "alone", "(", "F", ")", ".", "Forty", "-", "women", "with", "primary", "breast", "cancer", "undergoing", "a", "modified", "radical", "mastectomy", "were", "randomized", "to", "receive", "postoperative", "analgesia", "with", "flurbiprofen", "axetil", "combined", "with", "fentanyl", "or", "fentanyl", "alone", ".", "Venous", "blood", "was", "sampled", "before", "anesthesia", ",", "at", "the", "end", "of", "surgery", ",", "and", "at", "48", "hours", "after", "surgery", ",", "and", "the", "serum", "was", "analyzed", ".", "The", "primary", "endpoint", "was", "changes", "in", "the", "VEGF", "-", "C", "concentrations", "in", "serum", ".", "Group", "FA", "patients", "reported", "similar", "analgesic", "effects", "as", "group", "F", "patients", "at", "2", ",", "24", ",", "and", "48", "hours", ".", "At", "48", "hours", ",", "mean", "postoperative", "concentrations", "of", "VEGF", "-", "C", "in", "group", "F", "patients", "were", "higher", "than", "in", "group", "FA", "patients", ",", "730.9", "versus", ".", "354.1", "pg", "/", "mL", "(", "P", "=", "0.003", ")", ",", "respectively", ".", "The", "mean", "postoperative", "concentrations", "of", "TNF", "-", "α", "in", "group", "F", "patients", "were", "also", "higher", "compared", "with", "group", "FA", "patients", "27.1", "vs.", "15.8", "pg", "/", "mL", "(", "P", "=", "0.005", ")", ".", "Finally", ",", "the", "mean", "postoperative", "concentrations", "of", "IL-", "1", "ß", "in", "group", "F", "were", "also", "significantly", "higher", "than", "in", "group", "FA", "497.5", "vs.", "197.7", "pg", "/", "mL", "(", "P", "=", "0.001", ")", ".", "In", "patients", "undergoing", "a", "mastectomy", ",", "postoperative", "analgesia", "with", "flurbiprofen", "axetil", ",", "combined", "with", "fentanyl", ",", "were", "associated", "with", "decreases", "in", "serum", "concentrations", "of", "VEGF", "-", "C", ",", "TNF", "-", "α", ",", "and", "IL-", "1", "ß", "compared", "with", "patients", "receiving", "doses", "of", "only", "fentanyl", "." ]
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188
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