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pico-human-corpus_nerfair_processed

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10459028
[ "A", "randomized", ",", "prospective", "study", "of", "endometrial", "resection", "to", "prevent", "recurrent", "endometrial", "polyps", "in", "women", "with", "breast", "cancer", "receiving", "tamoxifen", ".", "To", "assess", "the", "role", "of", "endometrial", "resection", "in", "preventing", "recurrence", "of", "tamoxifen", "-", "associated", "endometrial", "polyps", "in", "women", "with", "breast", "cancer", ".", "Randomized", ",", "prospective", "study", "(", "Canadian", "Task", "Force", "classification", "I", ")", ".", "Tertiary", "university", "-", "affiliated", "medical", "center", ".", "Twenty", "consecutive", "women", "(", "age", "range", "43", "-", "61", "yrs", ")", ".", "Hysteroscopic", "removal", "of", "tamoxifen", "-", "associated", "endometrial", "polyps", "with", "or", "without", "simultaneous", "resection", "of", "the", "endometrium", ".", "Patients", "were", "randomized", "to", "undergo", "(", "10", "women", ")", "or", "not", "undergo", "(", "10", ")", "concomitant", "endometrial", "resection", ".", "They", "were", "followed", "for", "at", "least", "18", "months", "(", "range", "18", "-", "24", "mo", ")", ",", "including", "transvaginal", "ultrasonography", "every", "6", "months", "and", "hysteroscopy", "when", "endometrial", "irregularity", "was", "noted", ".", "The", "main", "outcome", "variable", "was", "recurrence", "of", "endometrial", "polyps", ";", "occurrence", "of", "uterine", "bleeding", "was", "also", "noted", ".", "In", "women", "who", "underwent", "endometrial", "resection", ",", "only", "one", "had", "a", "1", "x", "1", "-", "cm", "endometrial", "polyp", "diagnosed", "and", "removed", "during", "follow", "-", "up", ".", "Seven", "women", "remained", "amenorrheic", ",", "and", "three", "experienced", "spotting", "for", "a", "few", "days", "every", "month", ".", "In", "the", "control", "group", ",", "six", "women", "had", "recurrent", "endometrial", "polyps", "requiring", "hysteroscopic", "removal", "(", "two", "-", "tail", "Fisher", "'", "s", "exact", "test", "p", "<", "0", ".", "06", ")", ".", "Recurrence", "of", "endometrial", "polyps", ",", "one", "of", "the", "most", "common", "problems", "in", "patients", "with", "breast", "cancer", "receiving", "long", "-", "term", "treatment", "with", "tamoxifen", ",", "may", "be", "reduced", "by", "performing", "endometrial", "resection", "at", "the", "time", "of", "hysteroscopic", "removal", "of", "polyps", ".", "The", "possible", "risk", "of", "occult", "endometrial", "cancer", "is", "yet", "to", "be", "determined", ".", "(", "J", "Am", "Assoc", "Gynecol", "Laparosc", "6", "(", "3", ")", ":", "285", "-", "288", ",", "1999", ")" ]
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10547391
[ "Randomized", "trial", "of", "fenretinide", "to", "prevent", "second", "breast", "malignancy", "in", "women", "with", "early", "breast", "cancer", ".", "Fenretinide", ",", "a", "vitamin", "A", "analogue", ",", "has", "been", "shown", "to", "inhibit", "breast", "carcinogenesis", "in", "preclinical", "studies", ".", "We", "determined", "the", "efficacy", "of", "fenretinide", "in", "preventing", "a", "second", "breast", "malignancy", "in", "women", "with", "breast", "cancer", ".", "We", "randomly", "assigned", "2972", "women", ",", "aged", "30", "-", "70", "years", ",", "with", "surgically", "removed", "stage", "I", "breast", "cancer", "or", "ductal", "carcinoma", "in", "situ", "to", "receive", "for", "5", "years", "either", "fenretinide", "orally", "(", "200", "mg", "/", "day", ")", "or", "no", "treatment", ".", "The", "primary", "end", "point", "was", "the", "incidence", "of", "contralateral", "breast", "cancer", "or", "ipsilateral", "breast", "cancer", "7", "years", "after", "randomization", ".", "Other", "end", "points", "considered", "post", "hoc", "were", "the", "same", "outcomes", "stratified", "by", "menopausal", "status", ",", "incidence", "of", "distant", "metastases", ",", "overall", "mortality", ",", "and", "tumors", "in", "other", "organs", ".", "The", "hazards", "of", "breast", "cancer", "occurrence", "were", "determined", "by", "Cox", "proportional", "hazards", "regression", "analysis", ".", "Statistical", "tests", "were", "two", "-", "sided", ".", "At", "a", "median", "observation", "time", "of", "97", "months", ",", "there", "were", "no", "statistically", "significant", "differences", "in", "the", "occurrence", "of", "contralateral", "breast", "cancer", "(", "P", "=", ".", "642", ")", "or", "ipsilateral", "breast", "cancer", "(", "P", "=", ".", "177", ")", "between", "the", "two", "arms", ".", "However", ",", "an", "interaction", "was", "detected", "between", "fenretinide", "treatment", "and", "menopausal", "status", "in", "both", "outcomes", "(", "P", "for", "interaction", "in", "both", "outcomes", "=", ".", "045", ")", ",", "with", "a", "possible", "beneficial", "effect", "in", "premenopausal", "women", "(", "contralateral", "breast", "cancer", ":", "adjusted", "hazard", "ratio", "[", "HR", "]", "=", "0", ".", "66", ",", "and", "95", "%", "confidence", "interval", "[", "CI", "]", "=", "0", ".", "41", "-", "1", ".", "07", ";", "ipsilateral", "breast", "cancer", ":", "adjusted", "HR", "=", "0", ".", "65", ",", "and", "95", "%", "CI", "=", "0", ".", "46", "-", "0", ".", "92", ")", "and", "an", "opposite", "effect", "in", "postmenopausal", "women", "(", "contralateral", "breast", "cancer", ":", "adjusted", "HR", "=", "1", ".", "32", ",", "and", "95", "%", "CI", "=", "0", ".", "82", "-", "2", ".", "15", ";", "ipsilateral", "breast", "cancer", ":", "adjusted", "HR", "=", "1", ".", "19", ",", "and", "95", "%", "CI", "=", "0", ".", "75", "-", "1", ".", "89", ")", ".", "There", "were", "no", "statistically", "significant", "differences", "between", "the", "two", "arms", "in", "tumors", "in", "other", "organs", ",", "incidence", "of", "distant", "metastasis", ",", "and", "all", "-", "cause", "mortality", ".", "Fenretinide", "treatment", "of", "women", "with", "breast", "cancer", "for", "5", "years", "appears", "to", "have", "no", "statistically", "significant", "effect", "on", "the", "incidence", "of", "second", "breast", "malignancies", "overall", ",", "although", "a", "possible", "benefit", "was", "detected", "in", "premenopausal", "women", ".", "These", "studies", ",", "particularly", "the", "post", "hoc", "analyses", ",", "are", "considered", "exploratory", "and", "need", "to", "be", "confirmed", "." ]
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11136837
[ "Cardiovascular", "effects", "of", "tamoxifen", "in", "women", "with", "and", "without", "heart", "disease", ":", "breast", "cancer", "prevention", "trial", ".", "National", "Surgical", "Adjuvant", "Breast", "and", "Bowel", "Project", "Breast", "Cancer", "Prevention", "Trial", "Investigators", ".", "The", "overall", "effect", "of", "prophylactic", "tamoxifen", "in", "women", "depends", "on", "the", "balance", "between", "the", "effects", "of", "the", "drug", ",", "which", "include", "preventing", "breast", "cancer", "and", "altering", "cardiovascular", "risk", ".", "In", "a", "recent", "clinical", "trial", ",", "postmenopausal", "estrogen", "-", "progestin", "therapy", "was", "shown", "to", "increase", "the", "risk", "of", "early", "cardiovascular", "events", "among", "women", "with", "a", "history", "of", "coronary", "heart", "disease", "(", "CHD", ")", ".", "The", "cardiovascular", "effects", "of", "tamoxifen", "in", "women", "with", "and", "without", "CHD", "are", "not", "known", ".", "The", "National", "Surgical", "Adjuvant", "Breast", "and", "Bowel", "Project", "Breast", "Cancer", "Prevention", "Trial", "(", "BCPT", ")", "is", "the", "only", "clinical", "trial", "that", "provides", "data", "to", "assess", "the", "cardiovascular", "effects", "of", "tamoxifen", "in", "women", "with", "and", "without", "CHD", ".", "A", "total", "of", "13", "388", "women", "at", "increased", "risk", "for", "breast", "cancer", "were", "randomly", "assigned", "in", "the", "BCPT", "to", "receive", "either", "tamoxifen", "(", "20", "mg", "/", "day", ")", "or", "placebo", ".", "Cardiovascular", "follow", "-", "up", "was", "available", "for", "13", "194", "women", ",", "1048", "of", "whom", "had", "prior", "clinical", "CHD", ".", "Fatal", "and", "nonfatal", "myocardial", "infarction", ",", "unstable", "angina", ",", "and", "severe", "angina", "were", "tabulated", "(", "mean", "follow", "-", "up", ":", "49", "months", ")", ".", "All", "statistical", "tests", "were", "two", "-", "sided", ".", "Cardiovascular", "event", "rates", "were", "not", "statistically", "significantly", "different", "between", "women", "assigned", "to", "receive", "tamoxifen", "and", "those", "assigned", "to", "receive", "placebo", ",", "independent", "of", "pre", "-", "existing", "CHD", ".", "Among", "women", "without", "CHD", "(", "6074", "on", "tamoxifen", "versus", "6072", "on", "placebo", ")", ",", "risk", "ratios", "(", "95", "%", "confidence", "intervals", "[", "CIs", "]", ")", "for", "tamoxifen", "users", "were", "1", ".", "75", "(", "0", ".", "44", "to", "8", ".", "13", ")", "for", "fatal", "myocardial", "infarction", ",", "1", ".", "11", "(", "0", ".", "55", "to", "2", ".", "28", ")", "for", "nonfatal", "myocardial", "infarction", ",", "0", ".", "69", "(", "0", ".", "29", "to", "1", ".", "57", ")", "for", "unstable", "angina", ",", "and", "0", ".", "83", "(", "0", ".", "32", "to", "2", ".", "10", ")", "for", "severe", "angina", ".", "In", "women", "with", "CHD", "(", "516", "on", "tamoxifen", "versus", "532", "on", "placebo", ")", ",", "risk", "ratios", "(", "95", "%", "CIs", ")", "for", "tamoxifen", "users", "were", "0", ".", "00", "(", "0", "to", "1", ".", "58", ")", "for", "fatal", "myocardial", "infarction", ",", "1", ".", "25", "(", "0", ".", "32", "to", "5", ".", "18", ")", "for", "nonfatal", "myocardial", "infarction", ",", "2", ".", "26", "(", "0", ".", "87", "to", "6", ".", "55", ")", "for", "unstable", "angina", ",", "and", "1", ".", "39", "(", "0", ".", "23", "to", "9", ".", "47", ")", "for", "severe", "angina", ".", "There", "was", "no", "evidence", "that", "the", "lack", "of", "association", "between", "tamoxifen", "and", "cardiovascular", "events", "was", "related", "to", "an", "early", "increase", "in", "risk", "that", "may", "have", "been", "offset", "by", "a", "late", "decrease", "in", "risk", ".", "When", "used", "for", "breast", "cancer", "prevention", "in", "women", "with", "or", "without", "heart", "disease", ",", "tamoxifen", "is", "not", "associated", "with", "beneficial", "or", "adverse", "cardiovascular", "effects", "." ]
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11283119
[ "Tamoxifen", "for", "the", "prevention", "of", "breast", "cancer", ":", "psychosocial", "impact", "on", "women", "participating", "in", "two", "randomized", "controlled", "trials", ".", "The", "purpose", "of", "this", "study", "was", "to", "evaluate", "the", "psychosocial", "implications", "of", "tamoxifen", "versus", "placebo", "in", "women", "who", "are", "at", "increased", "risk", "of", "breast", "cancer", ".", "The", "488", "women", "in", "the", "psychosocial", "study", "were", "recruited", "from", "participants", "in", "two", "placebo", "-", "controlled", ",", "double", "-", "blind", ",", "randomized", ",", "controlled", "trials", "that", "investigated", "the", "efficacy", "of", "tamoxifen", "in", "the", "prevention", "of", "breast", "cancer", "in", "women", "who", "are", "at", "high", "familial", "risk", ".", "During", "a", "5", "-", "year", "period", ",", "repeated", "assessments", "were", "made", "of", "anxiety", ",", "psychological", "distress", ",", "and", "sexual", "functioning", "using", "standardized", "questionnaires", "before", "treatment", "at", "baseline", "and", "at", "6", "-", "month", "intervals", "during", "the", "trial", ".", "Questionnaire", "completion", "over", "5", "years", "was", "good", ",", "with", "71", ".", "1", "%", "of", "women", "returning", "at", "least", "8", "of", "10", "follow", "-", "up", "assessments", ".", "Although", "scores", "from", "individuals", "showed", "considerable", "fluctuation", "and", "variation", "over", "time", ",", "changes", "in", "anxiety", ",", "mood", ",", "and", "sexual", "functioning", "were", "not", "associated", "with", "treatment", "group", ".", "The", "number", "of", "symptoms", "reported", "at", "48", "months", "via", "a", "self", "-", "report", "checklist", "were", "not", "associated", "with", "treatment", "group", ",", "but", "vasomotor", "symptoms", "were", "more", "frequent", "among", "tamoxifen", "-", "treated", "women", ".", "Symptoms", "of", "low", "energy", ",", "breast", "sensitivity", ",", "and", "visual", "blurring", "were", "reported", "most", "frequently", "in", "the", "placebo", "group", ".", "In", "general", ",", "these", "results", "are", "comparable", "to", "those", "from", "the", "National", "Surgical", "Adjuvant", "Breast", "and", "Bowel", "Project", "psychosocial", "study", "despite", "differences", "in", "study", "populations", ",", "methodology", ",", "and", "instruments", ".", "The", "long", "-", "term", "use", "of", "tamoxifen", "and", "other", "selective", "estrogen", "response", "modulators", "as", "preventive", "agents", "in", "high", "-", "risk", "groups", "has", "been", "questioned", ",", "but", "we", "found", "no", "evidence", "of", "treatment", "-", "related", "side", "effects", "that", "affect", "women", "'", "s", "psychosocial", "and", "sexual", "functioning", "." ]
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12374678
[ "A", "phase", "II", "breast", "cancer", "chemoprevention", "trial", "of", "oral", "alpha", "-", "difluoromethylornithine", ":", "breast", "tissue", ",", "imaging", ",", "and", "serum", "and", "urine", "biomarkers", ".", "A", "double", "-", "blind", "randomized", "Phase", "II", "chemoprevention", "trial", "of", "alpha", "-", "difluoromethylornithine", "(", "DFMO", ")", "was", "conducted", "in", "a", "group", "of", "women", "at", "high", "risk", "for", "development", "of", "breast", "cancer", ".", "DFMO", "is", "an", "irreversible", "inhibitor", "of", "ornithine", "decarboxylase", ",", "the", "limiting", "enzyme", "of", "polyamine", "synthesis", "that", "is", "often", "up", "-", "regulated", "in", "breast", "cancer", ".", "Study", "entrants", "were", "required", "to", "have", "random", "periareolar", "fine", "-", "needle", "aspiration", "cytology", "prior", "to", "entry", "that", "exhibited", "hyperplasia", "or", "hyperplasia", "with", "atypia", ",", "as", "well", "as", "a", "mammogram", "and", "clinical", "breast", "exam", "judged", "as", "not", "suspicious", "for", "breast", "cancer", "and", "no", "clinical", "hearing", "loss", ".", "Subjects", "were", "randomized", "to", "6", "months", "of", "oral", "DFMO", "(", "0", ".", "5", "g", "/", "m", "(", "2", ")", "/", "day", ")", "or", "placebo", ",", "followed", "by", "repeat", "fine", "-", "needle", "aspiration", "and", "biomarker", "assessment", ".", "The", "main", "study", "end", "point", "was", "an", "improvement", "in", "cytologic", "pattern", ".", "Of", "119", "subjects", "entered", ",", "96", "%", "completed", "the", "study", "and", "were", "evaluable", "for", "the", "main", "study", "end", "point", ".", "A", "modest", "reduction", "(", "28", "%", ")", "in", "average", "total", "urine", "polyamines", "was", "obtained", "in", "the", "DFMO", "group", ",", "but", "there", "was", "no", "reduction", "in", "the", "spermidine", ":", "spermine", "ratio", ".", "There", "was", "no", "difference", "in", "cytologic", "improvement", "between", "DFMO", "and", "placebo", ".", "Likewise", ",", "there", "was", "no", "difference", "between", "DFMO", "and", "placebo", "for", "the", "secondary", "end", "points", "of", "breast", "molecular", "marker", "changes", "(", "immunocytochemical", "expression", "of", "proliferating", "cell", "nuclear", "antigen", ",", "p53", ",", "and", "epidermal", "growth", "factor", "receptor", ")", ",", "mammographic", "breast", "density", ",", "serum", "insulin", "-", "like", "growth", "factor", "I", ":", "insulin", "-", "like", "growth", "factor", "binding", "protein", "3", "ratio", ",", "adverse", "events", ",", "quality", "of", "life", "indices", ",", "or", "subsequent", "cancer", "development", ".", "DFMO", "at", "a", "dose", "level", "of", "0", ".", "5", "g", "/", "m", "(", "2", ")", "/", "day", "administered", "for", "6", "months", "does", "not", "modulate", "breast", "risk", "biomarkers", "tested", "in", "this", "study", "." ]
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12377957
[ "Tamoxifen", ",", "radiation", "therapy", ",", "or", "both", "for", "prevention", "of", "ipsilateral", "breast", "tumor", "recurrence", "after", "lumpectomy", "in", "women", "with", "invasive", "breast", "cancers", "of", "one", "centimeter", "or", "less", ".", "This", "trial", "was", "prompted", "by", "uncertainty", "about", "the", "need", "for", "breast", "irradiation", "after", "lumpectomy", "in", "node", "-", "negative", "women", "with", "invasive", "breast", "cancers", "of", "<", "/", "=", "1", "cm", ",", "by", "speculation", "that", "tamoxifen", "(", "TAM", ")", "might", "be", "as", "or", "more", "effective", "than", "radiation", "therapy", "(", "XRT", ")", "in", "reducing", "the", "rate", "of", "ipsilateral", "breast", "tumor", "recurrence", "(", "IBTR", ")", "in", "such", "women", ",", "and", "by", "the", "thesis", "that", "both", "modalities", "might", "be", "more", "effective", "than", "either", "alone", ".", "After", "lumpectomy", ",", "1", ",", "009", "women", "were", "randomly", "assigned", "to", "TAM", "(", "n", "=", "336", ")", ",", "XRT", "and", "placebo", "(", "n", "=", "336", ")", ",", "or", "XRT", "and", "TAM", "(", "n", "=", "337", ")", ".", "Rates", "of", "IBTR", ",", "distant", "recurrence", ",", "and", "contralateral", "breast", "cancer", "(", "CBC", ")", "were", "among", "the", "end", "points", "for", "analysis", ".", "Cumulative", "incidence", "of", "IBTR", "and", "of", "CBC", "was", "computed", "accounting", "for", "competing", "risks", ".", "Results", "with", "two", "-", "sided", "P", "values", "of", ".", "05", "or", "less", "were", "statistically", "significant", ".", "XRT", "and", "placebo", "resulted", "in", "a", "49", "%", "lower", "hazard", "rate", "of", "IBTR", "than", "did", "TAM", "alone", ";", "XRT", "and", "TAM", "resulted", "in", "a", "63", "%", "lower", "rate", "than", "did", "XRT", "and", "placebo", ".", "When", "compared", "with", "TAM", "alone", ",", "XRT", "plus", "TAM", "resulted", "in", "an", "81", "%", "reduction", "in", "hazard", "rate", "of", "IBTR", ".", "Cumulative", "incidence", "of", "IBTR", "through", "8", "years", "was", "16", ".", "5", "%", "with", "TAM", ",", "9", ".", "3", "%", "with", "XRT", "and", "placebo", ",", "and", "2", ".", "8", "%", "with", "XRT", "and", "TAM", ".", "XRT", "reduced", "IBTR", "below", "the", "level", "achieved", "with", "TAM", "alone", ",", "regardless", "of", "estrogen", "receptor", "(", "ER", ")", "status", ".", "Distant", "treatment", "failures", "were", "infrequent", "and", "not", "significantly", "different", "among", "the", "groups", "(", "P", "=", ".", "28", ")", ".", "When", "TAM", "-", "treated", "women", "were", "compared", "with", "those", "who", "received", "XRT", "and", "placebo", ",", "there", "was", "a", "significant", "reduction", "in", "CBC", "(", "hazard", "ratio", ",", "0", ".", "45", ";", "95", "%", "confidence", "interval", ",", "0", ".", "21", "to", "0", ".", "95", ";", "P", "=", ".", "039", ")", ".", "Survival", "in", "the", "three", "groups", "was", "93", "%", ",", "94", "%", ",", "and", "93", "%", ",", "respectively", "(", "P", "=", ".", "93", ")", ".", "In", "women", "with", "tumors", "<", "/", "=", "1", "cm", ",", "IBTR", "occurs", "with", "enough", "frequency", "after", "lumpectomy", "to", "justify", "considering", "XRT", ",", "regardless", "of", "tumor", "ER", "status", ",", "and", "TAM", "plus", "XRT", "when", "tumors", "are", "ER", "positive", "." ]
