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[ "Levofloxacin", "for", "prophylaxis", "in", "breast", "cancer", "surgery", "compared", "with", "ofloxacin", ".", "We", "found", "that", "once", "-", "daily", "use", "of", "ofloxacin", "is", "beneficial", "from", "the", "standpoints", "of", "economy", "and", "patient", "compliance", ".", "Levofloxacin", ",", "has", "twice", "the", "antimicrobial", "activity", "and", "same", "toxicity", "of", "ofloxacin", ".", "We", "investigated", "the", "clinical", "usefulness", "of", "levofloxacin", "compared", "with", "ofloxacin", "in", "breast", "surgery", ".", "Between", "July", ",", "1996", "and", "April", ",", "1999", ",", "199", "consecutive", "patients", "hospitalized", "in", "our", "department", "for", "treatment", "of", "breast", "cancer", "were", "enrolled", "in", "this", "study", "with", "their", "informed", "consent", "and", "181", "patients", "were", "evaluated", ".", "Four", "(", "4", "%", ")", "of", "the", "99", "patients", "in", "the", "levofloxacin", "group", "had", "wound", "infections", ",", "as", "did", "5", "(", "6", "%", ")", "of", "the", "82", "patients", "in", "the", "ofloxacin", "group", ".", "The", "median", "times", "needed", "for", "wound", "care", ",", "with", "25", "th", "and", "75", "th", "percentiles", ",", "were", "13", "[", "9", ",", "16", "]", "days", "in", "the", "levofloxacin", "group", "and", "11", "[", "9", ",", "16", "]", "days", "in", "the", "ofloxacin", "group", ".", "From", "infected", "wound", "three", "strains", "of", "Staphylococcus", "aureus", "were", "detected", "from", "the", "levofloxacin", "group", "and", "two", "strains", "were", "from", "ofloxacin", "group", ",", "but", "no", "methicillin", "-", "resistant", "strains", "were", "isolated", ".", "Multiple", "regression", "analysis", "showed", "that", "only", "wound", "dehiscence", "was", "a", "significant", "factor", "in", "the", "occurrence", "of", "wound", "infection", "and", "the", "period", "of", "wound", "care", ".", "No", "signs", "or", "symptoms", "suggesting", "levofloxacin", "or", "ofloxacin", "toxicity", "were", "observed", ".", "Laboratory", "test", "changes", "before", "and", "after", "treatment", "were", "similar", "in", "the", "two", "groups", ".", "It", "appears", "that", "levofloxacin", "is", "not", "superior", "to", "ofloxacin", "in", "prophylactic", "efficacy", "for", "postoperative", "wound", "infection", "after", "breast", "surgery", "." ]
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1
[ "Effects", "of", "hydrochlorothiazide", "on", "drainage", "volume", "and", "seroma", "formation", "in", "deep", "inferior", "epigastric", "perforator", "flap", "breast", "reconstruction", ":", "Randomized", "controlled", "trial", ".", "Seroma", "is", "a", "recognized", "complication", "encountered", "at", "the", "reconstructed", "breast", "and", "donor", "site", "after", "abdominal", "-", "based", "breast", "reconstruction", ".", "Seroma", "is", "caused", "by", "lymphatic", "channel", "disruption", "and", "the", "formation", "of", "a", "large", "space", "between", "the", "deep", "fascia", "during", "flap", "elevation", ".", "Surgical", "techniques", "to", "preserve", "the", "lymphatics", "and", "secure", "the", "closure", "of", "the", "donor", "site", "can", "reduce", "seroma", "formation", ".", "This", "study", "investigated", "the", "safety", "and", "effectiveness", "of", "the", "diuretic", "hydrochlorothiazide", "at", "reducing", "interstitial", "fluid", "accumulation", "and", "seroma", "formation", "during", "deep", "inferior", "epigastric", "perforator", "(", "DIEP", ")", "flap", "breast", "reconstruction", ".", "Sixty", "patients", "with", "breast", "cancer", "who", "underwent", "skin-", "or", "nipple", "-", "sparing", "mastectomy", "and", "DIEP", "flap", "reconstruction", "were", "enrolled", "between", "August", "2016", "and", "June", "2017", ".", "The", "patients", "were", "randomly", "assigned", "to", "receive", "either", "25", "mg", "per", "day", "of", "hydrochlorothiazide", "from", "the", "second", "to", "the", "twentieth", "day", "after", "surgery", "(", "treatment", ")", "or", "no", "diuretic", "(", "control", ")", ".", "The", "clinicopathological", "characteristics", ",", "drainage", "time", ",", "and", "drainage", "volume", "were", "statistically", "compared", "between", "the", "two", "groups", ".", "The", "average", "total", "drainage", "volume", "at", "the", "donor", "site", "was", "291", "mL", "in", "the", "treatment", "group", "and", "434", "mL", "in", "the", "control", "group", "(", "p", "=", "0.003", ")", ".", "The", "differences", "in", "body", "mass", "index", "and", "flap", "weight", "between", "the", "two", "groups", "were", "not", "statistically", "significant", "(", "p", "=", "0.879", "and", "p", "=", "0.963", ",", "respectively", ")", ".", "No", "hypotension", "or", "electrolyte", "imbalance", "was", "noted", "during", "the", "follow", "-", "up", ".", "Intake", "of", "25", "mg", "per", "day", "of", "hydrochlorothiazide", "tablets", "effectively", "reduced", "the", "total", "abdominal", "drainage", "volume", "and", "removal", "time", "of", "indwelling", "drains", ".", "However", ",", "the", "adverse", "effects", "should", "be", "further", "investigated", "in", "a", "large", "population", "and", "multiracial", "cohort", "before", "using", "hydrochlorothiazide", "for", "seroma", "prevention", "." ]
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2
[ "Prophylactic", "use", "of", "levonorgestrel", "-", "releasing", "intrauterine", "system", "in", "women", "with", "breast", "cancer", "treated", "with", "tamoxifen", ":", "a", "randomized", "controlled", "trial", ".", "To", "estimate", "the", "rate", "of", "endometrial", "pathology", "with", "the", "prophylactic", "use", "of", "levonorgestrel", "-", "releasing", "intrauterine", "system", "in", "women", "with", "breast", "cancer", "treated", "with", "tamoxifen", ".", "This", "was", "a", "randomized", "contro", "-", "lled", "trial", "of", "129", "Chinese", "women", "who", "attended", "a", "university", "hospital", "in", "Hong", "Kong", "and", "required", "adjuvant", "tamoxifen", "for", "breast", "cancer", "after", "the", "completion", "of", "postoperative", "radiotherapy", "and", "chemotherapy", ".", "Women", "were", "randomized", "to", "treatment", "(", "prophylactic", "levonorgestrel", "-", "releasing", "intrauterine", "system", "insertion", "before", "the", "commencement", "of", "tamoxifen", ")", "or", "control", "group", ".", "The", "uterine", "cavity", "was", "examined", "by", "hysteroscopy", "and", "endometrial", "sampling", "before", "the", "commencement", "of", "tamoxifen", "and", "at", "12", ",", "24", ",", "45", ",", "and", "60", "months", "afterward", ".", "Any", "endometrial", "polyps", "or", "submucosal", "fibroids", "were", "resected", "through", "hysteroscopy", "at", "each", "assessment", "and", "specimens", "were", "sent", "for", "histologic", "confirmation", ".", "A", "total", "of", "94", "women", "completed", "5", "-year", "follow", "-", "up", ".", "There", "was", "no", "significant", "difference", "in", "the", "occurrence", "of", "submucosal", "fibroids", "(", "1", "[", "1.8", "%", "]", "compared", "with", "2", "[", "3.4", "%", "]", ")", "and", "endometrial", "hyperplasia", "(", "both", "0", ")", "in", "the", "treatment", "and", "control", "groups", ",", "respectively", ".", "Levonorgestrel", "-", "releasing", "intrauterine", "system", "significantly", "reduced", "de", "novo", "endometrial", "polyps", "(", "hazard", "ratio", "0.19", ",", "95", "%", "confidence", "interval", "0.07", "-", "0.48", ")", "over", "the", "course", "of", "5", "years", "on", "an", "intention", "-", "to", "-", "treat", "basis", ".", "There", "was", "no", "statistically", "significant", "increase", "in", "breast", "cancer", "recurrence", "rate", "(", "10", "[", "17.2", "%", "]", "compared", "with", "6", "[", "10.0", "%", "]", ")", "or", "cancer", "-", "related", "deaths", "(", "6", "[", "10.3", "%", "]", "compared", "with", "5", "[", "8.3", "%", "]", ")", "in", "the", "treatment", "group", ",", "but", "the", "study", "was", "underpowered", "in", "this", "regard", ".", "Prophylactic", "levonorgestrel", "-", "releasing", "intrauterine", "system", "prevents", "de", "novo", "endometrial", "polyps", "in", "women", "using", "tamoxifen", ".", "However", ",", "its", "role", "in", "the", "prevention", "of", "endometrial", "hyperplasia", "and", "adenocarcinoma", "as", "well", "as", "its", "effect", "on", "risk", "of", "breast", "cancer", "recurrence", "remain", "uncertain", ".", "Chinese", "Clinical", "Trial", "Registry", ",", "http://www.chictr.org/en/", ",", "ChiCTR", "-", "TRC-", "09000625", ".", "I", "." ]
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3
[ "Preoperative", "MRI", "and", "surgical", "management", "in", "patients", "with", "nonpalpable", "breast", "cancer", ":", "the", "MONET", "-", "randomised", "controlled", "trial", ".", "We", "evaluated", "whether", "performing", "contrast", "-", "enhanced", "breast", "MRI", "in", "addition", "to", "mammography", "and/or", "ultrasound", "in", "patients", "with", "nonpalpable", "suspicious", "breast", "lesions", "improves", "breast", "cancer", "management", ".", "The", "MONET", "-", "study", "(", "MR", "mammography", "of", "nonpalpable", "breast", "tumours", ")", "is", "a", "randomised", "controlled", "trial", "in", "patients", "with", "a", "nonpalpable", "BIRADS", "3", "-", "5", "lesion", ".", "Patients", "were", "randomly", "assigned", "to", "receive", "routine", "medical", "care", ",", "including", "mammography", ",", "ultrasound", "and", "lesion", "sampling", "by", "large", "core", "needle", "biopsy", "or", "additional", "MRI", "preceding", "biopsy", ".", "Patients", "with", "cancer", "were", "referred", "for", "surgery", ".", "Primary", "end", "-", "point", "was", "the", "rate", "of", "additional", "surgical", "procedures", "(", "re", "-", "excisions", "and", "conversion", "to", "mastectomy", ")", "in", "patients", "with", "a", "nonpalpable", "breast", "cancer", ".", "Four", "hundred", "and", "eighteen", "patients", "were", "randomised", ",", "207", "patients", "were", "allocated", "to", "MRI", ",", "and", "211", "patients", "to", "the", "control", "group", ".", "In", "the", "MRI", "group", "74", "patients", "had", "83", "malignant", "lesions", ",", "compared", "to", "75", "patients", "with", "80", "malignant", "lesions", "in", "the", "control", "group", ".", "The", "primary", "breast", "conserving", "surgery", "(", "BCS", ")", "rate", "was", "similar", "in", "both", "groups", ";", "68", "%", "in", "the", "MRI", "group", "versus", "66", "%", "in", "the", "control", "group", ".", "The", "number", "of", "re", "-", "excisions", "performed", "because", "of", "positive", "resection", "margins", "after", "primary", "BCS", "was", "increased", "in", "the", "MRI", "group", ";", "18", "/", "53", "(", "34", "%", ")", "patients", "in", "the", "MRI", "group", "versus", "6", "/", "50", "(", "12", "%", ")", "in", "the", "control", "group", "(", "p=", "0.008", ")", ".", "The", "number", "of", "conversions", "to", "mastectomy", "did", "not", "differ", "significantly", "between", "groups", ".", "Overall", ",", "the", "rate", "of", "an", "additional", "surgical", "intervention", "(", "BCS", "and", "mastectomy", "combined", ")", "after", "initial", "breast", "conserving", "surgery", "was", "24", "/", "53", "(", "45", "%", ")", "in", "the", "MRI", "group", "versus", "14", "/", "50", "(", "28", "%", ")", "in", "the", "control", "group", "(", "p=", "0.069", ")", ".", "Addition", "of", "MRI", "to", "routine", "clinical", "care", "in", "patients", "with", "nonpalpable", "breast", "cancer", "was", "paradoxically", "associated", "with", "an", "increased", "re", "-", "excision", "rate", ".", "Breast", "MRI", "should", "not", "be", "used", "routinely", "for", "preoperative", "work", "-", "up", "of", "patients", "with", "nonpalpable", "breast", "cancer", "." ]
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4
[ "Association", "of", "tamoxifen", "use", "and", "reduced", "cardiovascular", "events", "among", "asian", "females", "with", "breast", "cancer", ".", "Tamoxifen", "is", "used", "for", "breast", "cancer", "treatment", "and", "has", "been", "reported", "to", "be", "beneficial", "for", "the", "cardiovascular", "system", ",", "but", "it", "is", "unclear", "whether", "tamoxifen", "exhibits", "a", "favorable", "cardiovascular", "effect", "in", "Asian", "patients", ".", "From", "January", ",", "1998", "to", "December", ",", "2006", ",", "a", "breast", "cancer", "cohort", "study", "was", "conducted", "using", "the", "Taiwan", "National", "Health", "Insurance", "database", ".", "Patients", "were", "divided", "according", "to", "whether", "tamoxifen", "was", "used", ".", "Study", "endpoints", "were", "occurrence", "of", "acute", "myocardial", "infarction", "(", "AMI", ")", ",", "ischemic", "or", "hemorrhagic", "stroke", "and", "total", "cardiovascular", "events", ".", "A", "total", "of", "3", ",", "690", "female", "subjects", "were", "enrolled", "(", "mean", "age", "50.1", "±", "11.3", ")", ",", "2", ",", "056", "of", "whom", "received", "tamoxifen", "and", "1", ",", "634", "did", "not", ".", "During", "a", "mean", "follow", "-", "up", "of", "6.9", "years", ",", "the", "tamoxifen", "group", "had", "a", "significantly", "lower", "incidence", "of", "AMI", "(", "0.15", "%", "vs.", "0.67", "%", ",", "P=", "0.008", ")", ",", "ischemic", "stroke", "(", "1.99", "%", "vs.", "3.30", "%", ",", "P=", "0.008", ")", ",", "hemorrhagic", "stroke", "(", "0.15", "%", "vs.", "0.55", "%", ",", "P=", "0.029", ")", ",", "and", "total", "cardiovascular", "events", "(", "2.24", "%", "vs.", "4.16", "%", ",", "P", "<", "0.001", ")", "than", "the", "non", "-", "exposed", "group", ".", "After", "adjusting", "for", "comorbidities", ",", "tamoxifen", "was", "independently", "associated", "with", "a", "reduced", "risk", "of", "myocardial", "infarction", "(", "hazard", "ratio", "[", "HR", "]", "0.22", ";", "95", "%", "confidence", "interval", "[", "CI", "]", "0.07", "-", "0.70", ",", "ischemic", "stroke", "(", "HR", "0.52", ";", "95", "%", "CI", "0.35", "-", "0.78", ")", ",", "hemorrhagic", "stroke", "(", "HR", "0.25", ";", "95", "%", "CI", "0.07", "-", "0.92", ")", ",", "and", "total", "cardiovascular", "events", "(", "HR", "0.54", ";", "95", "%", "CI", "0.37", "-", "0.78", ")", ".", "In", "Asian", "female", "breast", "cancer", "patients", ",", "tamoxifen", "use", "was", "associated", "with", "reduced", "risks", "of", "AMI", ",", "ischemic", ",", "hemorrhagic", "stroke", "and", "total", "cardiovascular", "events", "." ]
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5
[ "Smartphone", "-", "Enabled", "Health", "Coaching", "Intervention", "(", "iMOVE", ")", "to", "Promote", "Long", "-", "Term", "Maintenance", "of", "Physical", "Activity", "in", "Breast", "Cancer", "Survivors", ":", "Protocol", "for", "a", "Feasibility", "Pilot", "Randomized", "Controlled", "Trial", ".", "Although", "physical", "activity", "has", "been", "shown", "to", "contribute", "to", "long", "-", "term", "disease", "control", "and", "health", "in", "breast", "cancer", "survivors", ",", "a", "majority", "of", "breast", "cancer", "survivors", "do", "not", "meet", "physical", "activity", "guidelines", ".", "Past", "research", "has", "focused", "on", "promoting", "physical", "activity", "components", "for", "short", "-", "term", "breast", "cancer", "survivor", "benefits", ",", "but", "insufficient", "attention", "has", "been", "devoted", "to", "long", "-", "term", "outcomes", "and", "sustained", "exercise", "adherence", ".", "We", "are", "assessing", "a", "health", "coach", "intervention", "(", "iMOVE", ")", "that", "uses", "mobile", "technology", "to", "increase", "and", "sustain", "physical", "activity", "maintenance", "in", "initially", "inactive", "breast", "cancer", "survivors", ".", "This", "pilot", "randomized", "controlled", "trial", "(", "RCT", ")", "is", "an", "initial", "step", "in", "evaluating", "the", "iMOVE", "intervention", "and", "will", "inform", "development", "of", "a", "full", "-", "scale", "pragmatic", "RCT", ".", "We", "will", "enroll", "107", "physically", "inactive", "breast", "cancer", "survivors", "and", "randomly", "assign", "them", "to", "intervention", "or", "control", "groups", "at", "the", "University", "Health", "Network", ",", "a", "tertiary", "cancer", "care", "center", "in", "Toronto", ",", "Canada", ".", "Participants", "will", "be", "women", "(", "age", "18", "to", "74", "years", ")", "stratified", "by", "age", "(", "55", "years", "and", "older", "/", "younger", "than", "55", "years", ")", "and", "adjuvant", "hormone", "therapy", "(", "AHT", ")", "exposure", "(", "AHT", "vs", "no", "AHT", ")", "following", "breast", "cancer", "treatment", "with", "no", "metastases", "or", "recurrence", "who", "report", "less", "than", "60", "minutes", "of", "preplanned", "physical", "activity", "per", "week", ".", "Both", "intervention", "and", "control", "groups", "receive", "the", "12", "-week", "physical", "activity", "program", "with", "weekly", "group", "sessions", "and", "an", "individualized", ",", "progressive", ",", "home", "-", "based", "exercise", "program", ".", "The", "intervention", "group", "will", "additionally", "receive", "(", "1", ")", "10", "telephone", "-", "based", "health", "coaching", "sessions", ",", "(", "2", ")", "smartphone", "with", "data", "plan", ",", "if", "needed", ",", "(", "3", ")", "supportive", "health", "tracking", "software", "(", "Connected", "Wellness", ",", "NexJ", "Health", "Inc", ")", ",", "and", "(", "4", ")", "a", "wearable", "step", "-", "counting", "device", "linked", "to", "a", "smartphone", "program", ".", "We", "will", "be", "assessing", "recruitment", "rates", ";", "acceptability", "reflected", "in", "selective", ",", "semistructured", "interviews", ";", "and", "enrollment", ",", "retention", ",", "and", "adherence", "quantitative", "intervention", "markers", "as", "pilot", "outcome", "measures", ".", "The", "primary", "clinical", "outcome", "will", "be", "directly", "measured", "peak", "oxygen", "consumption", ".", "Secondary", "clinical", "outcomes", "include", "health", "-", "related", "quality", "of", "life", "and", "anthropometric", "measures", ".", "All", "outcome", "measures", "are", "administered", "at", "baseline", ",", "after", "exercise", "program", "(", "month", "3", ")", ",", "and", "6", "months", "after", "program", "(", "month", "9", ")", ".", "This", "pilot", "RCT", "will", "inform", "full", "-", "scale", "RCT", "planning", ".", "We", "will", "assess", "pilot", "procedures", "and", "interventions", "and", "collect", "preliminary", "effect", "estimates", ".", "ClinicalTrials.gov", "NCT", "02620735", ";", "https://clinicaltrials.gov/ct2/show/NCT", "02620735", "(", "Archived", "by", "WebCite", "at", "https://clinicaltrials.gov/ct2/show/NCT", "02620735", ")", "." ]
