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508
[ "Hypofractionated", "radiation", "treatment", "following", "mastectomy", "in", "early", "breast", "cancer", ":", "the", "Christchurch", "experience", ".", "Although", "hypofractionated", "radiotherapy", "(", "HFRT", ")", "has", "become", "an", "accepted", "option", "for", "whole", "-", "breast", "irradiation", "after", "breast", "-", "conserving", "surgery", ",", "there", "is", "limited", "evidence", "to", "support", "HFRT", "to", "the", "chest", "wall", "following", "mastectomy", ".", "We", "retrospectively", "analysed", "post", "-", "mastectomy", "patients", "treated", "with", "HFRT", "in", "Christchurch", "to", "determine", "whether", "HFRT", "yields", "acceptable", "efficacy", "and", "toxicity", ".", "The", "Christchurch", "oncology", "database", "was", "used", "to", "identify", "breast", "cancer", "patients", "treated", "with", "adjuvant", "HFRT", "to", "the", "chest", "wall", "following", "a", "mastectomy", "between", "2003", "and", "2008", ".", "Eligible", "post", "-", "mastectomy", "patients", "were", "treated", "with", "40", "Gy", "in", "16", "daily", "fractions", ".", "Treatment", "outcomes", "assessed", "included", "local", "recurrence", "-", "free", "survival", ",", "breast", "cancer", "survival", ",", "overall", "survival", "and", "acute", "toxicities", ".", "One", "hundred", "thirty", "-", "three", "patients", "were", "identified", ".", "The", "median", "follow", "-", "up", "period", "was", "5.03", "years", ".", "Three", "patients", "had", "a", "local", "recurrence", "as", "a", "first", "event", ",", "resulting", "in", "5", "-year", "local", "recurrence", "-", "free", "survival", "of", "97.6", "%", ".", "Five", "-", "year", "overall", "survival", "and", "5", "-year", "breast", "cancer", "survival", "were", "74.7", "%", "and", "77.7", "%", ",", "respectively", ".", "The", "prospectively", "assessed", "acute", "toxicities", "were", "mostly", "grade", "1", ".", "In", "particular", ",", "the", "incidence", "of", "grade", "2", "skin", "toxicity", "was", "10.7", "%", ",", "and", "no", "patients", "experienced", "grade", "3", "skin", "toxicity", ".", "The", "high", "local", "control", "rate", "with", "HFRT", ",", "combined", "with", "acceptable", "toxicity", "and", "the", "practical", "benefits", "of", "a", "shorter", "treatment", "time", ",", "supports", "its", "ongoing", "use", "in", "the", "eligible", "patient", "group", ".", "A", "randomised", "controlled", "trial", "would", "be", "necessary", "to", "more", "completely", "assess", "the", "acute", "and", "long", "-", "term", "toxicity", "of", "HFRT", "compared", "with", "standard", "fractionation", "." ]
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509
[ "Visceral", "osteopathic", "manipulative", "treatment", "reduces", "patient", "reported", "digestive", "toxicities", "induced", "by", "adjuvant", "chemotherapy", "in", "breast", "cancer", ":", "A", "randomized", "controlled", "clinical", "study", ".", "Breast", "cancer", "patients", "often", "benefit", "from", "adjuvant", "chemotherapy", ",", "a", "protocol", "whose", "effectiveness", "is", "accompanied", "by", "disabling", "adverse", "effects", ".", "The", "aim", "of", "this", "controlled", "clinical", "study", "was", "to", "determine", "the", "impact", "of", "visceral", "osteopathy", "on", "the", "incidence", "of", "nausea", "/", "vomiting", ",", "constipation", "and", "overall", "quality", "of", "life", "(", "QoL", ")", "in", "women", "operated", "for", "breast", "cancer", "and", "undergoing", "adjuvant", "chemotherapy", "in", "Centre", "Georges", "François", "Leclerc", ",", "CGFL", ".", "Ninety", "-", "four", "women", "operated", "for", "a", "breast", "cancer", "stage", "1", "-", "3", ",", "in", "complete", "resection", "and", "to", "whom", "a", "3", "FEC", "100", "chemotherapy", "was", "prescribed", ",", "were", "randomly", "allocated", "to", "experimental", "or", "placebo", "group", ".", "Experimental", "group", "underwent", "a", "visceral", "osteopathic", "technique", "and", "placebo", "group", "was", "subjected", "to", "a", "superficial", "manipulation", "after", "each", "chemotherapy", "cycle", ".", "Rate", "of", "grade", "≥", "1", "nausea", "/", "vomiting", "or", "constipation", ",", "on", "the", "first", "3", "cycles", "of", "FEC", "100", ",", "were", "reported", ".", "QoL", "was", "evaluated", "using", "the", "EORTC", "QLQ", "-", "C", "30", "questionnaire", ".", "Rate", "of", "nausea", "/", "vomiting", "episodes", "of", "grade", "≥", "1", "was", "high", "in", "both", "experimental", "and", "placebo", "group", ".", "Constipation", "episodes", "of", "grade", "≥", "1", "were", "also", "frequent", ".", "No", "significant", "differences", "were", "found", "between", "the", "two", "groups", "concerning", "the", "rate", "of", "nausea", "/", "vomiting", "(", "p", "=", "0.569", ")", "or", "constipation", "(", "p", "=", "0.204", ")", "according", "to", "clinician", "reported", "side", "-", "effects", "but", "patient", "reported", "impact", "of", "constipation", "and", "diarrhoea", "on", "quality", "of", "life", "was", "significantly", "lower", "in", "experimental", "group", "(", "p", "=", "0.036", "and", "p", "=", "0.038", ",", "respectively", ")", ".", "Osteopathy", "does", "not", "reduce", "the", "incidence", "of", "nausea", "/", "vomiting", "in", "women", "operated", "for", "breast", "cancer", "and", "undergoing", "adjuvant", "chemotherapy", ".", "In", "contrast", ",", "patient", "reported", "digestive", "quality", "of", "life", "was", "significantly", "ameliorated", "by", "osteopathy", ".", "Clinicaltrials.gov", "Identifier", ":", "NCT", "02840890", "." ]