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12393819
[ "Twenty", "-", "year", "follow", "-", "up", "of", "a", "randomized", "study", "comparing", "breast", "-", "conserving", "surgery", "with", "radical", "mastectomy", "for", "early", "breast", "cancer", ".", "We", "conducted", "20", "years", "of", "follow", "-", "up", "of", "women", "enrolled", "in", "a", "randomized", "trial", "to", "compare", "the", "efficacy", "of", "radical", "(", "Halsted", ")", "mastectomy", "with", "that", "of", "breast", "-", "conserving", "surgery", ".", "From", "1973", "to", "1980", ",", "701", "women", "with", "breast", "cancers", "measuring", "no", "more", "than", "2", "cm", "in", "diameter", "were", "randomly", "assigned", "to", "undergo", "radical", "mastectomy", "(", "349", "patients", ")", "or", "breast", "-", "conserving", "surgery", "(", "quadrantectomy", ")", "followed", "by", "radiotherapy", "to", "the", "ipsilateral", "mammary", "tissue", "(", "352", "patients", ")", ".", "After", "1976", ",", "patients", "in", "both", "groups", "who", "had", "positive", "axillary", "nodes", "also", "received", "adjuvant", "chemotherapy", "with", "cyclophosphamide", ",", "methotrexate", ",", "and", "fluorouracil", ".", "Thirty", "women", "in", "the", "group", "that", "underwent", "breast", "-", "conserving", "therapy", "had", "a", "recurrence", "of", "tumor", "in", "the", "same", "breast", ",", "whereas", "eight", "women", "in", "the", "radical", "-", "mastectomy", "group", "had", "local", "recurrences", "(", "P", "<", "0", ".", "001", ")", ".", "The", "crude", "cumulative", "incidence", "of", "these", "events", "was", "8", ".", "8", "percent", "and", "2", ".", "3", "percent", ",", "respectively", ",", "after", "20", "years", ".", "In", "contrast", ",", "there", "was", "no", "significant", "difference", "between", "the", "two", "groups", "in", "the", "rates", "of", "contralateral", "-", "breast", "carcinomas", ",", "distant", "metastases", ",", "or", "second", "primary", "cancers", ".", "After", "a", "median", "follow", "-", "up", "of", "20", "years", ",", "the", "rate", "of", "death", "from", "all", "causes", "was", "41", ".", "7", "percent", "in", "the", "group", "that", "underwent", "breast", "-", "conserving", "surgery", "and", "41", ".", "2", "percent", "in", "the", "radical", "-", "mastectomy", "group", "(", "P", "=", "1", ".", "0", ")", ".", "The", "respective", "rates", "of", "death", "from", "breast", "cancer", "were", "26", ".", "1", "percent", "and", "24", ".", "3", "percent", "(", "P", "=", "0", ".", "8", ")", ".", "The", "long", "-", "term", "survival", "rate", "among", "women", "who", "undergo", "breast", "-", "conserving", "surgery", "is", "the", "same", "as", "that", "among", "women", "who", "undergo", "radical", "mastectomy", ".", "Breast", "-", "conserving", "surgery", "is", "therefore", "the", "treatment", "of", "choice", "for", "women", "with", "relatively", "small", "breast", "cancers", "." ]
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12425756
[ "Dose", "-", "dense", "biweekly", "doxorubicin", "/", "docetaxel", "versus", "sequential", "neoadjuvant", "chemotherapy", "with", "doxorubicin", "/", "cyclophosphamide", "/", "docetaxel", "in", "operable", "breast", "cancer", ":", "second", "interim", "analysis", ".", "Timing", "of", "systemic", "treatment", "in", "primary", "operable", "breast", "cancer", "is", "subject", "to", "extensive", "investigation", ",", "suggesting", "that", "pathologic", "complete", "remission", "(", "pCR", ")", "might", "improve", "survival", "in", "this", "setting", ".", "The", "German", "Adjuvant", "Breast", "Cancer", "Group", "previously", "demonstrated", "the", "feasibility", "of", "a", "dose", "-", "dense", "biweekly", "schedule", "of", "4", "cycles", "doxorubicin", "50", "mg", "/", "m2", "and", "docetaxel", "75", "mg", "/", "m2", "(", "ddAT", ")", "+", "/", "-", "tamoxifen", "in", "the", "neoadjuvant", "setting", "to", "yield", "a", "pCR", "of", "9", ".", "7", "%", "(", "Gepardo", "trial", ")", ".", "Patients", "assigned", "to", "ddAT", "received", "prophylactic", "granulocyte", "colony", "-", "stimulating", "factor", "support", "(", "5", "micro", "g", "/", "kg", "days", "5", "-", "10", ")", ".", "The", "current", "study", "(", "GeparDUO", ")", "was", "designed", "to", "assess", "whether", "the", "pCR", "rate", ",", "including", "no", "viable", "invasive", "and", "preinvasive", "tumor", "cells", ",", "achieved", "with", "ddAT", "was", "equivalent", "to", "sequential", "administration", "of", "doxorubicin", "/", "cyclophosphamide", "followed", "by", "docetaxel", "(", "AC", "-", "DOC", ")", "over", "24", "weeks", "in", "primary", "operable", "breast", "cancer", ".", "From", "June", "1999", "to", "September", "2001", ",", "913", "patients", "were", "enrolled", "in", "this", "trial", ".", "In", "total", ",", "395", "patients", "randomized", "before", "August", "1", ",", "2000", ",", "were", "included", "in", "the", "second", "interim", "analysis", ".", "Safety", "data", "were", "available", "from", "369", "patients", "(", "ddAT", ",", "n", "=", "191", ";", "AC", "-", "DOC", ",", "n", "=", "178", ")", "demonstrating", "that", "toxicity", "of", "both", "regimens", "was", "tolerable", ".", "Grade", "3", "/", "4", "neutropenia", "occurred", "in", "39", ".", "8", "%", "of", "patients", "receiving", "ddAT", "and", "in", "69", ".", "3", "%", "of", "patients", "treated", "with", "AC", "-", "DOC", ".", "Efficacy", "data", "were", "available", "in", "378", "patients", ".", "A", "pCR", "occurred", "in", "14", ".", "8", "%", "of", "the", "primary", "breast", "tumors", ".", "According", "to", "the", "recommendations", "of", "the", "data", "monitoring", "committee", ",", "recruitment", "to", "the", "study", "was", "halted", "as", "of", "September", "2001", "(", "n", "=", "913", "/", "1000", ")", "due", "to", "the", "significant", "difference", "in", "pCR", "rates", "observed", "between", "the", "treatment", "arms", ".", "Surgery", "was", "documented", "in", "380", "patients", ".", "Breast", "conservation", "was", "possible", "in", "288", "cases", "(", "75", ".", "8", "%", ")", ".", "The", "application", "of", "both", "schedules", "is", "safe", "and", "feasible", "in", "an", "outpatient", "setting", ".", "Although", ",", "results", "obtained", "from", "this", "interim", "analysis", "are", "encouraging", ",", "caution", "is", "recommended", "until", "the", "results", "obtained", "show", "statistical", "difference", "in", "pCR", "." ]
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12439707
[ "Docetaxel", "vs", "5", "-", "fluorouracil", "plus", "vinorelbine", "in", "metastatic", "breast", "cancer", "after", "anthracycline", "therapy", "failure", ".", "This", "multicentre", ",", "randomised", "phase", "III", "study", "compared", "docetaxel", "with", "5", "-", "fluorouracil", "+", "vinorelbine", "in", "patients", "with", "metastatic", "breast", "cancer", "after", "failure", "of", "neo", "/", "adjuvant", "or", "one", "line", "of", "palliative", "anthracycline", "-", "based", "chemotherapy", ".", "One", "hundred", "and", "seventy", "-", "six", "metastatic", "breast", "cancer", "patients", "were", "randomised", "to", "receive", "docetaxel", "(", "100", "mg", "m", "(", "-", "2", ")", ")", "every", "3", "weeks", "or", "5", "-", "fluorouracil", "+", "vinorelbine", ":", "5", "-", "fluorouracil", "(", "750", "mg", "m", "(", "-", "2", ")", "per", "day", "continuous", "infusion", ")", "D1", "-", "5", "plus", "vinorelbine", "(", "25", "mg", "m", "(", "-", "2", ")", ")", "D1", "and", "D5", "of", "each", "3", "-", "week", "cycle", ".", "Eighty", "-", "six", "patients", "received", "516", "cycles", "of", "docetaxel", ";", "90", "patients", "received", "476", "cycles", "of", "5", "-", "fluorouracil", "+", "vinorelbine", ".", "Median", "time", "to", "progression", "(", "6", ".", "5", "vs", "5", ".", "1", "months", ")", "and", "overall", "survival", "(", "16", ".", "0", "vs", "15", ".", "0", "months", ")", "did", "not", "differ", "significantly", "between", "the", "docetaxel", "and", "5", "-", "fluorouracil", "+", "vinorelbine", "arms", ",", "respectively", ".", "Six", "(", "7", "%", ")", "complete", "responses", "and", "31", "(", "36", "%", ")", "partial", "responses", "occurred", "with", "docetaxel", "(", "overall", "response", "rate", "43", "%", ",", "95", "%", "confidence", "interval", ":", "32", "-", "53", "%", ")", ",", "while", "4", "(", "4", ".", "4", "%", ")", "complete", "responses", "and", "31", "(", "34", ".", "4", "%", ")", "partial", "responses", "occurred", "with", "5", "-", "fluorouracil", "+", "vinorelbine", "(", "overall", "response", "rate", "38", ".", "8", "%", ",", "95", "%", "confidence", "interval", ":", "29", "-", "49", "%", ")", ".", "Main", "grade", "3", "-", "4", "toxicities", "were", "(", "docetaxel", "vs", "5", "-", "fluorouracil", "+", "vinorelbine", ")", ":", "neutropenia", "82", "%", "vs", "67", "%", ";", "stomatitis", "5", "%", "vs", "40", "%", ";", "febrile", "neutropenia", "13", "%", "vs", "22", "%", ";", "and", "infection", "2", "%", "vs", "7", "%", ".", "There", "was", "one", "possible", "treatment", "-", "related", "death", "in", "the", "docetaxel", "arm", "and", "five", "with", "5", "-", "fluorouracil", "+", "vinorelbine", ".", "In", "anthracycline", "-", "pretreated", "metastatic", "breast", "cancer", "patients", ",", "docetaxel", "showed", "comparable", "efficacy", "to", "5", "-", "fluorouracil", "+", "vinorelbine", ",", "but", "was", "less", "toxic", "." ]
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12540501
[ "Fenretinide", "breast", "cancer", "prevention", "trial", ":", "drug", "and", "retinol", "plasma", "levels", "in", "relation", "to", "age", "and", "disease", "outcome", ".", "To", "assess", ",", "in", "women", "participating", "in", "a", "breast", "cancer", "prevention", "trialon", "fenretinide", "(", "4", "-", "HPR", ")", ",", "the", "relationship", "of", "drug", "and", "retinol", "levels", "with", "the", "risk", "of", "second", "breast", "malignancy", ",", "taking", "into", "account", "age", "and", "menopausal", "status", ".", "In", "a", "multicenter", "prevention", "trial", ",", "women", "with", "early", "breast", "cancer", "were", "randomly", "assigned", "to", "receive", "no", "treatment", "or", "200", "mg", "of", "4", "-", "HPR", "/", "day", "for", "5", "years", ".", "Blood", "was", "collected", "at", "baseline", "and", "on", "a", "yearly", "basis", "during", "intervention", "from", "women", "recruited", "at", "the", "Istituto", "Tumori", "(", "Milan", ",", "Italy", ";", "818", "and", "756", "in", "the", "4", "-", "HPR", "and", "control", "arm", ",", "respectively", ",", "who", "accounted", "for", "53", "%", "of", "the", "participants", "in", "the", "trial", ")", ".", "The", "plasma", "concentrations", "of", "4", "-", "HPR", ",", "its", "main", "metabolite", "N", "-", "(", "4", "-", "methoxyphenyl", ")", "retinamide", ",", "and", "retinol", "were", "assayed", "by", "high", "-", "performance", "liquid", "chromatography", ".", "Three", "age", "ranges", "(", "<", "or", "=", "45", ",", "46", "-", "55", ",", "and", ">", "or", "=", "56", "years", ")", ",", "menopausal", "status", "at", "baseline", ",", "and", "disease", "outcome", "at", "a", "median", "follow", "-", "up", "of", "97", "months", "were", "taken", "into", "account", "in", "the", "analysis", ".", "Baseline", "retinol", "levels", "were", "significantly", "lower", "(", "P", "<", "or", "=", "0", ".", "05", ")", "in", "subjects", "<", "or", "=", "45", "years", "than", "in", "older", "subjects", ",", "and", "among", "subjects", "in", "the", "age", "range", "46", "-", "55", "years", ",", "they", "were", "significantly", "higher", "(", "P", "<", "or", "=", "0", ".", "001", ")", "in", "those", "in", "postmenopause", "than", "in", "those", "in", "premenopause", ".", "Baseline", "retinol", "levels", "were", "not", "related", "to", "the", "risk", "of", "a", "second", "breast", "malignancy", ".", "4", "-", "HPR", "and", "N", "-", "(", "4", "-", "methoxyphenyl", ")", "retinamide", "levels", "were", "not", "affected", "by", "menopausal", "status", ".", "They", "slightly", ",", "but", "significantly", "(", "P", "<", "or", "=", "0", ".", "05", ")", ",", "increased", "with", "age", "(", ">", "or", "=", "46", "years", "versus", "<", "or", "=", "45", "years", ")", "but", "only", "in", "disease", "-", "free", "subjects", ".", "Among", "subjects", "<", "45", "years", ",", "they", "were", "slightly", ",", "but", "significantly", "(", "P", "<", "or", "=", "0", ".", "05", ")", ",", "higher", "in", "those", "subjects", "in", "which", "breast", "cancer", "recurred", ".", "4", "-", "HPR", "treatment", "caused", "a", "retinol", "level", "reduction", ",", "which", "was", "strongly", "(", "r", ">", "or", "=", "0", ".", "71", ";", "P", "<", "or", "=", "0", ".", "001", ")", "related", "to", "pretreatment", "retinol", "levels", ".", "Retinol", "plasma", "levels", "increased", "with", "age", "and", "after", "menopause", "and", "were", "not", "related", "to", "breast", "cancer", "recurrence", ".", "4", "-", "HPR", "levels", "were", "lower", "in", "subjects", "<", "45", "years", "than", "in", "older", "subjects", ".", "The", "inverse", "relationship", "between", "drug", "plasma", "levels", "and", "4", "-", "HPR", "preventive", "effects", "observed", "in", "young", "women", "suggests", "a", "role", "for", "4", "-", "HPR", "plasma", "sequestration", "in", "4", "-", "HPR", "biological", "activity", "." ]
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12598347
[ "Tamoxifen", "alone", "versus", "adjuvant", "tamoxifen", "for", "operable", "breast", "cancer", "of", "the", "elderly", ":", "long", "-", "term", "results", "of", "the", "phase", "III", "randomized", "controlled", "multicenter", "GRETA", "trial", ".", "To", "evaluate", "the", "efficacy", "of", "tamoxifen", "as", "primary", "treatment", "in", "women", "aged", "over", "70", "years", "with", "operable", "breast", "cancer", "versus", "surgery", "followed", "by", "adjuvant", "tamoxifen", ".", "Patients", "randomly", "received", "tamoxifen", "alone", "(", "160", "mg", "day", "1", ",", "then", "20", "mg", "/", "day", ")", "for", "5", "years", "or", "surgery", "followed", "by", "tamoxifen", "(", "20", "mg", "/", "day", ")", "for", "5", "years", ".", "Overall", "survival", "was", "the", "main", "study", "end", "point", ";", "secondary", "objectives", "included", "breast", "cancer", "survival", "and", "local", "control", "of", "the", "disease", ".", "Between", "1987", "and", "1992", ",", "239", "patients", "were", "assigned", "to", "surgery", "plus", "tamoxifen", "and", "235", "to", "tamoxifen", "alone", ".", "Treatment", "arms", "were", "comparable", "for", "tumor", "size", ",", "clinical", "nodal", "status", "and", "performance", "status", ".", "At", "a", "median", "follow", "-", "up", "of", "80", "months", "274", "patients", "had", "died", ".", "No", "difference", "between", "groups", "had", "emerged", "in", "overall", "and", "breast", "cancer", "survival", ".", "There", "were", "27", "local", "progressions", "in", "the", "surgery", "plus", "tamoxifen", "group", "and", "106", "in", "the", "tamoxifen", "-", "alone", "group", "(", "P", "=", "0", ".", "0001", ")", ".", "In", "the", "surgery", "plus", "tamoxifen", "group", ",", "no", "difference", "in", "overall", "survival", "had", "emerged", "according", "to", "the", "extension", "of", "operation", ".", "The", "long", "-", "term", "results", "of", "the", "study", "confirm", "the", "3", "-", "year", "interim", "analysis", "already", "reported", ".", "Surgery", "(", "radical", "or", "minimal", ")", "followed", "by", "adjuvant", "tamoxifen", "does", "not", "modify", "overall", "and", "breast", "cancer", "survival", "as", "compared", "with", "tamoxifen", "alone", "in", "early", "breast", "cancer", "of", "older", "women", ".", "Because", "of", "the", "high", "rate", "of", "local", "progressions", "with", "tamoxifen", "alone", ",", "minimal", "surgery", "followed", "by", "tamoxifen", "appears", "to", "be", "the", "appropriate", "treatment", "in", "such", "patients", ".", "More", "extensive", "surgery", "is", "not", "useful", ".", "Tamoxifen", "alone", "is", "an", "adequate", "alternative", "treatment", "in", "very", "old", "or", "frail", "patients", "." ]
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12609560
[ "Cimicifuga", "racemosa", "for", "the", "treatment", "of", "hot", "flushes", "in", "women", "surviving", "breast", "cancer", ".", "To", "examine", "the", "effect", "of", "Cimicifuga", "racemosa", "(", "CR", "BNO", "1055", ")", "on", "hot", "flushes", "caused", "by", "tamoxifen", "adjuvant", "therapy", "in", "young", "premenopausal", "breast", "cancer", "survivors", ".", "This", "treatment", "presents", "an", "off", "-", "label", "use", "of", "CR", "BNO", "1055", ".", "Between", "May", "1999", "and", "December", "2001", ",", "we", "accrued", "136", "breast", "cancer", "survivors", "aged", "35", "-", "52", "years", ".", "After", "treatment", "with", "segmental", "or", "total", "mastectomy", ",", "radiation", "therapy", "and", "adjuvant", "chemotherapy", ",", "participants", "were", "in", "open", "-", "label", "randomly", "assigned", "(", "1", "-", "2", ")", "to", "receive", "tamoxifen", "20", "mg", "per", "day", "orally", "(", "usual", "-", "care", "group", ";", "n", "=", "46", ")", "or", "tamoxifen", "(", "same", "dose", "and", "posology", ")", "plus", "CR", "BNO", "1055", "(", "Menofem", "/", "Klimadynon", ",", "corresponding", "to", "20", "mg", "of", "herbal", "drug", ";", "intervention", "group", "n", "=", "90", ")", ".", "Duration", "of", "treatment", "was", "5", "years", "for", "tamoxifen", ",", "according", "to", "international", "standards", "for", "adjuvant", "therapies", ",", "and", "12", "months", "for", "CR", "BNO", "1055", ".", "Follow", "-", "up", "included", "clinical", "assessment", "every", "2", "months", ";", "the", "primary", "endpoint", "was", "to", "record", "the", "number", "and", "intensity", "of", "hot", "flushes", ".", "Comparing", "patients", "assigned", "to", "usual", "-", "care", "group", "with", "those", "assigned", "to", "intervention", "group", ",", "the", "number", "and", "severity", "of", "hot", "flushes", "were", "reduced", "after", "intervention", ".", "Almost", "half", "of", "the", "patients", "of", "the", "intervention", "group", "were", "free", "of", "hot", "flushes", ",", "while", "severe", "hot", "flushes", "were", "reported", "by", "24", ".", "4", "%", "of", "patients", "of", "intervention", "group", "and", "73", ".", "9", "%", "of", "the", "usual", "-", "care", "group", "(", "P", "<", "0", ".", "01", ")", ".", "Hot", "flushes", "were", "the", "most", "frequent", "adverse", "reaction", "to", "tamoxifen", "adjuvant", "therapy", "in", "breast", "cancer", "survivors", ".", "The", "combined", "administration", "of", "tamoxifen", "plus", "CR", "BNO", "1055", "for", "a", "period", "of", "12", "months", "allowed", "satisfactory", "reduction", "in", "the", "number", "and", "severity", "of", "hot", "flushes", "." ]