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6
[ "Long", "-", "term", "prevention", "of", "skeletal", "complications", "of", "metastatic", "breast", "cancer", "with", "pamidronate", ".", "Protocol", "19", "Aredia", "Breast", "Cancer", "Study", "Group", ".", "Pamidronate", ",", "an", "aminobisphosphonate", ",", "has", "been", "shown", "to", "lower", "the", "risk", "of", "skeletal", "complications", "associated", "with", "lytic", "bone", "lesions", "for", "up", "to", "1", "year", "in", "women", "with", "stage", "IV", "breast", "cancer", "who", "received", "chemotherapy", ".", "We", "studied", "the", "long", "-", "term", "effectiveness", "and", "safety", "of", "continued", "treatment", "with", "intravenous", "pamidronate", "infusions", "for", "up", "to", "2", "years", ".", "Three", "hundred", "eighty", "-", "two", "women", "with", "metastatic", "breast", "cancer", "and", "lytic", "bone", "lesions", "who", "received", "chemotherapy", "were", "randomly", "assigned", "to", "receive", "either", "90", "mg", "of", "pamidronate", "or", "placebo", "intravenously", "every", "3", "to", "4", "weeks", "in", "this", "double", "-", "blind", ",", "multicenter", ",", "parallel", "-", "group", "trial", ".", "Patients", "were", "evaluated", "monthly", "for", "2", "years", "for", "skeletal", "complications", ",", "which", "included", "pathologic", "fractures", ",", "need", "for", "radiation", "or", "surgery", "to", "treat", "bone", "complications", ",", "spinal", "cord", "compression", ",", "and", "hypercalcemia", ".", "Bone", "pain", ",", "analgesic", "use", ",", "bone", "biochemical", "markers", ",", "performance", "status", ",", "quality", "of", "life", ",", "radiologic", "response", "in", "bone", ",", "and", "survival", "were", "also", "evaluated", ".", "As", "in", "the", "first", "year", "of", "treatment", ",", "the", "proportion", "of", "patients", "with", "any", "skeletal", "complication", "was", "significantly", "less", "for", "the", "pamidronate", "than", "the", "placebo", "group", "at", "15", ",", "18", ",", "21", ",", "and", "24", "months", "(", "P", "<", ".", "001", ")", ".", "The", "proportions", "of", "patients", "with", "any", "pathologic", "fracture", "(", "i.e.", ",", "vertebral", "and", "nonvertebral", "fractures", ")", ",", "need", "for", "radiation", "or", "surgery", "to", "treat", "bone", "complications", ",", "and", "hypercalcemia", "were", "also", "statistically", "less", "for", "the", "pamidronate", "than", "the", "placebo", "group", ".", "The", "median", "time", "to", "the", "first", "skeletal", "complication", "was", "13.9", "months", "in", "the", "pamidronate", "-", "treated", "women", "and", "7.0", "months", "in", "the", "placebo", "group", "(", "P", "<", ".", "001", ")", ".", "Long", "-", "term", "treatment", "did", "not", "result", "in", "any", "unexpected", "adverse", "events", ".", "Survival", "did", "not", "differ", "between", "the", "two", "groups", ".", "The", "risk", "for", "osteolytic", "bone", "lesion", "complications", "in", "metastatic", "breast", "cancer", "was", "significantly", "decreased", "with", "monthly", "infusions", "of", "90", "mg", "of", "pamidronate", ",", "and", "this", "effect", "was", "maintained", "for", "at", "least", "2", "years", ".", "Pamidronate", "is", "a", "useful", "adjunct", "to", "standard", "chemotherapy", "in", "the", "palliative", "treatment", "of", "metastatic", "breast", "cancer", "." ]
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7
[ "OlympiAD", "final", "overall", "survival", "and", "tolerability", "results", ":", "Olaparib", "versus", "chemotherapy", "treatment", "of", "physician", "'s", "choice", "in", "patients", "with", "a", "germline", "BRCA", "mutation", "and", "HER", "2", "-", "negative", "metastatic", "breast", "cancer", ".", "In", "the", "OlympiAD", "study", ",", "olaparib", "was", "shown", "to", "improve", "progression", "-", "free", "survival", "compared", "with", "chemotherapy", "treatment", "of", "physician", "'s", "choice", "(", "TPC", ")", "in", "patients", "with", "a", "germline", "BRCA", "1", "and/or", "BRCA", "2", "mutation", "(", "BRCAm", ")", "and", "human", "epidermal", "growth", "factor", "receptor", "2", "(", "HER", "2", ")", "-negative", "metastatic", "breast", "cancer", "(", "mBC", ")", ".", "We", "now", "report", "the", "planned", "final", "overall", "survival", "(", "OS", ")", "results", ",", "and", "describe", "the", "most", "common", "adverse", "events", "(", "AEs", ")", "to", "better", "understand", "olaparib", "tolerability", "in", "this", "population", ".", "OlympiAD", ",", "a", "Phase", "III", ",", "randomized", ",", "controlled", ",", "open", "-", "label", "study", "(", "NCT", "02000622", ")", ",", "enrolled", "patients", "with", "a", "germline", "BRCAm", "and", "HER", "2", "-", "negative", "mBC", "who", "had", "received", "≤", "2", "lines", "of", "chemotherapy", "for", "mBC", ".", "Patients", "were", "randomized", "to", "olaparib", "tablets", "(", "300", "mg", "bid", ")", "or", "predeclared", "TPC", "(", "capecitabine", ",", "vinorelbine", ",", "or", "eribulin", ")", ".", "OS", "and", "safety", "were", "secondary", "end", "points", ".", "A", "total", "of", "205", "patients", "were", "randomized", "to", "olaparib", "and", "97", "to", "TPC", ".", "At", "64", "%", "data", "maturity", ",", "median", "OS", "was", "19.3", "months", "with", "olaparib", "versus", "17.1", "months", "with", "TPC", "(", "HR", "0.90", ",", "95", "%", "CI", "0.66", "-", "1.23", ";", "P", "=", "0.513", ")", ";", "median", "follow", "-", "up", "was", "25.3", "and", "26.3", "months", ",", "respectively", ".", "HR", "for", "OS", "with", "olaparib", "versus", "TPC", "in", "prespecified", "subgroups", "were", ":", "prior", "chemotherapy", "for", "mBC", "[", "no", "(", "first", "-", "line", "setting", ")", ":", "0.51", ",", "95", "%", "CI", "0.29", "-", "0.90", ";", "yes", "(", "second", "/", "third", "-", "line", ")", ":", "1.13", ",", "0.79", "-", "1.64", "]", ";", "receptor", "status", "(", "triple", "negative", ":", "0.93", ",", "0.62", "-", "1.43", ";", "hormone", "receptor", "positive", ":", "0.86", ",", "0.55", "-", "1.36", ")", ";", "prior", "platinum", "(", "yes", ":", "0.83", ",", "0.49", "-", "1.45", ";", "no", ":", "0.91", ",", "0.64", "-", "1.33", ")", ".", "Adverse", "events", "during", "olaparib", "treatment", "were", "generally", "low", "grade", "and", "manageable", "by", "supportive", "treatment", "or", "dose", "modification", ".", "There", "was", "a", "low", "rate", "of", "treatment", "discontinuation", "(", "4.9", "%", ")", ",", "and", "the", "risk", "of", "developing", "anemia", "did", "not", "increase", "with", "extended", "olaparib", "exposure", ".", "While", "there", "was", "no", "statistically", "significant", "improvement", "in", "OS", "with", "olaparib", "compared", "to", "TPC", ",", "there", "was", "the", "possibility", "of", "meaningful", "OS", "benefit", "among", "patients", "who", "had", "not", "received", "chemotherapy", "for", "metastatic", "disease", ".", "Olaparib", "was", "generally", "well", "-", "tolerated", ",", "with", "no", "evidence", "of", "cumulative", "toxicity", "during", "extended", "exposure", ".", "Please", "see", "the", "article", "online", "for", "additional", "video", "content", "." ]
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8
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9
[ "Risk", "Model", "-", "Guided", "Antiemetic", "Prophylaxis", "vs", "Physician", "'s", "Choice", "in", "Patients", "Receiving", "Chemotherapy", "for", "Early", "-", "Stage", "Breast", "Cancer", ":", "A", "Randomized", "Clinical", "Trial", ".", "Despite", "multiple", "patient", "-", "centered", "factors", "being", "associated", "with", "the", "risk", "of", "chemotherapy", "-", "induced", "nausea", "and", "vomiting", "(", "CINV", ")", ",", "these", "factors", "are", "rarely", "considered", "when", "making", "antiemetic", "recommendations", ".", "To", "compare", "risk", "model", "-", "guided", "(", "RMG", ")", "antiemetic", "prophylaxis", "with", "physician", "'s", "choice", "(", "PC", ")", "in", "patients", "receiving", "chemotherapy", "for", "early", "-", "stage", "breast", "cancer", ".", "A", "randomized", "clinical", "trial", "of", "324", "patients", "with", "early", "-", "stage", "breast", "cancer", "undergoing", "chemotherapy", "(", "cyclophosphamide", "and", "an", "anthracycline", ")", "for", "the", "first", "time", "at", "2", "specialty", "cancer", "care", "centers", "in", "Ottawa", "from", "April", "10", ",", "2012", ",", "to", "September", "2", ",", "2014", ".", "Patients", "were", "randomized", "to", "either", "the", "RMG", "arm", "(", "n", "=", "154", ")", "or", "the", "PC", "control", "arm", "(", "n", "=", "170", ")", ".", "Prior", "to", "each", "cycle", "of", "chemotherapy", "patients", "in", "the", "RMG", "group", "were", "categorized", "as", "low", "or", "high", "risk", "for", "CINV", ",", "and", "their", "antiemetic", "treatments", "were", "adjusted", "accordingly", ".", "Patients", "considered", "to", "be", "at", "low", "risk", "received", "standard", "dexamethasone", "and", "a", "5", "-HT", "3", "antagonist", ",", "while", "those", "at", "high", "risk", "also", "received", "aprepitant", "with", "or", "without", "olanzapine", ",", "based", "on", "their", "risk", "level", ".", "The", "PC", "control", "group", "received", "antiemetic", "agents", "according", "to", "the", "treating", "physician", "'s", "discretion", ".", "The", "primary", "end", "points", "were", "control", "of", "both", "nausea", "and", "vomiting", "in", "the", "acute", "posttreatment", "period", "(", "first", "24", "hours", "after", "therapy", ")", "and", "in", "the", "delayed", "posttreatment", "period", "(", "days", "2", "-", "5", "after", "therapy", ")", ".", "The", "total", "numbers", "of", "chemotherapy", "cycles", "delivered", "in", "the", "RMG", "and", "PC", "control", "groups", "were", "497", "and", "551", "respectively", ".", "In", "the", "acute", "period", ",", "significantly", "more", "patients", "in", "the", "RMG", "group", "reported", "no", "nausea", "(", "53.7", "%", "[", "95", "%", "CI", ",", "49.2", "%", "-", "58.1", "%", "]", "vs", "41.6", "%", "[", "95", "%", "CI", ",", "37.4", "%", "-", "45.3", "%", "]", ";", "P", "<", ".", "001", ")", "and", "no", "vomiting", "(", "91.8", "%", "[", "95", "%", "CI", ",", "89.0", "%", "-", "94.0", "%", "]", "vs", "82.2", "%", "[", "95", "%", "CI", ",", "78.8", "%", "-", "85.3", "%", "]", ";", "P", "<", ".", "001", ")", "compared", "with", "the", "PC", "control", "group", ".", "Similarly", ",", "significantly", "more", "patients", "in", "the", "RMG", "group", "reported", "no", "nausea", "(", "39.6", "%", "[", "95", "%", "CI", ",", "35.3", "%", "-", "44.1", "%", "]", "vs", "30.7", "%", "[", "95", "%", "CI", ",", "26.8", "%", "-", "34.7", "%", "]", ";", "P", "=", ".", "01", ")", "and", "no", "vomiting", "(", "87.1", "%", "[", "95", "%", "CI", ",", "83.8", "%", "-", "90.0", "%", ")", "vs", "78.0", "%", "[", "95", "%", "CI", ",", "74.3", "%", "-", "81.4", "%", "]", ";", "P", "<", ".", "001", ")", "in", "the", "delayed", "period", "respectively", ".", "In", "this", "trial", ",", "the", "RMG", "antiemetic", "prophylaxis", "led", "to", "improved", "control", "of", "acute", "and", "delayed", "CINV", "compared", "with", "physician", "'s", "choice", "of", "therapy", ".", "clinicaltrials.gov", "Identifier", ":", "NCT", "01913990", "." ]
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11
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18
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19
[ "Intake", "of", "vitamin", "D", "and", "calcium", ",", "sun", "exposure", ",", "and", "risk", "of", "breast", "cancer", "subtypes", "among", "black", "women", ".", "The", "randomized", "placebo", "-", "controlled", "Vitamin", "D", "and", "Omega-", "3", "Trial", "suggested", "a", "possible", "benefit", "of", "vitamin", "D", "on", "cancer", "incidence", "among", "black", "individuals", ".", "However", ",", "data", "are", "limited", "regarding", "the", "impact", "of", "vitamin", "D", "on", "breast", "cancer", "subtypes", "among", "African", "-", "American", "/", "black", "women", ",", "who", "tend", "to", "develop", "more", "aggressive", "forms", "of", "breast", "cancer", ".", "We", "hypothesize", "that", "more", "vitamin", "D", "exposure", "(", "through", "diet", ",", "supplements", ",", "and", "sunlight", ")", "and", "higher", "intake", "of", "calcium", "are", "associated", "with", "decreased", "risk", "of", "estrogen", "receptor", "(", "ER", ")", "+", "and", "ER-", "breast", "cancer", ",", "and", "of", "triple", "-", "negative", "breast", "cancer", "(", "TNBC", ")", "among", "black", "women", ".", "This", "study", "was", "conducted", "among", "1724", "black", "cases", "and", "1233", "controls", "in", "the", "Women", "'s", "Circle", "of", "Health", "Study", "(", "WCHS", ")", "and", "WCHS", "2", ".", "Polytomous", "logistic", "regressions", "were", "used", "to", "estimate", "ORs", "and", "95", "%", "CIs", "of", "ER+", "and", "ER-", "breast", "cancer", ";", "logistic", "regressions", "were", "used", "for", "TNBC", ".", "The", "ORs", "from", "each", "study", "were", "pooled", "using", "an", "inverse", "-", "variance", "-", "weighted", "random", "-", "effects", "model", ".", "Dietary", "vitamin", "D", "and", "calcium", "intake", "were", "not", "associated", "with", "risk", "of", "breast", "cancer", "subtypes", "in", "the", "pooled", "analysis", ".", "For", "supplemental", "vitamin", "D", ",", "we", "observed", "possible", "inverse", "associations", "between", "intake", "of", "≤", "800", "IU", "/", "d", "(", "compared", "with", "nonuse", ")", "and", "risk", "of", "several", "subtypes", ",", "with", "effects", "that", "appeared", "strongest", "for", "TNBC", "(", "OR", ":", "0.58", ";", "95", "%", "CI", ":", "0.35", ",", "0.94", ")", ";", "no", "association", "was", "found", "for", ">", "800", "IU", "/", "d.", "More", "daylight", "hours", "spent", "outdoors", "in", "a", "year", "was", "associated", "with", "lower", "risk", "of", "ER+", ",", "ER-", ",", "and", "TNBC", "(", "e.g.", ",", "highest", "compared", "with", "lowest", "quartile", ":", "TNBC", "OR", ":", "0.53", ";", "95", "%", "CI", ":", "0.31", ",", "0.91", ";", "P", "-", "trend", "=", "0.02", ")", ".", "Moderate", "supplemental", "vitamin", "D", "intake", "was", "associated", "with", "decreased", "risk", "of", "TNBC", ",", "and", "increased", "sun", "exposure", "was", "associated", "with", "reduced", "risk", "of", "ER+", ",", "ER-", ",", "and", "TNBC", "among", "black", "women", "." ]