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510
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514
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515
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516
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522
[ "Increasing", "Adherence", "to", "Adjuvant", "Hormone", "Therapy", "Among", "Patients", "With", "Breast", "Cancer", ":", "A", "Smart", "Phone", "App", "-", "Based", "Pilot", "Study", ".", "This", "study", "tested", "the", "feasibility", "and", "efficacy", "of", "using", "a", "text", "-", "based", "intervention", "to", "increase", "initiation", ",", "decrease", "discontinuation", ",", "and", "improve", "adherence", "as", "prescribed", "to", "adjuvant", "hormone", "therapy", "(", "AHT", ")", "among", "hyphenate", "post", "-", "menopausal", "breast", "cancer", "survivors", ".", "The", "3", "-month", "intervention", "consisted", "of", "daily", "text", "message", "reminders", "to", "take", "medication", ",", "coupled", "with", "a", "dynamic", "(", "eg", ",", "feedback", "on", "progress", ")", "tailored", "intervention", "using", "weekly", "interactive", "surveys", "delivered", "by", "a", "smartphone", "app", ".", "Five", "clinic", "sites", "within", "the", "Alliance", "for", "Clinical", "Trials", "in", "Oncology", "participated", ".", "Hormone", "levels", "were", "measured", "prior", "to", "AHT", "initiation", "and", "at", "study", "exit", ".", "Of", "the", "39", "patients", "recruited", "to", "the", "pilot", "study", ",", "27", "(", "69.2", "%", ")", "completed", "all", "study", "requirements", "(", "completed", "both", "the", "baseline", "and", "the", "exit", "surveys", ",", "both", "blood", "draws", ",", "and", "did", "not", "miss", "more", "than", "2", "weekly", "surveys", ")", ".", "Significant", "improvements", "were", "observed", "pre-", "to", "postintervention", "for", "self", "-", "reported", "medication", "adherence", "(", "P", "=", ".", "015", ")", ",", "mental", "health", "functioning", "(", "P", "=", ".", "007", ")", ",", "and", "perceived", "stress", "(", "P", "=", ".", "04", ")", ".", "Significant", "decreases", "in", "estradiol", ",", "estrogen", ",", "and", "estrone", "hormone", "levels", "were", "observed", "from", "baseline", "to", "study", "exit", "(", "P", "<", ".", "001", ")", ",", "indicating", "the", "accuracy", "of", "self", "-", "reported", "AHT", "adherence", ".", "Participants", "(", "91.9", "%", ")", "and", "physicians", "(", "100", "%", ")", "agreed", "that", "participant", "participation", "in", "the", "intervention", "was", "beneficial", ".", "The", "results", "of", "this", "pilot", "study", "established", "the", "general", "feasibility", "and", "efficacy", "of", "an", "app", "-", "based", "intervention", "to", "support", "patient", "AHT", "adherence", ".", "Larger", "controlled", ",", "randomized", "trials", "are", "needed", "to", "examine", "the", "effectiveness", "of", "the", "app", "-", "based", "intervention", "in", "improving", "AHT", "and", "quality", "of", "life", "among", "breast", "cancer", "survivors", "." ]
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523
[ "Low", "-", "molecular", "-", "weight", "heparin", "versus", "placebo", "for", "the", "prevention", "of", "venous", "thromboembolism", "in", "metastatic", "breast", "cancer", "or", "stage", "III", "/", "IV", "lung", "cancer", ".", "In", "2", "double", "-", "blind", "studies", ",", "ambulatory", "patients", "with", "objectively", "proven", ",", "disseminated", "metastatic", "breast", "carcinoma", "(", "TOPIC-", "1", ")", "or", "stage", "III", "/", "IV", "non", "-", "small", "-", "cell", "lung", "carcinoma", "(", "TOPIC-", "2", ")", "were", "randomized", "to", "certoparin", "3000", "IU", "or", "placebo", "subcutaneously", "once", "daily", ",", "for", "6", "months", ".", "Primary", "efficacy", "outcome", "was", "objectively", "confirmed", "symptomatic", "or", "asymptomatic", "venous", "thromboembolism", "(", "VTE", ")", ".", "Safety", "outcomes", "included", "bleeding", "(", "major", "and", "minor", ")", ",", "and", "thrombocytopenia", ".", "TOPIC-", "1", "was", "halted", "after", "an", "interim", "analysis", ".", "Venous", "thromboembolism", "occurrence", "was", "not", "different", "between", "treatment", "groups", "in", "TOPIC-", "1", "(", "4", "%", "treated", "with", "certoparin", ",", "7", "of", "174", "vs", "4", "%", "receiving", "placebo", ",", "7", "of", "177", ",", "odds", "ratio", "[", "OR", "]", "1.02", ";", "95", "%", "confidence", "interval", "[", "CI", "]", "0.30", "-", "3.48", ")", "and", "in", "TOPIC-", "2", "(", "4.5", "%", ",", "12", "of", "268", ")", "vs", "8.3", "%", ",", "22", "of", "264", ",", "respectively", ",", "OR", "0.52", ";", "CI", "0.23", "-", "1.12", ")", ".", "Mortality", "was", "not", "different", "between", "groups", ".", "A", "post", "hoc", "analysis", "showed", "certoparin", "significantly", "reduced", "VTE", "in", "stage", "IV", "lung", "carcinoma", "(", "3.5", "%", "vs", "10.2", "%", ";", "P", "=", ".", "032", ")", "without", "increased", "bleeding", ".", "In", "conclusion", ",", "thrombosis", "risk", "and", "prophylactic", "benefit", "was", "highest", "in", "stage", "IV", "lung", "carcinoma", "patients", "." ]
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524