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12621740
[ "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", "25th", "and", "75th", "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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12637464
[ "Phase", "II", ",", "randomized", ",", "double", "-", "blind", "study", "of", "two", "dose", "levels", "of", "arzoxifene", "in", "patients", "with", "locally", "advanced", "or", "metastatic", "breast", "cancer", ".", "To", "select", "a", "daily", "dose", "of", "arzoxifene", "(", "LY353381", ")", ",", "a", "selective", "estrogen", "receptor", "modulator", ",", "for", "use", "in", "future", "studies", "in", "women", "with", "locally", "advanced", "or", "metastatic", "breast", "cancer", "who", "are", "either", "potentially", "tamoxifen", "sensitive", "(", "TS", ")", "or", "tamoxifen", "refractory", "(", "TR", ")", ".", "This", "trial", "was", "a", "randomized", ",", "double", "-", "blind", ",", "phase", "II", "study", "of", "arzoxifene", "20", "mg", "(", "n", "=", "55", ")", "and", "50", "mg", "(", "n", "=", "57", ")", "in", "women", "with", "advanced", "or", "metastatic", "breast", "cancer", ".", "Patients", "were", "randomly", "assigned", "to", "balance", "for", "number", "of", "metastatic", "disease", "sites", ",", "prior", "tamoxifen", "therapy", ",", "and", "estrogen", "receptor", "status", ".", "The", "primary", "end", "point", "was", "tumor", "response", "rate", "(", "RR", ")", ".", "Secondary", "end", "points", "included", "clinical", "benefit", "rate", "(", "CBR", ")", ",", "time", "to", "progression", "(", "TTP", ")", ",", "and", "toxicity", ".", "Forty", "-", "nine", "patients", "were", "TS", "and", "63", "were", "TR", ".", "According", "to", "independent", "review", ",", "among", "TS", "patients", ",", "RR", "was", "higher", "in", "the", "20", "-", "mg", "arm", "than", "the", "50", "-", "mg", "arm", "(", "26", ".", "1", "%", "v", "8", ".", "0", "%", ")", ",", "with", "a", "longer", "TTP", "(", "8", ".", "3", "v", "3", ".", "2", "months", ";", "P", ">", ".", "05", ")", ".", "Among", "the", "TR", "patients", ",", "response", "rate", "was", "the", "same", "in", "the", "20", "-", "mg", "and", "50", "-", "mg", "arms", "(", "10", ".", "3", "%", ")", "with", "similar", "TTP", "(", "2", ".", "7", "and", "2", ".", "8", "months", ",", "respectively", ";", "P", ">", ".", "05", ")", ".", "CBR", "was", "higher", "in", "the", "20", "-", "mg", "arm", "than", "in", "the", "50", "-", "mg", "arm", "among", "TS", "patients", "(", "39", ".", "1", "%", "v", "20", ".", "0", "%", ")", "and", "TR", "patients", "(", "13", ".", "8", "%", "v", "10", ".", "3", "%", ")", ".", "Arzoxifene", "was", "well", "tolerated", ".", "Dose", "-", "dependent", "toxicity", "was", "not", "demonstrated", ".", "There", "were", "no", "deaths", "during", "study", ".", "Arzoxifene", "is", "effective", "in", "the", "treatment", "of", "TS", "and", "TR", "patients", "with", "advanced", "or", "metastatic", "breast", "cancer", "at", "the", "20", "-", "mg", "and", "50", "-", "mg", "dose", "levels", ".", "Toxicities", "are", "minimal", ",", "and", "the", "therapy", "is", "tolerated", ".", "The", "20", "-", "mg", "dose", "seems", "to", "be", "at", "least", "as", "effective", "as", "the", "50", "-", "mg", "dose", ".", "Accordingly", ",", "arzoxifene", "20", "mg", "/", "d", "was", "selected", "for", "further", "study", "in", "patients", "with", "breast", "cancer", "." ]
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12697850
[ "Helping", "patients", "make", "informed", "choices", ":", "a", "randomized", "trial", "of", "a", "decision", "aid", "for", "adjuvant", "chemotherapy", "in", "lymph", "node", "-", "negative", "breast", "cancer", ".", "In", "recent", "years", ",", "patients", "have", "indicated", "a", "desire", "for", "more", "information", "about", "their", "disease", "and", "to", "be", "involved", "in", "making", "decisions", "about", "their", "care", ".", "We", "developed", "an", "aid", "called", "the", "\"", "Decision", "Board", "\"", "to", "help", "clinicians", "inform", "patients", "with", "lymph", "node", "-", "negative", "breast", "cancer", "of", "the", "risks", "and", "benefits", "of", "adjuvant", "chemotherapy", ".", "We", "determined", "whether", "adding", "the", "Decision", "Board", "to", "the", "medical", "consultation", "improved", "patient", "knowledge", "and", "satisfaction", "compared", "with", "the", "medical", "consultation", "alone", ".", "Between", "October", "1995", "and", "March", "2000", ",", "176", "women", "with", "lymph", "node", "-", "negative", "breast", "cancer", "who", "were", "candidates", "for", "adjuvant", "chemotherapy", "were", "randomly", "assigned", "to", "receive", "the", "Decision", "Board", "plus", "the", "medical", "consultation", "(", "83", "patients", ")", "or", "the", "medical", "consultation", "alone", "(", "93", "patients", ")", ".", "One", "week", "after", "the", "consultation", ",", "patients", "completed", "a", "questionnaire", "assessing", "their", "knowledge", "about", "breast", "cancer", "and", "chemotherapy", ".", "Satisfaction", "with", "decision", "making", "was", "assessed", "1", "week", "and", "3", ",", "6", ",", "and", "12", "months", "after", "randomization", ",", "and", "differences", "between", "groups", "were", "analyzed", "by", "a", "repeated", "measures", "analysis", "of", "variance", ".", "All", "statistical", "tests", "were", "two", "-", "sided", ".", "Patients", "in", "the", "Decision", "Board", "arm", "were", "better", "informed", "about", "breast", "cancer", "and", "adjuvant", "chemotherapy", "than", "patients", "in", "the", "control", "arm", "(", "mean", "knowledge", "score", "=", "80", ".", "2", "[", "on", "a", "scale", "of", "0", "-", "100", "]", ",", "95", "%", "confidence", "interval", "[", "CI", "]", "=", "77", ".", "1", "to", "83", ".", "3", ",", "and", "71", ".", "7", ",", "95", "%", "CI", "=", "69", ".", "0", "to", "74", ".", "4", ",", "respectively", ";", "P", "<", ".", "001", ")", ".", "Over", "the", "entire", "study", "period", ",", "satisfaction", "with", "decision", "making", "was", "higher", "for", "patients", "in", "the", "Decision", "Board", "arm", "than", "for", "patients", "in", "the", "control", "arm", "(", "P", "=", ".", "032", ")", ".", "There", "was", "no", "statistically", "significant", "difference", "between", "the", "two", "groups", "in", "the", "number", "of", "patients", "who", "chose", "adjuvant", "chemotherapy", "(", "77", "%", "and", "70", "%", "for", "patients", "in", "the", "Decision", "Board", "arm", "and", "those", "in", "the", "control", "arm", ",", "respectively", ";", "P", "=", ".", "303", ")", ".", "When", "making", "decisions", "regarding", "adjuvant", "chemotherapy", ",", "patients", "with", "early", "breast", "cancer", "who", "had", "been", "exposed", "to", "the", "Decision", "Board", "had", "better", "knowledge", "of", "the", "disease", "and", "treatment", "options", "and", "greater", "satisfaction", "with", "their", "decision", "making", "than", "those", "who", "received", "the", "standard", "consultation", "." ]
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12721239
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12775735
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12796608
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12812657
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12839848
[ "Preoperative", "FLAC", "/", "granulocyte", "-", "colony", "-", "stimulating", "factor", "chemotherapy", "for", "stage", "II", "breast", "cancer", ":", "a", "prospective", "randomized", "trial", ".", "Preoperative", "chemotherapy", "for", "stage", "II", "breast", "cancer", "may", "reduce", "locoregional", "tumors", "and", "provides", "initial", "treatment", "for", "systemic", "micrometastases", ".", "We", "conducted", "a", "prospective", ",", "randomized", "trial", "to", "evaluate", "the", "ability", "of", "intensive", "preoperative", "chemotherapy", "to", "enhance", "the", "outcome", "of", "this", "approach", ".", "Patients", "with", "clinical", "stage", "II", "breast", "cancer", "(", "T2N0", ",", "T1N1", ",", "and", "T2N1", ")", "were", "prospectively", "randomized", "to", "receive", "either", "preoperative", "or", "postoperative", "chemotherapy", "with", "five", "21", "-", "day", "cycles", "of", "fluorouracil", ",", "leucovorin", "calcium", ",", "doxorubicin", ",", "and", "cyclophosphamide", "(", "FLAC", ")", "/", "granulocyte", "-", "colony", "-", "stimulating", "factor", ".", "Local", "therapy", "consisted", "of", "modified", "radical", "mastectomy", "or", "segmentectomy", "/", "axillary", "dissection", "/", "breast", "radiotherapy", ",", "according", "to", "patient", "preference", ".", "Fifty", "-", "three", "women", "were", "randomized", "(", "26", "preoperative", "chemotherapy", "and", "27", "postoperative", "chemotherapy", ")", ".", "The", "objective", "clinical", "response", "rate", "of", "the", "primary", "tumor", "to", "preoperative", "chemotherapy", "was", "80", "%", ",", "and", "the", "pathologic", "complete", "response", "rate", "was", "20", "%", ".", "Preoperative", "chemotherapy", "reduced", "the", "overall", "incidence", "and", "number", "of", "axillary", "lymph", "node", "metastases", ".", "There", "was", "no", "difference", "in", "the", "use", "of", "breast", "-", "conserving", "local", "therapy", "between", "the", "two", "treatment", "arms", ".", "There", "were", "20", "local", "/", "regional", "or", "distant", "recurrences", "(", "9", "preoperative", "and", "11", "postoperative", ")", ".", "There", "was", "no", "difference", "in", "the", "overall", "or", "disease", "-", "free", "survival", "between", "the", "preoperative", "and", "postoperative", "chemotherapy", "arms", ".", "Preoperative", "FLAC", "/", "granulocyte", "-", "colony", "-", "stimulating", "factor", "chemotherapy", "was", "effective", "against", "local", "/", "regional", "tumors", "in", "stage", "II", "breast", "cancer", "but", "was", "otherwise", "comparable", "to", "postoperative", "chemotherapy", "." ]
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12840087
[ "High", "-", "dose", "chemotherapy", "with", "hematopoietic", "stem", "-", "cell", "rescue", "for", "high", "-", "risk", "breast", "cancer", ".", "The", "use", "of", "high", "-", "dose", "adjuvant", "chemotherapy", "for", "high", "-", "risk", "primary", "breast", "cancer", "is", "controversial", ".", "We", "studied", "its", "efficacy", "in", "patients", "with", "4", "to", "9", "or", "10", "or", "more", "tumor", "-", "positive", "axillary", "lymph", "nodes", ".", "Patients", "younger", "than", "56", "years", "of", "age", "who", "had", "undergone", "surgery", "for", "breast", "cancer", "and", "who", "had", "no", "distant", "metastases", "were", "eligible", "if", "they", "had", "at", "least", "four", "tumor", "-", "positive", "axillary", "lymph", "nodes", ".", "Patients", "in", "the", "conventional", "-", "dose", "group", "received", "fluorouracil", ",", "epirubicin", ",", "and", "cyclophosphamide", "(", "FEC", ")", "every", "three", "weeks", "for", "five", "courses", ",", "followed", "by", "radiotherapy", "and", "tamoxifen", ".", "The", "high", "-", "dose", "treatment", "was", "identical", ",", "except", "that", "high", "-", "dose", "chemotherapy", "(", "6", "g", "of", "cyclophosphamide", "per", "square", "meter", "of", "body", "-", "surface", "area", ",", "480", "mg", "of", "thiotepa", "per", "square", "meter", ",", "and", "1600", "mg", "of", "carboplatin", "per", "square", "meter", ")", "with", "autologous", "peripheral", "-", "blood", "hematopoietic", "progenitor", "-", "cell", "transplantation", "replaced", "the", "fifth", "course", "of", "FEC", ".", "Of", "the", "885", "patients", ",", "442", "were", "assigned", "to", "the", "high", "-", "dose", "group", "and", "443", "to", "the", "conventional", "-", "dose", "group", ".", "After", "a", "median", "follow", "-", "up", "of", "57", "months", ",", "the", "actuarial", "5", "-", "year", "relapse", "-", "free", "survival", "rates", "were", "59", "percent", "in", "the", "conventional", "-", "dose", "group", "and", "65", "percent", "in", "the", "high", "-", "dose", "group", "(", "hazard", "ratio", "for", "relapse", "in", "the", "high", "-", "dose", "group", ",", "0", ".", "83", ";", "95", "percent", "confidence", "interval", ",", "0", ".", "66", "to", "1", ".", "03", ";", "P", "=", "0", ".", "09", ")", ".", "In", "the", "group", "with", "10", "or", "more", "positive", "nodes", ",", "the", "relapse", "-", "free", "survival", "rates", "were", "51", "percent", "in", "the", "conventional", "-", "dose", "group", "and", "61", "percent", "in", "the", "high", "-", "dose", "group", "(", "P", "=", "0", ".", "05", "by", "the", "log", "-", "rank", "test", ";", "hazard", "ratio", "for", "relapse", ",", "0", ".", "71", ";", "95", "percent", "confidence", "interval", ",", "0", ".", "50", "to", "1", ".", "00", ")", ".", "High", "-", "dose", "alkylating", "therapy", "improves", "relapse", "-", "free", "survival", "among", "patients", "with", "stage", "II", "or", "III", "breast", "cancer", "and", "10", "or", "more", "positive", "axillary", "lymph", "nodes", ".", "This", "benefit", "may", "be", "confined", "to", "patients", "with", "HER", "-", "2", "/", "neu", "-", "negative", "tumors", "." ]
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12904519
[ "A", "randomized", "comparison", "of", "sentinel", "-", "node", "biopsy", "with", "routine", "axillary", "dissection", "in", "breast", "cancer", ".", "Although", "numerous", "studies", "have", "shown", "that", "the", "status", "of", "the", "sentinel", "node", "is", "an", "accurate", "predictor", "of", "the", "status", "of", "the", "axillary", "nodes", "in", "breast", "cancer", ",", "the", "efficacy", "and", "safety", "of", "sentinel", "-", "node", "biopsy", "require", "validation", ".", "From", "March", "1998", "to", "December", "1999", ",", "we", "randomly", "assigned", "516", "patients", "with", "primary", "breast", "cancer", "in", "whom", "the", "tumor", "was", "less", "than", "or", "equal", "to", "2", "cm", "in", "diameter", "either", "to", "sentinel", "-", "node", "biopsy", "and", "total", "axillary", "dissection", "(", "the", "axillary", "-", "dissection", "group", ")", "or", "to", "sentinel", "-", "node", "biopsy", "followed", "by", "axillary", "dissection", "only", "if", "the", "sentinel", "node", "contained", "metastases", "(", "the", "sentinel", "-", "node", "group", ")", ".", "The", "number", "of", "sentinel", "nodes", "found", "was", "the", "same", "in", "the", "two", "groups", ".", "A", "sentinel", "node", "was", "positive", "in", "83", "of", "the", "257", "patients", "in", "the", "axillary", "-", "dissection", "group", "(", "32", ".", "3", "percent", ")", ",", "and", "in", "92", "of", "the", "259", "patients", "in", "the", "sentinel", "-", "node", "group", "(", "35", ".", "5", "percent", ")", ".", "In", "the", "axillary", "-", "dissection", "group", ",", "the", "overall", "accuracy", "of", "the", "sentinel", "-", "node", "status", "was", "96", ".", "9", "percent", ",", "the", "sensitivity", "91", ".", "2", "percent", ",", "and", "the", "specificity", "100", "percent", ".", "There", "was", "less", "pain", "and", "better", "arm", "mobility", "in", "the", "patients", "who", "underwent", "sentinel", "-", "node", "biopsy", "only", "than", "in", "those", "who", "also", "underwent", "axillary", "dissection", ".", "There", "were", "15", "events", "associated", "with", "breast", "cancer", "in", "the", "axillary", "-", "dissection", "group", "and", "10", "such", "events", "in", "the", "sentinel", "-", "node", "group", ".", "Among", "the", "167", "patients", "who", "did", "not", "undergo", "axillary", "dissection", ",", "there", "were", "no", "cases", "of", "overt", "axillary", "metastasis", "during", "follow", "-", "up", ".", "Sentinel", "-", "node", "biopsy", "is", "a", "safe", "and", "accurate", "method", "of", "screening", "the", "axillary", "nodes", "for", "metastasis", "in", "women", "with", "a", "small", "breast", "cancer", "." ]
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12919237
[ "Effect", "of", "nurse", "case", "management", "on", "the", "treatment", "of", "older", "women", "with", "breast", "cancer", ".", "To", "evaluate", "the", "effect", "of", "nurse", "case", "management", "on", "the", "treatment", "of", "older", "women", "with", "breast", "cancer", ".", "Randomized", "prospective", "trial", ".", "Sixty", "surgeons", "practicing", "at", "13", "community", "and", "two", "public", "hospitals", "in", "southeast", "Texas", ".", "Three", "hundred", "thirty", "-", "five", "women", "(", "166", "control", "and", "169", "intervention", ")", "aged", "65", "and", "older", "newly", "diagnosed", "with", "breast", "cancer", ".", "Women", "seeing", "surgeons", "randomized", "to", "the", "intervention", "group", "received", "the", "services", "of", "a", "nurse", "case", "manager", "for", "12", "months", "after", "the", "diagnosis", "of", "breast", "cancer", ".", "The", "primary", "outcome", "was", "the", "type", "and", "use", "of", "cancer", "-", "specific", "therapies", "received", "in", "the", "first", "6", "months", "after", "diagnosis", ".", "Secondary", "outcomes", "were", "patient", "satisfaction", "and", "arm", "function", "on", "the", "affected", "side", "2", "months", "after", "diagnosis", ".", "More", "women", "in", "the", "intervention", "group", "received", "breast", "-", "conserving", "surgery", "(", "28", ".", "6", "%", "vs", "18", ".", "7", "%", ";", "P", "=", ".", "031", ")", "and", "radiation", "therapy", "(", "36", ".", "0", "%", "vs", "19", ".", "0", "%", ";", "P", "=", ".", "003", ")", ".", "Of", "women", "undergoing", "breast", "-", "conserving", "surgery", ",", "greater", "percentages", "in", "the", "case", "management", "group", "received", "adjuvant", "radiation", "(", "78", ".", "3", "%", "vs", "44", ".", "8", "%", ";", "P", "=", ".", "001", ")", "and", "axillary", "dissection", "(", "71", ".", "4", "%", "vs", "44", ".", "8", "%", ";", "P", "=", ".", "057", ")", ".", "Women", "in", "the", "case", "management", "group", "were", "also", "more", "likely", "to", "receive", "more", "breast", "reconstruction", "surgery", "(", "9", ".", "3", "%", "vs", "2", ".", "6", "%", ",", "P", "=", ".", "054", ")", ",", "and", "women", "in", "the", "case", "management", "group", "with", "advanced", "cancer", "were", "more", "likely", "to", "receive", "chemotherapy", "(", "72", ".", "7", "%", "vs", "30", ".", "0", "%", ",", "P", "=", ".", "057", ")", ".", "Two", "months", "after", "surgery", ",", "higher", "percentages", "of", "women", "in", "the", "case", "manager", "group", "had", "normal", "arm", "function", "(", "93", "%", "vs", "84", "%", ";", "P", "=", ".", "037", ")", "and", "were", "more", "likely", "to", "state", "that", "they", "had", "a", "real", "choice", "in", "their", "treatment", "(", "82", ".", "2", "%", "vs", "69", ".", "9", "%", ",", "P", "=", ".", "020", ")", ".", "Women", "with", "indicators", "of", "poor", "social", "support", "were", "more", "likely", "to", "benefit", "from", "nurse", "case", "management", ".", "Nurse", "case", "management", "results", "in", "more", "appropriate", "management", "of", "older", "women", "with", "breast", "cancer", "." ]
