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  • Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node-negative breast cancer: a randomized trial
    International breast cancer study group ...
    Background: The role of adjuvant chemotherapy in postmenopausal patients with lymph node-negative breast cancer is controversial. After demonstrating the efficacy of chemotherapy combined with ... tamoxifen for postmenopausal patients with lymph node-positive disease, the International Breast Cancer Study Group launched a randomized trial (Trial IX) to evaluate the role of adjuvant chemotherapy preceding treatment with tamoxifen for patients with lymph node-negative disease. Methods: After stratification by estrogen receptor (ER)status, patients were randomly assigned to receive three 28-day courses of"classical" adjuvant CMF chemotherapy cyclophosphamide at 100 mg/m(2) on days 1-14, orally; methotrexate at 40 mg/m(2) on days 1 and 8, intravenously;and 5-fluorouracil at 600 mg/m(2) on days 1 and 8, intravenously) followed by tamoxifen (20 mg/day, orally for 57 months) (CMF-->tamoxifen) or to receive tamoxifen alone (20 mg/day, orally for 60 months). We enrolled 1669 eligible patients, 382 (23%) with ER-negative tumors, 1217 (73%) with ER-positive tumors, and 70 (4%) with unknown ER status. The median follow-up was 71 months. All statistical tests were two-sided. RESULTS: The added benefit of CMF followed by tamoxifen over tamoxifen alone was statistically significantly dependent on ER status (tests for interaction: P =.01 for disease-free survival (DFS) and P =.07 for overallsurvival (OS)). For patients with ER-negative tumors, the addition of CMF statistically significantly improved DFS (5-year DFS = 84% for CMF-->tamoxifen versus 69% for tamoxifen alone; difference = 15%; 95% confidence interval (CI) = 6% to 24%; risk ratio (RR) = 0.52; 95% CI = 0.34 to0.79; P =.003) and OS (5-year OS = 89% for CMF-->tamoxifen versus 81% for tamoxifen alone; difference = 8%; 95% CI = 0% to 16%; RR = 0.51; 95% CI = 0.30to 0.87; P =.01). (Abstract truncated at 2000 charactercs).
    Vir: Journal of the National Cancer Institute. - ISSN 0027-8874 (Letn. 94, št. 14, 2002, str. 1054-1065)
    Vrsta gradiva - članek, sestavni del
    Leto - 2002
    Jezik - angleški
    COBISS.SI-ID - 15349209

vir: Journal of the National Cancer Institute. - ISSN 0027-8874 (Letn. 94, št. 14, 2002, str. 1054-1065)

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