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[ "Effectiveness", "of", "Tailored", "Rehabilitation", "Education", "in", "Improving", "the", "Health", "Literacy", "and", "Health", "Status", "of", "Postoperative", "Patients", "With", "Breast", "Cancer", ":", "A", "Randomized", "Controlled", "Trial", ".", "The", "improvement", "of", "breast", "cancer", "treatment", "and", "the", "extension", "of", "survivorship", "have", "led", "to", "the", "development", "of", "postoperative", "complications", "among", "cancer", "survivors", ".", "Health", "literacy", "(", "HL", ")", ",", "defined", "as", "patients", "'", "capability", "of", "using", "health", "information", "to", "maintain", "their", "health", "status", ",", "can", "enable", "breast", "cancer", "patients", "to", "manage", "postoperative", "complications", ".", "The", "aims", "of", "this", "study", "were", "to", "develop", "a", "tailored", "rehabilitation", "education", "(", "TRE", ")", "program", "and", "examine", "the", "effectiveness", "of", "this", "program", "in", "improving", "the", "HL", "and", "health", "status", "with", "breast", "cancer", ".", "This", "randomized", "controlled", "trial", "recruited", "99", "breast", "cancer", "patients", "(", "49", "and", "50", "in", "the", "intervention", "and", "control", "groups", ",", "respectively", ")", "within", "1", "week", "after", "surgery", ".", "Four", "-", "week", "individualized", "TRE", "programs", "were", "implemented", "to", "improve", "their", "HL", "and", "health", "status", ".", "Our", "results", "showed", "that", "the", "TRE", "program", "produced", "significant", "improvements", "in", "HL", "and", "health", "status", "in", "the", "components", "of", "the", "International", "Classification", "of", "Functioning", ",", "Disability", "and", "Health", ".", "However", ",", "no", "significant", "difference", "was", "observed", "in", "the", "activity", "scores", "obtained", "using", "the", "Barthel", "Index", "between", "the", "2", "groups", ".", "Our", "finding", "supports", "the", "effectiveness", "of", "1", "-month", "TRE", "in", "improving", "HL", "and", "all", "components", "of", "the", "International", "Classification", "of", "Functioning", ",", "Disability", "and", "Health", "status", ",", "except", "the", "activity", "component", "among", "breast", "cancer", "in", "Taiwan", ".", "Clinicians", "could", "incorporate", "the", "TRE", "techniques", "in", "the", "rehabilitation", "sessions", "according", "to", "the", "healthcare", ",", "disease", "prevention", ",", "and", "health", "promotion", "domains", "to", "improve", "the", "clinical", "outcomes", "as", "well", "as", "change", "their", "health", "behaviors", "and", "attitudes", "of", "patients", "with", "breast", "cancer", "." ]
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22
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23
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27
[ "Phase", "III", "trial", "comparing", "doxorubicin", "plus", "cyclophosphamide", "with", "docetaxel", "plus", "cyclophosphamide", "as", "adjuvant", "therapy", "for", "operable", "breast", "cancer", ".", "The", "combination", "of", "doxorubicin", "and", "cyclophosphamide", "(", "AC", ")", "is", "a", "standard", "adjuvant", "chemotherapy", "regimen", ".", "Studies", "of", "docetaxel", "and", "cyclophosphamide", "(", "TC", ")", "in", "metastatic", "breast", "cancer", "(", "MBC", ")", "showed", "promise", "in", "MBC", ".", "In", "1997", ",", "we", "initiated", "a", "randomized", "adjuvant", "trial", "of", "TC", "compared", "with", "standard", "-", "dose", "AC", "with", "a", "primary", "end", "point", "of", "disease", "-", "free", "survival", "(", "DFS", ")", ".", "Patients", "were", "eligible", "if", "they", "had", "stage", "I", "to", "III", "operable", "invasive", "breast", "cancer", "with", "complete", "surgical", "excision", "of", "the", "primary", "tumor", ".", "Between", "June", "1997", "and", "December", "1999", ",", "1", ",", "016", "patients", "were", "randomly", "assigned", "to", "four", "cycles", "of", "either", "standard", "-", "dose", "AC", "(", "60", "and", "600", "mg", "/", "m", "2", ",", "respectively", ";", "n", "=", "510", ")", "or", "TC", "(", "75", "and", "600", "mg", "/", "m", "2", ",", "respectively", ";", "n", "=", "506", ")", ",", "administered", "intravenously", "every", "3", "weeks", "as", "adjuvant", "chemotherapy", ".", "Radiation", "therapy", "(", "as", "indicated", ")", "and", "tamoxifen", ",", "for", "patients", "with", "hormone", "receptor", "-", "positive", "disease", ",", "were", "administered", "after", "completion", "of", "chemotherapy", ".", "Both", "treatment", "groups", "(", "TC", "and", "AC", ")", "were", "well", "balanced", "with", "respect", "to", "major", "prognostic", "factors", ".", "Patients", "were", "observed", "through", "2005", "for", "a", "median", "of", "5.5", "years", ".", "At", "5", "years", ",", "DFS", "rate", "was", "significantly", "superior", "for", "TC", "compared", "with", "AC", "(", "86", "%", "v", "80", "%", ",", "respectively", ";", "hazard", "ratio", "[", "HR", "]", "=", "0.67", ";", "95", "%", "CI", ",", "0.50", "to", "0.94", ";", "P", "=", ".", "015", ")", ".", "Overall", "survival", "rates", "for", "TC", "and", "AC", "were", "90", "%", "and", "87", "%", ",", "respectively", "(", "HR", "=", "0.76", ";", "95", "%", "CI", ",", "0.52", "to", "1.1", ";", "P", "=", ".", "13", ")", ".", "More", "myalgia", ",", "arthralgia", ",", "edema", ",", "and", "febrile", "neutropenia", "occurred", "on", "the", "TC", "arm", ";", "more", "nausea", "and", "vomiting", "occurred", "on", "the", "AC", "arm", "as", "well", "as", "one", "incident", "of", "congestive", "heart", "failure", ".", "At", "5", "years", ",", "TC", "was", "associated", "with", "a", "superior", "DFS", "and", "a", "different", "toxicity", "profile", "compared", "with", "AC", "." ]
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28
[ "Randomized", ",", "controlled", "trial", "of", "yoga", "in", "women", "with", "breast", "cancer", "undergoing", "radiotherapy", ".", "Previous", "research", "incorporating", "yoga", "(", "YG", ")", "into", "radiotherapy", "(", "XRT", ")", "for", "women", "with", "breast", "cancer", "finds", "improved", "quality", "of", "life", "(", "QOL", ")", ".", "However", ",", "shortcomings", "in", "this", "research", "limit", "the", "findings", ".", "Patients", "with", "stages", "0", "to", "III", "breast", "cancer", "were", "recruited", "before", "starting", "XRT", "and", "were", "randomly", "assigned", "to", "YG", "(", "n", "=", "53", ")", "or", "stretching", "(", "ST", ";", "n", "=", "56", ")", "three", "times", "a", "week", "for", "6", "weeks", "during", "XRT", "or", "waitlist", "(", "WL", ";", "n", "=", "54", ")", "control", ".", "Self", "-", "report", "measures", "of", "QOL", "(", "Medical", "Outcomes", "Study", "36", "-item", "short", "-", "form", "survey", ";", "primary", "outcomes", ")", ",", "fatigue", ",", "depression", ",", "and", "sleep", "quality", ",", "and", "five", "saliva", "samples", "per", "day", "for", "3", "consecutive", "days", "were", "collected", "at", "baseline", ",", "end", "of", "treatment", ",", "and", "1", ",", "3", ",", "and", "6", "months", "later", ".", "The", "YG", "group", "had", "significantly", "greater", "increases", "in", "physical", "component", "scale", "scores", "compared", "with", "the", "WL", "group", "at", "1", "and", "3", "months", "after", "XRT", "(", "P", "=", ".", "01", "and", "P", "=", ".", "01", ")", ".", "At", "1", ",", "3", ",", "and", "6", "months", ",", "the", "YG", "group", "had", "greater", "increases", "in", "physical", "functioning", "compared", "with", "both", "ST", "and", "WL", "groups", "(", "P", "<", ".", "05", ")", ",", "with", "ST", "and", "WL", "differences", "at", "only", "3", "months", "(", "P", "<", ".", "02", ")", ".", "The", "group", "differences", "were", "similar", "for", "general", "health", "reports", ".", "By", "the", "end", "of", "XRT", ",", "the", "YG", "and", "ST", "groups", "also", "had", "a", "reduction", "in", "fatigue", "(", "P", "<", ".", "05", ")", ".", "There", "were", "no", "group", "differences", "for", "mental", "health", "and", "sleep", "quality", ".", "Cortisol", "slope", "was", "steepest", "for", "the", "YG", "group", "compared", "with", "the", "ST", "and", "WL", "groups", "at", "the", "end", "(", "P", "=", ".", "023", "and", "P", "=", ".", "008", ")", "and", "1", "month", "after", "XRT", "(", "P", "=", ".", "05", "and", "P", "=", ".", "04", ")", ".", "YG", "improved", "QOL", "and", "physiological", "changes", "associated", "with", "XRT", "beyond", "the", "benefits", "of", "simple", "ST", "exercises", ",", "and", "these", "benefits", "appear", "to", "have", "long", "-", "term", "durability", "." ]
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29
[ "Sensitivity", "and", "specificity", "of", "mammography", "and", "adjunctive", "ultrasonography", "to", "screen", "for", "breast", "cancer", "in", "the", "Japan", "Strategic", "Anti", "-", "cancer", "Randomized", "Trial", "(", "J", "-", "START", ")", ":", "a", "randomised", "controlled", "trial", ".", "Mammography", "is", "the", "only", "proven", "method", "for", "breast", "cancer", "screening", "that", "reduces", "mortality", ",", "although", "it", "is", "inaccurate", "in", "young", "women", "or", "women", "with", "dense", "breasts", ".", "We", "investigated", "the", "efficacy", "of", "adjunctive", "ultrasonography", ".", "Between", "July", ",", "2007", ",", "and", "March", ",", "2011", ",", "we", "enrolled", "asymptomatic", "women", "aged", "40", "-", "49", "years", "at", "42", "study", "sites", "in", "23", "prefectures", "into", "the", "Japan", "Strategic", "Anti", "-", "cancer", "Randomized", "Trial", "(", "J", "-", "START", ")", ".", "Eligible", "women", "had", "no", "history", "of", "any", "cancer", "in", "the", "previous", "5", "years", "and", "were", "expected", "to", "live", "for", "more", "than", "5", "years", ".", "Randomisation", "was", "done", "centrally", "by", "the", "Japan", "Clinical", "Research", "Support", "Unit", ".", "Participants", "were", "randomly", "assigned", "in", "1", ":1", "ratio", "to", "undergo", "mammography", "and", "ultrasonography", "(", "intervention", "group", ")", "or", "mammography", "alone", "(", "control", "group", ")", "twice", "in", "2", "years", ".", "The", "primary", "outcome", "was", "sensitivity", ",", "specificity", ",", "cancer", "detection", "rate", ",", "and", "stage", "distribution", "at", "the", "first", "round", "of", "screening", ".", "Analysis", "was", "by", "intention", "to", "treat", ".", "This", "study", "is", "registered", ",", "number", "UMIN", "000000757", ".", "Of", "72", ",", "998", "women", "enrolled", ",", "36", ",", "859", "were", "assigned", "to", "the", "intervention", "group", "and", "36", ",", "139", "to", "the", "control", "group", ".", "Sensitivity", "was", "significantly", "higher", "in", "the", "intervention", "group", "than", "in", "the", "control", "group", "(", "91", "·", "1", "%", ",", "95", "%", "CI", "87", "·", "2", "-", "95", "·", "0", "vs", "77", "·", "0", "%", ",", "70", "·", "3", "-", "83", "·", "7", ";", "p=", "0", "·", "0004", ")", ",", "whereas", "specificity", "was", "significantly", "lower", "(", "87", "·", "7", "%", ",", "87", "·", "3", "-", "88", "·", "0", "vs", "91", "·", "4", "%", ",", "91", "·", "1", "-", "91", "·", "7", ";", "p", "<", "0", "·", "0001", ")", ".", "More", "cancers", "were", "detected", "in", "the", "intervention", "group", "than", "in", "the", "control", "group", "(", "184", "[", "0", "·", "50", "%", "]", "vs", "117", "[", "0", "·", "32", "%", "]", ",", "p=", "0", "·", "0003", ")", "and", "were", "more", "frequently", "stage", "0", "and", "I", "(", "144", "[", "71", "·", "3", "%", "]", "vs", "79", "[", "52", "·", "0", "%", "]", ",", "p=", "0", "·", "0194", ")", ".", "18", "(", "0", "·", "05", "%", ")", "interval", "cancers", "were", "detected", "in", "the", "intervention", "group", "compared", "with", "35", "(", "0", "·", "10", "%", ")", "in", "the", "control", "group", "(", "p=", "0", "·", "034", ")", ".", "Adjunctive", "ultrasonography", "increases", "sensitivity", "and", "detection", "rate", "of", "early", "cancers", ".", "Ministry", "of", "Health", ",", "Labour", "and", "Welfare", "of", "Japan", "." ]
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30
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31
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32
[ "Randomized", "placebo", "-", "controlled", "study", "of", "recombinant", "human", "interleukin-", "11", "to", "prevent", "chemotherapy", "-", "induced", "thrombocytopenia", "in", "patients", "with", "breast", "cancer", "receiving", "dose", "-", "intensive", "cyclophosphamide", "and", "doxorubicin", ".", "Thrombocytopenia", "may", "compromise", "cancer", "treatment", ",", "causing", "chemotherapy", "dose", "reductions", ",", "schedule", "alterations", ",", "or", "the", "need", "for", "platelet", "transfusions", ".", "We", "evaluated", "the", "efficacy", "and", "safety", "of", "recombinant", "human", "interleukin-", "11", "(", "rhIL-", "11", ";", "Neumega", ",", "Genetics", "Institute", ",", "Inc", ",", "Cambridge", ",", "MA", ")", ",", "a", "novel", "thrombopoietic", "growth", "factor", ",", "in", "reducing", "the", "need", "for", "platelet", "transfusions", "in", "patients", "who", "undergo", "dose", "-", "intensive", "chemotherapy", ".", "Women", "with", "advanced", "breast", "cancer", "received", "cyclophosphamide", "(", "3", ",", "200", "mg", "/", "m", "2", ")", "and", "doxorubicin", "(", "75", "mg", "/", "m", "2", ")", "plus", "granulocyte", "colony", "-", "stimulating", "factor", "(", "G", "-", "CSF", ";", "5", "microg", "/", "kg", "/", "d", ")", ".", "Patients", "were", "randomized", "to", "blinded", "treatment", "with", "placebo", "or", "50", "microg", "/", "kg", "/", "d", "rhIL-", "11", "subcutaneously", "for", "10", "or", "17", "days", "after", "the", "first", "two", "chemotherapy", "cycles", ".", "Seventy", "-", "seven", "patients", "were", "randomized", "and", "constitute", "the", "intent", "-", "to", "-", "treat", "(", "ITT", ")", "population", ".", "Sixty", "-", "seven", "patients", "(", "the", "assessable", "subgroup", ")", "either", "completed", "both", "cycles", "without", "a", "major", "protocol", "violation", "(", "n", "=", "62", ")", "or", "received", "a", "platelet", "transfusion", "before", "treatment", "was", "discontinued", "after", "the", "first", "cycle", ".", "In", "the", "ITT", "population", ",", "rhIL-", "11", "significantly", "decreased", "the", "requirement", "for", "platelet", "transfusions", ";", "27", "of", "40", "(", "68", "%", ")", "patients", "who", "received", "rhIL-", "11", "did", "not", "require", "transfusions", ",", "compared", "with", "15", "of", "37", "(", "41", "%", ")", "in", "the", "placebo", "group", "(", "P", "=", ".", "04", ")", ".", "Treatment", "with", "rhIL-", "11", "significantly", "reduced", "the", "total", "number", "of", "platelet", "transfusions", "required", "in", "the", "assessable", "subgroup", "(", "P", "=", ".", "03", ")", "and", "the", "time", "to", "platelet", "recovery", "to", "more", "than", "50", ",", "000", "/microL", "in", "the", "second", "cycle", "(", "P", "=", ".", "01", ")", ".", "Most", "adverse", "events", "associated", "with", "rhIL-", "11", "were", "reversible", ",", "mild", "to", "moderate", "in", "severity", ",", "and", "likely", "related", "to", "fluid", "retention", ".", "rhIL-", "11", "is", "safe", "and", "effective", "in", "reducing", "treatment", "-", "associated", "thrombocytopenia", "and", "the", "need", "for", "platelet", "transfusions", "in", "patients", "who", "undergo", "dose", "-", "intensive", "chemotherapy", ",", "and", "thus", "may", "permit", "chemotherapy", "to", "be", "administered", "as", "planned", "at", "intended", "doses", "and", "thereby", "maximize", "the", "potential", "for", "a", "successful", "outcome", "." ]
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33
[ "Effect", "of", "a", "Scalp", "Cooling", "Device", "on", "Alopecia", "in", "Women", "Undergoing", "Chemotherapy", "for", "Breast", "Cancer", ":", "The", "SCALP", "Randomized", "Clinical", "Trial", ".", "Chemotherapy", "may", "induce", "alopecia", ".", "Although", "scalp", "cooling", "devices", "have", "been", "used", "to", "prevent", "this", "alopecia", ",", "efficacy", "has", "not", "been", "assessed", "in", "a", "randomized", "clinical", "trial", ".", "To", "assess", "whether", "a", "scalp", "cooling", "device", "is", "effective", "at", "reducing", "chemotherapy", "-", "induced", "alopecia", "and", "to", "assess", "adverse", "treatment", "effects", ".", "Multicenter", "randomized", "clinical", "trial", "of", "women", "with", "breast", "cancer", "undergoing", "chemotherapy", ".", "Patients", "were", "enrolled", "from", "December", "9", ",", "2013", ",", "to", "September", "30", ",", "2016", ".", "One", "interim", "analysis", "was", "planned", "to", "allow", "the", "study", "to", "stop", "early", "for", "efficacy", ".", "Data", "reported", "are", "from", "the", "interim", "analysis", ".", "This", "study", "was", "conducted", "at", "7", "sites", "in", "the", "United", "States", ",", "and", "182", "women", "with", "breast", "cancer", "requiring", "chemotherapy", "were", "enrolled", "and", "randomized", ".", "Participants", "were", "randomized", "to", "scalp", "cooling", "(", "n", "=", "119", ")", "or", "control", "(", "n", "=", "63", ")", ".", "Scalp", "cooling", "was", "done", "using", "a", "scalp", "cooling", "device", ".", "The", "primary", "efficacy", "end", "points", "were", "successful", "hair", "preservation", "assessed", "using", "the", "Common", "Terminology", "Criteria", "for", "Adverse", "Events", "version", "4.0", "scale", "(", "grade", "0", "[", "no", "hair", "loss", "]", "or", "grade", "1", "[", "<", "50", "%", "hair", "loss", "not", "requiring", "a", "wig", "]", "were", "considered", "to", "have", "hair", "preservation", ")", "at", "the", "end", "of", "4", "cycles", "of", "chemotherapy", "by", "a", "clinician", "unaware", "of", "treatment", "assignment", ",", "and", "device", "safety", ".", "Secondary", "end", "points", "included", "wig", "use", "and", "scores", "on", "the", "European", "Organisation", "for", "Research", "and", "Treatment", "of", "Cancer", "Quality", "of", "Life", "Questionnaire", "-", "Core", "30", ",", "Hospital", "Anxiety", "and", "Depression", "Scale", ",", "and", "a", "summary", "scale", "of", "the", "Body", "Image", "Scale", ".", "At", "the", "time", "of", "the", "interim", "analysis", ",", "142", "participants", "were", "evaluable", ".", "The", "mean", "(", "SD", ")", "age", "of", "the", "patients", "was", "52.6", "(", "10.1", ")", "years", ";", "36", "%", "(", "n", "=", "51", ")", "received", "anthracycline", "-", "based", "chemotherapy", "and", "64", "%", "(", "n", "=", "91", ")", "received", "taxane", "-", "based", "chemotherapy", ".", "Successful", "hair", "preservation", "was", "found", "in", "48", "of", "95", "women", "with", "cooling", "(", "50.5", "%", ";", "95", "%", "CI", ",", "40.7", "%", "-", "60.4", "%", ")", "compared", "with", "0", "of", "47", "women", "in", "the", "control", "group", "(", "0", "%", ";", "95", "%", "CI", ",", "0", "%", "-", "7.6", "%", ")", "(", "success", "rate", "difference", ",", "50.5", "%", ";", "95", "%", "CI", ",", "40.5", "%", "-", "60.6", "%", ")", ".", "Because", "the", "1", "-tailed", "P", "value", "from", "the", "Fisher", "exact", "test", "was", "<", ".", "001", ",", "which", "crossed", "the", "superiority", "boundary", "(", "P", "=", ".", "0061", ")", ",", "the", "data", "and", "safety", "monitoring", "board", "recommended", "study", "termination", "on", "September", "26", ",", "2016", ".", "There", "were", "no", "statistically", "significant", "differences", "in", "changes", "in", "any", "of", "the", "scales", "of", "quality", "of", "life", "from", "baseline", "to", "chemotherapy", "cycle", "4", "among", "the", "scalp", "cooling", "and", "control", "groups", ".", "Only", "adverse", "events", "related", "to", "device", "use", "were", "collected", ";", "54", "adverse", "events", "were", "reported", "in", "the", "cooling", "group", ",", "all", "grades", "1", "and", "2", ".", "There", "were", "no", "serious", "adverse", "device", "events", ".", "Among", "women", "with", "stage", "I", "to", "II", "breast", "cancer", "receiving", "chemotherapy", "with", "a", "taxane", ",", "anthracycline", ",", "or", "both", ",", "those", "who", "underwent", "scalp", "cooling", "were", "significantly", "more", "likely", "to", "have", "less", "than", "50", "%", "hair", "loss", "after", "the", "fourth", "chemotherapy", "cycle", "compared", "with", "those", "who", "received", "no", "scalp", "cooling", ".", "Further", "research", "is", "needed", "to", "assess", "longer", "-", "term", "efficacy", "and", "adverse", "effects", ".", "clinicaltrials.gov", "Identifier", ":", "NCT", "01986140", "." ]