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12926095
[ "Bone", "turnover", "markers", "and", "insulin", "-", "like", "growth", "factor", "components", "in", "metastatic", "breast", "cancer", ":", "results", "from", "a", "randomised", "trial", "of", "exemestane", "vs", "megestrol", "acetate", ".", "The", "aim", "of", "this", "randomised", "study", "was", "to", "compare", "the", "effects", "of", "progestins", "and", "aromatase", "inactivators", "on", "bone", "remodelling", "markers", "and", "the", "components", "of", "insulin", "-", "like", "growth", "factor", "in", "patients", "with", "metastatic", "breast", "cancer", ".", "Within", "the", "framework", "of", "a", "large", "(", "769", "patients", ")", ",", "randomised", "double", "-", "blind", "clinical", "trial", "comparing", "exemestane", "(", "EXE", ")", "with", "megestrol", "acetate", "(", "MA", ")", ",", "serum", "17", "beta", "-", "estradiol", "(", "E2", ")", ",", "estrone", "(", "E1", ")", ",", "estrone", "sulphate", "(", "E1S", ")", ",", "bone", "alkaline", "phosphatase", "(", "BAP", ")", ",", "carboxy", "-", "terminal", "cross", "-", "linking", "telopeptide", "of", "type", "I", "collagen", "(", "ICTP", ")", "and", "the", "components", "of", "insulin", "-", "like", "growth", "factor", "(", "IGF", ")", "family", "(", "IGF", "-", "1", ",", "IGF", "-", "2", "and", "IGFBP", "-", "3", ")", "were", "determined", "in", "53", "patients", "(", "24", "randomised", "to", "EXE", "and", "29", "ramdomised", "to", "MA", ")", ".", "After", "eight", "weeks", "of", "treatment", ",", "both", "ICTP", "and", "BAP", "increased", "(", "p", "<", "0", ".", "01", ")", "in", "the", "EXE", "group", ",", "but", "only", "ICTP", "in", "the", "MA", "group", "(", "p", "<", "0", ".", "03", ")", ".", "The", "8", "-", "week", "suppression", "of", "E2", "and", "E1S", "was", "more", "pronounced", "in", "the", "EXE", "group", "(", "to", ",", "respectively", ",", "11", ".", "2", "%", "and", "9", ".", "9", "%", "of", "baseline", "values", ")", "than", "in", "the", "MA", "group", "(", "33", ".", "1", "%", "and", "29", ".", "7", "%", ")", ".", "IGF", "-", "1", "increased", "(", "p", "<", "0", ".", "01", ")", "in", "both", "groups", ",", "but", "more", "so", "in", "the", "patients", "treated", "with", "MA", ".", "Estrogen", "levels", "negatively", "correlated", "with", "ICTP", "in", "both", "groups", ",", "but", "were", "not", "related", "to", "BAP", "in", "either", ".", "IGF", "-", "1", "negatively", "correlated", "with", "estrogens", "in", "both", "groups", ".", "The", "results", "of", "this", "study", "indicate", "that", "anti", "-", "aromatase", "therapy", "is", "associated", "with", "increased", "osteoclast", "activity", ",", "and", "suggest", "the", "existence", "of", "possible", "differential", "effects", "of", "different", "hormonal", "therapies", "on", "bone", "remodelling", "markers", "regardless", "of", "the", "estrogen", "suppression", "induced", "by", "EXE", "." ]
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12957243
[ "Locoregional", "recurrence", "after", "doxorubicin", "-", "based", "chemotherapy", "and", "postmastectomy", ":", "Implications", "for", "breast", "cancer", "patients", "with", "early", "-", "stage", "disease", "and", "predictors", "for", "recurrence", "after", "postmastectomy", "radiation", ".", "To", "compare", "rates", "of", "locoregional", "recurrence", "(", "LRR", ")", "after", "mastectomy", ",", "doxorubicin", "-", "based", "chemotherapy", ",", "and", "radiation", "with", "those", "of", "patients", "receiving", "mastectomy", "and", "doxorubicin", "-", "based", "chemotherapy", "without", "radiation", "and", "to", "determine", "predictors", "of", "LRR", "after", "postmastectomy", "radiation", ".", "Kaplan", "-", "Meier", "freedom", "-", "from", "-", "LRR", "rates", "were", "calculated", "for", "470", "patients", "treated", "with", "mastectomy", ",", "doxorubicin", "-", "based", "chemotherapy", ",", "and", "postmastectomy", "radiation", "in", "five", "single", "-", "institution", "clinical", "trials", ".", "The", "LRR", "rates", "in", "these", "patients", "were", "compared", "to", "previously", "reported", "rates", "in", "1031", "patients", "treated", "without", "radiation", "in", "the", "same", "trials", ".", "Median", "follow", "-", "up", "was", "14", "years", ".", "Irradiated", "patients", "had", "significantly", "less", "favorable", "prognostic", "factors", "for", "LRR", "than", "did", "unirradiated", "patients", ".", "Despite", "this", ",", "in", "all", "subsets", "of", "node", "-", "positive", "patients", ",", "postmastectomy", "radiation", "led", "to", "lower", "rates", "of", "LRR", ".", "This", "included", "patients", "with", "T1", "or", "T2", "tumors", "and", "one", "to", "three", "positive", "nodes", "(", "10", "-", "year", "LRR", "rates", "of", "3", "%", "vs", ".", "13", "%", ",", "p", "=", "0", ".", "003", ")", ".", "Multivariate", "analysis", "of", "LRR", "for", "patients", "with", "this", "stage", "of", "disease", "revealed", "that", "no", "radiation", ",", "close", "/", "positive", "margins", ",", "gross", "extracapsular", "extension", ",", "and", "dissection", "of", "<", "10", "nodes", "predicted", "for", "increased", "LRR", "(", "hazard", "ratios", "6", ".", "25", ",", "4", ".", "61", ",", "3", ".", "27", ",", "and", "2", ".", "66", ",", "respectively", ")", ".", "Significant", "predictors", "of", "LRR", "for", "patients", "treated", "with", "postmastectomy", "radiation", "were", "higher", "number", "and", ">", "or", "=", "20", "%", "positive", "nodes", ",", "larger", "tumor", "size", ",", "lymphovascular", "space", "invasion", ",", "and", "estrogen", "receptor", "(", "ER", ")", "-", "negative", "disease", ".", "Recursive", "partitioning", "analysis", "revealed", "ER", "-", "negative", "status", "to", "be", "the", "most", "powerful", "discriminator", "of", "LRR", "in", "irradiated", "patients", ".", "Postmastectomy", "radiation", "decreases", "LRR", "for", "patients", "with", "breast", "cancer", ",", "including", "those", "with", "Stage", "II", "breast", "cancer", "and", "one", "to", "three", "positive", "lymph", "nodes", "." ]
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14525573
[ "Sentinel", "node", "biopsy", "in", "breast", "cancer", ":", "validation", "study", "and", "comparison", "of", "blue", "dye", "alone", "with", "triple", "modality", "localization", ".", "Sentinel", "node", "biopsy", "(", "SNB", ")", "for", "breast", "cancer", "patients", "is", "a", "new", "technique", "with", "the", "potential", "to", "provide", "an", "accurate", "staging", "of", "the", "axillary", "nodal", "status", "while", "avoiding", "the", "morbidity", "of", "an", "axillary", "dissection", ".", "The", "objective", "of", "the", "present", "study", "is", "to", "validate", "the", "use", "of", "sentinel", "node", "biopsy", "in", "a", "New", "Zealand", "hospital", "and", "to", "compare", "the", "ability", "of", "patent", "blue", "dye", "(", "PB", ")", "alone", "with", "triple", "modality", "(", "TM", ")", "(", "preoperative", "lymphoscintigraphy", ",", "intraoperative", "gamma", "probe", "and", "intraoperative", "blue", "dye", ")", "to", "identify", "the", "sentinel", "node", ".", "A", "total", "of", "104", "patients", "who", "had", "a", "palpable", "breast", "lump", "that", "was", "confirmed", "to", "be", "malignant", "by", "radiology", "and", "cytology", "and", "a", "clinical", "diagnosis", "of", "stage", "I", "or", "stage", "II", "breast", "cancer", ",", "were", "enrolled", "for", "SNB", "and", "randomly", "assigned", "to", "triple", "modality", "or", "blue", "dye", "alone", "for", "the", "localization", "of", "the", "sentinel", "node", ".", "Axillary", "dissection", "was", "performed", "after", "the", "sentinel", "node", "(", "s", ")", "had", "been", "removed", ".", "There", "were", "63", "patients", "in", "the", "PB", "group", "and", "41", "patients", "in", "the", "TM", "group", ".", "Both", "groups", "are", "comparable", ",", "with", "a", "similar", "mean", "age", "and", "primary", "tumour", "size", ".", "A", "sentinel", "node", "was", "identified", "in", "57", "(", "90", "%", ")", "of", "the", "PB", "group", "patients", "and", "40", "(", "98", "%", ")", "of", "the", "TM", "group", "patients", ".", "Of", "these", "23", "(", "37", "%", ")", "of", "the", "PB", "group", "and", "23", "(", "56", "%", ")", "in", "the", "TM", "group", "had", "axillary", "nodes", "positive", "for", "malignancy", ".", "There", "was", "one", "false", "negative", "SNB", "in", "the", "PB", "group", "and", "two", "false", "negative", "results", "in", "the", "TM", "group", ".", "Therefore", ",", "the", "PB", "group", "had", "an", "accuracy", "of", "98", "%", "and", "a", "sensitivity", "of", "96", "%", "compared", "to", "an", "accuracy", "of", "95", "%", "and", "a", "sensitivity", "of", "91", "%", "for", "the", "TM", "group", ".", "The", "results", "of", "the", "present", "study", "validate", "the", "use", "of", "SNB", "in", "suitable", "breast", "cancer", "patients", ".", "Identification", "and", "the", "accuracy", "of", "the", "sentinel", "node", "localization", "were", "similar", "between", "the", "two", "groups", ".", "Therefore", ",", "in", "hospital", "centres", "without", "adequate", "access", "to", "a", "nuclear", "medical", "facility", ",", "it", "would", "be", "feasible", "to", "conduct", "SNB", "using", "blue", "dye", "alone", "." ]
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14556922
[ "Efficacy", "of", "tamoxifen", "following", "anastrozole", "(", "'", "Arimidex", "'", ")", "compared", "with", "anastrozole", "following", "tamoxifen", "as", "first", "-", "line", "treatment", "for", "advanced", "breast", "cancer", "in", "postmenopausal", "women", ".", "Anastrozole", "(", "'", "Arimidex", "'", ")", "is", "indicated", "for", "the", "treatment", "of", "advanced", "breast", "cancer", "in", "postmenopausal", "women", ".", "Combined", "analysis", "of", "two", "international", "randomised", ",", "double", "-", "blind", "trials", "(", "n", "=", "1021", ")", "showed", "that", "in", "patients", "with", "hormone", "receptor", "-", "positive", "tumours", ",", "first", "-", "line", "treatment", "with", "anastrozole", "significantly", "prolonged", "the", "time", "to", "progression", "(", "TTP", ")", "compared", "with", "tamoxifen", "(", "median", "TTP", ":", "10", ".", "7", "versus", "6", ".", "4", "months", ",", "respectively", ";", "P", "=", "0", ".", "022", ")", ".", "Second", "-", "line", "tamoxifen", "following", "anastrozole", ",", "or", "vice", "versa", ",", "in", "this", "trial", "population", "was", "unblinded", ".", "The", "treatments", "were", "crossed", "over", "and", "then", "efficacy", "was", "assessed", "using", "a", "questionnaire", ".", "Of", "511", "patients", "randomised", "to", "anastrozole", ",", "137", "(", "26", ".", "8", "%", ")", "received", "second", "-", "line", "tamoxifen", ".", "Questionnaire", "data", "were", "available", "for", "119", "patients", ";", "58", "(", "48", ".", "7", "%", ")", "gained", "clinical", "benefit", "(", "CB", "=", "complete", "+", "partial", "response", "(", "CR", "+", "PR", ")", "+", "(", "stable", "disease", "(", "SD", ")", ">", "/", "=", "24", "weeks", ")", ")", ",", "while", "12", "(", "10", ".", "1", "%", ")", "had", "an", "objective", "response", "(", "OR", "=", "CR", "+", "PR", ")", ".", "Of", "510", "patients", "randomised", "to", "tamoxifen", ",", "134", "(", "26", ".", "3", "%", ")", "received", "second", "-", "line", "anastrozole", ".", "Questionnaire", "data", "from", "95", "patients", "showed", "that", "54", "(", "56", ".", "8", "%", ")", "gained", "CB", "and", "7", "of", "the", "patients", "gaining", "CB", "(", "7", ".", "4", "%", ")", "had", "an", "OR", ".", "Previous", "studies", "showed", "anastrozole", "is", "effective", "after", "first", "-", "line", "tamoxifen", ".", "These", "data", "show", "that", "the", "sequential", "administration", "of", "first", "-", "line", "anastrozole", "followed", "by", "tamoxifen", "provides", "effective", "use", "of", "these", "drugs", "in", "the", "treatment", "of", "postmenopausal", "women", "with", "advanced", "breast", "cancer", "." ]
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14637388
[ "\"", "Tumour", "marker", "guided", "\"", "salvage", "treatment", "prolongs", "survival", "of", "breast", "cancer", "patients", ":", "final", "report", "of", "a", "7", "-", "year", "study", ".", "Randomised", "trials", "on", "breast", "cancer", "showed", "no", "significant", "benefit", "from", "post", "-", "operative", "follow", "-", "up", "with", "clinical", "and", "/", "or", "conventional", "radiological", "means", ".", "We", "hypothesised", "that", "carcinoembryonic", "antigen", "(", "CEA", ")", ",", "tissue", "polipeptyde", "antigen", "(", "TPA", ")", ",", "breast", "cancer", "associated", "antigen", "115", "D8", "/", "DF3", "(", "CA15", ".", "3", ")", "tumour", "marker", "panel", "is", "sensitive", "enough", "for", "significantly", "anticipating", "salvage", "treatment", "and", "prolonging", "survival", "of", "relapsing", "breast", "cancer", "patients", ".", "From", "October", "1981", "to", "May", "1999", ",", "68", "(", "62", "%", ")", "of", "109", "patients", "with", "distant", "metastases", "were", "recruited", ".", "Thirty", "-", "six", "(", "53", "%", ")", "received", "salvage", "treatment", "at", "the", "time", "of", "significant", "increase", "in", "one", "or", "more", "components", "of", "CEA", "-", "TPA", "-", "CA15", ".", "3", "tumour", "marker", "panel", "and", "negative", "instrumental", "examinations", "(", "\"", "tumour", "marker", "guided", "\"", "treatment", ")", "and", "32", "(", "47", "%", ")", "were", "treated", "only", "after", "radiological", "confirmation", "of", "metastases", "(", "conventional", "treatment", ")", ".", "The", "prognostic", "factors", "of", "the", "two", "groups", "did", "not", "show", "any", "statistically", "significant", "difference", ".", "The", "time", "from", "one", "or", "more", "tumour", "marker", "increase", "to", "clear", "clinical", "and", "/", "or", "radiological", "signs", "of", "distant", "metastases", "(", "lead", "time", ")", "was", "significantly", "prolonged", "in", "the", "36", "patients", "with", "\"", "tumour", "marker", "guided", "\"", "treatment", "(", "17", ".", "3", "+", "/", "-", "13", ".", "1", "vs", ".", "2", ".", "9", "+", "/", "-", "2", ".", "9", "months", ",", "P", "<", "0", ".", "001", ",", "Wilcoxon", "test", ")", "as", "well", "as", "the", "survival", "curves", "from", "salvage", "therapy", "and", "from", "mastectomy", "(", "the", "proportion", "of", "survivors", "was", ":", "at", "36", "months", "from", "salvage", "therapy", "28", "%", "vs", ".", "9", "%", ",", "P", "=", "0", ".", "0094", ";", "at", "84", "months", "from", "mastectomy", "42", "%", "vs", ".", "19", "%", ",", "P", "=", "0", ".", "0017", ")", ".", "The", "multivariate", "Cox", "analysis", "showed", "that", "time", "from", "mastectomy", "to", "tumour", "marker", "increase", "and", "\"", "tumour", "marker", "guided", "\"", "salvage", "treatment", "were", "the", "only", "significantly", "different", "variables", "(", "P", "=", "0", ".", "00001", "and", "0", ".", "005", ",", "respectively", ")", ".", "These", "data", "point", "out", "that", "\"", "tumour", "marker", "guided", "\"", "salvage", "treatment", "significantly", "prolongs", "disease", "-", "free", "and", "overall", "survivals", "of", "relapsing", "responsive", "patients", "." ]
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14722733
[ "A", "cancer", "research", "(", "UK", ")", "randomized", "phase", "II", "study", "of", "idoxifene", "in", "patients", "with", "locally", "advanced", "/", "metastatic", "breast", "cancer", "resistant", "to", "tamoxifen", ".", "Idoxifene", "is", "a", "novel", "selective", "oestrogen", "receptor", "modulator", "(", "SERM", ")", "which", "had", "greater", "binding", "affinity", "for", "the", "oestrogen", "receptor", "(", "ER", ")", "and", "reduced", "agonist", "activity", "compared", "with", "tamoxifen", "in", "preclinical", "studies", ".", "In", "a", "randomized", "phase", "II", "trial", "in", "56", "postmenopausal", "patients", "with", "progressive", "locally", "advanced", "/", "metastatic", "breast", "cancer", "we", "assessed", "whether", "idoxifene", "showed", "evidence", "of", "activity", "compared", "with", "an", "increased", "40", "mg", "/", "day", "dose", "of", "tamoxifen", "in", "patients", "who", "had", "previously", "demonstrated", "resistance", "to", "the", "standard", "20", "mg", "/", "day", "dose", "of", "tamoxifen", ".", "Of", "47", "patients", "eligible", "for", "response", "(", "25", "idoxifene", ",", "22", "tamoxifen", ")", ",", "two", "partial", "responses", "and", "two", "disease", "stabilizations", "(", "SD", ")", "for", ">", "6", "months", "were", "seen", "with", "idoxifene", "(", "overall", "clinical", "benefit", "rate", "16", "%", ",", "95", "%", "CI", "4", ".", "5", "-", "36", ".", "1", "%", ")", ".", "The", "median", "duration", "of", "clinical", "benefit", "was", "9", ".", "8", "months", ".", "In", "contrast", ",", "no", "objective", "responses", "were", "seen", "with", "the", "increased", "40", "mg", "/", "day", "dose", "of", "tamoxifen", ",", "although", "two", "patients", "had", "SD", "for", "7", "and", "14", "months", "(", "clinical", "benefit", "rate", "9", "%", ",", "95", "%", "CI", "1", ".", "1", "-", "29", ".", "2", "%", ")", ".", "Idoxifene", "was", "well", "tolerated", "and", "the", "reported", "possible", "drug", "-", "related", "toxicities", "were", "similar", "in", "frequency", "to", "those", "with", "tamoxifen", "(", "hot", "flushes", "13", "%", "vs", "15", "%", ",", "mild", "nausea", "20", "%", "vs", "15", "%", ")", ".", "Endocrine", "and", "lipid", "analysis", "in", "both", "groups", "showed", "a", "similar", "significant", "fall", "in", "serum", "follicle", "-", "stimulating", "hormone", "and", "luteinizing", "hormone", "after", "4", "weeks", ",", "together", "with", "a", "significant", "rise", "in", "sex", "hormone", "binding", "globulin", "levels", "and", "11", "%", "reduction", "in", "serum", "cholesterol", "levels", ".", "In", "conclusion", ",", "while", "idoxifene", "was", "associated", "with", "only", "modest", "evidence", "of", "clinical", "activity", "in", "patients", "with", "tamoxifen", "-", "resistant", "breast", "cancer", ",", "its", "toxicity", "profile", "and", "effects", "on", "endocrine", "/", "lipid", "parameters", "were", "similar", "to", "those", "of", "tamoxifen", "." ]
