Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial.

摘要: BACKGROUND Although chemotherapy and ovarian function suppression are both effective adjuvant therapies for patients with early-stage breast cancer, little is known of the efficacy their sequential combination. In an International Breast Cancer Study Group (IBCSG) randomized clinical trial (Trial VIII) pre- perimenopausal women lymph node-negative we compared followed by gonadotropin-releasing hormone agonist goserelin each modality alone. METHODS From March 1990 through October 1999, 1063 stratified estrogen receptor (ER) status radiotherapy plan were randomly assigned to receive 24 months (n = 346), six courses "classical" CMF (cyclophosphamide, methotrexate, 5-fluorouracil) 360), or classical 18 (CMF --> goserelin; n 357). A fourth arm (no treatment) 46 was discontinued in 1992. Tumors classified as ER-negative (30%), ER-positive (68%), ER unknown (3%). Twenty percent aged 39 years younger. The median follow-up 7 years. primary outcome disease-free survival (DFS). RESULTS Patients tumors achieved better if they received (5-year DFS 84%, 95% confidence interval [CI] 77% 91%; 5-year 88%, CI 82% 94%) than alone 73%, 64% 81%). By contrast, disease, provided similar outcomes treatment groups 81%, 76% 87%), whereas therapy 86%, 91%) a statistically nonsignificant improvement either alone, primarily because results among younger women. CONCLUSIONS Premenopausal (i.e., endocrine nonresponsive), cancer should chemotherapy. For responsive) combination other agents, use be studied.