[ "Efficacy", "of", "a", "combined", "alendronate", "and", "calcitriol", "agent", "(", "Maxmarvil", "®", ")", "in", "Korean", "postmenopausal", "women", "with", "early", "breast", "cancer", "receiving", "aromatase", "inhibitor", ":", "a", "double", "-", "blind", ",", "randomized", ",", "placebo", "-", "controlled", "study", ".", "The", "use", "of", "aromatase", "inhibitor", "(", "AI", ")", "in", "postmenopausal", "women", "with", "hormone", "receptor", "(", "HR", ")", "-positive", "early", "breast", "cancer", "(", "EBC", ")", "produces", "a", "deleterious", "effect", "on", "bone", "mass", "and", "an", "increase", "in", "fractures", ".", "Several", "studies", "using", "intravenous", "bisphosphonates", "have", "shown", "effective", "management", "of", "AI", "-", "induced", "bone", "loss", ".", "To", "determine", "whether", "a", "lower", "dosage", "in", "oral", "form", "combined", "with", "calcitriol", "can", "effectively", "manage", "AI", "-", "induced", "bone", "loss", ",", "we", "performed", "a", "randomized", ",", "double", "-", "blind", ",", "prospective", ",", "placebo", "-", "controlled", "24", "-week", "trial", "with", "a", "combination", "of", "alendronate", "and", "0.5", "-µg", "of", "calcitriol", "daily", "to", "HR", "-", "positive", "EBC", "patients", ".", "A", "total", "of", "98", "Korean", "postmenopausal", "women", "with", "HR", "-", "positive", "EBC", "who", "received", "daily", "AI", ",", "calcium", "and", "vitamin", "D", "were", "randomly", "assigned", "to", "5", "-mg", "of", "alendronate", "and", "0.5", "-µg", "of", "calcitriol", "(", "Maxmarvil", "®", ")", "or", "placebo", "groups", ".", "The", "bone", "mineral", "density", "(", "BMD", ")", "and", "turnover", "markers", "were", "measured", ".", "At", "week", "24", ",", "the", "difference", "in", "lumbar", "BMD", "between", "the", "groups", "was", "3.0", "%", "(", "p", "<", "0.005", ")", ".", "The", "increase", "in", "C", "-", "telopeptide", "after", "24", "weeks", "was", "significantly", "less", "in", "the", "Maxmarvil", "group", "compared", "to", "that", "in", "the", "placebo", "group", "(", "35.2", "±", "17.5", "%", "vs.", "109.8", "±", "28.6", "%", ",", "p", "<", "0.05", ")", ".", "Our", "study", "demonstrates", "that", "a", "combination", "of", "5", "-mg", "alendronate", "and", "0.5", "-µg", "calcitriol", "is", "effective", "to", "prevent", "bone", "loss", "due", "to", "AI", "in", "Korean", "postmenopausal", "women", "with", "EBC", "." ]
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525
[ "Effect", "of", "melatonin", "on", "depressive", "symptoms", "and", "anxiety", "in", "patients", "undergoing", "breast", "cancer", "surgery", ":", "a", "randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "trial", ".", "Depression", ",", "anxiety", "and", "sleep", "disturbances", "are", "known", "problems", "in", "patients", "with", "breast", "cancer", ".", "The", "effect", "of", "melatonin", "as", "an", "antidepressant", "in", "humans", "with", "cancer", "has", "not", "been", "investigated", ".", "We", "investigated", "whether", "melatonin", "could", "lower", "the", "risk", "of", "depressive", "symptoms", "in", "women", "with", "breast", "cancer", "in", "a", "three", "-", "month", "period", "after", "surgery", "and", "assessed", "the", "effect", "of", "melatonin", "on", "subjective", "parameters", ":", "anxiety", ",", "sleep", ",", "general", "well", "-", "being", ",", "fatigue", ",", "pain", "and", "sleepiness", ".", "Randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "trial", "undertaken", "from", "July", "2011", "to", "December", "2012", "at", "a", "department", "of", "breast", "surgery", "in", "Copenhagen", ",", "Denmark", ".", "Women", ",", "30", "-", "75", "years", ",", "undergoing", "surgery", "for", "breast", "cancer", "and", "without", "signs", "of", "depression", "on", "Major", "Depression", "Inventory", "(", "MDI", ")", "were", "included", "1", "week", "before", "surgery", "and", "received", "6", "mg", "oral", "melatonin", "or", "placebo", "for", "3", "months", ".", "The", "primary", "outcome", "was", "the", "incidence", "of", "depressive", "symptoms", "measured", "by", "MDI", ".", "The", "secondary", "outcomes", "were", "area", "under", "the", "curve", "(", "AUC", ")", "for", "the", "subjective", "parameters", ".", "54", "patients", "were", "randomized", "to", "melatonin", "(", "n", "=", "28", ")", "or", "placebo", "(", "n", "=", "26", ")", "and", "11", "withdrew", "from", "the", "study", "(", "10", "placebo", "group", "and", "1", "melatonin", "group", ",", "P", "=", "0.002", ")", ".", "The", "risk", "of", "developing", "depressive", "symptoms", "was", "significantly", "lower", "with", "melatonin", "than", "with", "placebo", "(", "3", "[", "11", "%", "]", "of", "27", "vs.", "9", "[", "45", "%", "]", "of", "20", ";", "relative", "risk", "0.25", "[", "95", "%", "CI", "0.077", "-", "0.80", "]", ")", ",", "giving", "a", "NNT", "of", "3.0", "[", "95", "%", "CI", "1.7", "-", "11.0", "]", ".", "No", "significant", "differences", "were", "found", "between", "AUC", "for", "the", "subjective", "parameters", ".", "No", "differences", "in", "side", "effects", "were", "found", "(", "P", "=", "0.78", ")", ".", "Melatonin", "significantly", "reduced", "the", "risk", "of", "depressive", "symptoms", "in", "women", "with", "breast", "cancer", "during", "a", "three", "-", "month", "period", "after", "surgery", "." ]
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526