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34
[ "Acute", "and", "Short", "-", "term", "Toxic", "Effects", "of", "Conventionally", "Fractionated", "vs", "Hypofractionated", "Whole", "-", "Breast", "Irradiation", ":", "A", "Randomized", "Clinical", "Trial", ".", "The", "most", "appropriate", "dose", "fractionation", "for", "whole", "-", "breast", "irradiation", "(", "WBI", ")", "remains", "uncertain", ".", "To", "assess", "acute", "and", "6", "-month", "toxic", "effects", "and", "quality", "of", "life", "(", "QOL", ")", "with", "conventionally", "fractionated", "WBI", "(", "CF", "-", "WBI", ")", "vs", "hypofractionated", "WBI", "(", "HF", "-", "WBI", ")", ".", "Unblinded", "randomized", "trial", "of", "CF", "-", "WBI", "(", "n", "=", "149", ";", "50.00", "Gy", "/", "25", "fractions", "+", "boost", "[", "10.00", "-", "14.00", "Gy", "/", "5", "-", "7", "fractions", "]", ")", "vs", "HF", "-", "WBI", "(", "n", "=", "138", ";", "42.56", "Gy", "/", "16", "fractions", "+", "boost", "[", "10.00", "-", "12.50", "Gy", "/", "4", "-", "5", "fractions", "]", ")", "following", "breast", "-", "conserving", "surgery", "administered", "in", "community", "-", "based", "and", "academic", "cancer", "centers", "to", "287", "women", "40", "years", "or", "older", "with", "stage", "0", "to", "II", "breast", "cancer", "for", "whom", "WBI", "without", "addition", "of", "a", "third", "field", "was", "recommended", ";", "76", "%", "of", "study", "participants", "(", "n", "=", "217", ")", "were", "overweight", "or", "obese", ".", "Patients", "were", "enrolled", "from", "February", "2011", "through", "February", "2014", "and", "observed", "for", "a", "minimum", "of", "6", "months", ".", "Administration", "of", "CF", "-", "WBI", "or", "HF", "-", "WBI", ".", "Physician", "-", "reported", "acute", "and", "6", "-month", "toxic", "effects", "using", "National", "Cancer", "Institute", "Common", "Toxicity", "Criteria", ",", "and", "patient", "-", "reported", "QOL", "using", "the", "Functional", "Assessment", "of", "Cancer", "Therapy", "for", 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"CF", "-", "WBI", ",", "14", "%", ";", "P", "=", ".", "54", ")", ".", "Maximum", "physician", "-", "reported", "acute", "dermatitis", "(", "36", "%", "vs", "69", "%", ";", "P", "<", ".", "001", ")", ",", "pruritus", "(", "54", "%", "vs", "81", "%", ";", "P", "<", ".", "001", ")", ",", "breast", "pain", "(", "55", "%", "vs", "74", "%", ";", "P", "=", ".", "001", ")", ",", "hyperpigmentation", "(", "9", "%", "vs", "20", "%", ";", "P", "=", ".", "002", ")", ",", "and", "fatigue", "(", "9", "%", "vs", "17", "%", ";", "P", "=", ".", "02", ")", "during", "irradiation", "were", "lower", "in", "patients", "randomized", "to", "HF", "-", "WBI", ".", "The", "rate", "of", "overall", "grade", "2", "or", "higher", "acute", "toxic", "effects", "was", "less", "with", "HF", "-", "WBI", "than", "with", "CF", "-", "WBI", "(", "47", "%", "vs", "78", "%", ";", "P", "<", ".", "001", ")", ".", "Six", "months", "after", "irradiation", ",", "physicians", "reported", "less", "fatigue", "in", "patients", "randomized", "to", "HF", "-", "WBI", "(", "0", "%", "vs", "6", "%", ";", "P", "=", ".", "01", ")", ",", "and", "patients", "randomized", "to", "HF", "-", "WBI", "reported", "less", "lack", "of", "energy", "(", "23", "%", "vs", "39", "%", ";", "P", "<", ".", "001", ")", "and", "less", "trouble", "meeting", "family", "needs", "(", "3", "%", "vs", "9", "%", ";", "P", "=", ".", "01", ")", ".", "Multivariable", "regression", "confirmed", "the", "superiority", "of", "HF", "-", "WBI", "in", "terms", "of", "patient", "-", "reported", "lack", "of", "energy", "(", "odds", "ratio", "[", "OR", "]", ",", "0.39", ";", "95", "%", "CI", ",", "0.24", "-", "0.63", ")", "and", "trouble", "meeting", "family", "needs", "(", "OR", ",", "0.34", ";", "95", "%", "CI", ",", "0.16", "-", "0.75", ")", ".", "Treatment", "with", "HF", "-", "WBI", "appears", "to", "yield", "lower", "rates", "of", "acute", "toxic", "effects", "than", "CF", "-", "WBI", "as", "well", "as", "less", "fatigue", "and", "less", "trouble", "meeting", "family", "needs", "6", "months", "after", "completing", "radiation", "therapy", ".", "These", "findings", "should", "be", "communicated", "to", "patients", "as", "part", "of", "shared", "decision", "making", ".", "clinicaltrials.gov", "Identifier", ":", "NCT", "01266642", "." ]
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35
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37
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38
[ "Long", "-", "term", "survival", "analysis", "of", "addition", "of", "carboplatin", "to", "neoadjuvant", "chemotherapy", "in", "HER", "2", "-", "negative", "breast", "cancer", ".", "Addition", "of", "carboplatin", "(", "CBDCA", ")", "to", "neoadjuvant", "chemotherapy", "(", "NAC", ")", "in", "triple", "-", "negative", "breast", "cancer", "(", "TNBC", ")", "has", "improved", "pathological", "complete", "response", "(", "pCR", ")", "rates", "in", "previous", "studies", ".", "We", "present", "long", "-", "term", "survival", "outcomes", "(", "disease", "-", "free", "survival", "[", "DFS", "]", ",", "pre", "-", "planned", "secondary", "endpoint", ";", "overall", "survival", "[", "OS", "]", ",", "post", "hoc", "exploratory", "endpoint", ")", "of", "our", "randomized", "study", "of", "the", "addition", "of", "CBDCA", "to", "NAC", "for", "HER", "2", "-", "negative", "breast", "cancer", ".", "Patients", "with", "stage", "II", "/", "III", ",", "HER", "2", "-", "negative", "breast", "cancer", "(", "N", "=", "179", ")", "were", "randomly", "assigned", "to", "receive", "CP", "-", "CEF", "(", "four", "3", "-week", "cycles", "of", "CBDCA", "[", "area", "under", "the", "curve", ",", "5", "mg", "/", "mL", "/", "min", ",", "day", "1", "]", "and", "weekly", "paclitaxel", "[", "wPTX", ",", "80", "mg", "/", "m", "2", ",", "day", "1", ",", "8", ",", "15", "]", "followed", "by", "four", "3", "-week", "cycles", "of", "cyclophosphamide", ",", "epirubicin", ",", "and", "5", "-fluorouracil", "[", "CEF", ",", "500", "/", "100", "/", "500", "mg", "/", "m", "2", "]", ")", "or", "P", "-", "CEF", "(", "four", "cycles", "of", "wPTX", "followed", "by", "four", "cycles", "of", "CEF", ")", "as", "NAC", ".", "DFS", "and", "OS", "were", "analyzed", "at", "each", "population", "of", "pCR", "status", "and", "assigned", "treatment", "arm", ".", "Of", "179", "patients", ",", "154", "were", "available", "for", "long", "-", "term", "follow", "-", "up", ".", "At", "a", "median", "follow", "-", "up", "of", "6.6", "years", "(", "range", ",", "0.7", "-", "8.0", "years", ")", ",", "patients", "who", "achieved", "pCR", "[", "n", "=", "42", ",", "23.5", "%", "(", "CP", "-", "CEF", ":", "n", "=", "28", ",", "P", "-", "CEF", ":", "n", "=", "16", ")", "]", "had", "longer", "DFS", "and", "OS", "than", "non", "-", "pCR", "patients", "[", "DFS", ";", "HR", "0.15", "(", "0.04", "-", "0.61", ")", ",", "P", "=", "0.008", ",", "OS", ";", "log", "-", "rank", "P", "=", "0.003", "]", ".", "Addition", "of", "carboplatin", "to", "NAC", "significantly", "improved", "DFS", "and", "OS", "in", "the", "subset", "of", "patients", "with", "TNBC", "[", "DFS", ":", "HR", ",", "0.22", "(", "0.06", "-", "0.82", ")", ",", "P", "=", "0.015", ";", "OS", ":", "HR", ",", "0.12", "(", "0.01", "-", "0.96", ")", ",", "P", "=", "0.046", "]", ",", "but", "not", "in", "the", "subset", "of", "patients", "with", "hormone", "receptor", "-", "positive", "disease", "or", "among", "all", "patients", ".", "Addition", "of", "carboplatin", "to", "neoadjuvant", "chemotherapy", "significantly", "improved", "DFS", "and", "OS", "in", "patients", "with", "TNBC", "but", "not", "in", "those", "with", "hormone", "receptor", "-", "positive", ",", "HER", "2", "-", "negative", "breast", "cancer", "." ]
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39
[ "The", "effect", "of", "body", "mass", "index", "on", "overall", "and", "disease", "-", "free", "survival", "in", "node", "-", "positive", "breast", "cancer", "patients", "treated", "with", "docetaxel", "and", "doxorubicin", "-", "containing", "adjuvant", "chemotherapy", ":", "the", "experience", "of", "the", "BIG", "02", "-", "98", "trial", ".", "Obesity", "has", "been", "shown", "to", "be", "an", "indicator", "of", "poor", "prognosis", "for", "patients", "with", "primary", "breast", "cancer", "(", "BC", ")", "regardless", "of", "the", "use", "of", "adjuvant", "systemic", "therapy", ".", "This", "is", "a", "retrospective", "analysis", "of", "2", ",", "887", "node", "-", "positive", "BC", "patients", "enrolled", "in", "the", "BIG", "02", "-", "98", "adjuvant", "study", ",", "a", "randomised", "phase", "III", "trial", "whose", "primary", "objective", "was", "to", "evaluate", "disease", "-", "free", "survival", "(", "DFS", ")", "by", "adding", "docetaxel", "to", "doxorubicin", "-", "based", "chemotherapy", ".", "In", "the", "current", "analysis", ",", "the", "effect", "of", "body", "mass", "index", "(", "BMI", ")", "on", "DFS", "and", "overall", "survival", "(", "OS", ")", "was", "assessed", ".", "BMI", "was", "obtained", "before", "the", "first", "cycle", "of", "chemotherapy", ".", "Obesity", "was", "defined", "as", "a", "BMI", ">", "or=", "30", "kg", "/", "m", "2", ".", "In", "total", ",", "547", "(", "19", "%", ")", "patients", "were", "obese", "at", "baseline", ",", "while", "2", ",", "340", "(", "81", "%", ")", "patients", "were", "non", "-", "obese", ".", "Estimated", "5", "-year", "OS", "was", "87.5", "%", "for", "non", "-", "obese", "and", "82.9", "%", "for", "obese", "patients", "(", "HR", "1.34", ";", "P", "=", "0.013", ")", ".", "Estimated", "5", "-years", "DFS", "was", "75.9", "%", "for", "nonobese", "and", "70.0", "%", "for", "obese", "patients", "(", "HR", "1.20", ";", "P", "=", "0.041", ")", ".", "Ina", "multivariate", "model", ",", "obesity", "remained", "an", "independent", "prognostic", "factor", "for", "OS", "and", "DFS", ".", "In", "this", "study", ",", "obesity", "was", "associated", "with", "poorer", "outcome", "in", "node", "-", "positive", "BC", "patients", ".", "Given", "the", "increasing", "prevalence", "of", "obesity", "worldwide", ",", "more", "research", "on", "improving", "the", "treatment", "of", "obese", "BC", "patients", "is", "needed", "." ]
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40
[ "Role", "of", "axillary", "clearance", "after", "a", "tumor", "-", "positive", "sentinel", "node", "in", "the", "administration", "of", "adjuvant", "therapy", "in", "early", "breast", "cancer", ".", "PURPOSE", "The", "After", "Mapping", "of", "the", "Axilla", ":", "Radiotherapy", "or", "Surgery", "?", "(", "AMAROS", ")", "phase", "III", "study", "compares", "axillary", "lymph", "node", "dissection", "(", "ALND", ")", "and", "axillary", "radiation", "therapy", "(", "ART", ")", "in", "early", "breast", "cancer", "patients", "with", "tumor", "-", "positive", "sentinel", "nodes", ".", "In", "the", "ART", "arm", ",", "the", "extent", "of", "nodal", "involvement", "remains", "unknown", ",", "which", "could", "have", "implications", "on", "the", "administration", "of", "adjuvant", "therapy", ".", "In", "this", "preliminary", "analysis", ",", "we", "studied", "the", "influence", "of", "random", "assignment", "to", "ALND", "or", "ART", "on", "the", "choice", "for", "adjuvant", "treatment", ".", "PATIENTS", "AND", "METHODS", "In", "the", "first", "2", ",", "000", "patients", "enrolled", "in", "the", "AMAROS", "trial", ",", "we", "analyzed", "the", "administration", "of", "adjuvant", "systemic", "therapy", ".", "Multivariate", "analysis", "was", "used", "to", "assess", "variables", "affecting", "the", "administration", "of", "adjuvant", "chemotherapy", ".", "Adjuvant", "therapy", "was", "applied", "according", "to", "institutional", "guidelines", ".", "Results", "Of", "2", ",", "000", "patients", ",", "566", "patients", "had", "a", "positive", "sentinel", "node", "and", "were", "treated", "per", "random", "assignment", ".", "There", "was", "no", "significant", "difference", "in", "the", "administration", "of", "adjuvant", "systemic", "therapy", ".", "In", "the", "ALND", "and", "ART", "arms", ",", "58", "%", "(", "175", "of", "300", ")", "and", "61", "%", "(", "162", "of", "266", ")", "of", "the", "patients", ",", "respectively", ",", "received", "chemotherapy", ".", "Endocrine", "therapy", "was", "administered", "in", "78", "%", "(", "235", "of", "300", ")", "of", "the", "patients", "in", "the", "ALND", "arm", "and", "in", "76", "%", "(", "203", "of", "266", ")", "of", "the", "patients", "in", "the", "ART", "arm", ".", "Treatment", "arm", "was", "not", "a", "significant", "factor", "in", "the", "decision", ",", "and", "no", "interactions", "between", "treatment", "arm", "and", "other", "factors", "were", "observed", ".", "Multivariate", "analysis", "showed", "that", "age", ",", "tumor", "grade", ",", "multifocality", ",", "and", "size", "of", "the", "sentinel", "node", "metastasis", "significantly", "affected", "the", "administration", "of", "chemotherapy", ".", "Within", "the", "ALND", "arm", ",", "the", "extent", "of", "nodal", "involvement", "remained", "not", "significant", "in", "a", "sensitivity", "multivariate", "analysis", ".", "CONCLUSION", "Absence", "of", "knowledge", "regarding", "the", "extent", "of", "nodal", "involvement", "in", "the", "ART", "arm", "appears", "to", "have", "no", "major", "impact", "on", "the", "administration", "of", "adjuvant", "therapy", "." ]
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41