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15014181
[ "A", "randomized", "trial", "of", "exemestane", "after", "two", "to", "three", "years", "of", "tamoxifen", "therapy", "in", "postmenopausal", "women", "with", "primary", "breast", "cancer", ".", "Tamoxifen", ",", "taken", "for", "five", "years", ",", "is", "the", "standard", "adjuvant", "treatment", "for", "postmenopausal", "women", "with", "primary", ",", "estrogen", "-", "receptor", "-", "positive", "breast", "cancer", ".", "Despite", "this", "treatment", ",", "however", ",", "some", "patients", "have", "a", "relapse", ".", "We", "conducted", "a", "double", "-", "blind", ",", "randomized", "trial", "to", "test", "whether", ",", "after", "two", "to", "three", "years", "of", "tamoxifen", "therapy", ",", "switching", "to", "exemestane", "was", "more", "effective", "than", "continuing", "tamoxifen", "therapy", "for", "the", "remainder", "of", "the", "five", "years", "of", "treatment", ".", "The", "primary", "end", "point", "was", "disease", "-", "free", "survival", ".", "Of", "the", "4742", "patients", "enrolled", ",", "2362", "were", "randomly", "assigned", "to", "switch", "to", "exemestane", ",", "and", "2380", "to", "continue", "to", "receive", "tamoxifen", ".", "After", "a", "median", "follow", "-", "up", "of", "30", ".", "6", "months", ",", "449", "first", "events", "(", "local", "or", "metastatic", "recurrence", ",", "contralateral", "breast", "cancer", ",", "or", "death", ")", "were", "reported", "-", "-", "183", "in", "the", "exemestane", "group", "and", "266", "in", "the", "tamoxifen", "group", ".", "The", "unadjusted", "hazard", "ratio", "in", "the", "exemestane", "group", "as", "compared", "with", "the", "tamoxifen", "group", "was", "0", ".", "68", "(", "95", "percent", "confidence", "interval", ",", "0", ".", "56", "to", "0", ".", "82", ";", "P", "<", "0", ".", "001", "by", "the", "log", "-", "rank", "test", ")", ",", "representing", "a", "32", "percent", "reduction", "in", "risk", "and", "corresponding", "to", "an", "absolute", "benefit", "in", "terms", "of", "disease", "-", "free", "survival", "of", "4", ".", "7", "percent", "(", "95", "percent", "confidence", "interval", ",", "2", ".", "6", "to", "6", ".", "8", ")", "at", "three", "years", "after", "randomization", ".", "Overall", "survival", "was", "not", "significantly", "different", "in", "the", "two", "groups", ",", "with", "93", "deaths", "occurring", "in", "the", "exemestane", "group", "and", "106", "in", "the", "tamoxifen", "group", ".", "Severe", "toxic", "effects", "of", "exemestane", "were", "rare", ".", "Contralateral", "breast", "cancer", "occurred", "in", "20", "patients", "in", "the", "tamoxifen", "group", "and", "9", "in", "the", "exemestane", "group", "(", "P", "=", "0", ".", "04", ")", ".", "Exemestane", "therapy", "after", "two", "to", "three", "years", "of", "tamoxifen", "therapy", "significantly", "improved", "disease", "-", "free", "survival", "as", "compared", "with", "the", "standard", "five", "years", "of", "tamoxifen", "treatment", "." ]
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15023242
[ "Paclitaxel", "improves", "the", "prognosis", "in", "estrogen", "receptor", "negative", "inflammatory", "breast", "cancer", ":", "the", "M", ".", "D", ".", "Anderson", "Cancer", "Center", "experience", ".", "The", "treatment", "of", "inflammatory", "breast", "cancer", "includes", "preoperative", "anthracycline", "-", "based", "chemotherapy", ",", "surgery", ",", "and", "radiation", "therapy", ".", "In", "the", "past", "few", "years", ",", "taxanes", ",", "mainly", "paclitaxel", ",", "have", "been", "frequently", "used", "for", "preoperative", "chemotherapy", ",", "usually", "in", "sequence", "with", "anthracyclines", ".", "The", "purpose", "of", "this", "retrospective", "analysis", "was", "to", "determine", "how", "adding", "paclitaxel", "to", "anthracycline", "-", "based", "regimens", "affects", "prognosis", ".", "A", "total", "of", "240", "patients", "treated", "in", "6", "consecutive", "trials", "between", "1973", "and", "2000", "were", "included", "in", "the", "analysis", ".", "Group", "1", "(", "N", "=", "178", ")", "consisted", "of", "patients", "treated", "in", "the", "first", "4", "trials", "(", "1973", "-", "1993", ")", "with", "FAC", "(", "5", "-", "fluorouracil", "/", "doxorubicin", "/", "cyclophosphamide", ")", "based", "regimens", ".", "Group", "2", "(", "N", "=", "62", ")", "consisted", "of", "patients", "treated", "in", "the", "last", "2", "trials", "(", "1994", "-", "2000", ")", "with", "FAC", "followed", "by", "paclitaxel", "given", "every", "3", "weeks", "or", "given", "in", "a", "high", "-", "dose", "weekly", "schedule", ".", "The", "2", "groups", "differed", "with", "respect", "to", "median", "follow", "-", "up", "durations", ",", "which", "were", "148", "months", "(", "range", ",", "85", "-", "283", "months", ")", "in", "group", "1", "and", "45", "months", "(", "range", ",", "21", "-", "99", "months", ")", "in", "group", "2", ".", "Estrogen", "receptor", "(", "ER", ")", "status", "was", "negative", "in", "58", "cases", "(", "33", "%", ")", "in", "group", "1", "and", "40", "cases", "(", "65", "%", ")", "in", "group", "2", ".", "There", "was", "no", "difference", "in", "median", "age", "between", "the", "groups", ".", "The", "objective", "response", "rates", "(", "complete", "and", "partial", ")", "were", "similar", "(", "group", "1", ",", "74", "%", ";", "group", "2", ",", "82", "%", ")", ".", "The", "median", "overall", "survival", "(", "OS", ")", "and", "progression", "-", "free", "survival", "(", "PFS", ")", "were", "better", "in", "the", "patients", "treated", "with", "paclitaxel", ",", "and", "these", "differences", "reached", "statistical", "significance", "in", "the", "patients", "with", "ER", "-", "negative", "disease", "(", "median", "OS", ":", "group", "1", ",", "32", "months", ";", "group", "2", ",", "54", "months", ";", "P", "=", "0", ".", "03", ";", "median", "PFS", ":", "group", "1", ",", "18", "months", ";", "group", "2", ",", "27", "months", ";", "P", "=", "0", ".", "04", ")", ".", "It", "may", "be", "concluded", "that", "the", "addition", "of", "paclitaxel", "to", "anthracycline", "-", "based", "therapy", "resulted", "in", "a", "statistically", "significant", "improvement", "in", "outcome", "in", "patients", "with", "ER", "-", "negative", "inflammatory", "breast", "cancer", "." ]
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15026791
[ "Oral", "ibandronate", "reduces", "the", "risk", "of", "skeletal", "complications", "in", "breast", "cancer", "patients", "with", "metastatic", "bone", "disease", ":", "results", "from", "two", "randomised", ",", "placebo", "-", "controlled", "phase", "III", "studies", ".", "Although", "intravenous", "(", "i", ".", "v", ".", ")", "bisphosphonates", "are", "the", "standard", "of", "care", "for", "metastatic", "bone", "disease", ",", "they", "are", "less", "than", "ideal", "for", "many", "patients", "due", "to", "infusion", "-", "related", "adverse", "events", "(", "AEs", ")", ",", "an", "increased", "risk", "of", "renal", "toxicity", "and", "the", "inconvenience", "of", "regular", "hospital", "visits", ".", "The", "use", "of", "oral", "bisphosphonate", "therapy", "is", "limited", "by", "concerns", "over", "efficacy", "and", "gastrointestinal", "(", "GI", ")", "side", "effects", ".", "There", "remains", "a", "clinical", "need", "for", "an", "oral", "bisphosphonate", "that", "offers", "equivalent", "efficacy", "to", "i", ".", "v", ".", "bisphosphonates", ",", "good", "tolerability", "and", "dosing", "convenience", ".", "Oral", "ibandronate", ",", "a", "highly", "potent", ",", "third", "-", "generation", "aminobisphosphonate", ",", "has", "been", "evaluated", "in", "phase", "III", "clinical", "trials", "of", "patients", "with", "bone", "metastases", "from", "breast", "cancer", ".", "In", "two", "pooled", "phase", "III", "studies", ",", "patients", "with", "breast", "cancer", "and", "bone", "metastases", "were", "randomised", "to", "receive", "oral", "ibandronate", "50", "mg", "(", "n", "=", "287", ")", "or", "placebo", "(", "n", "=", "277", ")", "once", "daily", "for", "up", "to", "96", "weeks", ".", "The", "primary", "end", "point", "was", "the", "skeletal", "morbidity", "period", "rate", "(", "SMPR", ")", ",", "defined", "as", "the", "number", "of", "12", "-", "week", "periods", "with", "new", "skeletal", "complications", ".", "Multivariate", "Poisson", "'", "s", "regression", "analysis", "was", "used", "to", "assess", "the", "relative", "risk", "of", "skeletal", "-", "related", "events", "in", "each", "treatment", "group", "during", "the", "study", "period", ".", "Oral", "ibandronate", "50", "mg", "significantly", "reduced", "the", "mean", "SMPR", "compared", "with", "placebo", "(", "0", ".", "95", "vs", "1", ".", "18", ",", "P", "=", "0", ".", "004", ")", ".", "There", "was", "a", "significant", "reduction", "in", "the", "mean", "number", "of", "events", "requiring", "radiotherapy", "(", "0", ".", "73", "vs", "0", ".", "98", ",", "P", "<", "0", ".", "001", ")", "and", "events", "requiring", "surgery", "(", "0", ".", "47", "vs", "0", ".", "53", ",", "P", "=", "0", ".", "037", ")", ".", "Poisson", "'", "s", "regression", "analysis", "confirmed", "that", "oral", "ibandronate", "significantly", "reduced", "the", "risk", "of", "a", "skeletal", "event", "compared", "with", "placebo", "(", "hazard", "ratio", "0", ".", "62", ",", "95", "%", "CI", "=", "0", ".", "48", ",", "0", ".", "79", ";", "P", "=", "0", ".", "0001", ")", ".", "The", "incidence", "of", "mild", "treatment", "-", "related", "upper", "GI", "AEs", "was", "slightly", "higher", "in", "the", "oral", "ibandronate", "50", "mg", "group", "compared", "with", "placebo", ",", "but", "very", "few", "serious", "drug", "-", "related", "AEs", "were", "reported", ".", "Oral", "ibandronate", "50", "mg", "is", "an", "effective", ",", "well", "-", "tolerated", "and", "convenient", "treatment", "for", "the", "prevention", "of", "skeletal", "complications", "of", "metastatic", "bone", "disease", "." ]
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15084618
[ "Phase", "III", "randomized", "trial", "of", "Calendula", "officinalis", "compared", "with", "trolamine", "for", "the", "prevention", "of", "acute", "dermatitis", "during", "irradiation", "for", "breast", "cancer", ".", "The", "effectiveness", "of", "nonsteroid", "topical", "agents", "for", "the", "prevention", "of", "acute", "dermatitis", "during", "adjuvant", "radiotherapy", "for", "breast", "carcinoma", "has", "not", "been", "demonstrated", ".", "The", "goal", "of", "this", "study", "was", "to", "compare", "the", "effectiveness", "of", "calendula", "(", "Pommade", "au", "Calendula", "par", "Digestion", ";", "Boiron", "Ltd", ",", "Levallois", "-", "Perret", ",", "France", ")", "with", "that", "of", "trolamine", "(", "Biafine", ";", "Genmedix", "Ltd", ",", "France", ")", ",", "which", "is", "considered", "in", "many", "institutions", "to", "be", "the", "reference", "topical", "agent", ".", "Between", "July", "1999", "and", "June", "2001", ",", "254", "patients", "who", "had", "been", "operated", "on", "for", "breast", "cancer", "and", "who", "were", "to", "receive", "postoperative", "radiation", "therapy", "were", "randomly", "allocated", "to", "application", "of", "either", "trolamine", "(", "128", "patients", ")", "or", "calendula", "(", "126", "patients", ")", "on", "the", "irradiated", "fields", "after", "each", "session", ".", "The", "primary", "end", "point", "was", "the", "occurrence", "of", "acute", "dermatitis", "of", "grade", "2", "or", "higher", ".", "Prognostic", "factors", ",", "including", "treatment", "modalities", "and", "patient", "characteristics", ",", "were", "also", "investigated", ".", "Secondary", "end", "points", "were", "the", "occurrence", "of", "pain", ",", "the", "quantity", "of", "topical", "agent", "used", ",", "and", "patient", "satisfaction", ".", "The", "occurrence", "of", "acute", "dermatitis", "of", "grade", "2", "or", "higher", "was", "significantly", "lower", "(", "41", "%", "v", "63", "%", ";", "P", "<", ".", "001", ")", "with", "the", "use", "of", "calendula", "than", "with", "trolamine", ".", "Moreover", ",", "patients", "receiving", "calendula", "had", "less", "frequent", "interruption", "of", "radiotherapy", "and", "significantly", "reduced", "radiation", "-", "induced", "pain", ".", "Calendula", "was", "considered", "to", "be", "more", "difficult", "to", "apply", ",", "but", "self", "-", "assessed", "satisfaction", "was", "greater", ".", "Body", "mass", "index", "and", "adjuvant", "chemotherapy", "before", "radiotherapy", "after", "lumpectomy", "were", "significant", "prognostic", "factors", "for", "acute", "dermatitis", ".", "Calendula", "is", "highly", "effective", "for", "the", "prevention", "of", "acute", "dermatitis", "of", "grade", "2", "or", "higher", "and", "should", "be", "proposed", "for", "patients", "undergoing", "postoperative", "irradiation", "for", "breast", "cancer", "." ]
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15117982
[ "Comparison", "of", "fulvestrant", "versus", "tamoxifen", "for", "the", "treatment", "of", "advanced", "breast", "cancer", "in", "postmenopausal", "women", "previously", "untreated", "with", "endocrine", "therapy", ":", "a", "multinational", ",", "double", "-", "blind", ",", "randomized", "trial", ".", "To", "evaluate", "the", "efficacy", "and", "tolerability", "of", "fulvestrant", "(", "Faslodex", ";", "AstraZeneca", "Pharmaceuticals", "LP", ",", "Wilmington", ",", "DE", ")", ",", "a", "new", "estrogen", "receptor", "(", "ER", ")", "antagonist", "that", "downregulates", "ER", "and", "has", "no", "agonist", "effects", ",", "versus", "tamoxifen", ",", "an", "antiestrogen", "with", "agonist", "and", "antagonist", "effects", ",", "for", "the", "treatment", "of", "advanced", "breast", "cancer", "in", "postmenopausal", "women", ".", "In", "this", "multicenter", ",", "double", "-", "blind", ",", "randomized", "trial", ",", "patients", "with", "metastatic", "/", "locally", "advanced", "breast", "cancer", "previously", "untreated", "for", "advanced", "disease", "were", "randomly", "assigned", "to", "receive", "either", "fulvestrant", "(", "250", "mg", ",", "via", "intramuscular", "injection", ",", "once", "monthly", ";", "n", "=", "313", ")", "or", "tamoxifen", "(", "20", "mg", ",", "orally", ",", "once", "daily", ";", "n", "=", "274", ")", ".", "Patients", "'", "tumors", "were", "positive", "for", "ER", "(", "ER", "+", ")", "and", "/", "or", "progesterone", "receptor", "(", "PgR", "+", ")", ",", "or", "had", "an", "unknown", "receptor", "status", ".", "At", "a", "median", "follow", "-", "up", "of", "14", ".", "5", "months", ",", "there", "was", "no", "significant", "difference", "between", "fulvestrant", "and", "tamoxifen", "for", "the", "primary", "end", "point", "of", "time", "to", "progression", "(", "TTP", ";", "median", "TTP", ",", "6", ".", "8", "months", "and", "8", ".", "3", "months", ",", "respectively", ";", "hazard", "ratio", ",", "1", ".", "18", ";", "95", "%", "CI", ",", "0", ".", "98", "to", "1", ".", "44", ";", "P", "=", ".", "088", ")", ".", "In", "a", "prospectively", "planned", "subset", "analysis", "of", "patients", "with", "known", "ER", "+", "and", "/", "or", "PgR", "+", "tumors", "(", "approximately", "78", "%", ")", ",", "median", "TTP", "was", "8", ".", "2", "months", "for", "fulvestrant", "and", "8", ".", "3", "months", "for", "tamoxifen", "(", "hazard", "ratio", ",", "1", ".", "10", ";", "95", "%", "CI", ",", "0", ".", "89", "to", "1", ".", "36", ";", "P", "=", ".", "39", ")", ".", "The", "objective", "response", "rate", "for", "the", "overall", "population", "was", "31", ".", "6", "%", "with", "fulvestrant", "and", "33", ".", "9", "%", "with", "tamoxifen", ",", "and", "33", ".", "2", "%", "and", "31", ".", "1", "%", ",", "respectively", ",", "in", "the", "known", "hormone", "receptor", "-", "positive", "subgroup", ".", "Both", "treatments", "were", "well", "tolerated", ".", "In", "the", "overall", "population", ",", "between", "-", "group", "differences", "in", "efficacy", "end", "points", "favored", "tamoxifen", ",", "and", "statistical", "noninferiority", "of", "fulvestrant", "could", "not", "be", "demonstrated", ".", "However", ",", "in", "patients", "with", "hormone", "receptor", "-", "positive", "tumors", ",", "fulvestrant", "had", "similar", "efficacy", "to", "tamoxifen", "and", "was", "well", "tolerated", "." ]
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15135472
[ "Sentinel", "lymph", "node", "biopsy", "in", "patients", "with", "multifocal", "breast", "cancer", ".", "Multifocal", "or", "multicentric", "breast", "cancer", "has", "been", "suggested", "as", "a", "contraindication", "for", "sentinel", "node", "biopsy", "(", "SNB", ")", ".", "However", ",", "recent", "studies", "have", "demonstrated", "that", "all", "quadrants", "of", "the", "breast", "drain", "through", "common", "afferent", "channels", "to", "a", "common", "axillary", "sentinel", "node", ".", "This", "should", "mean", "that", "the", "presence", "of", "multifocal", "tumour", "should", "not", "affect", "the", "lymphatic", "drainage", ".", "The", "purpose", "of", "this", "study", "was", "to", "evaluate", "the", "feasibility", "and", "accuracy", "of", "SNB", "in", "patients", "with", "multifocal", "breast", "cancer", "using", "a", "peritumoural", "injection", "technique", "for", "sentinel", "lymph", "node", "(", "SN", ")", "mapping", ".", "In", "the", "ALMANAC", "multicentre", "trial", "validation", "phase", ",", "we", "took", "SNB", "samples", "from", "842", "patients", "with", "node", "negative", ",", "invasive", "breast", "cancer", "with", "use", "of", "a", "blue", "dye", "and", "radiolabelled", "colloid", "mapping", "technique", "at", "the", "peritumoural", "injection", "site", ".", "All", "patients", "underwent", "standard", "axillary", "treatment", "after", "SNB", ".", "Seventy", "-", "five", "of", "the", "842", "patients", "had", "multifocal", "lesions", "on", "final", "histopathologic", "examination", ".", "The", "following", "analysis", "is", "focused", "on", "patients", "with", "multifocal", "lesions", ".", "A", "mean", "number", "of", "2", ".", "4", "SNs", "were", "identified", "in", "71", "of", "75", "patients", "(", "identification", "rate", ":", "94", ".", "7", "%", ")", ".", "Thirty", "-", "one", "patients", "had", "a", "positive", "SN", ",", "40", "a", "negative", "SN", ".", "Standard", "axillary", "treatment", "confirmed", "the", "SN", "to", "be", "negative", "in", "37", "of", "40", "patients", ",", "whereas", "three", "patients", "revealed", "positive", "non", "-", "sentinel", "lymph", "nodes", "(", "false", "-", "negative", "rate", ":", "8", ".", "8", "%", ")", ".", "Overall", "SN", "biopsy", "accurately", "predicted", "axillary", "lymph", "node", "status", "in", "68", "of", "71", "patients", "(", "95", ".", "8", "%", ")", ".", "SNB", "accurately", "staged", "the", "axilla", "in", "multifocal", "breast", "cancer", "and", "may", "become", "an", "alternative", "to", "complete", "axillary", "lymph", "node", "dissection", "in", "node", "negative", "patients", "with", "multifocal", "breast", "cancer", "." ]