[ "Effect", "of", "anaesthetic", "technique", "on", "oestrogen", "receptor", "-", "negative", "breast", "cancer", "cell", "function", "in", "vitro", ".", "Metastatic", "recurrence", "is", "the", "main", "cause", "of", "breast", "cancer", "-", "related", "deaths", ".", "Tumour", "cell", "proliferation", "and", "migration", "are", "crucial", "steps", "in", "the", "metastatic", "process", ".", "Several", "perioperative", "factors", ",", "including", "general", "anaesthesia", "and", "opioid", "analgesia", ",", "adversely", "affect", "immune", "function", ",", "potentially", "increasing", "metastatic", "recurrence", ".", "Regional", "anaesthesia", "-", "analgesia", "has", "been", "consistently", "shown", "to", "attenuate", "the", "stress", "response", "to", "surgery", ",", "and", "also", "reduce", "opioid", "and", "general", "anaesthesia", "requirements", ",", "thereby", "attenuating", "this", "perioperative", "immunosuppression", ".", "We", "investigated", "the", "effect", "of", "serum", "from", "breast", "cancer", "surgery", "patients", "who", "received", "different", "anaesthetic", "techniques", "on", "breast", "cancer", "cell", "function", "in", "vitro", ".", "Patients", "were", "randomized", "to", "receive", "propofol", "/", "paravertebral", "anaesthesia", "-", "analgesia", "(", "propofol", "/", "paravertebral", ",", "n=", "11", ")", "or", "sevoflurane", "general", "anaesthesia", "with", "opioid", "analgesia", "(", "sevoflurane", "/", "opioid", ",", "n=", "11", ")", ".", "The", "ER", "-", "negative", "MDA", "-", "MB-", "231", "cell", "line", "was", "treated", "with", "patient", "serum", "from", "both", "groups", ".", "The", "effects", "on", "proliferation", "and", "migration", "were", "measured", ".", "Treatment", "groups", "were", "well", "balanced", "for", "age", ",", "weight", ",", "surgical", "procedure", ",", "and", "cancer", "pathology", ".", "Pain", "scores", "were", "lower", "at", "1", "and", "2", "h", "in", "the", "propofol", "/", "paravertebral", "analgesia", "group", ".", "Compared", "with", "preoperative", "values", ",", "proliferation", "of", "MDA", "-", "MB-", "231", "cells", "treated", "with", "postoperative", "patient", "serum", "at", "10", "%", "concentration", "from", "the", "propofol", "/", "paravertebral", "group", "was", "significantly", "reduced", "compared", "with", "the", "sevoflurane", "/", "opioid", "group", "(", "-", "24", "%", "vs", "73", "%", ",", "P=", "0.01", ")", ".", "There", "was", "no", "significant", "change", "in", "MDA", "-", "MB-", "231", "cell", "migration", "after", "treatment", "with", "patient", "serum", "between", "the", "two", "groups", ".", "Serum", "from", "patients", "receiving", "propofol", "/", "paravertebral", "anaesthesia", "for", "breast", "cancer", "surgery", "inhibited", "proliferation", ",", "but", "not", "migration", ",", "of", "ER", "-", "MDA", "-", "MB-", "231", "cells", "in", "vitro", ",", "to", "a", "greater", "extent", "than", "that", "from", "patients", "receiving", "sevoflurane", "/", "opioid", "anaesthesia", "-", "analgesia", ".", "This", "implies", "that", "anaesthetic", "technique", "alters", "the", "serum", "molecular", "milieu", "in", "ways", "that", "may", "affect", "breast", "cancer", "cell", "function", ",", "possibly", "by", "altering", "anaesthetic", "and", "opioid", "drug", "administration", "and", "resultant", "pain", "scores", "." ]
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528
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529
[ "Randomized", "phase", "II", "study", "of", "two", "irinotecan", "schedules", "for", "patients", "with", "metastatic", "breast", "cancer", "refractory", "to", "an", "anthracycline", ",", "a", "taxane", ",", "or", "both", ".", "A", "pressing", "need", "exists", "for", "agents", "active", "against", "anthracycline-", "or", "taxane", "-", "refractory", "metastatic", "breast", "cancer", "(", "MBC", ")", ",", "or", "both", ".", "Previous", "clinical", "trials", "suggested", "that", "irinotecan", "might", "have", "such", "activity", ".", "We", "conducted", "this", "multicenter", "phase", "II", "study", "to", "assess", "efficacy", "and", "tolerability", "of", "two", "irinotecan", "schedules", ".", "MBC", "patients", "who", "experienced", "disease", "progression", "after", "one", "to", "three", "chemotherapy", "regimens", ",", "including", "at", "least", "one", "anthracycline-", "or", "taxane", "-", "based", "regimen", ",", "were", "randomly", "assigned", "to", "irinotecan", "in", "6", "-week", "cycles", "comprising", "100", "mg", "/", "m", "(", "2", ")", "weekly", "for", "4", "weeks", ",", "then", "a", "2", "-week", "rest", "(", "weekly", ")", "or", "240", "mg", "/", "m", "(", "2", ")", "every", "3", "weeks", ".", "The", "weekly", "arm", "had", "52", "assessable", "patients", ";", "the", "every-", "3", "-", "weeks", "arm", "had", "51", "assessable", "patients", ".", "In", "the", "weekly", "arm", ",", "the", "objective", "response", "(", "complete", "regression", "[", "CR", "]", "+", "partial", "regression", "[", "PR", "]", ")", "rate", "was", "23", "%", "(", "one", "CR", ",", "11", "PR", ";", "95", "%", "CI", ",", "13", "%", "to", "37", "%", ")", ".", "Median", "response", "duration", "was", "4.9", "months", "(", "range", ",", "1.9", "to", "15.9", "months", ")", ",", "and", "median", "overall", "survival", "was", "9.7", "months", "(", "95", "%", "CI", ",", "8.0", "to", "14.2", "months", ")", ".", "In", "the", "every-", "3", "-", "weeks", "arm", ",", "the", "objective", "response", "rate", "was", "14", "%", "(", "nine", "PR", ";", "95", "%", "CI", ",", "6", "%", "to", "26", "%", ")", ",", "median", "response", "duration", "was", "4.2", "months", "(", "range", ",", "3.1", "to", "13.9", "months", ")", ",", "and", "median", "overall", "survival", "was", "8.6", "months", "(", "95", "%", "CI", ",", "7.0", "to", "12.3", "months", ")