[ "[", "Survival", "of", "breast", "cancer", "patients", "treated", "with", "inhibitors", "of", "the", "aromatase", "vs", "tamoxifen", "]", ".", "In", "Mexico", "the", "breast", "cancer", "occupies", "the", "second", "place", "as", "cause", "of", "death", "by", "oncological", "illness", "and", "the", "etiology", "is", "considered", "multifactorial", ".", "The", "systemic", "treatment", "of", "this", "cancer", "is", "necessarily", "after", "the", "surgery", "and", "simultaneously", "when", "radiotherapy", "is", "used", ";", "therefore", "the", "recent", "introduction", "of", "newly", "non", "toxics", "and", "efficient", "antiestrogens", "which", "block", "the", "effect", "of", "estrogens", "from", "circulation", "have", "become", "drugs", "of", "first", "line", "in", "the", "metastasis", "illness", ".", "To", "compare", "the", "clinical", "evolution", "and", "the", "survival", "of", "patients", "with", "locally", "advanced", "breast", "cancer", "and", "metastasis", "with", "the", "use", "of", "two", "therapeutic", "modalities", ".", "Under", "informed", "consent", "20", "patients", "with", "diagnosis", "of", "breast", "cancer", "and", "out", "of", "oncological", "therapeutic", "processing", "were", "included", ".", "Randomly", "an", "inhibitor", "of", "the", "aromatase", "(", "anastrozole", ",", "1", "mg", "for", "day", ")", "was", "used", "in", "10", "patients", "and", "in", "the", "other", "10", "patients", "tamoxifen", "(", "20", "mg", "for", "day", ")", "both", "for", "2", "years", ",", "subject", "to", "verification", "of", "positive", "estrogens", "-", "progesterone", "receptors", ".", "Half", "of", "the", "patients", "of", "each", "group", "had", "a", "clinical", "stage", "III", ".", "The", "most", "frequent", "histological", "diagnosis", "was", "the", "ductal", "carcinoma", "in", "70", "%", "of", "the", "group", "with", "tamoxifen", "use", ",", "while", "in", "anastrozole", "group", "was", "90", "%", ";", "the", "mastectomy", "prior", "to", "the", "tamoxifen", "was", "carried", "out", "in", "60", "%", "of", "the", "patients", "and", "in", "50", "%", "of", "the", "group", "with", "anastrozole", ".", "The", "acceptable", "response", "to", "the", "processing", "in", "the", "patients", "with", "tamoxifen", "was", "complete", "in", "the", "60", "%", "of", "the", "cases", ",", "but", "with", "the", "use", "of", "anastrozole", "was", "80", "%", ";", "survival", "in", "the", "group", "with", "anastrozole", "was", "of", "100", "%", "in", "two", "years", "of", "follow", "up", ",", "while", "in", "women", "that", "received", "tamoxifen", "the", "survival", "was", "90", "%", "(", "p", "<", "0.001", ")", ".", "The", "use", "of", "anastrozole", "improved", "the", "survival", "as", "well", "as", "the", "quality", "of", "life", ",", "showing", "no", "side", "effects", "in", "this", "group", "of", "patients", "." ]
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42
[ "Effects", "of", "adjuvant", "exemestane", "versus", "anastrozole", "on", "bone", "mineral", "density", "for", "women", "with", "early", "breast", "cancer", "(", "MA.", "27", "B", ")", ":", "a", "companion", "analysis", "of", "a", "randomised", "controlled", "trial", ".", "Treatment", "of", "breast", "cancer", "with", "aromatase", "inhibitors", "is", "associated", "with", "damage", "to", "bones", ".", "NCIC", "CTG", "MA", ".", "27", "was", "an", "open", "-", "label", ",", "phase", "3", ",", "randomised", "controlled", "trial", "in", "which", "women", "with", "breast", "cancer", "were", "assigned", "to", "one", "of", "two", "adjuvant", "oral", "aromatase", "inhibitors", "-", "exemestane", "or", "anastrozole", ".", "We", "postulated", "that", "exemestane", "-", "a", "mildly", "androgenic", "steroid", "-", "might", "have", "a", "less", "detrimental", "effect", "on", "bone", "than", "non", "-", "steroidal", "anastrozole", ".", "In", "this", "companion", "study", "to", "MA", ".", "27", ",", "we", "compared", "changes", "in", "bone", "mineral", "density", "(", "BMD", ")", "in", "the", "lumbar", "spine", "and", "total", "hip", "between", "patients", "treated", "with", "exemestane", "and", "patients", "treated", "with", "anastrozole", ".", "In", "MA", ".", "27", ",", "postmenopausal", "women", "with", "early", "stage", "hormone", "(", "oestrogen", ")", "receptor", "-", "positive", "invasive", "breast", "cancer", "were", "randomly", "assigned", "to", "exemestane", "25", "mg", "versus", "anastrozole", "1", "mg", ",", "daily", ".", "MA.", "27", "B", "recruited", "two", "groups", "of", "women", "from", "MA", ".", "27", ":", "those", "with", "BMD", "T", "-", "scores", "of", "-", "2", "·", "0", "or", "more", "(", "up", "to", "2", "SDs", "below", "sex", "-", "matched", ",", "young", "adult", "mean", ")", "and", "those", "with", "at", "least", "one", "T", "-", "score", "(", "hip", "or", "spine", ")", "less", "than", "-", "2", "·", "0", ".", "Both", "groups", "received", "vitamin", "D", "and", "calcium", ";", "those", "with", "baseline", "T", "-", "scores", "of", "less", "than", "-", "2", "·", "0", "also", "received", "bisphosphonates", ".", "The", "primary", "endpoints", "were", "percent", "change", "of", "BMD", "at", "2", "years", "in", "lumbar", "spine", "and", "total", "hip", "for", "both", "groups", ".", "We", "analysed", "patients", "according", "to", "which", "aromatase", "inhibitor", "and", "T", "-", "score", "groups", "they", "were", "allocated", "to", "but", "BMD", "assessments", "ceased", "if", "patients", "deviated", "from", "protocol", ".", "This", "study", "is", "registered", "with", "ClinicalTrials.gov", ",", "NCT", "00354302", ".", "Between", "April", "24", ",", "2006", ",", "and", "May", "30", ",", "2008", ",", "300", "patients", "with", "baseline", "T", "-", "scores", "of", "-", "2", "·", "0", "or", "more", "were", "accrued", "(", "147", "allocated", "exemestane", ",", "153", "anastrozole", ")", ";", "and", "197", "patients", "with", "baseline", "T", "-", "scores", "of", "less", "than", "-", "2", "·", "0", "(", "101", "exemestane", ",", "96", "anastrozole", ")", ".", "For", "patients", "with", "T", "-", "scores", "greater", "than", "-", "2", "·", "0", "at", "baseline", ",", "mean", "change", "of", "bone", "mineral", "density", "in", "the", "spine", "at", "2", "years", "did", "not", "differ", "significantly", "between", "patients", "taking", "exemestane", "and", "patients", "taking", "anastrozole", "(", "-", "0", "·", "92", "%", ",", "95", "%", "CI", "-", "2", "·", "35", "to", "0", "·", "50", "vs", "-", "2", "·", "39", "%", ",", "95", "%", "CI", "-", "3", "·", "77", "to", "-", "1", "·", "01", ";", "p=", "0", "·", "08", ")", ".", "Respective", "mean", "loss", "in", "the", "hip", "was", "-", "1", "·", "93", "%", "(", "95", "%", "CI", "-", "2", "·", "93", "to", "-", "0", "·", "93", ")", "versus", "-", "2", "·", "71", "%", "(", "95", "%", "CI", "-", "4", "·", "32", "to", "-", "1", "·", "11", ";", "p=", "0", "·", "10", ")", ".", "Likewise", "for", "those", "who", "started", "with", "T", "-", "scores", "of", "less", "than", "-", "2", "·", "0", ",", "mean", "change", "of", "spine", "bone", "mineral", "density", "at", "2", "years", "did", "not", "differ", "significantly", "between", "the", "exemestane", "and", "anastrozole", "treatment", "groups", "(", "2", "·", "11", "%", ",", "95", "%", "CI", "-", "0", "·", "84", "to", "5", "·", "06", "vs", "3", "·", "72", "%", ",", "95", "%", "CI", "1", "·", "54", "to", "5", "·", "89", ";", "p=", "0", "·", "26", ")", ",", "nor", "did", "hip", "bone", "mineral", "density", "(", "2", "·", "09", "%", ",", "95", "%", "CI", "-", "1", "·", "45", "to", "5", "·", "63", "vs", "0", "·", "0", "%", ",", "95", "%", "CI", "-", "3", "·", "67", "to", "3", "·", "66", ";", "p=", "0", "·", "28", ")", ".", "Patients", "with", "baseline", "T", "-", "score", "of", "-", "2", "·", "0", "or", "more", "taking", "exemestane", "had", "two", "fragility", "fractures", "and", "two", "other", "fractures", ",", "those", "taking", "anastrozole", "had", "three", "fragility", "fractures", "and", "five", "other", "fractures", ".", "For", "patients", "who", "had", "baseline", "T", "-", "scores", "of", "less", "than", "-", "2", "·", "0", "taking", "exemestane", ",", "one", "had", "a", "fragility", "fracture", "and", "four", "had", "other", "fractures", ",", "whereas", "those", "taking", "anastrozole", "had", "five", "fragility", "fractures", "and", "one", "other", "fracture", ".", "Our", "results", "demonstrate", "that", "adjuvant", "treatment", "with", "aromatase", "inhibitors", "can", "be", "considered", "for", "breast", "cancer", "patients", "who", "have", "T", "-", "scores", "less", "than", "-", "2", "·", "0", ".", "Canadian", "Cancer", "Society", "Research", "Institute", ",", "Pfizer", ",", "Canadian", "Institutes", "of", "Health", "Research", "." ]
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43
[ "Effectiveness", "of", "early", "physiotherapy", "to", "prevent", "lymphoedema", "after", "surgery", "for", "breast", "cancer", ":", "randomised", ",", "single", "blinded", ",", "clinical", "trial", ".", "To", "determine", "the", "effectiveness", "of", "early", "physiotherapy", "in", "reducing", "the", "risk", "of", "secondary", "lymphoedema", "after", "surgery", "for", "breast", "cancer", ".", "Randomised", ",", "single", "blinded", ",", "clinical", "trial", ".", "University", "hospital", "in", "Alcalá", "de", "Henares", ",", "Madrid", ",", "Spain", ".", "120", "women", "who", "had", "breast", "surgery", "involving", "dissection", "of", "axillary", "lymph", "nodes", "between", "May", "2005", "and", "June", "2007", ".", "The", "early", "physiotherapy", "group", "was", "treated", "by", "a", "physiotherapist", "with", "a", "physiotherapy", "programme", "including", "manual", "lymph", "drainage", ",", "massage", "of", "scar", "tissue", ",", "and", "progressive", "active", "and", "action", "assisted", "shoulder", "exercises", ".", "This", "group", "also", "received", "an", "educational", "strategy", ".", "The", "control", "group", "received", "the", "educational", "strategy", "only", ".", "Incidence", "of", "clinically", "significant", "secondary", "lymphoedema", "(", ">", "2", "cm", "increase", "in", "arm", "circumference", "measured", "at", "two", "adjacent", "points", "compared", "with", "the", "non", "-", "affected", "arm", ")", ".", "116", "women", "completed", "the", "one", "year", "follow", "-", "up", ".", "Of", "these", ",", "18", "developed", "secondary", "lymphoedema", "(", "16", "%", ")", ":", "14", "in", "the", "control", "group", "(", "25", "%", ")", "and", "four", "in", "the", "intervention", "group", "(", "7", "%", ")", ".", "The", "difference", "was", "significant", "(", "P=", "0.01", ")", ";", "risk", "ratio", "0.28", "(", "95", "%", "confidence", "interval", "0.10", "to", "0.79", ")", ".", "A", "survival", "analysis", "showed", "a", "significant", "difference", ",", "with", "secondary", "lymphoedema", "being", "diagnosed", "four", "times", "earlier", "in", "the", "control", "group", "than", "in", "the", "intervention", "group", "(", "intervention", "/", "control", ",", "hazard", "ratio", "0.26", ",", "95", "%", "confidence", "interval", "0.09", "to", "0.79", ")", ".", "Early", "physiotherapy", "could", "be", "an", "effective", "intervention", "in", "the", "prevention", "of", "secondary", "lymphoedema", "in", "women", "for", "at", "least", "one", "year", "after", "surgery", "for", "breast", "cancer", "involving", "dissection", "of", "axillary", "lymph", "nodes", ".", "Current", "controlled", "trials", "ISRCTN", "95870846", "." ]
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44
[ "Effectiveness", "of", "OK-", "432", "(", "Sapylin", ")", "to", "reduce", "seroma", "formation", "after", "axillary", "lymphadenectomy", "for", "breast", "cancer", ".", "The", "occurrence", "of", "seroma", "formation", "after", "axillary", "lymphadenectomy", "for", "breast", "cancer", "can", "not", "be", "ignored", ".", "Various", "approaches", "have", "been", "used", "in", "an", "effort", "to", "reduce", "it", ",", "but", "these", "results", "are", "still", "controversial", ".", "We", "aimed", "to", "describe", "a", "new", "method", "of", "application", "of", "OK-", "432", "(", "Sapylin", ",", "heat", "-", "treated", "Su", "strain", "of", "Streptococcus", ")", "to", "reduce", "seroma", "formation", "after", "axillary", "lymphadenectomy", "for", "breast", "cancer", "and", "to", "verify", "the", "safety", "and", "efficacy", "of", "it", "as", "a", "beneficial", "supplement", "for", "conventional", "surgery", ".", "A", "prospective", ",", "randomized", "analysis", "of", "consecutive", "quadrantectomy", "or", "mastectomy", "plus", "axillary", "lymphadenectomy", "using", "or", "not", "using", "OK-", "432", "was", "designed", ".", "From", "July", "2010", "to", "November", "2011", ",", "a", "total", "of", "111", "patients", "were", "enrolled", "in", "this", "prospective", ",", "randomized", "study", "and", "completed", "the", "follow", "-", "up", ".", "OK-", "432", "applied", "to", "the", "axillary", "fossa", "plus", "placement", "of", "closed", "suction", "drainage", "was", "used", "in", "54", "patients", "(", "the", "experimental", "group", ")", ";", "placement", "of", "closed", "suction", "drainage", "was", "used", "in", "57", "patients", "(", "the", "control", "group", ")", ".", "There", "were", "no", "statistical", "significance", "between", "the", "two", "groups", "in", "terms", "of", "age", ",", "body", "mass", "index", ",", "treatment", "received", ",", "tumor", "size", ",", "number", "of", "removed", "lymph", "nodes", ",", "and", "lymph", "node", "status", ".", "Postoperative", "drainage", "magnitude", "and", "duration", "were", "significantly", "reduced", "in", "the", "experimental", "group", "(", "P", "=", "0.008", "and", "0.003", ",", "respectively", ")", ".", "One", "week", "after", "hospital", "discharge", ",", "fewer", "patients", "developed", "a", "palpable", "seroma", "in", "the", "experimental", "group", ":", "10", "in", "the", "experimental", "group", "versus", "28", "in", "the", "control", "group", "(", "P", "=", "0.001", ")", ".", "Fewer", "seromas", "needed", "aspiration", "(", "mean", "1", "[", "range", "0", "-", "3", "]", "in", "the", "experimental", "group", "vs.", "mean", "4", "[", "range", "1", "-", "5", "]", "in", "the", "control", "group", ";", "P", "<", "0.001", ")", ".", "There", "were", "no", "significant", "differences", "in", "terms", "of", "the", "incidence", "of", "complications", "associated", "with", "axillary", "lymphadenectomy", "(", "P", "=", "0.941", ")", ".", "OK-", "432", "is", "a", "feasible", "and", "safe", "option", "for", "axillary", "lymphadenectomy", "for", "breast", "cancer", ".", "The", "use", "of", "it", "does", "not", "always", "prevent", "seroma", "formation", ",", "but", "it", "can", "reduce", "drainage", "magnitude", "and", "duration", ",", "as", "well", "as", "decrease", "the", "incidence", "of", "seroma", "after", "the", "removal", "of", "drainage", ".", "It", "may", "be", "increasingly", "conducted", "in", "day", "surgery", "clinics", "." ]
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45
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56
[ "Palbociclib", ":", "A", "Novel", "Cyclin", "-", "Dependent", "Kinase", "Inhibitor", "for", "Hormone", "Receptor", "-", "Positive", "Advanced", "Breast", "Cancer", ".", "To", "review", "palbociclib", ",", "a", "novel", "small", "-", "molecule", "inhibitor", "of", "cyclin", "-", "dependent", "kinases", "4", "and", "6", ",", "and", "its", "current", "place", "in", "therapy", "for", "the", "treatment", "of", "hormone", "receptor", "(", "HMR", ")", "-positive", ",", "human", "epidermal", "growth", "factor", "receptor", "2", "(", "Her", "2", ")", "-negative", "advanced", "breast", "cancer", ".", "Four", "phase", "I", "trials", ",", "2", "phase", "II", "trials", ",", "and", "1", "phase", "III", "trial", "were", "identified", "from", "May", "2004", "to", "May", "2015", "using", "PubMed", ",", "American", "Society", "of", "Clinical", "Oncology", "(", "ASCO", ")", "abstracts", ",", "and", "European", "Society", "of", "Medical", "Oncology", "(", "ESMO", ")", "abstracts", ".", "In", "the", "first", "-", "line", "setting", ",", "the", "phase", "II", "PALbociclib", ":", "Ongoing", "trials", "in", "the", "Management", "of", "breast", "cAncer", "(", "PALOMA", ")", "-", "1", "trial", "randomized", "patients", "to", "receive", "letrozole", "alone", "or", "letrozole", "plus", "palbociclib", "125", "mg", "daily", "for", "3", "weeks", ",", "followed", "by", "1", "week", "off", ",", "as", "initial", "therapy", "for", "advanced", "breast", "cancer", ".", "The", "investigator", "-", "assessed", "median", "progression", "-", "free", "survival", "(", "PFS", ")", "was", "20.2", "months", "for", "the", "combination", "versus", "10.2", "months", "for", "letrozole", "alone", "(", "hazard", "ratio", "[", "HR", "]", "=", "0.488", ";", "95", "%", "CI", "=", "0.319", "-", "0.748", ";", "1", "-sided", "P", "=", "0.0004", ")", ".", "The", "ensuing", "Food", "and", "Drug", "Administration", "approval", "of", "palbociclib", "was", "given", "a", "\"", "breakthrough", "therapy", "\"", "designation", ",", "where", "preliminary", "evidence", "suggests", "substantial", "improvement", "over", "existing", "therapies", "for", "a", "serious", "or", "life", "-", "threatening", "disease", ".", "A", "confirmatory", "phase", "III", "trial", ",", "PALOMA-", "2", ",", "is", "under", "way", ".", "In", "patients", "who", "were", "previously", "treated", "with", "endocrine", "therapy", "for", "advanced", "breast", "cancer", ",", "the", "phase", "III", "PALOMA-", "3", "trial", "randomized", "patients", "to", "fulvestrant", "plus", "palbociclib", "versus", "fulvestrant", "plus", "placebo", ".", "The", "investigator", "-", "assessed", "median", "PFS", "at", "the", "time", "of", "a", "preplanned", "analysis", "was", "9.2", "months", "with", "palbociclib", "-", "fulvestrant", "compared", "with", "3.8", "months", "with", "placebo", "-", "fulvestrant", "(", "HR", "=", "0.42", ";", "95", "%", "CI", "=", "0.32", "-", "0.56", ";", "P", "<", "0.001", ")", ".", "Palbociclib", ",", "the", "first", "-", "in", "-", "class", "CDK", "4", "/", "6", "inhibitor", ",", "significantly", "extended", "PFS", "in", "combination", "with", "endocrine", "therapy", "in", "the", "first", "and", "subsequent", "lines", "of", "treatment", "for", "HMR", "-", "positive", ",", "Her", "2", "-", "negative", "advanced", "breast", "cancer", "." ]
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57
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58