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15135481
[ "Seroma", "prevention", "following", "axillary", "dissection", "in", "patients", "with", "breast", "cancer", "by", "using", "ultrasound", "scissors", ":", "a", "prospective", "clinical", "study", ".", "Seroma", "formation", "following", "axillary", "dissection", "is", "a", "common", "complication", "of", "breast", "surgery", ".", "The", "aims", "of", "this", "study", "were", "(", "1", ")", "to", "analyse", "the", "risk", "factors", "of", "seroma", "formation", ",", "and", "(", "2", ")", "to", "evaluate", "the", "role", "of", "ultrasound", "scissors", "in", "performing", "axillary", "dissection", "in", "patients", "with", "primary", "breast", "cancer", "undergoing", "mastectomy", "and", "breast", "-", "conserving", "surgery", ".", "Ninety", "-", "two", "women", "(", "median", "age", "55", "years", ",", "range", "33", "-", "73", "years", ")", "requiring", "surgery", "for", "known", "unilateral", "primary", "breast", "cancer", "(", "pT1a", "=", "1", ",", "pT1b", "=", "20", ",", "pT1c", "=", "43", ",", "pT2", "=", "25", ",", "pT3", "=", "3", ")", "were", "prospectively", "randomised", "to", "undergo", "axillary", "dissection", "by", "either", "using", "(", "Group", "A", ",", "45", "patients", ")", "or", "not", "using", "(", "Group", "B", ",", "47", "patients", ")", "ultrasound", "scissors", "(", "US", ")", ".", "Thirty", "-", "eight", "(", "41", ".", "3", "%", ")", "patients", "underwent", "modified", "radical", "mastectomy", ",", "while", "54", "(", "58", ".", "7", "%", ")", "underwent", "breast", "-", "conserving", "surgery", ".", "Twenty", "-", "eight", "(", "30", ".", "4", "%", ")", "patients", "(", "Group", "A", "=", "9", "out", "of", "45", ",", "20", "%", ";", "Group", "B", "=", "19", "out", "of", "47", ",", "42", "%", ";", "P", "=", "NS", ")", "developed", "a", "wound", "seroma", ".", "Multivariate", "analysis", "using", "a", "logistic", "regression", "model", "showed", "that", "surgical", "procedure", "(", "RR", "=", "8", ".", "9", ";", "95", "%", "CI", ":", "3", ".", "2", "-", "25", ".", "3", ")", ",", "total", "amount", "of", "drainage", "(", "RR", "=", "7", ".", "8", ";", "95", "%", "CI", ":", "2", ".", "8", "-", "22", ".", "0", ")", ",", "and", "size", "of", "the", "tumour", "(", "RR", "=", "6", ".", "0", ";", "95", "%", "CI", ":", "2", ".", "2", "-", "16", ".", "5", ")", "independently", "correlated", "with", "seroma", "formation", ".", "The", "logistic", "regression", "function", "(", "RR", "=", "19", ".", "4", ";", "95", "%", "CI", ":", "6", "-", "62", ")", "correctly", "allocated", "75", "out", "of", "92", "(", "81", ".", "5", "%", ")", "patients", ".", "Size", "of", "the", "tumour", ",", "and", "total", "amount", "of", "drainage", "represent", "the", "principal", "factors", "of", "seroma", "formation", "following", "axillary", "dissection", "in", "patients", "undergoing", "surgery", "for", "breast", "cancer", ".", "Although", "the", "use", "of", "ultrasound", "cutting", "devices", "may", "reduce", "the", "risk", "of", "seroma", "formation", ",", "further", "studies", "are", "need", "to", "verify", "the", "real", "impact", "on", "long", "-", "term", "morbidity", "of", "such", "technique", "." ]
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15154664
[ "Local", "recurrence", "in", "breast", "cancer", "after", "conservative", "surgery", ":", "timing", "of", "radiotherapy", "and", "sequencing", "of", "chemotherapy", ".", "A", "randomized", "trial", "was", "conducted", "to", "determine", "(", "a", ")", "the", "role", "of", "radiotherapy", "and", "chemotherapy", "on", "local", "control", "and", "(", "b", ")", "to", "determine", "the", "timing", "of", "radiotherapy", "for", "early", "-", "stage", "breast", "cancer", ".", "Five", "hundred", "and", "ninety", "patients", "were", "treated", "with", "both", "conservative", "surgery", "and", "radiotherapy", "(", "group", "A", ")", ".", "The", "average", "time", "interval", "between", "surgery", "and", "radiation", "was", "90", "days", "for", "452", "patients", "and", "over", "90", "days", "for", "138", "patients", ".", "One", "hundred", "and", "ninety", "-", "four", "patients", "underwent", "adjuvant", "therapy", "based", "on", "CMF", "regimens", "(", "group", "B", ")", ".", "Among", "396", "patients", "of", "group", "A", ",", "8", ".", "1", "%", "had", "local", "failure", ";", "we", "observed", "7", ".", "2", "%", "local", "recurrences", "in", "363", "patients", "who", "received", "therapy", "before", "90", "days", "and", "18", ".", "2", "%", "in", "patients", "who", "received", "therapy", "after", "90", "days", ".", "Among", "patients", "of", "group", "B", ",", "7", ".", "7", "%", "had", "local", "failure", ";", "for", "patients", "who", "underwent", "radiotherapy", "before", "90", "days", ",", "the", "local", "recurrence", "rate", "was", "6", ".", "6", "%", ",", "compared", "with", "12", ".", "3", "%", "for", "patients", "who", "underwent", "therapy", "more", "than", "90", "days", "after", "surgery", ".", "In", "patients", "who", "are", "eligible", "to", "receive", "chemotherapy", ",", "it", "is", "possible", "to", "administer", "radiotherapy", "after", "systemic", "treatment", ",", "while", "in", "patients", "who", "have", "to", "be", "treated", "with", "radiotherapy", "more", "then", "90", "days", "after", "breast", "surgery", ",", "chemotherapy", "can", "reduce", "the", "local", "failure", "rate", "." ]
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15179836
[ "Postoperative", "adjuvant", "use", "of", "carmofur", "for", "early", "breast", "cancer", ".", "The", "efficacy", "of", "oral", "fluoropyrimidine", "carmofur", "was", "evaluated", "for", "adjuvant", "use", "for", "breast", "cancer", ".", "150", "patients", "with", "breast", "cancer", "of", "T0N1", ",", "T1", ",", "N1", ",", "T2N0", ",", "and", "T2N1", "were", "randomized", "to", "100", "for", "carmofur", "and", "50", "for", "carboquone", ".", "Both", "drugs", "were", "administered", "continuously", "for", "28", "days", "cyclically", "for", "5", "years", "with", "a", "cessation", "period", "of", "28", "days", "for", "carmofur", "and", "56", "days", "for", "carboquone", ".", "Overall", "survival", "excluding", "non", "-", "breast", "cancer", "death", "was", "90", "%", "for", "the", "carmofur", "group", "and", "88", "%", "for", "the", "carboquone", "group", ",", "adjusted", "by", "Cox", "'", "s", "regression", "analysis", ".", "Difference", "in", "drug", "never", "affected", "survival", ".", "Leukocyte", "count", "was", "decreased", "in", "the", "carboquone", "group", ",", "but", "no", "change", "in", "serum", "transaminase", "was", "found", "in", "either", "group", ".", "Ten", "patients", ",", "5", "for", "carmofur", "and", "5", "for", "carboquone", ",", "suffered", "from", "second", "malignancy", ",", "more", "than", "expected", "in", "the", "normal", "population", ",", "but", "difference", "in", "the", "cumulative", "rate", "of", "each", "group", "was", "not", "significant", ".", "Adjuvant", "use", "of", "carmofur", "as", "well", "as", "carboquone", "is", "beneficial", "for", "early", "breast", "cancer", "." ]
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15245618
[ "High", "-", "dose", "oral", "medroxyprogesterone", "acetate", "or", "tamoxifen", "as", "adjuvant", "hormone", "therapy", "for", "node", "-", "negative", "early", "-", "stage", "breast", "cancer", ":", "randomized", "trial", "with", "7", "-", "year", "update", ".", "A", "randomized", "adjuvant", "trial", "compared", "tamoxifen", "20", "mg", "daily", "for", "5", "years", "with", "high", "-", "dose", "oral", "medroxyprogesterone", "acetate", "(", "MPA", ")", "1", "g", "orally", "for", "9", "months", ".", "One", "hundred", "ninety", "-", "four", "patients", "with", "histologically", "proven", "primary", "node", "-", "negative", "breast", "carcinoma", "were", "enrolled", "between", "December", "1990", "and", "October", "1996", ",", "with", "98", "patients", "randomized", "into", "the", "tamoxifen", "arm", "and", "96", "into", "the", "MPA", "arm", ".", "At", "a", "median", "follow", "-", "up", "of", "86", "months", ",", "25", "relapses", "and", "13", "deaths", "were", "recorded", ".", "The", "relapse", "-", "free", "survival", "rate", "at", "7", "years", "in", "the", "tamoxifen", "arm", "was", "93", "%", ",", "versus", "81", "%", "in", "the", "MPA", "arm", "(", "P", "=", "0", ".", "02", ")", ".", "The", "difference", "was", "observed", "in", "patients", "with", "stage", "T2", "disease", "(", "100", "%", "in", "the", "tamoxifen", "group", "vs", ".", "64", "%", "in", "the", "MPA", "group", ";", "P", "=", "0", ".", "01", ")", ",", "in", "younger", "and", "/", "or", "premenopausal", "patients", "(", "in", "patients", "<", "50", "years", "of", "age", ",", "100", "%", "in", "the", "tamoxifen", "arm", "vs", ".", "81", "%", "in", "the", "MPA", "arm", "[", "P", "=", "0", ".", "02", "]", ",", "and", "in", "patients", ">", "or", "=", "50", "years", "of", "age", ",", "90", "%", "in", "the", "tamoxifen", "arm", "vs", ".", "82", "%", "in", "the", "MPA", "arm", "[", "P", "=", "0", ".", "16", "]", ")", ".", "Also", ",", "the", "overall", "survival", "rate", "at", "7", "years", "was", "lower", "in", "women", "<", "50", "years", "of", "age", "(", "P", "=", "0", ".", "04", ")", "." ]
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15254052
[ "Randomized", "phase", "II", "study", "of", "two", "irinotecan", "schedules", "for", "patients", "with", "metastatic", "breast", "cancer", "refractory", "to", "an", "anthracycline", ",", "a", "taxane", ",", "or", "both", ".", "A", "pressing", "need", "exists", "for", "agents", "active", "against", "anthracycline", "-", "or", "taxane", "-", "refractory", "metastatic", "breast", "cancer", "(", "MBC", ")", ",", "or", "both", ".", "Previous", "clinical", "trials", "suggested", "that", "irinotecan", "might", "have", "such", "activity", ".", "We", "conducted", "this", "multicenter", "phase", "II", "study", "to", "assess", "efficacy", "and", "tolerability", "of", "two", "irinotecan", "schedules", ".", "MBC", "patients", "who", "experienced", "disease", "progression", "after", "one", "to", "three", "chemotherapy", "regimens", ",", "including", "at", "least", "one", "anthracycline", "-", "or", "taxane", "-", "based", "regimen", ",", "were", "randomly", "assigned", "to", "irinotecan", "in", "6", "-", "week", "cycles", "comprising", "100", "mg", "/", "m", "(", "2", ")", "weekly", "for", "4", "weeks", ",", "then", "a", "2", "-", "week", "rest", "(", "weekly", ")", "or", "240", "mg", "/", "m", "(", "2", ")", "every", "3", "weeks", ".", "The", "weekly", "arm", "had", "52", "assessable", "patients", ";", "the", "every", "-", "3", "-", "weeks", "arm", "had", "51", "assessable", "patients", ".", "In", "the", "weekly", "arm", ",", "the", "objective", "response", "(", "complete", "regression", "[", "CR", "]", "+", "partial", "regression", "[", "PR", "]", ")", "rate", "was", "23", "%", "(", "one", "CR", ",", "11", "PR", ";", "95", "%", "CI", ",", "13", "%", "to", "37", "%", ")", ".", "Median", "response", "duration", "was", "4", ".", "9", "months", "(", "range", ",", "1", ".", "9", "to", "15", ".", "9", "months", ")", ",", "and", "median", "overall", "survival", "was", "9", ".", "7", "months", "(", "95", "%", "CI", ",", "8", ".", "0", "to", "14", ".", "2", "months", ")", ".", "In", "the", "every", "-", "3", "-", "weeks", "arm", ",", "the", "objective", "response", "rate", "was", "14", "%", "(", "nine", "PR", ";", "95", "%", "CI", ",", "6", "%", "to", "26", "%", ")", ",", "median", "response", "duration", "was", "4", ".", "2", "months", "(", "range", ",", "3", ".", "1", "to", "13", ".", "9", "months", ")", ",", "and", "median", "overall", "survival", "was", "8", ".", "6", "months", "(", "95", "%", "CI", ",", "7", ".", "0", "to", "12", ".", "3", "months", ")", ".", "Treatment", "generally", "was", "well", "tolerated", ",", "especially", "in", "the", "weekly", "arm", ".", "Grade", "3", "to", "4", "adverse", "events", "with", ">", "or", "=", "10", "%", "incidence", "included", "neutropenia", "(", "29", "%", ")", "and", "diarrhea", "(", "17", "%", ")", "in", "the", "weekly", "arm", "and", "neutropenia", "(", "36", "%", ")", ",", "vomiting", "(", "20", "%", ")", ",", "dyspnea", "(", "18", "%", ")", ",", "nausea", "(", "16", "%", ")", ",", "and", "diarrhea", "(", "12", "%", ")", "in", "the", "every", "-", "3", "-", "weeks", "arm", ".", "Irinotecan", "is", "active", "with", "good", "tolerability", "in", "refractory", "MBC", ".", "Irinotecan", "(", "especially", "weekly", ")", "warrants", "additional", "study", "as", "monotherapy", "and", "in", "combination", "regimens", "in", "this", "setting", "." ]
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15280341
[ "Effect", "of", "a", "decision", "aid", "on", "knowledge", "and", "treatment", "decision", "making", "for", "breast", "cancer", "surgery", ":", "a", "randomized", "trial", ".", "The", "long", "-", "term", "results", "of", "randomized", "trials", "have", "demonstrated", "equivalent", "survival", "rates", "for", "mastectomy", "and", "breast", "-", "conserving", "therapy", "for", "the", "treatment", "of", "early", "stage", "breast", "cancer", ".", "Consequently", ",", "the", "choice", "of", "treatment", "should", "be", "based", "on", "a", "patient", "'", "s", "preferences", ".", "To", "evaluate", "the", "impact", "of", "a", "decision", "aid", "regarding", "the", "different", "surgical", "treatment", "options", "on", "patient", "decision", "making", ".", "A", "cluster", "randomized", "trial", "for", "which", "general", "surgeons", "in", "the", "communities", "of", "central", "-", "west", ",", "and", "eastern", "Ontario", ",", "Canada", ",", "were", "randomly", "assigned", "to", "use", "the", "decision", "aid", "or", "not", "in", "the", "surgical", "consultation", ".", "Patients", "received", "the", "decision", "aid", "or", "not", "based", "on", "the", "surgeon", "seen", ".", "Twenty", "surgeons", "participated", "in", "the", "study", ".", "Of", "the", "208", "eligible", "women", "with", "newly", "diagnosed", "clinical", "stage", "I", "or", "II", "breast", "cancer", "seen", "by", "study", "surgeons", ",", "201", "agreed", "to", "be", "evaluated", ":", "94", "were", "assigned", "to", "the", "decision", "board", "and", "107", "to", "usual", "practice", ".", "Patients", "were", "recruited", "from", "November", "1999", "to", "April", "2002", ".", "The", "decision", "board", "is", "a", "decision", "aid", "designed", "to", "help", "physicians", "inform", "their", "patients", "about", "different", "treatment", "options", "and", "to", "enable", "patients", "to", "express", "a", "preference", "for", "treatment", ".", "Patient", "knowledge", "about", "the", "surgical", "treatment", "of", "breast", "cancer", ";", "decisional", "conflict", ";", "satisfaction", "with", "decision", "making", ";", "and", "the", "treatment", "decision", "following", "the", "consultation", ".", "Patients", "in", "the", "decision", "board", "group", "had", "higher", "knowledge", "scores", "about", "their", "treatment", "options", "(", "66", ".", "9", "vs", "58", ".", "7", ";", "P", "<", ".", "001", ")", ",", "had", "less", "decisional", "conflict", "(", "1", ".", "40", "vs", "1", ".", "62", ",", "P", "=", ".", "02", ")", ",", "and", "were", "more", "satisfied", "with", "decision", "making", "(", "4", ".", "50", "vs", "4", ".", "32", ",", "P", "=", ".", "05", ")", "following", "the", "consultation", ".", "Patients", "who", "used", "the", "decision", "board", "were", "more", "likely", "to", "choose", "BCT", "(", "94", "%", "vs", "76", "%", ",", "P", "=", ".", "03", ")", ".", "The", "decision", "board", "was", "helpful", "in", "improving", "communication", "and", "enabling", "women", "to", "make", "a", "choice", "regarding", "treatment", ".", "Such", "instruments", "should", "be", "considered", "by", "surgeons", "when", "communicating", "the", "different", "surgical", "options", "to", "women", "with", "breast", "cancer", "." ]
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15284257
[ "Long", "-", "term", "cardiac", "follow", "-", "up", "in", "relapse", "-", "free", "patients", "after", "six", "courses", "of", "fluorouracil", ",", "epirubicin", ",", "and", "cyclophosphamide", ",", "with", "either", "50", "or", "100", "mg", "of", "epirubicin", ",", "as", "adjuvant", "therapy", "for", "node", "-", "positive", "breast", "cancer", ":", "French", "adjuvant", "study", "group", ".", "PURPOSE", "To", "evaluate", "long", "-", "term", "cardiac", "function", "in", "patients", "without", "disease", "who", "had", "received", "six", "cycles", "of", "fluorouracil", "500", "mg", "/", "m", "(", "2", ")", ",", "epirubicin", "50", "mg", "/", "m", "(", "2", ")", ",", "and", "cyclophosphamide", "500", "mg", "/", "m", "(", "2", ")", "(", "FEC", "50", ")", "or", "the", "same", "regimen", "with", "epirubicin", "100", "mg", "/", "m", "(", "2", ")", "(", "FEC", "100", ")", "as", "adjuvant", "chemotherapy", "for", "node", "-", "positive", "breast", "cancer", "in", "the", "French", "Adjuvant", "Study", "Group", "-", "05", "trial", ".", "PATIENTS", "AND", "METHODS", "One", "hundred", "fifty", "patients", "(", "FEC", "50", ",", "n", "=", "65", ";", "FEC", "100", ",", "n", "=", "85", ")", "who", "were", "without", "disease", "and", "who", "gave", "their", "informed", "consent", "were", "enrolled", "for", "long", "-", "term", "cardiac", "assessment", ".", "The", "assessment", "included", "cardiac", "events", "occurring", "after", "the", "end", "of", "chemotherapy", ",", "vital", "signs", ",", "concomitant", "disease", ",", "ECG", ",", "isotopic", "left", "ventricular", "ejection", "fraction", "(", "LVEF", ")", ",", "and", "echographic", "parameters", ".", "Abnormal", "files", "were", "blindly", "reviewed", "by", "cardiologists", "and", "oncologists", ".", "Results", "The", "median", "follow", "-", "up", "time", "was", "102", "months", ".", "After", "FEC", "100", ",", "LVEF", "was", "less", "than", "50", "%", "in", "five", "patients", "(", "radioisotopic", "method", ")", ",", "and", "two", "patients", "experienced", "congestive", "heart", "failure", "(", "CHF", ")", "that", "was", "possibly", "related", "to", "treatment", ".", "Asymptomatic", "left", "ventricular", "dysfunction", "(", "LVD", ")", "was", "experienced", "in", "18", "patients", "after", "FEC", "100", "and", "in", "one", "patient", "after", "FEC", "50", ".", "In", "these", "patients", ",", "treatment", "causality", "was", "probable", "in", "eight", "patients", ".", "Two", "additional", "years", "after", "this", "assessment", ",", "all", "18", "patients", "were", "still", "asymptomatic", ".", "CONCLUSION", "After", "more", "than", "8", "years", "of", "follow", "-", "up", ",", "the", "cardiac", "toxicity", "observed", "after", "adjuvant", "treatment", "with", "FEC", "100", "comprised", "two", "cases", "of", "well", "-", "controlled", "CHF", "and", "18", "cases", "of", "asymptomatic", "LVD", ".", "In", "the", "majority", "of", "women", "with", "primary", "breast", "cancer", ",", "the", "benefits", "of", "treatment", "with", "FEC", "100", "in", "terms", "of", "disease", "-", "free", "and", "overall", "survival", "outweigh", "the", "risks", ",", "and", "cardiac", "risk", "factors", "should", "be", "carefully", "evaluated", "in", "patient", "selection", "." ]