", ".", "Treatment", "generally", "was", "well", "tolerated", ",", "especially", "in", "the", "weekly", "arm", ".", "Grade", "3", "to", "4", "adverse", "events", "with", ">", "or", "=", "10", "%", "incidence", "included", "neutropenia", "(", "29", "%", ")", "and", "diarrhea", "(", "17", "%", ")", "in", "the", "weekly", "arm", "and", "neutropenia", "(", "36", "%", ")", ",", "vomiting", "(", "20", "%", ")", ",", "dyspnea", "(", "18", "%", ")", ",", "nausea", "(", "16", "%", ")", ",", "and", "diarrhea", "(", "12", "%", ")", "in", "the", "every-", "3", "-", "weeks", "arm", ".", "Irinotecan", "is", "active", "with", "good", "tolerability", "in", "refractory", "MBC", ".", "Irinotecan", "(", "especially", "weekly", ")", "warrants", "additional", "study", "as", "monotherapy", "and", "in", "combination", "regimens", "in", "this", "setting", "." ]
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530
[ "Evaluation", "of", "Short", "-", "Term", "Use", "of", "N", "-", "Acetylcysteine", "as", "a", "Strategy", "for", "Prevention", "of", "Anthracycline", "-", "Induced", "Cardiomyopathy", ":", "EPOCH", "Trial", "-", "A", "Prospective", "Randomized", "Study", ".", "We", "investigate", "to", "determine", "whether", "N", "-", "acetylcysteine", "(", "NAC", ")", "can", "prevent", "anthracycline", "-", "induced", "cardiotoxicity", ".", "A", "total", "of", "103", "patients", "were", "enrolled", "in", "this", "prospective", "randomized", "open", "label", "controlled", "trial", ".", "They", "are", "patients", "first", "diagnosed", "with", "breast", "cancer", "or", "lymphoma", ",", "who", "require", "chemotherapy", ",", "including", "anthracycline", "like", "adriamycine", "or", "epirubicine", ".", "Patients", "were", "randomized", "to", "the", "NAC", "group", "{", "n=", "50", ";", "1200", "mg", "orally", "every", "8", "hours", "starting", "before", "and", "ending", "after", "the", "intravenous", "infusion", "of", "anthracycline", "in", "all", "chemotherapy", "cycles", "(", "3", "-", "6", ")", "}", "or", "the", "control", "group", "(", "n=", "53", ")", ".", "Primary", "outcome", "was", "the", "decrease", "in", "left", "ventricular", "ejection", "fraction", "(", "LVEF", ")", "absolutely", "≥", "10", "%", "from", "the", "baseline", "and", "concomitantly", "<", "50", "%", "at", "6", "-month", ".", "Composite", "of", "all", "-", "cause", "death", ",", "heart", "failure", "and", "readmission", "were", "compared", ".", "The", "primary", "outcome", "was", "not", "significantly", "different", "in", "the", "NAC", "and", "control", "groups", "{", "3", "/", "47", "(", "6.4", "%", ")", "vs.", "1", "/", "52", "(", "1.9", "%", ")", ",", "p=", "0.343", "}", ".", "The", "mean", "LVEF", "significantly", "decreased", "in", "both", "the", "NAC", "(", "from", "64.5", "to", "60.8", "%", ",", "p=", "0.001", ")", "and", "control", "groups", "(", "from", "64.1", "to", "61.3", "%", ",", "p", "<", "0.001", ")", "after", "the", "completion", "of", "whole", "chemotherapy", ".", "The", "mean", "LVEF", "change", "did", "not", "differ", "between", "the", "two", "groups", "(", "-", "3.64", "%", "in", "NAC", "vs.", "-", "2.78", "%", "in", "control", "group", ",", "p=", "0.502", ")", ".", "Left", "ventricular", "(", "LV", ")", "end", "systolic", "dimension", "increased", "with", "higher", "trend", "in", "NAC", "by", "3.08", "±", "4.56", "mm", "as", "compared", "with", "1.47", "±", "1.83", "mm", "in", "the", "control", "group", "(", "p=", "0.064", ")", ".", "LV", "end", "diastolic", "dimension", "did", "not", "change", "in", "each", "group", "and", "change", "does", "not", "differ", "in", "both", ".", "Peak", "E", ",", "A", "and", "E", "/", "A", "ratio", "change", "and", "cardiac", "enzymes", "were", "comparable", "in", "two", "groups", ".", "Cumulative", "12", "-month", "event", "rate", "was", "6", "%", "and", "3.8", "%", "in", "the", "NAC", "group", "and", "the", "control", "group", ",", "respectively", ",", "with", "no", "difference", "(", "p=", "0.672", ")", ".", "We", "can", "not", "prove", "that", "NAC", "prevents", "anthracycline", "-", "induced", "cardiomyopathy", "." ]
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531
[ "Clinical", "outcomes", "of", "ethnic", "minority", "women", "in", "MA", ".", "17", ":", "a", "trial", "of", "letrozole", "after", "5", "years", "of", "tamoxifen", "in", "postmenopausal", "women", "with", "early", "stage", "breast", "cancer", ".", "Aromatase", "inhibitors", "are", "widely", "employed", "in", "the", "adjuvant", "treatment", "of", "early", "stage", "breast", "cancer", ".", "The", "impact", "of", "aromatase", "inhibitors", "has", "not", "been", "established", "in", "ethnic", "minority", "women", ".", "The", "purpose", "of", "this", "study", "was", "to", "evaluate", "the", "impact", "of", "letrozole", "on", "minority", "women", "in", "MA", ".", "17", ",", "a", "placebo", "-", "controlled", "trial", "of", "letrozole", "following", "5", "years", "of", "tamoxifen", "in", "postmenopausal", "women", "with", "early", "stage", "breast", "cancer", ".", "Retrospective", "comparison", "of", "disease", "-", "free", "survival", "(", "DFS", ")", ",", "side", "effects", ",", "and", "mean", "changes", "in", "quality", "of", "life", "(", "QOL", ")", "scores", "from", "baseline", "between", "Caucasian", "and", "minority", "women", "was", "performed", ".", "Minority", "(", "n", "=", "352", ")", "and", "Caucasian", "(", "n", "=", "4708", ")", "women", "were", "analyzed", ".", "There", "was", "no", "difference", "between", "these", "groups", "in", "DFS", "(", "91.6", "%", "versus", "92.4", "%", "respectively", "for", "4", "year", "DFS", ")", ".", "Letrozole", ",", "compared", "with", "placebo", ",", "significantly", "improved", "DFS", "for", "Caucasians", "(", "HR", "=", "0.55", ";", "P", "<", "0.0001", ")", "but", "not", "for", "minorities", "(", "HR", "=", "1.39", ";", "P", "=", "0.53", ")", ".", "Among", "women", "who", "received", "letrozole", ",", "minorities", "had", "a", "significantly", "lower", "incidence", "of", "hot", "flashes", "(", "49", "%", "versus", "58", "%", ";", "P", "=", "0.02", ")", ",", "fatigue", "(", "29", "%", "versus", "39", "%", ";", "P", "=", "0.005", ")", ",", "and", "arthritis", "(", "2", "%", "versus", "7", "%", ";", "P", "=", "0.006", ")", "compared", "with", "Caucasians", ".", "Mean", "change", "in", "QOL", "scores", "for", "minority", "women", "who", "received", "letrozole", "demonstrated", "improved", "mental", "health", "at", "the", "6", "-month", "assessment", "(", "P", "=", "0.02", ")", "and", "less", "bodily", "pain", "at", "the", "12", "-month", "assessment", "(", "P", "=", "0.046", ")", ".", "Letrozole", "improved", "DFS", "in", "Caucasians", "but", "a", "definite", "benefit", "in", "minority", "women", "has", "not", "yet", "been", "demonstrated", ".", "Minority", "women", "tolerated", "letrozole", "better", "than", "Caucasians", "in", "terms", "of", "toxicity", ".", "These", "results", "need", "confirmation", "in", "other", "trials", "of", "aromatase", "inhibitors", "." ]
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532
[ "A", "randomized", "controlled", "trial", "testing", "a", "hyaluronic", "acid", "spacer", "injection", "for", "skin", "toxicity", "reduction", "of", "brachytherapy", "accelerated", "partial", "breast", "irradiation", "(", "APBI", ")", ":", "a", "study", "protocol", ".", "Accelerated", "partial", "breast", "irradiation", "(", "APBI", ")", "is", "a", "treatment", "option", "for", "selected", "early", "stage", "breast", "cancer", "patients", ".", "Some", "APBI", "techniques", "lead", "to", "skin", "toxicity", "with", "the", "skin", "dose", "as", "main", "risk", "factor", ".", "We", "hypothesize", "that", "a", "spacer", "injected", "between", "the", "skin", "and", "target", "volume", "reduces", "the", "skin", "dose", "and", "subsequent", "toxicity", "in", "permanent", "breast", "seed", "implant", "(", "PBSI", ")", "patients", ".", "In", "this", "parallel", "-", "group", ",", "single", "-", "center", ",", "randomized", "controlled", "trial", ",", "the", "effect", "of", "a", "subcutaneous", "spacer", "injection", "on", "skin", "toxicity", "among", "patients", "treated", "with", "PBSI", "is", "tested", ".", "Eligibility", "for", "participation", "is", "derived", "from", "international", "guidelines", "for", "suitable", "patients", "for", "partial", "breast", "radiotherapy", ",", "e.g.", "women", "aged", "≥", "50", "years", "with", "a", "histologically", "proven", "non", "-", "lobular", "breast", "carcinoma", "and/or", "ductal", "carcinoma", "in", "situ", "(", "DCIS", ")", ",", "tumor", "size", "≤", "3", "cm", ",", "node", "-", "negative", ",", "and", "PBSI", "technically", "feasible", ".", "Among", "exclusion", "criteria", "are", "neoadjuvant", "chemotherapy", ",", "lymphovascular", "invasion", ",", "and", "allergy", "for", "hyaluronic", "acid", ".", "For", "the", "patients", "allocated", "to", "receive", "spacer", ",", "after", "the", "PBSI", "procedure", ",", "4", "-", "10", "cc", "of", "biodegradable", "hyaluronic", "acid", "(", "Barrigel", "™", ",", "Palette", "Life", "Sciences", ",", "Santa", "Barbara", ",", "CA", ",", "USA", "or", "Restylane", "SubQ", "®", ",", "Galderma", "Benelux", ",", "Breda", ",", "the", "Netherlands", ")", "is", "injected", "directly", "under", "the", "skin", "using", "ultrasound", "guidance", "to", "create", "an", "extra", "0.5", "-", "1", "cm", "space", "between", "the", "treatment", "volume", "and", "the", "skin", ".", "The", "primary", "outcome", "is", "the", "rate", "of", "telangiectasia", "at", "two", "years", ",", "blindly", "assessed", "using", "Bentzen", "'s", "4", "-point", "scale", ".", "Secondary", "outcomes", "include", ":", "local", "recurrence", ";", "disease", "-", "free", "and", "overall", "survival", "rates", ";", "adverse", "events", "(", "pain", ",", "redness", ",", "skin", "/", "subcutaneous", "induration", ",", "radiation", "dermatitis", ",", "pigmentation", ",", "surgical", "site", "infection", ")", ";", "skin", "dose", ";", "cosmetic", "and", "functional", "results", ";", "and", "health", "-", "related", "quality", "of", "life", ".", "A", "Fisher", "'s", "exact", "test", "will", "be", "used", "to", "test", "differences", "between", "groups", "on", "the", "primary", "outcome", ".", "Previous", "studies", "found", "22.4", "%", "telangiectasia", "at", "two", "years", ".", "We", "expect", "the", "use", "of", "a", "spacer", "could", "reduce", "the", "occurrence", "of", "telangiectasia", "to", "7.7", "%", ".", "A", "sample", "size", "of", "230", "patients", "will", "allow", "for", "a", "10", "%", "lost", "to", "follow", "-", "up", "rate", ".", "In", "this", "study", ",", "the", "effect", "of", "a", "subcutaneous", "spacer", "injection", "on", "the", "skin", "dose", ",", "late", "skin", "toxicity", ",", "and", "cosmetic", "outcome", "is", "tested", "in", "patients", "treated", "with", "PBSI", "in", "the", "setting", "of", "breast", "-", "conserving", "therapy", ".", "Our", "results", "will", "be", "relevant", "for", "most", "forms", "of", "breast", "brachytherapy", "as", "well", "as", "robotic", "radiosurgery", ",", "as", "skin", "spacers", "could", "protect", "the", "skin", "with", "these", "other", "techniques", ".", "Netherlands", "Trial", "Register", ",", "NTR", "6549", ".", "Registered", "on", "27", "June", "2017", "." ]