[ "Five", "-", "year", "outcome", "for", "women", "randomised", "in", "a", "phase", "III", "trial", "comparing", "doxorubicin", "and", "cyclophosphamide", "with", "doxorubicin", "and", "docetaxel", "as", "primary", "medical", "therapy", "in", "early", "breast", "cancer", ":", "an", "Anglo", "-", "Celtic", "Cooperative", "Oncology", "Group", "study", ".", "To", "compare", "the", "long", "-", "term", "outcome", "of", "women", "with", "primary", "or", "locally", "advanced", "breast", "cancer", "randomised", "to", "receive", "either", "doxorubicin", "and", "cyclophosphamide", "(", "AC", ")", "or", "doxorubicin", "and", "docetaxel", "(", "AD", ")", "as", "primary", "chemotherapy", ".", "Eligible", "patients", "with", "histologic", "-", "proven", "breast", "cancer", "with", "primary", "tumours", ">", "or", "=", "3", "cm", ",", "inflammatory", "or", "locally", "advanced", "disease", ",", "and", "no", "evidence", "of", "distant", "metastases", ",", "were", "randomised", "to", "receive", "a", "maximum", "of", "6", "cycles", "of", "either", "doxorubicin", "(", "60", "mg", "/", "m", "(", "2", ")", ")", "plus", "cyclophosphamide", "(", "600", "mg", "/", "m", "(", "2", ")", ")", "i", "/", "v", "or", "doxorubicin", "(", "50", "mg", "/", "m", "(", "2", ")", ")", "plus", "docetaxel", "(", "75", "mg", "/", "m", "(", "2", ")", ")", "i", "/", "v", "every", "3", "weeks", ",", "followed", "by", "surgery", "on", "completion", "of", "chemotherapy", ".", "Clinical", "and", "pathologic", "responses", "have", "previously", "been", "reported", ".", "Time", "to", "relapse", ",", "site", "of", "relapse", ",", "and", "all", "-", "cause", "mortality", "were", "recorded", ".", "This", "updated", "analysis", "compares", "long", "-", "term", "disease", "-", "free", "(", "DFS", ")", "and", "overall", "survival", "(", "OS", ")", "using", "stratified", "log", "rank", "methods", ".", "A", "total", "of", "363", "patients", "were", "randomised", "to", "AC", "(", "n", "=", "181", ")", "or", "AD", "(", "n", "=", "182", ")", ".", "A", "complete", "pathologic", "response", "was", "observed", "in", "16", "%", "for", "AC", "and", "12", "%", "for", "AD", "(", "P", "=", "0.43", ")", ".", "The", "number", "of", "patients", "with", "positive", "axillary", "nodes", "at", "surgery", "with", "AC", "was", "61", "%", "and", "AD", "66", "%", "(", "P", "=", "0.36", ")", ".", "At", "a", "median", "follow", "-", "up", "of", "99", "months", "there", "is", "no", "significant", "difference", "between", "the", "two", "groups", "for", "DFS", "(", "P", "=", "0.20", ")", "and", "OS", "(", "P", "=", "0.24", ")", ".", "Deaths", "were", "due", "to", "metastatic", "breast", "cancer", "in", "96", "%", "of", "patients", ".", "Our", "data", "do", "not", "support", "a", "clinical", "benefit", "for", "simultaneous", "administration", "of", "AD", "compared", "with", "AC", ".", "However", ",", "the", "data", "do", "not", "exclude", "a", "smaller", "benefit", "than", "the", "study", "was", "powered", "to", "detect", "and", "are", "consistent", "with", "an", "increase", "in", "both", "disease", "-", "free", "and", "overall", "survival", "of", "about", "5", "%", "for", "AD", "compared", "with", "AC", ".", "Outcome", "is", "consistent", "with", "the", "pathologic", "complete", "response", "following", "surgery", "." ]
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60
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61
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69
[ "Randomized", "trial", "of", "proactive", "rapid", "genetic", "counseling", "versus", "usual", "care", "for", "newly", "diagnosed", "breast", "cancer", "patients", ".", "Breast", "cancer", "patients", "who", "carry", "BRCA", "1", "/", "BRCA", "2", "gene", "mutations", "may", "consider", "bilateral", "mastectomy", ".", "Having", "bilateral", "mastectomy", "at", "the", "time", "of", "diagnosis", "not", "only", "reduces", "risk", "of", "a", "contralateral", "breast", "cancer", ",", "but", "can", "eliminate", "the", "need", "for", "radiation", "therapy", "and", "yield", "improved", "reconstruction", "options", ".", "However", ",", "most", "patients", "do", "not", "receive", "genetic", "counseling", "or", "testing", "at", "the", "time", "of", "their", "diagnosis", ".", "In", "this", "trial", ",", "we", "tested", "proactive", "rapid", "genetic", "counseling", "and", "testing", "(", "RGCT", ")", "in", "newly", "diagnosed", "breast", "cancer", "patients", "in", "order", "to", "facilitate", "pre", "-", "surgical", "genetic", "counseling", "and", "testing", ".", "We", "recruited", "newly", "diagnosed", "breast", "cancer", "patients", "at", "increased", "risk", "for", "carrying", "a", "BRCA", "1", "/", "2", "mutation", ".", "Of", "379", "eligible", "patients", "who", "completed", "a", "baseline", "survey", ",", "330", "agreed", "to", "randomization", "in", "a", "2", ":1", "ratio", "to", "RGCT", "(", "n", "=", "220", ")", "versus", "UC", "(", "n", "=", "108", ")", ".", "Primary", "outcomes", "were", "genetic", "counseling", "and", "testing", "uptake", "and", "breast", "cancer", "surgical", "decisions", ".", "RGCT", "led", "to", "higher", "overall", "(", "83.8", "%", "vs.", "54.6", "%", ";", "p", "<", "0.0001", ")", "and", "pre", "-", "surgical", "(", "57.8", "%", "vs.", "38.7", "%", ";", "p", "=", "0.001", ")", "genetic", "counseling", "uptake", "compared", "to", "UC", ".", "Despite", "higher", "rates", "of", "genetic", "counseling", ",", "RGCT", "did", "not", "differ", "from", "UC", "in", "overall", "(", "54.1", "%", "vs.", "49.1", "%", ",", "p", ">", "0.10", ")", "or", "pre", "-", "surgical", "(", "30.6", "%", "vs.", "27.4", "%", ",", "p", ">", "0.10", ")", "receipt", "of", "genetic", "test", "results", "nor", "did", "they", "differ", "in", "uptake", "of", "bilateral", "mastectomy", "(", "26.6", "%", "vs.", "21.8", "%", ",", "p", ">", "0.10", ")", ".", "Although", "RGCT", "yielded", "increased", "genetic", "counseling", "participation", ",", "this", "did", "not", "result", "in", "increased", "rates", "of", "pre", "-", "surgical", "genetic", "testing", "or", "impact", "surgical", "decisions", ".", "These", "data", "suggest", "that", "those", "patients", "most", "likely", "to", "opt", "for", "genetic", "testing", "at", "the", "time", "of", "diagnosis", "are", "being", "effectively", "identified", "by", "their", "surgeons", "." ]
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70
[ "Measuring", "the", "impact", "of", "guideline", "-", "based", "antiemetic", "therapy", "on", "nausea", "and", "vomiting", "control", "in", "breast", "cancer", "patients", "with", "multiple", "risk", "factors", ".", "The", "objective", "of", "this", "exploratory", "analysis", "was", "to", "determine", "if", "individual", "patient", "risk", "factors", "could", "be", "used", "to", "optimize", "chemotherapy", "-", "induced", "nausea", "and", "vomiting", "(", "CINV", ")", ".", "Through", "validated", "risk", "prediction", "models", "which", "quantify", "patient", "risk", "factors", ",", "152", "patients", "with", "early", "-", "stage", "breast", "cancer", "scheduled", "to", "received", "adjuvant", "anthracycline", "-", "based", "chemotherapy", "were", "categorized", "as", "being", "at", "low", "(", "level", "0", ")", "or", "high", "-", "risk", "(", "level", "1", ")", "for", "CINV", ".", "Prior", "to", "the", "first", "cycle", "of", "chemotherapy", ",", "low", "-", "risk", "patients", "received", "ondansetron", "and", "dexamethasone", ",", "while", "high", "-", "risk", "level", "1", "patients", "also", "received", "aprepitant", ".", "For", "subsequent", "cycles", ",", "patients", "who", "experienced", "CINV", "had", "their", "antiemetics", "changed", "in", "a", "stepwise", "manner", "to", "level", "2", "(", "extended", "-", "duration", "dexamethasone", ")", "or", "level", "3", "(", "extended", "-", "duration", "dexamethasone", "and", "low", "-", "dose", "olanzapine", ")", ".", "The", "study", "enrolled", "152", "patients", "who", "received", "484", "cycles", "of", "chemotherapy", ".", "Forty", "patient", "cycles", "were", "classified", "as", "low", "risk", "(", "level", "0", ")", "compared", "to", "201", ",", "162", "and", "81", "that", "were", "classified", "as", "high", "-", "risk", "levels", "1", ",", "2", "and", "3", ",", "respectively", ".", "Complete", "control", "of", "acute", "and", "delayed", "vomiting", "was", "comparable", "and", "was", "achieved", "in", "over", "85", "%", "of", "patients", "across", "all", "risk", "levels", "(", "p", "=", "0.56", "and", "p", "=", "0.99", ")", ".", "In", "contrast", ",", "complete", "control", "of", "acute", "and", "delayed", "nausea", "was", "reduced", "in", "risk", "levels", "1", "to", "3", "compared", "to", "level", "0", "(", "acute", "=", "51.2", ",", "58.0", ",", "45.7", "vs.", "70.0", "%", ";", "p", "=", "0.013", ")", "-", "(", "delayed", "=", "32.8", ",", "45.7", ",", "34.6", "vs.", "62.5", "%", ";", "p", "<", "0.001", ")", ".", "Despite", "the", "addition", "of", "aprepitant", ",", "extended", "-", "duration", "dexamethasone", "and", "olanzapine", ",", "patients", "at", "high", "risk", "for", "CINV", "due", "to", "personal", "risk", "factors", "failed", "to", "achieve", "good", "nausea", "control", "." ]
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71
[ "Effect", "of", "Topical", "Anesthetic", "Cream", "on", "Pain", "During", "Periareolar", "Injection", "of", "Technetium", "Tc", "99", "m", "Sulfur", "Colloid", "for", "Sentinel", "Lymph", "Node", "Biopsy", "in", "Breast", "Cancer", ":", "A", "Randomized", "Control", "Trial", ".", "Injection", "of", "Tc", "99", "m", "to", "localize", "nodes", "for", "sentinel", "lymph", "node", "biopsy", "is", "reported", "by", "patients", "as", "very", "painful", ".", "The", "purpose", "of", "this", "study", "was", "to", "determine", "if", "anesthetic", "cream", "reduces", "pain", "associated", "with", "periareolar", "injection", "of", "Tc", "99", "m", "and", "to", "help", "elucidate", "conflicting", "literature", "regarding", "the", "efficacy", "of", "anesthetic", "cream", "for", "this", "procedure", ".", "A", "randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "methodology", "was", "used", "for", "adult", "females", "with", "breast", "cancer", "undergoing", "periareolar", "injection", "of", "Tc", "99", "m", "for", "sentinel", "lymph", "node", "biopsy", ".", "Pain", "levels", "were", "compared", "using", "anesthetic", "cream", "(", "2.5", "%", "lidocaine", "/", "2.5", "%", "prilocaine", ")", "vs.", "placebo", ".", "Patient", "exclusion", "criteria", "included", "use", "of", "opioids", "or", "adjuvant", "pain", "medication", "or", "injecting", "Tc", "99", "m", "the", "day", "before", "surgery", ".", "The", "Numerical", "Rating", "Scale", "was", "used", "to", "assess", "pain", "levels", "immediately", "after", "the", "injections", ".", "Comparing", "23", "experimental", "and", "26", "control", "patients", ",", "there", "was", "no", "significant", "difference", "between", "the", "experimental", "(", "median", "=", "4", ")", "and", "the", "control", "group", "(", "median", "=", "5", ")", "on", "level", "of", "pain", "experienced", "U=", "0.492", ",", "P", ">", ".", "05", ".", "The", "experimental", "group", "had", "a", "slightly", "lower", "median", "pain", "score", ";", "however", ",", "there", "was", "no", "statistically", "significant", "difference", "between", "those", "who", "used", "the", "cream", "compared", "with", "those", "who", "used", "a", "placebo", ",", "supporting", "the", "conclusion", "that", "anesthetic", "cream", "does", "not", "reduce", "pain", "during", "Tc", "99", "m", "injections", ".", "This", "study", "adds", "to", "the", "current", "literature", "to", "provide", "a", "stronger", "position", "that", "there", "is", "no", "benefit", "to", "using", "anesthetic", "cream", "for", "this", "procedure", "." ]
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72
[ "Mammographic", "density", "change", "with", "1", "year", "of", "aerobic", "exercise", "among", "postmenopausal", "women", ":", "a", "randomized", "controlled", "trial", ".", "The", "Alberta", "Physical", "Activity", "and", "Breast", "Cancer", "Prevention", "(", "ALPHA", ")", "Trial", "examined", "the", "influence", "of", "aerobic", "exercise", "on", "biological", "factors", "that", "are", "associated", "with", "breast", "cancer", "risk", ".", "Mammographic", "density", ",", "a", "secondary", "outcome", ",", "is", "reported", "here", ".", "The", "ALPHA", "Trial", "was", "a", "parallel", "group", "randomized", "controlled", "trial", "conducted", "between", "May", "2003", "and", "July", "2007", ".", "Postmenopausal", ",", "sedentary", "women", "ages", "50", "to", "74", "years", "(", "n", "=", "320", ")", "were", "evenly", "randomized", "to", "aerobic", "exercise", "(", "45", "minutes", ",", "5", "days", "per", "week", ")", "or", "control", "(", "usual", "life", "-", "style", ")", "for", "1", "year", ".", "Dense", "fibroglandular", "tissue", "and", "nondense", "fatty", "tissue", "were", "measured", "from", "mammograms", "at", "baseline", "and", "1", "year", "using", "computer", "-", "assisted", "thresholding", "software", "for", "area", "measurements", "and", "a", "new", "technique", "that", "relies", "on", "the", "calibration", "of", "mammography", "units", "with", "a", "tissue", "-", "equivalent", "phantom", "for", "volumetric", "measurements", ".", "Nondense", "volume", "decreased", "in", "the", "exercise", "group", "relative", "to", "the", "control", "group", "(", "difference", "between", "groups", "=", "-", "38.5", "cm", "(", "3", ")", ";", "95", "%", "confidence", "interval", ",", "-", "61.6", "to", "15.4", ";", "P", "=", "0.001", ")", ".", "Changes", "in", "total", "body", "fat", "accounted", "for", "this", "decrease", ".", "Changes", "in", "dense", "area", "and", "dense", "volume", ",", "measures", "that", "have", "previously", "been", "associated", "with", "breast", "cancer", "risk", ",", "were", "not", "significantly", "different", "between", "the", "groups", "(", "P", ">", "or", "=", "0.26", ")", ".", "Achieving", "changes", "in", "mammographic", "measures", "may", "require", "more", "exercise", "or", "a", "study", "population", "with", "higher", "baseline", "levels", "of", "sex", "hormones", "or", "a", "wider", "range", "of", "mammographic", "density", ".", "The", "data", "from", "this", "study", ",", "however", ",", "suggest", "that", "the", "protective", "effect", "of", "exercise", "on", "breast", "cancer", "risk", "may", "operate", "through", "a", "mechanism", "other", "than", "mammographic", "density", "." ]
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73
[ "Perioperative", "intravenous", "lidocaine", "decreases", "the", "incidence", "of", "persistent", "pain", "after", "breast", "surgery", ".", "Breast", "cancer", "surgery", "is", "associated", "with", "a", "high", "incidence", "of", "persistent", "postsurgical", "pain", "(", "PPSP", ")", ".", "The", "aim", "of", "this", "study", "was", "to", "evaluate", "the", "impact", "of", "intravenous", "(", "IV", ")", "lidocaine", "on", "acute", "and", "PPSP", ",", "analgesic", "requirements", ",", "and", "sensation", "abnormalities", "in", "patients", "undergoing", "surgery", "for", "breast", "cancer", ".", "Thirty", "-", "six", "patients", "participated", "in", "this", "randomized", ",", "double", "-", "blinded", "study", ".", "Before", "induction", "of", "general", "anesthesia", ",", "patients", "received", "a", "bolus", "of", "intravenous", "lidocaine", "1.5", "mg", "/", "kg", "followed", "by", "a", "continuous", "infusion", "of", "lidocaine", "1.5", "mg", "/", "kgh", "(", "lidocaine", "group", ")", "or", "an", "equal", "volume", "of", "saline", "(", "control", "group", ")", ".", "The", "infusion", "was", "stopped", "1", "hour", "after", "the", "skin", "closure", ".", "Pain", "scores", "and", "analgesic", "consumption", "were", "recorded", "at", "2", ",", "4", ",", "24", "hours", ",", "and", "then", "daily", "for", "1", "week", "postoperatively", ".", "Three", "months", "later", ",", "patients", "were", "assessed", "for", "PPSP", "and", "secondary", "hyperalgesia", ".", "Two", "(", "11.8", "%", ")", "patients", "in", "the", "lidocaine", "group", "and", "9", "(", "47.4", "%", ")", "patients", "in", "the", "control", "group", "reported", "PPSP", "at", "3", "months", "follow", "-", "up", "(", "P=", "0.031", ")", ".", "McGill", "Pain", "Questionnaire", "revealed", "greater", "present", "pain", "intensity", "-", "visual", "analog", "scale", "in", "the", "control", "group", "(", "14.6", "±", "22.5", "vs.", "2.6", "±", "7.5", ";", "P=", "0.025", ")", ".", "Secondary", "hyperalgesia", "(", "area", "of", "hyperalgesia", "/", "length", "of", "surgical", "incision", ")", "was", "significantly", "less", "in", "the", "lidocaine", "group", "compared", "with", "control", "group", "(", "0.2", "±", "0.8", "vs.", "3.2", "±", "4.5", "cm", ";", "P=", "0.002", ")", ".", "The", "2", "groups", "were", "similar", "in", "terms", "of", "analgesic", "consumption", "during", "the", "early", "postoperative", "period", ".", "Intravenous", "perioperative", "lidocaine", "decreases", "the", "incidence", "and", "severity", "of", "PPSP", "after", "breast", "cancer", "surgery", ".", "Prevention", "of", "the", "induction", "of", "central", "hyperalgesia", "is", "a", "potential", "mechanism", "." ]
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82
