ADJUVANT CHEMOTHERAPY IN OPERABLE BREAST-CANCER - CYCLOPHOSPHAMIDE, METHOTREXATE, AND FLUOROURACIL VERSUS CHLORAMBUCIL, METHOTREXATE, AND FLUOROURACIL-11-YEAR RESULTS OF SWISS-GROUP-FOR-CLINICAL-CANCER-RESEARCH TRIAL SAKK-27 82/

Purpose: To compare two adjuvant combination chemotherapies, cyclophos phamide, methotrexate, and fluorouracil (CMF) and chlorambucil, methot rexate, and fluorouracil (LMF), for patients who had undergone potenti ally curative surgery for unilateral breast cancer, in terms of relaps e, survival, and toxicity. Patients and Methods: Selection criteria wa s as follows: stage pT1-3a, N+ or N-, M0, less than 72 years of age, E ligible patients were randomized to receive either CMF (cyclophosphami de 100 mg/m(2) orally on days 1 to 14, methotrexate 40 mg/m(2) intrave nously (IV) on days 1 and 8, fluorouracil 600 mg/m(2) IV on days 1 and 8) or LMF (Leukeran [Wellcome A.G., Bern, Switzerland] 5 mg/m(2) oral ly on days 1 to 14 with the same IV cytostatic drugs). Follow-up exami nations were performed every 3 months during the first 3 years after m astectomy, and every 6 months thereafter, Results: A total of 246 pati ents were randomized, of whom 232 who were fully eligible and contribu te to the analyses presented here, No statistically significant differ ence in favor of adjuvant CMF over LMF emerges after a median follow-u p duration of 11.2 years, for either overall survival (P = .15) or dis ease free survival (P = .14). A consistent trend suggestive of a possi ble relative benefit associated with CMF should be pointed out, Howeve r, CMF presents a significantly worse toxicity profile as concerns hem atologic parameters as well as alopecia, nausea, and vomiting, Conclus ion: This prospective trial has not identified a statistically signifi cant difference in disease-free survival or overall survival between t he two adjuvant regimens LMF and CMF, Although a trend in favor of CMF has been observed in premenopausal patients, this has to be weighted against its definitely more pronounced toxicity profile. (C) 1997 by A merican Society of Clinical Oncology.