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15341559
[ "Comparison", "of", "fracture", ",", "cardiovascular", "event", ",", "and", "breast", "cancer", "rates", "at", "3", "years", "in", "postmenopausal", "women", "with", "osteoporosis", ".", "To", "compare", "event", "rates", "for", "osteoporotic", "fractures", ",", "cardiovascular", "events", ",", "and", "breast", "cancer", "in", "postmenopausal", "women", "with", "osteoporosis", ".", "A", "prospective", ",", "observational", "study", "of", "the", "placebo", "group", "in", "the", "double", "-", "blind", ",", "randomized", "Multiple", "Outcomes", "of", "Raloxifene", "Evaluation", "trial", ".", "One", "hundred", "eighty", "clinical", "research", "centers", "in", "25", "countries", ".", "Postmenopausal", "women", "(", "n", "=", "2", ",", "565", ",", "mean", "age", "=", "67", ")", "with", "osteoporosis", "were", "given", "calcium", "(", "500", "mg", "/", "d", ")", "and", "vitamin", "D", "(", "400", "-", "600", "IU", "/", "d", ")", "supplements", ".", "The", "occurrence", "of", "at", "least", "one", "new", "fracture", ",", "cardiovascular", "event", ",", "or", "breast", "cancer", "diagnosis", "at", "3", "years", "was", "identified", "and", "adjudicated", ".", "The", "occurrence", "of", "any", "fracture", "was", "the", "most", "common", "event", "in", "these", "women", ".", "In", "women", "without", "prevalent", "vertebral", "fractures", "(", "n", "=", "1", ",", "627", ")", ",", "the", "event", "rates", "per", "1", ",", "000", "patient", "-", "years", "were", "45", ".", "4", "for", "any", "fracture", ",", "15", ".", "2", "for", "vertebral", "fracture", ",", "4", ".", "7", "for", "clinical", "vertebral", "fracture", ",", "0", ".", "9", "for", "hip", "fracture", ",", "8", ".", "3", "for", "any", "cardiovascular", "event", ",", "and", "5", ".", "2", "for", "all", "breast", "cancer", ".", "In", "women", "with", "prevalent", "vertebral", "fractures", "(", "n", "=", "938", ")", ",", "the", "event", "rates", "per", "1", ",", "000", "patient", "-", "years", "were", "117", ".", "4", "for", "any", "new", "fracture", ",", "77", ".", "1", "for", "new", "vertebral", "fracture", ",", "25", ".", "7", "for", "clinical", "vertebral", "fracture", ",", "5", ".", "8", "for", "hip", "fracture", ",", "15", ".", "1", "for", "any", "cardiovascular", "event", ",", "and", "2", ".", "6", "for", "all", "breast", "cancer", ".", "The", "effect", "of", "prevalent", "fracture", "status", "on", "event", "rates", "was", "not", "dependent", "on", "whether", "women", "were", "older", "or", "younger", "than", "65", ",", "but", "women", "aged", "65", "and", "older", "had", "a", "3", ".", "6", "times", "greater", "occurrence", "of", "cardiovascular", "events", "than", "younger", "women", ",", "irrespective", "of", "prevalent", "fracture", "status", ".", "These", "data", "on", "the", "relative", "incidence", "of", "clinically", "significant", "skeletal", "and", "extra", "-", "skeletal", "outcomes", "may", "be", "useful", "in", "choosing", "an", "agent", "for", "health", "maintenance", "for", "postmenopausal", "women", "with", "osteoporosis", "." ]
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15342804
[ "Tamoxifen", "with", "or", "without", "breast", "irradiation", "in", "women", "50", "years", "of", "age", "or", "older", "with", "early", "breast", "cancer", ".", "We", "determined", "the", "effect", "of", "breast", "irradiation", "plus", "tamoxifen", "on", "disease", "-", "free", "survival", "and", "local", "relapse", "in", "women", "50", "years", "of", "age", "or", "older", "who", "had", "T1", "or", "T2", "node", "-", "negative", "breast", "cancer", ".", "Between", "December", "1992", "and", "June", "2000", ",", "769", "women", "with", "early", "breast", "cancer", "(", "tumor", "diameter", ",", "5", "cm", "or", "less", ")", "were", "randomly", "assigned", "to", "receive", "breast", "irradiation", "plus", "tamoxifen", "(", "386", "women", ")", "or", "tamoxifen", "alone", "(", "383", "women", ")", ".", "The", "median", "follow", "-", "up", "was", "5", ".", "6", "years", ".", "The", "rate", "of", "local", "relapse", "at", "five", "years", "was", "7", ".", "7", "percent", "in", "the", "tamoxifen", "group", "and", "0", ".", "6", "percent", "in", "the", "group", "given", "tamoxifen", "plus", "irradiation", "(", "hazard", "ratio", ",", "8", ".", "3", ";", "95", "percent", "confidence", "interval", ",", "3", ".", "3", "to", "21", ".", "2", ";", "P", "<", "0", ".", "001", ")", ",", "with", "corresponding", "five", "-", "year", "disease", "-", "free", "survival", "rates", "of", "84", "percent", "and", "91", "percent", "(", "P", "=", "0", ".", "004", ")", ".", "A", "planned", "subgroup", "analysis", "of", "611", "women", "with", "T1", ",", "receptor", "-", "positive", "tumors", "indicated", "a", "benefit", "from", "radiotherapy", "(", "five", "-", "year", "rates", "of", "local", "relapse", ",", "0", ".", "4", "percent", "with", "tamoxifen", "plus", "radiotherapy", "and", "5", ".", "9", "percent", "with", "tamoxifen", "alone", ";", "P", "<", "0", ".", "001", ")", ".", "Overall", ",", "there", "was", "a", "significant", "difference", "in", "the", "rate", "of", "axillary", "relapse", "at", "five", "years", "(", "2", ".", "5", "percent", "in", "the", "tamoxifen", "group", "and", "0", ".", "5", "percent", "in", "the", "group", "given", "tamoxifen", "plus", "irradiation", ",", "P", "=", "0", ".", "049", ")", ",", "but", "no", "significant", "difference", "in", "the", "rates", "of", "distant", "relapse", "or", "overall", "survival", ".", "As", "compared", "with", "tamoxifen", "alone", ",", "radiotherapy", "plus", "tamoxifen", "significantly", "reduces", "the", "risk", "of", "breast", "and", "axillary", "recurrence", "after", "lumpectomy", "in", "women", "with", "small", ",", "node", "-", "negative", ",", "hormone", "-", "receptor", "-", "positive", "breast", "cancers", "." ]
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15342805
[ "Lumpectomy", "plus", "tamoxifen", "with", "or", "without", "irradiation", "in", "women", "70", "years", "of", "age", "or", "older", "with", "early", "breast", "cancer", ".", "In", "women", "70", "years", "of", "age", "or", "older", "who", "have", "early", "breast", "cancer", ",", "it", "is", "unclear", "whether", "lumpectomy", "plus", "tamoxifen", "is", "as", "effective", "as", "lumpectomy", "followed", "by", "tamoxifen", "plus", "radiation", "therapy", ".", "Between", "July", "1994", "and", "February", "1999", ",", "we", "randomly", "assigned", "636", "women", "who", "were", "70", "years", "of", "age", "or", "older", "and", "who", "had", "clinical", "stage", "I", "(", "T1N0M0", "according", "to", "the", "tumor", "-", "node", "-", "metastasis", "classification", ")", ",", "estrogen", "-", "receptor", "-", "positive", "breast", "carcinoma", "treated", "by", "lumpectomy", "to", "receive", "tamoxifen", "plus", "radiation", "therapy", "(", "317", "women", ")", "or", "tamoxifen", "alone", "(", "319", "women", ")", ".", "Primary", "end", "points", "were", "the", "time", "to", "local", "or", "regional", "recurrence", ",", "the", "frequency", "of", "mastectomy", "for", "recurrence", ",", "breast", "-", "cancer", "-", "specific", "survival", ",", "the", "time", "to", "distant", "metastasis", ",", "and", "overall", "survival", ".", "The", "only", "significant", "difference", "between", "the", "two", "groups", "was", "in", "the", "rate", "of", "local", "or", "regional", "recurrence", "at", "five", "years", "(", "1", "percent", "in", "the", "group", "given", "tamoxifen", "plus", "irradiation", "and", "4", "percent", "in", "the", "group", "given", "tamoxifen", "alone", ",", "P", "<", "0", ".", "001", ")", ".", "There", "were", "no", "significant", "differences", "between", "the", "two", "groups", "with", "regard", "to", "the", "rates", "of", "mastectomy", "for", "local", "recurrence", ",", "distant", "metastases", ",", "or", "five", "-", "year", "rates", "of", "overall", "survival", "(", "87", "percent", "in", "the", "group", "given", "tamoxifen", "plus", "irradiation", "and", "86", "percent", "in", "the", "tamoxifen", "group", ",", "P", "=", "0", ".", "94", ")", ".", "Assessment", "by", "physicians", "and", "patients", "of", "cosmetic", "results", "and", "adverse", "events", "uniformly", "rated", "tamoxifen", "plus", "irradiation", "inferior", "to", "tamoxifen", "alone", ".", "Lumpectomy", "plus", "adjuvant", "therapy", "with", "tamoxifen", "alone", "is", "a", "realistic", "choice", "for", "the", "treatment", "of", "women", "70", "years", "of", "age", "or", "older", "who", "have", "early", ",", "estrogen", "-", "receptor", "-", "positive", "breast", "cancer", "." ]
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15375502
[ "1", "-", "hexylcarbamoyl", "-", "5", "-", "fluorouracil", "+", "cyclophosphamide", "+", "tamoxifen", "versus", "CMF", "+", "tamoxifen", "in", "women", "with", "lymph", "node", "-", "positive", "breast", "cancer", "after", "primary", "surgery", ":", "a", "randomized", "controlled", "trial", ".", "We", "studied", "the", "usefulness", "of", "the", "oral", "5", "-", "FU", "anti", "-", "cancer", "drug", "1", "-", "hexylcarbamoyl", "-", "5", "-", "fluorouracil", "(", "HCFU", ")", "+", "cyclophosphamide", "(", "CPM", ")", "+", "tamoxifen", "(", "TAM", ")", "(", "HCT", "group", ")", "in", "comparison", "with", "CMF", "+", "TAM", "(", "CMFT", "group", ")", "in", "adjuvant", "therapy", "for", "breast", "cancer", "by", "a", "non", "-", "inferiority", "study", "based", "on", "a", "multi", "-", "institutional", "joint", "study", ".", "Clinical", "stage", "I", ",", "II", "primary", "breast", "cancers", "with", "histologically", "positive", "axillary", "lymph", "node", "metastasis", "were", "randomly", "assigned", "to", "the", "HCT", "group", "or", "the", "CMFT", "group", "after", "primary", "surgery", ".", "We", "registered", "136", "cases", "(", "HCT", "group", "68", "cases", ",", "CMFT", "group", "68", "cases", ")", ".", "No", "significant", "difference", "in", "the", "5", "-", "year", "overall", "survival", "rate", "(", "OS", ")", "and", "the", "5", "-", "year", "disease", "-", "free", "survival", "rate", "(", "DFS", ")", "was", "found", "between", "the", "two", "groups", ".", "In", "the", "stratified", "analysis", ",", "DFS", "in", "cases", "in", "which", "the", "number", "of", "metastatic", "lymph", "nodes", "was", "1", "-", "3", "was", "significantly", "better", "in", "the", "HCT", "group", "(", "HCT", "group", "84", ".", "3", "%", ",", "CMFT", "group", "69", ".", "4", "%", ",", "log", "-", "rank", "test", "p", "=", "0", ".", "0496", ")", ".", "No", "significant", "difference", "in", "the", "total", "incidence", "of", "adverse", "effects", "was", "found", "between", "the", "two", "groups", ",", "but", "there", "were", "significantly", "less", "adverse", "effects", "of", "grade", "2", "or", "over", "in", "the", "HCT", "group", "(", "p", "=", "0", ".", "034", ")", ".", "The", "QOL", "survey", "at", "3", "months", "after", "surgery", "showed", "a", "significant", "decline", "of", "the", "QOL", "regarding", "lassitude", ",", "degree", "of", "difficulty", "in", "daily", "life", ",", "satisfaction", "with", "treatment", "and", "present", "mood", "in", "the", "CMFT", "group", ".", "Study", "results", "suggest", "that", "2", "-", "year", "HCT", "therapy", "including", "the", "oral", "5", "-", "FU", "anti", "-", "cancer", "drug", "HCFU", "is", "a", "useful", "adjuvant", "therapy", "which", "can", "replace", "CMFT", "therapy", "in", "early", "breast", "cancer", "cases", "with", "3", "or", "lower", "metastatic", "lymph", "nodes", "." ]
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15477634
[ "Efficacy", "of", "first", "-", "line", "letrozole", "versus", "tamoxifen", "as", "a", "function", "of", "age", "in", "postmenopausal", "women", "with", "advanced", "breast", "cancer", ".", "To", "compare", "the", "efficacy", ",", "in", "regard", "to", "time", "to", "progression", "(", "TTP", ")", "and", "objective", "response", "rate", "(", "ORR", ")", ",", "of", "letrozole", "(", "Femara", ";", "Novartis", "Pharma", "AG", ";", "Basel", "Switzerland", ")", ",", "an", "oral", "aromatase", "inhibitor", ",", "with", "that", "of", "tamoxifen", "(", "Tamofen", ";", "Leiras", "OY", ";", "Turku", ",", "Finland", ")", "as", "first", "-", "line", "therapy", "in", "younger", "(", "<", "70", "years", ")", "and", "older", "(", ">", "/", "=", "70", "years", ")", "postmenopausal", "women", "with", "advanced", "breast", "cancer", ".", "Nine", "hundred", "seven", "patients", "with", "advanced", "breast", "cancer", "were", "randomly", "assigned", "to", "receive", "2", ".", "5", "mg", "letrozole", "(", "n", "=", "453", ")", "or", "20", "mg", "tamoxifen", "(", "n", "=", "454", ")", "once", "daily", "in", "a", "double", "-", "blind", ",", "multicenter", ",", "international", "trial", ".", "Among", "the", "prospectively", "planned", "analyses", "were", "analyses", "of", "TTP", "and", "ORR", "by", "age", "(", "<", "70", "and", ">", "/", "=", "70", "years", ")", ".", "The", "results", "of", "these", "prospectively", "planned", "analyses", "are", "reported", "here", ".", "Letrozole", "was", "as", "effective", "in", "older", "postmenopausal", "women", "(", ">", "/", "=", "70", "years", "of", "age", ")", "as", "it", "was", "in", "younger", "postmenopausal", "women", "(", "<", "70", "years", "of", "age", ")", ".", "The", "overall", "ORR", "in", "the", "older", "subgroup", "was", "significantly", "higher", "in", "patients", "treated", "with", "letrozole", "(", "38", "%", ")", "than", "in", "patients", "treated", "with", "tamoxifen", "(", "18", "%", ")", ".", "In", "the", "younger", "subgroup", "of", "postmenopausal", "patients", ",", "the", "ORRs", "were", "not", "significantly", "different", "(", "letrozole", ",", "26", "%", ";", "tamoxifen", ",", "22", "%", ")", ".", "TTP", "was", "significantly", "longer", "for", "letrozole", "than", "for", "tamoxifen", "in", "both", "age", "groups", "(", "younger", ":", "letrozole", "median", "TTP", ",", "8", ".", "8", "months", ";", "tamoxifen", ",", "6", ".", "0", "months", ";", "older", ":", "letrozole", "median", "TTP", ",", "12", ".", "2", "months", ";", "tamoxifen", ",", "5", ".", "8", "months", ")", ".", "Although", "age", "was", "independently", "prognostic", "of", "TTP", ",", "there", "was", "no", "significant", "effect", "of", "age", "on", "ORR", "in", "the", "presence", "of", "other", "factors", ".", "The", "data", "show", "that", "letrozole", ",", "2", ".", "5", "mg", "once", "daily", ",", "is", "as", "effective", "in", "older", ",", "postmenopausal", "women", "as", "it", "is", "in", "younger", "postmenopausal", "women", "with", "advanced", "breast", "cancer", ".", "In", "addition", ",", "letrozole", "was", "more", "effective", "than", "tamoxifen", "in", "both", "younger", "and", "older", "patients", "." ]
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15505276
[ "Disease", "-", "free", "survival", "advantage", "of", "weekly", "epirubicin", "plus", "tamoxifen", "versus", "tamoxifen", "alone", "as", "adjuvant", "treatment", "of", "operable", ",", "node", "-", "positive", ",", "elderly", "breast", "cancer", "patients", ":", "6", "-", "year", "follow", "-", "up", "results", "of", "the", "French", "adjuvant", "study", "group", "08", "trial", ".", "To", "assess", "whether", "an", "epirubicin", "(", "EPI", ")", "-", "based", "chemotherapy", "plus", "hormonal", "regimen", "improves", "disease", "-", "free", "(", "DFS", ")", "in", "women", "older", "than", "65", "years", ",", "with", "node", "-", "positive", ",", "operable", "breast", "cancer", "(", "BC", ")", ",", "relative", "to", "tamoxifen", "(", "TAM", ")", "alone", ".", "A", "total", "of", "338", "patients", "were", "randomly", "assigned", "after", "surgery", "to", "receive", "TAM", "30", "mg", "/", "d", "for", "3", "years", "(", "TAM", ",", "n", "=", "164", ")", ",", "or", "EPI", "30", "mg", "on", "days", "1", ",", "8", ",", "and", "15", "every", "28", "days", "for", "six", "cycles", "plus", "TAM", "30", "mg", "/", "d", "for", "3", "years", "(", "EPI", "-", "TAM", ",", "n", "=", "174", ")", ".", "In", "both", "arms", ",", "patients", "received", "radiotherapy", ",", "delivered", "after", "chemotherapy", "(", "CT", ")", "in", "the", "EPI", "-", "TAM", "group", ".", "The", "6", "-", "year", "DFS", "rates", "were", "69", ".", "3", "%", "with", "TAM", "and", "72", ".", "6", "%", "with", "EPI", "-", "TAM", "(", "P", "=", ".", "14", ")", ".", "The", "multivariate", "analysis", "shows", "a", "relative", "risk", "of", "relapse", "of", "1", ".", "93", "(", "95", "%", "CI", ",", "1", ".", "70", "to", "2", ".", "17", ")", "with", "TAM", "compared", "with", "EPI", "-", "TAM", "(", "P", "=", ".", "005", ")", ".", "The", "6", "-", "year", "OS", ",", "related", "to", "disease", "progression", ",", "was", "79", ".", "1", "%", "and", "79", ".", "8", "%", ",", "respectively", "(", "P", "=", ".", "41", ")", ".", "Compliance", "with", "CT", "was", "good", ":", "96", ".", "9", "%", "of", "patients", "received", "six", "cycles", ".", "The", "acute", "toxicity", "per", "patient", "was", "mild", ":", "grade", "2", "neutropenia", "in", "5", ".", "9", "%", ",", "grade", "2", "anemia", "in", "2", ".", "0", "%", ",", "grade", "3", "nausea", "or", "vomiting", "in", "4", ".", "6", "%", ",", "and", "grade", "3", "alopecia", "in", "7", ".", "2", "%", ".", "Five", "cases", "(", "in", "five", "patients", ")", "of", "decreased", "left", "ventricular", "ejection", "fraction", "occurred", "after", "CT", ":", "three", "after", "adjuvant", "CT", ",", "and", "two", "after", "anthracycline", "-", "based", "CT", "for", "relapse", ".", "One", "patient", "died", "as", "a", "result", "of", "dysrhythmia", "related", "to", "carcinomatous", "lymphangitis", ".", "No", "secondary", "leukemia", "occurred", ".", "This", "study", "conducted", "in", "node", "-", "positive", "elderly", "patients", "demonstrates", "a", "significant", "contribution", "of", "a", "weekly", "EPI", "regimen", "in", "terms", "of", "DFS", ".", "Moreover", ",", "this", "regimen", "is", "safe", "for", "hematologic", ",", "nonhematologic", ",", "and", "cardiac", "toxicities", "." ]