[ "Randomized", "Controlled", "Trial", "of", "Zoledronic", "Acid", "plus", "Chemotherapy", "versus", "Chemotherapy", "Alone", "as", "Neoadjuvant", "Treatment", "of", "HER", "2", "-", "Negative", "Primary", "Breast", "Cancer", "(", "JONIE", "Study", ")", ".", "Zoledronic", "acid", "(", "ZOL", ")", "is", "a", "nitrogen", "-", "containing", "bisphosphonate", "that", "induces", "osteoclast", "apoptosis", "and", "inhibits", "bone", "resorption", "by", "inhibiting", "the", "mevalonate", "pathway", ".", "Its", "benefit", "for", "the", "prevention", "of", "skeletal", "complications", "due", "to", "bone", "metastases", "has", "been", "established", ".", "However", ",", "the", "antitumor", "efficacy", "of", "ZOL", ",", "although", "suggested", "by", "multiple", "preclinical", "and", "clinical", "studies", ",", "has", "not", "yet", "been", "clinically", "proven", ".", "We", "performed", "the", "present", "randomized", "Phase", "2", "trial", "to", "investigate", "the", "antitumor", "effect", "of", "ZOL", "with", "chemotherapy", "(", "CT", ")", ".", "Asian", "patients", "with", "HER", "2", "-", "negative", "invasive", "breast", "cancer", "were", "randomly", "assigned", "to", "either", "the", "CT", "or", "CT+ZOL", "(", "CTZ", ")", "group", ".", "One", "hundred", "and", "eighty", "-", "eight", "patients", "were", "randomized", "to", "either", "the", "CT", "group", "(", "n", "=", "95", ")", "or", "the", "CTZ", "group", "(", "n", "=", "93", ")", "from", "March", "2010", "to", "April", "2012", ",", "and", "180", "patients", "were", "assessed", ".", "All", "patients", "received", "four", "cycles", "of", "FEC", "100", "(", "fluorouracil", "500", "mg", "/", "m", "2", ",", "epirubicin", "100", "mg", "/", "m", "2", ",", "and", "cyclophosphamide", "500", "mg", "/", "m", "2", ")", ",", "followed", "by", "12", "cycles", "of", "paclitaxel", "at", "80", "mg", "/", "m", "2", "weekly", ".", "ZOL", "(", "4", "mg", ")", "was", "administered", "three", "to", "four", "times", "weekly", "for", "7", "weeks", "to", "the", "patients", "in", "the", "CTZ", "group", ".", "The", "primary", "endpoint", "was", "the", "pathological", "complete", "response", "(", "pCR", ")", "rate", ",", "which", "was", "defined", "as", "no", "invasive", "cancer", "in", "the", "breast", "tissue", "specimen", ".", "Safety", "was", "assessed", "in", "all", "patients", "who", "received", "at", "least", "one", "dose", "of", "the", "study", "drug", ".", "This", "randomized", "controlled", "trial", "indicated", "that", "the", "rates", "of", "pCR", "in", "CTZ", "group", "(", "14.8", "%", ")", "was", "doubled", "to", "CT", "group", "(", "7.7", "%", ")", ",", "respectively", "(", "one", "-", "sided", "chi", "-", "square", "test", ",", "p", "=", "0.068", ")", ",", "though", "the", "additional", "efficacy", "of", "zoledronic", "acid", "was", "not", "demonstrated", "statistically", ".", "The", "pCR", "rate", "in", "postmenopausal", "patients", "was", "18.4", "%", "and", "5.1", "%", "in", "the", "CTZ", "and", "CT", "groups", ",", "respectively", "(", "one", "-", "sided", "Fisher", "'s", "exact", "test", ",", "p", "=", "0.071", ")", ",", "and", "that", "in", "patients", "with", "triple", "-", "negative", "breast", "cancer", "was", "35.3", "%", "and", "11.8", "%", "in", "the", "CTZ", "and", "CT", "groups", ",", "respectively", "(", "one", "-", "sided", "Fisher", "'s", "exact", "test", ",", "p", "=", "0.112", ")", ".", "Thus", "the", "addition", "of", "ZOL", "to", "neoadjuvant", "CT", "has", "potential", "anticancer", "benefits", "in", "postmenopausal", "patients", "and", "patients", "with", "triple", "-", "negative", "breast", "cancer", ".", "Further", "investigation", "is", "warranted", ".", "University", "Hospital", "Medical", "Information", "Network", ".", "UMIN", "000003261", "." ]
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83
[ "Weekly", "docetaxel", "versus", "CMF", "as", "adjuvant", "chemotherapy", "for", "elderly", "breast", "cancer", "patients", ":", "safety", "data", "from", "the", "multicentre", "phase", "3", "randomised", "ELDA", "trial", ".", "Within", "an", "ongoing", "multicentre", "phase", "3", "randomised", "trial", "(", "ELDA", ",", "cancertrials", ".", "gov", "ID", ":", "NCT", "00331097", ")", ",", "early", "breast", "cancer", "patients", ",", "65", "-", "79", "years", "old", ",", "with", "average", "to", "high", "risk", "of", "recurrence", ",", "are", "randomly", "assigned", "to", "receive", "CMF", "(", "cyclophosphamide", "600", "mg", "/", "m", "2", ",", "methotrexate", "40", "mg", "/", "m", "2", ",", "fluorouracil", "600", "mg", "/", "m", "2", ",", "days", "1", "-", "8", ")", "or", "docetaxel", "(", "35", "mg", "/", "m", "2", "days", "1", "-", "8", "-", "15", ")", ",", "every", "4", "weeks", ".", "Here", "we", "report", "an", "unplanned", "safety", "analysis", "prompted", "by", "an", "amendment", "introducing", "creatinine", "clearance", "as", "a", "tool", "to", "adjust", "methotrexate", "dose", ".", "Before", "such", "change", ",", "101", "patients", "with", "a", "median", "age", "of", "70", "were", "randomly", "assigned", "CMF", "(", "53", "patients", ")", "or", "docetaxel", "(", "48", "patients", ")", ".", "At", "least", "one", "grades", "3", "-", "4", "toxic", "event", "of", "any", "type", "was", "reported", "in", "40", "(", "75.5", "%", ")", "and", "19", "(", "39.6", "%", ")", "patients", "with", "CMF", "and", "docetaxel", ",", "respectively", "(", "p=", "0.0002", ")", ".", "Grades", "3", "-", "4", "hematological", "events", "were", "observed", "in", "37", "(", "69.8", "%", ")", "vs.", "4", "(", "8.3", "%", ")", "cases", "(", "p", "<", "0.0001", ")", "and", "grades", "3", "-", "4", "non", "-", "hematological", "toxicity", "in", "12", "(", "22.6", "%", ")", "vs.", "15", "(", "31.2", "%", ")", "patients", "(", "p=", "0.11", ")", ",", "with", "CMF", "and", "docetaxel", ",", "respectively", ".", "A", "higher", "incidence", "of", "anemia", ",", "neutropenia", ",", "thrombocytopenia", "and", "febrile", "neutropenia", "was", "reported", "with", "CMF", ".", "Constipation", ",", "mucositis", ",", "nausea", "and", "vomiting", "were", "more", "common", "with", "CMF", ";", "diarrhoea", ",", "abdominal", "pain", ",", "dysgeusia", ",", "neuropathy", "and", "liver", "toxicity", "were", "more", "frequent", "with", "docetaxel", ".", "No", "significant", "interaction", "was", "found", "between", "the", "occurrence", "of", "severe", "toxicity", "and", "baseline", "variables", ",", "including", "creatinine", "clearance", "and", "geriatric", "activity", "scales", ".", "In", "conclusion", ",", "weekly", "docetaxel", "appears", "to", "be", "less", "toxic", "than", "CMF", "in", "terms", "of", "hematological", "toxicity", "." ]
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84
[ "Association", "of", "Transforming", "Growth", "Factor", "β", "Polymorphism", "C-", "509", "T", "With", "Radiation", "-", "Induced", "Fibrosis", "Among", "Patients", "With", "Early", "-", "Stage", "Breast", "Cancer", ":", "A", "Secondary", "Analysis", "of", "a", "Randomized", "Clinical", "Trial", ".", "Whether", "genetic", "factors", "can", "identify", "patients", "at", "risk", "for", "radiation", "-", "induced", "fibrosis", "remains", "unconfirmed", ".", "To", "assess", "the", "association", "between", "the", "C-", "509", "T", "variant", "allele", "in", "the", "promoter", "region", "of", "TGFB", "1", "and", "breast", "fibrosis", "3", "years", "after", "radiotherapy", ".", "This", "is", "an", "a", "priori", "-", "specified", ",", "prospective", ",", "cohort", "study", "nested", "in", "an", "open", "-", "label", ",", "randomized", "clinical", "trial", ",", "which", "was", "conducted", "in", "community", "-", "based", "and", "academic", "cancer", "centers", "to", "compare", "hypofractionated", "whole", "-", "breast", "irradiation", "(", "WBI", ")", "(", "42.56", "Gy", "in", "16", "fractions", ")", "with", "conventionally", "fractionated", "WBI", "(", "50", "Gy", "in", "25", "fractions", ")", "after", "breast", "-", "conserving", "surgery", ".", "In", "total", ",", "287", "women", "40", "years", "or", "older", "with", "pathologically", "confirmed", "stage", "0", "to", "IIA", "breast", "cancer", "treated", "with", "breast", "-", "conserving", "surgery", "were", "enrolled", "from", "February", "2011", "to", "February", "2014", ".", "Patients", "were", "observed", "for", "a", "minimum", "of", "3", "years", ".", "Outcomes", "were", "compared", "using", "the", "1", "-sided", "Fisher", "exact", "test", "and", "multivariable", "logistic", "regression", ".", "A", "C", "-", "to", "-", "T", "single", "-", "nucleotide", "polymorphism", "at", "position", "-", "509", "relative", "to", "the", "first", "major", "transcription", "start", "site", "(", "C-", "509", "T", ")", "of", "the", "TGFB", "1", "gene", ".", "The", "primary", "outcome", "was", "grade", "2", "or", "higher", "breast", "fibrosis", "as", "assessed", "using", "the", "Late", "Effects", "Normal", "Tissue", "/", "Subjective", ",", "Objective", ",", "Medical", "Management", ",", "Analytic", "scale", "(", "range", ",", "0", "to", "3", ")", "three", "years", "after", "radiotherapy", ".", "Among", "287", "women", "enrolled", "in", "the", "trial", ",", "TGFB", "1", "genotype", "and", "3", "-year", "radiotherapy", "-", "induced", "toxicity", "data", "were", "available", "for", "174", "patients", ",", "of", "whom", "89", "patients", "(", "51", "%", ")", "with", "a", "mean", "(", "SD", ")", "age", "of", "60", "(", "8", ")", "years", "had", "at", "least", "1", "copy", "of", "C-", "509", "T", ".", "Grade", "2", "or", "higher", "breast", "fibrosis", "was", "present", "in", "12", "of", "87", "patients", "with", "C-", "509", "T", "(", "13.8", "%", ")", "compared", "with", "3", "of", "80", "patients", "without", "the", "allele", "variant", "(", "3.8", "%", ")", "(", "absolute", "difference", ",", "10.0", "%", ";", "95", "%", "CI", ",", "1.7", "%", "-", "18.4", "%", ";", "P", "=", ".", "02", ")", ".", "The", "results", "of", "multivariable", "analyses", "indicated", "that", "only", "C-", "509", "T", "(", "odds", "ratio", ",", "4.47", ";", "95", "%", "CI", ",", "1.25", "-", "15.99", ";", "P", "=", ".", "02", ")", "and", "postoperative", "cosmetic", "outcome", "(", "odds", "ratio", ",", "7.09", ";", "95", "%", "CI", ",", "2.41", "-", "20.90", ";", "P", "<", ".", "001", ")", "were", "significantly", "associated", "with", "breast", "fibrosis", "risk", ".", "To", "date", ",", "this", "study", "seems", "to", "be", "the", "first", "prospective", "validation", "of", "a", "genomic", "marker", "for", "radiation", "fibrosis", ".", "The", "C-", "509", "T", "allele", "in", "TGFB", "1", "is", "a", "key", "determinant", "of", "breast", "fibrosis", "risk", ".", "Assessing", "TGFB", "1", "genotype", "may", "facilitate", "a", "more", "personalized", "approach", "to", "locoregional", "treatment", "decisions", "in", "breast", "cancer", ".", "ClinicalTrials.gov", "identifier", ":", "NCT", "01266642", "." ]
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85
[ "Effect", "of", "everolimus", "on", "bone", "marker", "levels", "and", "progressive", "disease", "in", "bone", "in", "BOLERO-", "2", ".", "Breast", "Cancer", "Trials", "of", "Oral", "Everolimus", "2", "(", "BOLERO-", "2", ")", ",", "a", "phase", "III", "study", "in", "postmenopausal", "women", "with", "estrogen", "receptor", "-", "positive", "breast", "cancer", "progressing", "despite", "nonsteroidal", "aromatase", "inhibitor", "therapy", ",", "showed", "statistically", "significant", "benefits", "with", "adding", "everolimus", "to", "exemestane", ".", "Moreover", ",", "in", "preclinical", "studies", ",", "mammalian", "target", "of", "rapamycin", "inhibition", "was", "associated", "with", "decreased", "osteoclast", "survival", "and", "activity", ".", "Exploratory", "analyses", "in", "BOLERO-", "2", "evaluated", "the", "effect", "of", "everolimus", "on", "bone", "marker", "levels", "and", "progressive", "disease", "in", "bone", ".", "Patients", "were", "treated", "with", "exemestane", "(", "25", "mg", "/", "day", ")", "and", "randomized", "(", "2", ":1", ")", "to", "everolimus", "(", "10", "mg", "/", "day", ";", "combination", ")", "or", "placebo", "(", "exemestane", "only", ")", ".", "Exploratory", "endpoints", "included", "changes", "in", "bone", "turnover", "marker", "levels", "vs", "baseline", "and", "progressive", "disease", "in", "bone", ",", "defined", "as", "unequivocal", "progression", "of", "a", "preexisting", "bone", "lesion", "or", "the", "appearance", "of", "a", "new", "bone", "lesion", ".", "Baseline", "disease", "characteristics", "were", "well", "balanced", "between", "arms", "(", "N", "=", "724", ")", ";", "baseline", "bisphosphonate", "use", "was", "not", "(", "43.9", "%", "combination", "vs", "54.0", "%", "exemestane", "only", ")", ".", "At", "a", "median", "of", "18", "months", "of", "follow", "-", "up", ",", "median", "progression", "-", "free", "survival", "(", "primary", "endpoint", ")", "was", "statistically", "significantly", "longer", "with", "the", "combination", "vs", "exemestane", "only", "(", "Cox", "proportional", "hazard", "ratio", "=", "0.45", ",", "95", "%", "confidence", "interval", "=", "0.38", "to", "0.54", ";", "log", "-", "rank", ",", "1", "-sided", "P", "<", ".", "0001", ")", ".", "Bone", "marker", "levels", "at", "6", "and", "12", "weeks", "increased", "with", "exemestane", "only", ",", "as", "expected", ",", "but", "decreased", "with", "the", "combination", ".", "The", "cumulative", "incidence", "rate", "of", "progressive", "disease", "in", "bone", "was", "lower", "in", "the", "combination", "arm", ".", "Bone", "-", "related", "adverse", "events", "occurred", "with", "similar", "frequency", "in", "both", "arms", "(", "3.3", "%", "combination", "vs", "4.2", "%", "exemestane", "only", ")", ".", "These", "exploratory", "analyses", "suggest", "that", "everolimus", "has", "beneficial", "effects", "on", "bone", "turnover", "and", "progressive", "disease", "in", "bone", "in", "patients", "receiving", "exemestane", "for", "hormone", "receptor", "-", "positive", "breast", "cancer", "progressing", "during", "/", "after", "nonsteroidal", "aromatase", "inhibitor", "therapy", "." ]
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86
[ "Use", "of", "axillary", "deodorant", "and", "effect", "on", "acute", "skin", "toxicity", "during", "radiotherapy", "for", "breast", "cancer", ":", "a", "prospective", "randomized", "noninferiority", "trial", ".", "To", "prospectively", "determine", "the", "effect", "of", "deodorant", "use", "on", "acute", "skin", "toxicity", "and", "quality", "of", "life", "during", "breast", "radiotherapy", "(", "RT", ")", ".", "Before", "breast", "RT", ",", "84", "patients", "were", "randomly", "assigned", "to", "the", "deodorant", "group", "(", "n", "=", "40", ")", "or", "the", "no", "-", "deodorant", "group", "(", "n", "=", "44", ")", ".", "The", "patients", "were", "stratified", "by", "axillary", "RT", "and", "previous", "chemotherapy", ".", "Toxicity", "evaluations", "were", "always", "performed", "by", "the", "principal", "investigator", ",", "who", "was", "unaware", "of", "the", "group", "assignment", ",", "at", "the", "end", "of", "RT", "and", "2", "weeks", "after", "completion", "using", "the", "Radiation", "Therapy", "Oncology", "Group", "acute", "skin", "toxicity", "criteria", ".", "Symptoms", "of", "acute", "skin", "toxicity", "(", "i.", "e.", ",", "discomfort", ",", "pain", ",", "pruritus", ",", "sweating", ")", "and", "quality", "of", "life", "were", "self", "-", "evaluated", ".", "For", "each", "criterion", ",", "the", "point", "estimate", "of", "rate", "difference", "with", "the", "95", "%", "one", "-", "sided", "upper", "confidence", "limit", "was", "computed", ".", "To", "claim", "noninferiority", "owing", "to", "deodorant", "use", ",", "the", "95", "%", "one", "-", "sided", "upper", "confidence", "limit", "had", "to", "be", "lower", "than", "the", "noninferiority", "margin", ",", "fixed", "to", "12.8", "%", ".", "In", "the", "deodorant", "vs.", "no", "-", "deodorant", "groups", ",", "Grade", "2", "axillary", "radiodermatitis", "occurred", "in", "23", "%", "vs.", "30", "%", ",", "respectively", ",", "satisfying", "the", "statistical", "criteria", "for", "noninferiority", "(", "p", "=", ".", "019", ")", ".", "Grade", "2", "breast", "radiodermatitis", "occurred", "in", "30", "%", "vs.", "34", "%", "of", "the", "deodorant", "vs.", "no", "-", "deodorant", "groups", ",", "respectively", ",", "also", "satisfying", "the", "statistical", "criteria", "for", "noninferiority", "(", "p", "=", ".", "049", ")", ".", "Similar", "results", "were", "observed", "for", "the", "self", "-", "reported", "evaluations", ".", "The", "deodorant", "group", "reported", "less", "sweating", "(", "18", "%", "vs.", "39", "%", ",", "p", "=", ".", "032", ")", ".", "No", "Grade", "3", "or", "4", "radiodermatitis", "was", "observed", ".", "According", "to", "our", "noninferiority", "margin", "definition", ",", "the", "occurrence", "of", "skin", "toxicity", "and", "its", "related", "symptoms", "were", "statistically", "equivalent", "in", "both", "groups", ".", "No", "evidence", "was", "found", "to", "prohibit", "deodorant", "use", "(", "notwithstanding", "the", "use", "of", "an", "antiperspirant", "with", "aluminum", ")", "during", "RT", "for", "breast", "cancer", "." ]