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533
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538
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539
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540
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541
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546
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549
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550
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551
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552
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556
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561
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562
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568
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570
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574
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575
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576
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577
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579
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580
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581
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582
[ "A", "phase", "III", ",", "randomized", ",", "placebo", "-", "controlled", ",", "double", "-", "blind", "trial", "of", "flaxseed", "for", "the", "treatment", "of", "hot", "flashes", ":", "North", "Central", "Cancer", "Treatment", "Group", "N", "08", "C", "7", ".", "Preliminary", "data", "suggest", "that", "flaxseed", ",", "a", "rich", "source", "of", "dietary", "lignans", ",", "may", "be", "a", "potentially", "effective", "treatment", "of", "hot", "flashes", ".", "A", "phase", "III", ",", "randomized", ",", "placebo", ",", "controlled", "trial", "was", "conducted", "to", "evaluate", "the", "efficacy", "of", "flaxseed", "in", "reducing", "hot", "flashes", ".", "Postmenopausal", "women", "with", "or", "without", "breast", "cancer", "were", "randomly", "assigned", "to", "a", "flaxseed", "bar", "(", "providing", "410", "mg", "of", "lignans", ")", "for", "6", "weeks", "versus", "a", "placebo", "bar", ".", "Participants", "completed", "daily", ",", "prospective", ",", "hot", "flash", "diaries", "during", "the", "baseline", "week", ",", "and", "then", "ate", "one", "study", "bar", "per", "day", "for", "6", "weeks", "while", "recording", "their", "daily", "hot", "flashes", ".", "The", "intraparticipant", "difference", "in", "hot", "flash", "activity", "between", "baseline", "and", "the", "last", "treatment", "week", "was", "the", "primary", "endpoint", ".", "Adverse", "effects", "were", "evaluated", "through", "a", "self", "-", "report", "and", "the", "Common", "Terminology", "Criteria", "assessment", ".", "A", "total", "of", "188", "women", "were", "enrolled", "in", "this", "trial", ".", "The", "mean", "hot", "flash", "score", "was", "reduced", "4.9", "in", "the", "flaxseed", "group", "and", "3.5", "in", "the", "placebo", "group", "(", "P", "=", "0.29", ")", ".", "In", "both", "groups", ",", "slightly", "more", "than", "a", "third", "of", "the", "women", "received", "a", "50", "%", "reduction", "in", "their", "hot", "flash", "score", ".", "Only", "one", "adverse", "effect", "was", "significantly", "different", "between", "groups", ",", "grade", "1", "pruritus", ",", "which", "was", "more", "common", "in", "the", "placebo", "group", "(", "8", "%", "vs", "1", "%", ")", ".", "Both", "groups", "reported", "abdominal", "distension", ",", "flatulence", ",", "diarrhea", ",", "and", "nausea", ".", "Adherence", "and", "ability", "to", "detect", "treatment", "assignment", "did", "not", "differ", "between", "groups", ".", "The", "results", "of", "this", "trial", "do", "not", "support", "the", "use", "of", "410", "mg", "of", "lignans", "for", "the", "reduction", "of", "hot", "flashes", ".", "The", "bars", "were", "fairly", "well", "tolerated", ",", "with", "both", "groups", "reporting", "gastrointestinal", "effects", ",", "probably", "due", "to", "the", "fiber", "content", "." ]
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583
[ "Randomized", ",", "placebo", "-", "controlled", ",", "double", "-", "blind", ",", "phase", "II", "study", "of", "axitinib", "plus", "docetaxel", "versus", "docetaxel", "plus", "placebo", "in", "patients", "with", "metastatic", "breast", "cancer", ".", "This", "multicenter", ",", "randomized", ",", "double", "-", "blind", ",", "phase", "II", "study", "assessed", "safety", "and", "efficacy", "of", "axitinib", "plus", "docetaxel", "in", "metastatic", "breast", "cancer", "(", "MBC", ")", ".", "Women", "with", "MBC", "were", "randomly", "assigned", "2", ":1", "to", "receive", "docetaxel", "80", "mg", "/", "m", "2", "once", "every", "3", "weeks", "plus", "axitinib", "5", "mg", "twice", "per", "day", "(", "combination", "arm", ")", "or", "placebo", "(", "placebo", "arm", ")", ",", "following", "a", "lead", "-", "in", "phase", "I", "trial", ".", "The", "primary", "end", "point", "was", "time", "to", "progression", "(", "TTP", ")", ".", "In", "all", ",", "168", "patients", "were", "enrolled", ";", "112", "were", "randomly", "assigned", "to", "axitinib", "and", "56", "to", "placebo", ".", "Median", "TTP", "was", "numerically", "longer", "in", "the", "combination", "arm", "than", "in", "the", "placebo", "arm", "(", "8.1", "v", "7.1", "months", ")", ",", "but", "this", "difference", "was", "not", "statistically", "significant", "(", "hazard", "ratio", ",", "1.24", ";", "95", "%", "CI", ",", "0.82", "to", "1.87", ";", "one", "-", "sided", "P", "=", ".", "156", ")", ".", "The", "difference", "in", "median", "TTP", "was", "greatest", "among", "patients", "who", "had", "received", "prior", "adjuvant", "chemotherapy", "(", "9.2", "v", "7.0", "months", ";", "P", "=", ".", "043", ",", "prespecified", "subgroup", "analysis", ")", ".", "Objective", "response", "rate", "was", "higher", "in", "the", "combination", "arm", "(", "41.1", "%", "v", "23.6", "%", ";", "P", "=", ".", "011", ")", ".", "The", "most", "common", "grades", "3", "to", "4", "treatment", "-", "related", "adverse", "events", "(", "combination", "/", "placebo", ")", "included", "diarrhea", "(", "10.8", "%", "/", "0", "%", ")", ",", "fatigue", "(", "10.8", "%", "/", "5.4", "%", ")", ",", "stomatitis", "(", "12.6", "%", "/", "1.8", "%", ")", ",", "mucositis", "(", "9.0", "%", "/", "0", "%", ")", ",", "asthenia", "(", "7.2", "%", "/", "0", "%", ")", ",", "and", "hypertension", "(", "4.5", "%", "/", "0", "%", ")", ".", "Three", "patients", "in", "the", "combination", "arm", "experienced", "serious", "thromboembolic", "events", "(", "one", "death", ")", ".", "Febrile", "neutropenia", "was", "more", "frequent", "in", "the", "combination", "arm", "(", "15.3", "%", "v", "7.1", "%", ")", ";", "rates", "of", "other", "hematologic", "toxicities", "were", "comparable", ".", "Increased", "toxicity", "with", "axitinib", "was", "generally", "managed", "by", "dose", "reduction", "and/or", "growth", "factor", "support", ".", "The", "addition", "of", "axitinib", "to", "docetaxel", "did", "not", "improve", "TTP", "in", "first", "-", "line", "MBC", "treatment", ".", "Combination", "therapy", "may", "be", "more", "effective", "in", "patients", "previously", "exposed", "to", "adjuvant", "chemotherapy", "." ]
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584
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586
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588
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597
[ "Preventive", "Analgesic", "Efficacy", "of", "Nefopam", "in", "Acute", "and", "Chronic", "Pain", "After", "Breast", "Cancer", "Surgery", ":", "A", "Prospective", ",", "Double", "-", "Blind", ",", "and", "Randomized", "Trial", ".", "Breast", "cancer", "surgery", "is", "known", "to", "cause", "severe", "acute", "postoperative", "pain", ",", "which", "can", "persist", "for", "a", "long", "time", ".", "We", "administered", "nefopam", "preventively", "to", "patients", "undergoing", "lumpectomy", "with", "axillary", "lymph", "node", "dissection", "or", "sentinel", "lymph", "node", "biopsy", ",", "and", "evaluated", "its", "efficacy", "on", "acute", "and", "chronic", "postoperative", "pain", ".", "Enrolled", "patients", "were", "assigned", "to", "the", "nefopam", "(", "n", "=", "41", ")", "or", "the", "control", "(", "n", "=", "42", ")", "group", ".", "Before", "initiating", "the", "operation", ",", "20", "mg", "of", "nefopam", "was", "given", "to", "the", "patients", "of", "the", "nefopam", "group", ",", "and", "normal", "saline", "was", "used", "in", "the", "control", "group", ".", "Ketorolac", "was", "given", "at", "the", "end", "of", "surgery", ",", "and", "meloxicam", "was", "prescribed", "in", "the", "postoperative", "period", "to", "all", "patients", "in", "both", "groups", ".", "Pain", "was", "assessed", "using", "a", "numerical", "rating", "scale", "(", "NRS", ")", ",", "and", "the", "rescue", "analgesic", "drug", "was", "given", "when", "the", "NRS", "was", ">", "5", ".", "Implementation", "of", "postoperative", "chemotherapy", ",", "radiotherapy", "(", "RT", ")", ",", "or", "hormone", "therapy", "was", "evaluated", ".", "The", "NRS", "of", "postoperative", "pain", "was", "significantly", "lower", "in", "the", "nefopam", "than", "in", "the", "control", "group", "in", "the", "postanesthetic", "care", "unit", "(", "4.5", "±", "2.2", "vs", "5.7", "±", "1.5", ",", "respectively", ";", "P", "=", "0.01", ")", ",", "at", "postoperative", "6", "h", "(", "3.0", "±", "1.6", "vs", "4.5", "±", "1.3", ",", "respectively", ";", "P", "<", "0.001", ")", ",", "and", "at", "postoperative", "24", "h", "(", "3.1", "±", "1.1", "vs", "3.8", "±", "1.5", ",", "respectively", ";", "P", "=", "0.01", ")", "with", "reduced", "use", "of", "rescue", "analgesic", "drugs", ".", "Significantly", "fewer", "patients", "suffered", "from", "chronic", "postoperative", "pain", "in", "the", "nefopam", "than", "in", "the", "control", "group", "at", "postoperative", "3", "months", "(", "36.6", "%", "vs", "59.5", "%", ",", "P", "=", "0.04", ")", ".", "Considering", "only", "the", "cohort", "without", "postoperative", "adjuvant", "RT", ",", "the", "difference", "in", "the", "proportion", "of", "patients", "reporting", "chronic", "pain", "increased", "(", "23.5", "%", "in", "the", "nefopam", "group", "vs", "61.5", "%", "in", "the", "control", "group", ",", "P", "=", "0.04", ")", ".", "Preventive", "nefopam", "was", "helpful", "in", "reducing", "the", "acute", "postoperative", "pain", ",", "with", "reduced", "use", "of", "rescue", "analgesic", "drugs", ",", "and", "it", "contributed", "to", "reduced", "occurrence", "of", "chronic", "pain", "at", "postoperative", "3", "months", "after", "breast", "cancer", "surgery", "." ]
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