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15544076
[ "The", "effect", "of", "fibrin", "sealant", "combined", "with", "fibrinolysis", "inhibitor", "on", "reducing", "the", "amount", "of", "lymphatic", "leakage", "after", "axillary", "evacuation", "in", "breast", "cancer", ".", "A", "prospective", "randomized", "clinical", "trial", ".", "One", "third", "of", "women", "undergoing", "mastectomy", "with", "axillary", "evacuation", "for", "primary", "breast", "cancer", "suffer", "from", "postoperative", "seromas", "leading", "to", "unnecessary", "costs", "and", "complications", "such", "as", "infections", "and", "new", "operations", ".", "Different", "methods", "to", "prevent", "seroma", "formation", "have", "been", "tried", "without", "permanent", "success", ".", "The", "aim", "of", "this", "prospective", "randomised", "study", "was", "to", "examine", "the", "effect", "of", "fibrin", "sealant", "with", "fibrinolysis", "inhibitor", "firstly", "on", "the", "reduction", "of", "the", "amount", "of", "lymphatic", "leakage", "after", "axillary", "evacuation", "and", "secondly", "on", "the", "reduction", "of", "days", "with", "drains", "and", "postoperative", "seroma", "punctures", ".", "40", "patients", "with", "primary", "breast", "cancer", "were", "prospectively", "randomised", "to", "the", "treatment", "group", "(", "n", "=", "19", ")", "getting", "fibrin", "glue", "combined", "with", "fibrinolysis", "inhibitor", "(", "aprotinin", ")", "sprayed", "into", "the", "axillary", "fossa", "and", "to", "the", "control", "group", "(", "n", "=", "21", ")", ".", "There", "were", "no", "differences", "in", "the", "incidence", "of", "postoperative", "seromas", "between", "the", "groups", ".", "However", ",", "the", "seromas", "were", "easier", "to", "treat", "if", "fibrin", "clue", "was", "used", ".", "Total", "quantity", "(", "mean", "+", "/", "-", "SD", ")", "of", "lymphorrhea", "and", "total", "number", "of", "aspirations", "(", "mean", "+", "/", "-", "SD", ")", "were", "almost", "twice", "as", "high", "in", "the", "patients", "of", "the", "control", "group", "compared", "to", "those", "having", "fibrin", "sealant", ".", "In", "the", "treatment", "group", "seromas", "resolved", "after", "one", "or", "occasionally", "after", "two", "aspirations", "in", "71", "%", "of", "patients", ",", "while", "in", "the", "control", "group", "90", "%", "of", "patients", "needed", "three", "or", "more", "aspirations", ".", "Potentially", ",", "fibrin", "sealant", "combined", "with", "fibrinolysis", "inhibitor", "might", "be", "used", "for", "the", "treatment", "of", "post", "-", "axillary", "evacuation", "lymphorrhea", "and", "seroma", "." ]
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15545185
[ "Ten", "-", "year", "follow", "-", "up", "of", "a", "randomized", "controlled", "trial", "of", "adjuvant", "clodronate", "treatment", "in", "node", "-", "positive", "breast", "cancer", "patients", ".", "Ten", "-", "year", "follow", "-", "up", "results", "are", "presented", "of", "an", "adjuvant", "clodronate", "trial", "in", "patients", "with", "primary", "breast", "cancer", ".", "Between", "1990", "and", "1993", ",", "299", "women", "with", "primary", "node", "positive", "breast", "cancer", "were", "randomized", "to", "oral", "clodronate", "1600", "mg", "daily", "(", "149", ")", "or", "controls", "(", "150", ")", "for", "3", "years", ".", "All", "patients", "received", "adjuvant", "chemo", "-", "or", "endocrine", "therapy", ".", "Within", "10", "years", "bone", "metastases", "were", "detected", "at", "the", "same", "frequency", "in", "the", "clodronate", "and", "control", "groups", ":", "44", "(", "32", "%", ")", "vs", ".", "42", "(", "29", "%", ")", ",", "respectively", ",", "(", "p", "=", "0", ".", "35", ")", ".", "The", "frequency", "of", "non", "-", "skeletal", "recurrences", "(", "visceral", "and", "local", ")", "was", "significantly", "higher", "in", "the", "clodronate", "group", "69", "(", "50", "%", ")", "as", "compared", "with", "the", "controls", "51", "(", "36", "%", ")", "(", "p", "=", "0", ".", "005", ")", ".", "Ten", "-", "year", "disease", "-", "free", "survival", "(", "DFS", ")", "remained", "significantly", "lower", "in", "the", "clodronate", "group", "(", "45", "%", "vs", ".", "58", "%", ",", "p", "=", "0", ".", "01", ",", "respectively", ")", ".", "This", "was", "especially", "seen", "in", "oestrogen", "receptor", "negative", "patients", "(", "25", "%", "vs", ".", "58", "%", ",", "p", "=", "0", ".", "004", ",", "respectively", ")", ".", "No", "significant", "overall", "survival", "difference", "was", "found", "between", "the", "groups", ".", "As", "previously", "reported", "3", "-", "year", "adjuvant", "clodronate", "treatment", "did", "not", "prevent", "the", "development", "of", "bone", "metastases", "in", "node", "-", "positive", "breast", "cancer", "patients", ".", "A", "negative", "effect", "of", "clodronate", "on", "DFS", "by", "increasing", "the", "development", "of", "visceral", "metastases", "was", "still", "seen", "at", "10", "years", ",", "but", "this", "did", "not", "significantly", "compromise", "overall", "survival", "." ]
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15547180
[ "Clinically", "relevant", "pneumonitis", "after", "sequential", "paclitaxel", "-", "based", "chemotherapy", "and", "radiotherapy", "in", "breast", "cancer", "patients", ".", "Taxane", "-", "based", "chemotherapy", "has", "been", "associated", "with", "an", "increased", "risk", "of", "radiation", "pneumonitis", "in", "patients", "with", "breast", "cancer", ".", "To", "obtain", "additional", "information", "about", "this", "association", ",", "we", "investigated", "the", "association", "between", "paclitaxel", "chemotherapy", "and", "radiation", "pneumonitis", "in", "patients", "participating", "in", "a", "phase", "III", "randomized", "study", ".", "Five", "hundred", "and", "twenty", "-", "four", "breast", "cancer", "patients", "were", "prospectively", "and", "randomly", "assigned", "to", "receive", "either", "four", "cycles", "of", "paclitaxel", "followed", "by", "four", "cycles", "of", "5", "-", "fluorouracil", ",", "doxorubicin", ",", "cyclophosphamide", "(", "FAC", ")", "or", "eight", "cycles", "of", "FAC", ".", "One", "hundred", "and", "eighty", "-", "nine", "of", "these", "patients", "(", "100", "in", "the", "paclitaxel", "-", "FAC", "group", "and", "89", "in", "the", "FAC", "group", ")", "subsequently", "underwent", "radiation", "therapy", "in", "our", "institution", "and", "had", "medical", "records", "available", "to", "review", "for", "pulmonary", "symptoms", ".", "In", "addition", ",", "a", "radiologist", "who", "was", "unaware", "of", "the", "type", "of", "treatment", "scored", "chest", "x", "-", "ray", "changes", "after", "radiation", "treatment", ".", "Crude", "rates", "of", "radiation", "pneumonitis", "were", "compared", "with", "chi", "-", "square", "or", "Fisher", "'", "s", "exact", "test", ",", "and", "actuarial", "rates", "were", "assessed", "with", "Kaplan", "-", "Meier", "and", "log", "-", "rank", "tests", ".", "All", "statistical", "tests", "were", "two", "-", "sided", ".", "No", "difference", "in", "the", "rate", "of", "clinically", "relevant", "radiation", "pneumonitis", "was", "observed", "between", "the", "two", "groups", "(", "5", ".", "0", "%", "in", "the", "paclitaxel", "-", "FAC", "group", "versus", "4", ".", "5", "%", "in", "the", "FAC", "group", ";", "difference", "=", "0", ".", "5", "%", ",", "95", "%", "CI", "=", "-", "6", ".", "6", "%", "to", "5", ".", "5", "%", ";", "P", "=", "1", ".", "00", ")", ".", "Oral", "steroids", "for", "pneumonitis", "were", "taken", "by", "two", "patients", "in", "the", "paclitaxel", "-", "FAC", "group", "but", "by", "none", "in", "the", "FAC", "group", ",", "and", "no", "patient", "was", "hospitalized", "for", "or", "died", "of", "radiation", "pneumonitis", ".", "The", "paclitaxel", "-", "FAC", "group", "(", "39", ".", "3", "%", ")", "had", "a", "higher", "rate", "of", "radiographic", "changes", "after", "irradiation", "than", "the", "FAC", "group", "(", "23", ".", "7", "%", ";", "difference", "=", "15", ".", "6", "%", ",", "95", "%", "CI", "=", "-", "0", ".", "11", "%", "to", "28", ".", "8", "%", ";", "P", "=", ".", "034", ")", ".", "Patients", "with", "breast", "cancer", "treated", "with", "sequential", "paclitaxel", ",", "FAC", ",", "and", "radiation", "therapy", "appeared", "to", "have", "a", "very", "low", "rate", "of", "clinically", "relevant", "radiation", "pneumonitis", "that", "was", "no", "different", "from", "that", "of", "patients", "treated", "with", "FAC", "alone", "." ]
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15570070
[ "Randomized", "phase", "III", "trial", "of", "marimastat", "versus", "placebo", "in", "patients", "with", "metastatic", "breast", "cancer", "who", "have", "responding", "or", "stable", "disease", "after", "first", "-", "line", "chemotherapy", ":", "Eastern", "Cooperative", "Oncology", "Group", "trial", "E2196", ".", "To", "determine", "whether", "a", "matrix", "metalloproteinase", "inhibitor", "improves", "progression", "-", "free", "survival", "(", "PFS", ")", "in", "patients", "with", "metastatic", "breast", "cancer", "who", "have", "responding", "or", "stable", "disease", "after", "first", "-", "line", "chemotherapy", ".", "One", "hundred", "seventy", "-", "nine", "eligible", "patients", "were", "randomly", "assigned", "to", "receive", "oral", "marimastat", "(", "10", "mg", "bid", ";", "n", "=", "114", ")", "or", "a", "placebo", "(", "n", "=", "65", ")", "within", "3", "to", "6", "weeks", "of", "completing", "six", "to", "eight", "cycles", "of", "first", "-", "line", "doxorubicin", "-", "and", "/", "or", "taxane", "-", "containing", "chemotherapy", "for", "metastatic", "disease", ".", "Patients", "were", "evaluated", "every", "3", "months", "until", "disease", "progression", ".", "When", "comparing", "placebo", "with", "marimastat", ",", "there", "was", "no", "significant", "difference", "in", "PFS", "(", "median", ",", "3", ".", "1", "months", "v", "4", ".", "7", "months", ",", "respectively", ";", "hazard", "ratio", ",", "1", ".", "26", ";", "95", "%", "CI", ",", "0", ".", "91", "to", "1", ".", "74", ";", "P", "=", ".", "16", ")", "or", "overall", "survival", "(", "median", ",", "26", ".", "6", "months", "v", "24", ".", "7", "months", ",", "respectively", ";", "hazard", "ratio", ",", "1", ".", "03", ";", "95", "%", "CI", ",", "0", ".", "73", "to", "1", ".", "46", ";", "P", "=", ".", "86", ")", ".", "Patients", "treated", "with", "marimastat", "were", "more", "likely", "to", "develop", "grade", "2", "or", "3", "musculoskeletal", "toxicity", "(", "MST", ")", ",", "a", "known", "complication", "of", "the", "drug", "indicative", "of", "achieving", "a", "biologic", "effect", ",", "compared", "with", "patients", "administered", "placebo", "(", "63", "%", "v", "22", "%", ",", "respectively", ";", "P", "<", ".", "0001", ")", ".", "Patients", "with", "grade", "2", "or", "3", "MST", "had", "significantly", "inferior", "survival", "compared", "with", "patients", "who", "had", "grade", "0", "or", "1", "MST", "(", "median", ",", "22", ".", "5", "months", "v", "28", ".", "2", "months", ";", "P", "=", ".", "04", ")", ".", "In", "addition", ",", "patients", "who", "had", "a", "marimastat", "plasma", "concentration", "of", "at", "least", "10", "ng", "/", "mL", "at", "month", "1", "and", "/", "or", "3", "were", "significantly", "more", "likely", "to", "have", "grade", "2", "to", "3", "MST", "(", "P", "<", ".", "0001", ")", ".", "Marimastat", "does", "not", "prolong", "PFS", "when", "used", "after", "first", "-", "line", "chemotherapy", "for", "metastatic", "breast", "cancer", ".", "Patients", "with", "higher", "marimastat", "levels", "exhibited", "MST", ",", "and", "MST", "was", "associated", "with", "inferior", "survival", "." ]
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15571954
[ "The", "relevance", "of", "intraventricular", "chemotherapy", "for", "leptomeningeal", "metastasis", "in", "breast", "cancer", ":", "a", "randomised", "study", ".", "To", "assess", "the", "benefit", "of", "intraventricular", "chemotherapy", ",", "patients", "with", "leptomeningeal", "metastasis", "(", "LM", ")", "from", "breast", "cancer", "were", "randomised", "to", "treatment", "including", "intraventricular", "(", "IT", ")", "chemotherapy", "(", "n", "=", "17", ")", "or", "to", "non", "-", "intrathecal", "(", "non", "-", "IT", ")", "treatment", "(", "n", "=", "18", ")", ".", "Appropriate", "systemic", "therapy", "and", "involved", "field", "radiation", "therapy", "(", "RT", ")", "were", "given", "in", "both", "arms", ".", "Intention", "-", "to", "-", "treat", "analysis", "showed", "neurological", "improvement", "or", "stabilisation", "in", "59", "%", "of", "the", "IT", "and", "in", "67", "%", "of", "the", "non", "-", "IT", "group", ",", "with", "median", "time", "to", "progression", "of", "23", "weeks", "(", "IT", ")", "and", "24", "weeks", "(", "non", "-", "IT", ")", ".", "Median", "survival", "of", "IT", "patients", "was", "18", ".", "3", "weeks", "and", "30", ".", "3", "weeks", "for", "non", "-", "IT", "patients", "(", "difference", "12", ".", "9", "weeks", ";", "95", "%", "Confidence", "Interval", "(", "CI", ")", "-", "5", ".", "5", "to", "+", "34", ".", "3", "weeks", ";", "P", "=", "0", ".", "32", ")", ".", "Neurological", "complications", "of", "treatment", "occurred", "in", "47", "%", "(", "IT", ")", "vs", "6", "%", "(", "non", "-", "IT", ")", "(", "P", "=", "0", ".", "0072", ")", ".", "In", "conclusion", ",", "standard", "systemic", "chemotherapy", "with", "involved", "field", "RT", "for", "LM", "from", "breast", "cancer", "is", "feasible", ".", "Addition", "of", "intraventricular", "chemotherapy", "does", "not", "lead", "to", "survival", "benefit", "or", "improved", "neurological", "response", ",", "and", "is", "associated", "with", "an", "increased", "risk", "of", "neurotoxicity", "." ]
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15617992
[ "High", "-", "dose", "chemotherapy", "with", "haematopoietic", "stem", "cell", "transplantation", "for", "metastatic", "breast", "cancer", "patients", ":", "final", "results", "of", "the", "French", "multicentric", "randomised", "CMA", "/", "PEGASE", "04", "protocol", ".", "The", "aim", "of", "our", "study", "was", "to", "evaluate", "the", "impact", "on", "time", "to", "progression", "(", "TTP", ")", "and", "overall", "survival", "(", "OS", ")", "of", "high", "-", "dose", "chemotherapy", "(", "HD", "-", "CT", ")", "over", "conventional", "CT", "in", "metastatic", "breast", "cancer", "patients", ".", "Between", "09", "/", "92", "and", "12", "/", "96", ",", "61", "patients", "with", "chemosensitive", "metastatic", "breast", "cancer", "were", "randomised", "between", "HD", "-", "CT", "using", "the", "CMA", "regimen", "(", "Mitoxantrone", ",", "Cyclophosphamide", ",", "Melphalan", ")", "applied", "as", "consolidation", "(", "32", "patients", ")", "or", "maintenance", "CT", "(", "29", "patients", ")", ".", "At", "randomisation", ",", "13", "patients", "were", "in", "complete", "response", ",", "47", "in", "partial", "response", "and", "one", "had", "stable", "disease", ".", "The", "median", "TTPs", "from", "randomisation", "were", "6", "and", "12", "months", "in", "the", "standard", "and", "intensive", "groups", ",", "respectively", "(", "P", "<", "0", ".", "0056", ")", ",", "with", "a", "relapse", "rate", "of", "86", ".", "2", "%", "vs", ".", "62", ".", "5", "%", "at", "2", "years", ",", "and", "100", "%", "vs", ".", "81", ".", "3", "%", "at", "5", "years", ".", "The", "median", "OS", "times", "were", "19", ".", "3", "and", "44", ".", "1", "months", ",", "with", "an", "OS", "rate", "of", "13", ".", "8", "%", "vs", ".", "36", ".", "8", "%", "at", "5", "years", "(", "P", "<", "0", ".", "0294", ")", ".", "The", "CMA", "regimen", "could", "prolong", "the", "TTP", "of", "patients", "with", "chemosensitive", "metastatic", "breast", "cancer", ".", "Further", "studies", "are", "needed", "to", "determine", "if", "this", "translates", "into", "an", "effect", "on", "OS", "." ]
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15668261
[ "Avoiding", "axillary", "dissection", "in", "breast", "cancer", "surgery", ":", "a", "randomized", "trial", "to", "assess", "the", "role", "of", "axillary", "radiotherapy", ".", "The", "need", "to", "dissect", "axillary", "nodes", "in", "patients", "with", "early", "breast", "cancer", "and", "clinically", "negative", "axilla", "remains", "controversial", ".", "The", "aim", "of", "the", "study", "was", "to", "assess", "the", "role", "of", "axillary", "radiotherapy", "(", "RT", ")", "in", "reducing", "axillary", "metastases", "in", "patients", "with", "early", "breast", "cancer", "who", "did", "not", "receive", "axillary", "dissection", ".", "From", "1995", "to", "1998", ",", "435", "patients", "over", "45", "years", "old", "with", "breast", "cancer", "up", "to", "1", ".", "2", "cm", "and", "no", "palpable", "axillary", "nodes", "were", "randomized", "214", "to", "breast", "conservation", "without", "axillary", "treatment", "and", "221", "to", "breast", "conservation", "plus", "axillary", "RT", ".", "After", "a", "median", "follow", "-", "up", "of", "63", "months", ",", "overt", "axillary", "metastases", "were", "fewer", "than", "expected", ":", "three", "cases", "in", "the", "no", "axillary", "treatment", "group", "(", "1", ".", "5", "%", ")", "and", "one", "in", "the", "RT", "group", "(", "0", ".", "5", "%", ")", ".", "Expected", "cases", "were", "43", "in", "the", "no", "axillary", "treatment", "group", "and", "10", "in", "the", "RT", "group", ".", "Rates", "of", "distant", "metastases", "and", "local", "failures", "were", "low", ",", "and", "5", "-", "year", "disease", "free", "survival", "was", "96", ".", "0", "%", "(", "95", "%", "confidence", "interval", ",", "94", ".", "1", "%", "-", "97", ".", "9", "%", ")", "without", "significant", "differences", "between", "the", "two", "arms", ".", "This", "study", "suggests", "that", "occult", "axillary", "metastases", "might", "never", "become", "clinically", "overt", "and", "axillary", "dissection", "might", "be", "avoided", "in", "patients", "with", "small", "carcinomas", "and", "a", "clinically", "negative", "axilla", ".", "Axillary", "RT", "seems", "to", "protect", "the", "patients", "from", "axillary", "recurrence", "almost", "completely", "." ]
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15668474
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Benchmark dataset PICO

This dataset was generated by the Data preprocessing step of the NERFAIR workflow (More information: https://github.com/YasCoMa/ner-fair-workflow )

Original dataset: https://github.com/sociocom/PICO-Corpus/tree/main/pico_corpus_brat_annotated_files

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