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87
[ "Topical", "silymarin", "administration", "for", "prevention", "of", "acute", "radiodermatitis", "in", "breast", "cancer", "patients", ":", "A", "randomized", ",", "double", "-", "blind", ",", "placebo", "-", "controlled", "clinical", "trial", ".", "Radiation", "-", "induced", "dermatitis", "is", "one", "of", "the", "most", "common", "side", "effects", "of", "radiotherapy", ".", "Silymarin", ",", "a", "flavonoid", "extracted", "from", "the", "Silybum", "marianum", ",", "exhibits", "antioxidant", "and", "anti", "-", "inflammatory", "activities", ".", "The", "purpose", "of", "this", "study", "was", "to", "investigate", "the", "efficacy", "of", "silymarin", "gel", "in", "prevention", "of", "radiodermatitis", "in", "patients", "with", "breast", "cancer", ".", "During", "this", "randomized", ",", "double", "-", "blinded", ",", "placebo", "-", "controlled", "clinical", "trial", ",", "the", "preventive", "effect", "of", "silymarin", "1", "%", "gel", "was", "assessed", "in", "comparison", "with", "placebo", ",", "on", "radiodermatitis", "occurrence", ".", "Forty", "patients", "randomly", "received", "silymarin", "gel", "or", "placebo", "formulation", "on", "chest", "wall", "skin", "following", "modified", "radical", "mastectomy", ",", "once", "daily", "starting", "at", "the", "first", "day", "of", "radiotherapy", "for", "5", "weeks", ".", "Radiodermatitis", "severity", "was", "assessed", "weekly", "based", "on", "Radiation", "Therapy", "Oncology", "Group", "(", "RTOG", ")", "and", "National", "Cancer", "Institute", "Common", "Terminology", "for", "Adverse", "Events", "(", "NCI", "-", "CTCAE", ")", "criteria", "radiodermatits", "grading", "scale", "for", "5", "weeks", ".", "The", "median", "NCI", "-", "CTCAE", "and", "RTOG", "scores", "were", "significantly", "lower", "in", "silymarin", "group", "at", "the", "end", "of", "the", "third", "to", "fifth", "weeks", "(", "p", "value", "<", "0.05", ")", ".", "The", "scores", "increased", "significantly", "in", "both", "placebo", "and", "silymarin", "groups", "during", "radiotherapy", ",", "but", "there", "was", "a", "delay", "in", "radiodermatitis", "development", "and", "progression", "in", "silymarin", "group", ".", "Prophylactic", "administration", "of", "silymarin", "gel", "could", "significantly", "reduce", "the", "severity", "of", "radiodermatitis", "and", "delay", "its", "occurrence", "after", "5", "weeks", "of", "application", "." ]
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88
[ "Longitudinal", "social", "cognitive", "influences", "on", "physical", "activity", "and", "sedentary", "time", "in", "Hispanic", "breast", "cancer", "survivors", ".", "This", "study", "evaluated", "the", "effect", "of", "two", "home", "-", "based", "exercise", "interventions", "(", "one", "culturally", "adapted", "and", "one", "standard", ")", "on", "changes", "in", "social", "cognitive", "theory", "(", "SCT", ")", "variables", ",", "physical", "activity", "(", "PA", ")", ",", "and", "sedentary", "time", "(", "ST", ")", ",", "and", "determined", "the", "association", "between", "changes", "in", "SCT", "variables", "and", "changes", "in", "PA", "and", "ST", "in", "Hispanic", "breast", "cancer", "survivors", ".", "Project", "VIVA", "!", "was", "a", "16", "-week", "randomized", "controlled", "pilot", "study", "to", "test", "the", "effectiveness", "and", "feasibility", "of", "a", "culturally", "adapted", "exercise", "intervention", "for", "Mexican", "American", "and", "Puerto", "Rican", "breast", "cancer", "survivors", "in", "Houston", ",", "Texas", "and", "San", "Juan", ",", "Puerto", "Rico", ",", "respectively", ".", "Women", "(", "N", "=", "89", ")", "completed", "questionnaires", "on", "SCT", "variables", ",", "PA", ",", "and", "ST", "and", "were", "then", "randomized", "to", "a", "16", "-week", "culturally", "adapted", "exercise", "program", ",", "a", "non", "-", "culturally", "adapted", "standard", "exercise", "intervention", "or", "a", "wait", "-", "list", "control", "group", ".", "Multiple", "regression", "models", "were", "used", "to", "determine", "associations", "between", "changes", "in", "SCT", "variables", "and", "changes", "in", "PA", "and", "ST", ".", "Participants", "were", "in", "their", "late", "50", "s", "(", "58.5", "±", "9.2", "years", ")", "and", "obese", "(", "31.0", "±", "6.5", "kg", "/", "m", "2", ")", ".", "Women", "reported", "doing", "roughly", "34.5", "min", "/", "day", "of", "PA", "and", "spending", "over", "11", "h", "/", "day", "in", "sedentary", "activities", ".", "Across", "groups", ",", "women", "reported", "significant", "increases", "in", "exercise", "self", "-", "efficacy", "and", "moderate", "-", "intensity", ",", "vigorous", "-", "intensity", ",", "and", "total", "PA", "from", "baseline", "to", "follow", "-", "up", "(", "p", "<", "0.05", ")", ".", "Increased", "social", "support", "from", "family", "was", "associated", "with", "increases", "in", "vigorous", "-", "intensity", "PA", ".", "Increases", "in", "social", "modeling", "were", "associated", "with", "increases", "in", "moderate", "-", "intensity", "and", "total", "PA", "and", "with", "decreases", "in", "ST", "from", "baseline", "to", "follow", "-", "up", "(", "p", "<", "0.05", ")", ".", "Hispanic", "cancer", "survivors", "benefit", "from", "PA", "interventions", "that", "focus", "on", "increasing", "social", "support", "from", "family", "and", "friends", "and", "social", "modeling", ".", "Copyright", "©", "2015", "John", "Wiley", "&", "Sons", ",", "Ltd." ]
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89
[ "Maintaining", "normal", "hemoglobin", "levels", "with", "epoetin", "alfa", "in", "mainly", "nonanemic", "patients", "with", "metastatic", "breast", "cancer", "receiving", "first", "-", "line", "chemotherapy", ":", "a", "survival", "study", ".", "To", "evaluate", "the", "effect", "on", "survival", "and", "quality", "of", "life", "of", "maintaining", "hemoglobin", "(", "Hb", ")", "in", "the", "range", "of", "12", "to", "14", "g", "/", "dL", "with", "epoetin", "alfa", "versus", "placebo", "in", "women", "with", "metastatic", "breast", "cancer", "(", "MBC", ")", "receiving", "first", "-", "line", "chemotherapy", ".", "Eligible", "patients", "were", "randomly", "assigned", "to", "receive", "epoetin", "alfa", "40", ",", "000", "U", "once", "weekly", "or", "placebo", "for", "12", "months", ".", "Study", "drug", "was", "initiated", "if", "baseline", "Hb", "was", "<", "or", "=", "13", "g", "/", "dL", "or", "when", "Hb", "decreased", "to", "<", "or", "=", "13", "g", "/", "dL", "during", "the", "study", ".", "The", "primary", "end", "point", "was", "12", "-month", "overall", "survival", "(", "OS", ")", ".", "The", "study", "drug", "administration", "was", "stopped", "early", "in", "accordance", "with", "a", "recommendation", "from", "the", "Independent", "Data", "Monitoring", "Committee", "because", "of", "higher", "mortality", "in", "the", "group", "treated", "with", "epoetin", "alfa", ".", "Enrollment", "had", "been", "completed", ",", "with", "939", "patients", "enrolled", "(", "epoetin", "alfa", ",", "n", "=", "469", ";", "placebo", ",", "n", "=", "470", ")", ".", "Most", "patients", "had", "Hb", "more", "than", "12", "g", "/", "dL", "at", "baseline", "(", "median", "Hb", ",", "12.8", "g", "/", "dL", ")", "or", "during", "the", "study", ".", "From", "the", "final", "analysis", ",", "12", "-month", "OS", "was", "70", "%", "for", "epoetin", "alfa", "recipients", "and", "76", "%", "for", "placebo", "recipients", "(", "P", "=", ".", "01", ")", ".", "Optimal", "tumor", "response", "and", "time", "to", "disease", "progression", "were", "similar", "between", "groups", ".", "The", "reason", "for", "the", "difference", "in", "mortality", "between", "groups", "could", "not", "be", "determined", "from", "additional", "subsequent", "analyses", "involving", "both", "study", "data", "and", "chart", "review", ".", "In", "this", "trial", ",", "the", "use", "of", "epoetin", "alfa", "to", "maintain", "high", "Hb", "targets", "in", "women", "with", "MBC", ",", "most", "of", "whom", "did", "not", "have", "anemia", "at", "the", "start", "of", "treatment", ",", "was", "associated", "with", "decreased", "survival", ".", "Additional", "research", "is", "required", "to", "clarify", "the", "potential", "impact", "of", "erythropoietic", "agents", "on", "survival", "when", "the", "Hb", "target", "range", "is", "10", "to", "12", "g", "/", "dL", "." ]
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90
[ "[", "Comparison", "between", "intratumoral", "and", "peritumoral", "injection", "of", "radiotracer", "for", "locating", "and", "biopsying", "the", "sentinel", "lymph", "node", "in", "nonpalpable", "breast", "cancer", "]", ".", "To", "determine", "whether", "there", "are", "differences", "in", "the", "technical", "efficacy", "in", "detecting", "and", "biopsying", "the", "sentinel", "node", "after", "intratumoral", "or", "peritumoral", "administration", "of", "the", "radiotracer", "in", "patients", "with", "nonpalpable", "early", "-", "stage", "breast", "cancer", ".", "This", "prospective", ",", "randomized", "study", "included", "80", "patients", "with", "nonpalpable", "breast", "cancer", "without", "axillary", "adenopathies", "who", "were", "scheduled", "for", "primary", "surgical", "treatment", ".", "Patients", "were", "randomized", "to", "one", "of", "two", "groups", ":", "the", "INTRA", "group", "(", "intratumoral", "radiotracer", "administration", ",", "n=", "35", ")", "or", "the", "PERI", "group", "(", "peritumoral", "radiotracer", "administration", ",", "n=", "45", ")", ".", "Patients", "with", "suspicious", "axillary", "lymph", "nodes", "at", "clinical", "or", "ultrasonographic", "examination", "that", "had", "positive", "results", "after", "fine", "-", "needle", "aspiration", "cytology", "were", "excluded", ".", "The", "rates", "of", "sentinel", "node", "detection", "were", "97.1", "%", "(", "34", "/", "35", ")", "for", "intratumoral", "injection", "and", "84.4", "%", "(", "38", "/", "45", ")", "for", "peritumoral", "injection", ".", "Radiotracer", "migration", "failure", "occurred", "in", "8", "cases", "(", "one", "in", "the", "INTRA", "group", "and", "7", "in", "the", "PERI", "group", ")", ".", "The", "sentinel", "node", "was", "detected", "in", "an", "extra", "-", "axillary", "location", "in", "21.9", "%", "of", "cases", "(", "11", "/", "59", "in", "the", "INTRA", "group", "and", "16", "/", "64", "in", "the", "PERI", "group", ")", ".", "Our", "study", "found", "no", "statistically", "significant", "differences", "in", "the", "detection", "rates", "of", "axillary", "or", "extra", "-", "axillary", "sentinel", "lymph", "nodes", "between", "the", "two", "groups", ";", "however", ",", "we", "observed", "greater", "technical", "efficacy", "with", "intratumoral", "radiotracer", "administration", "." ]
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95
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97
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98
[ "Anthracycline", "could", "be", "essential", "for", "triple", "-", "negative", "breast", "cancer", ":", "A", "randomised", "phase", "II", "study", "by", "the", "Kanagawa", "Breast", "Oncology", "Group", "(", "KBOG", ")", "1101", ".", "It", "is", "important", "to", "determine", "whether", "anthracycline", "-", "containing", "regimens", "or", "taxane", "-", "containing", "regimens", "are", "more", "effective", "in", "individual", "patients", ".", "The", "present", "study", "compared", "the", "efficacy", "of", "six", "cycles", "of", "docetaxel", "and", "cyclophosphamide", "(", "TC", "6", ")", "with", "that", "of", "three", "cycles", "of", "5", "-fluorouracil", ",", "epirubicin", "and", "cyclophosphamide", "followed", "by", "docetaxel", "(", "FEC", "-", "D", ")", "in", "Japanese", "patients", "with", "hormone", "receptor", "(", "HR", ")", "-negative", "breast", "cancer", "(", "BC", ")", "to", "identify", "subtypes", "requiring", "anthracycline", "treatment", ".", "The", "study", "included", "103", "patients", "with", "operable", "HR", "-", "negative", "BC", ".", "Of", "these", "patients", "53", "received", "FEC", "-", "D", "and", "50", "received", "TC", "6", ".", "The", "primary", "endpoint", "was", "pathological", "complete", "response", "(", "pCR", ")", ".", "The", "secondary", "endpoints", "were", "safety", ",", "breast", "-", "conserving", "surgery", ",", "disease", "-", "free", "survival", "(", "DFS", ")", "and", "overall", "survival", "(", "OS", ")", ".", "The", "predictive", "factors", "for", "each", "regimen", "were", "evaluated", ".", "Of", "the", "103", "patients", ",", "97", "completed", "the", "study", "(", "FEC", "-", "D", ",", "50", "patients", ";", "TC", "6", ",", "47", "patients", ")", ".", "The", "pCR", "rate", "was", "higher", "with", "FEC", "-", "D", "(", "36", "%", ")", "than", "with", "TC", "6", "(", "25.5", "%", ")", ";", "however", ",", "the", "difference", "was", "not", "significant", "(", "P", "=", "0.265", ")", ".", "TC", "6", "was", "safer", "than", "FEC", "-", "D", ",", "as", "the", "adverse", "events", "with", "docetaxel", "in", "the", "FEC", "-", "D", "regimen", "were", "similar", "to", "those", "with", "the", "TC", "6", "regimen", ".", "Among", "patients", "with", "basal", "BC", ",", "the", "pCR", "rate", "was", "significantly", "higher", "with", "FEC", "-", "D", "(", "42.9", "%", ")", "than", "with", "TC", "6", "(", "13.6", "%", ";", "P", "=", "0.033", ")", ".", "Among", "patients", "with", "triple", "-", "negative", "breast", "cancer", "(", "TNBC", ")", ",", "the", "DFS", "and", "OS", "were", "significantly", "better", "with", "FEC", "-", "D", "than", "with", "TC", "6", "(", "P", "=", "0.016", "and", "P", "=", "0.034", ",", "respectively", ")", ".", "TC", "6", "was", "not", "as", "effective", "as", "FEC", "-", "D", "for", "treating", "HR", "-", "negative", "BC", ",", "as", "TC", "6", "was", "not", "sufficient", "to", "treat", "TNBC", ",", "particularly", "the", "basal", "subtype", ".", "Our", "findings", "suggest", "that", "anthracyclines", "are", "better", "treatment", "options", "than", "taxanes", "for", "basal", "BC", "." ]
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99
[ "Randomised", "controlled", "trial", "comparing", "hypnotherapy", "versus", "gabapentin", "for", "the", "treatment", "of", "hot", "flashes", "in", "breast", "cancer", "survivors", ":", "a", "pilot", "study", ".", "To", "compare", "the", "efficacy", "of", "hypnotherapy", "versus", "gabapentin", "for", "the", "treatment", "of", "hot", "flashes", "in", "breast", "cancer", "survivors", ",", "and", "to", "evaluate", "the", "feasibility", "of", "conducting", "a", "clinical", "trial", "comparing", "a", "drug", "with", "a", "complementary", "or", "alternative", "method", "(", "CAM", ")", ".", "Prospective", "randomised", "trial", ".", "Breast", "health", "centre", "of", "a", "tertiary", "care", "centre", ".", "15", "women", "with", "a", "personal", "history", "of", "breast", "cancer", "or", "an", "increased", "risk", "of", "breast", "cancer", "who", "reported", "at", "least", "one", "daily", "hot", "flash", ".", "Gabapentin", "900", "mg", "daily", "in", "three", "divided", "doses", "(", "control", ")", "compared", "with", "standardised", "hypnotherapy", ".", "Participation", "lasted", "8", "weeks", ".", "The", "primary", "endpoints", "were", "the", "number", "of", "daily", "hot", "flashes", "and", "hot", "flash", "severity", "score", "(", "HFSS", ")", ".", "The", "secondary", "endpoint", "was", "the", "Hot", "Flash", "Related", "Daily", "Interference", "Scale", "(", "HFRDIS", ")", ".", "27", "women", "were", "randomised", "and", "15", "(", "56", "%", ")", "were", "considered", "evaluable", "for", "the", "primary", "endpoint", "(", "n=", "8", "gabapentin", ",", "n=", "7", "hypnotherapy", ")", ".", "The", "median", "number", "of", "daily", "hot", "flashes", "at", "enrolment", "was", "4.5", "in", "the", "gabapentin", "arm", "and", "5", "in", "the", "hypnotherapy", "arm", ".", "HFSS", "scores", "were", "7.5", "in", "the", "gabapentin", "arm", "and", "10", "in", "the", "hypnotherapy", "arm", ".", "After", "8", "weeks", ",", "the", "median", "number", "of", "daily", "hot", "flashes", "was", "reduced", "by", "33.3", "%", "in", "the", "gabapentin", "arm", "and", "by", "80", "%", "in", "the", "hypnotherapy", "arm", ".", "The", "median", "HFSS", "was", "reduced", "by", "33.3", "%", "in", "the", "gabapentin", "arm", "and", "by", "85", "%", "in", "the", "hypnotherapy", "arm", ".", "HFRDIS", "scores", "improved", "by", "51.6", "%", "in", "the", "gabapentin", "group", "and", "by", "55.2", "%", "in", "the", "hypnotherapy", "group", ".", "There", "were", "no", "statistically", "significant", "differences", "between", "groups", ".", "Hypnotherapy", "and", "gabapentin", "demonstrate", "efficacy", "in", "improving", "hot", "flashes", ".", "A", "definitive", "trial", "evaluating", "traditional", "interventions", "against", "CAM", "methods", "is", "feasible", ",", "but", "not", "without", "challenges", ".", "Further", "studies", "aimed", "at", "defining", "evidence", "-", "based", "recommendations", "for", "CAM", "are", "necessary", ".", "clinicaltrials", ".", "gov", "(", "NCT", "00711529", ")", "." ]
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