A randomized trial of CMF versus CMFVP as adjuvant chemotherapy in women with node-positive stage II breast cancer: a CALGB Study.

Women treated by mastectomy for node-positive breast carcinoma were randomly assigned to receive an induction course and 2 years of maintenance chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) or CMF plus vincristine and prednisone (CMFVP). Five-hundred twenty-five evaluable patients were entered between 1975 and 1980. CMVFP was superior to CMF for patients with more than 3 positive nodes (p=0.01) with disease-free survival of 50% at 5 years with CMFVP compared with 36% with CMF. The advantage of CMFVP was not seen in patients with 1–3 positive nodes and was most marked in patients with 10 or more nodes. This suggests benefit from increased treatment with increasing disease burden. The superiority of CMFVP was more marked in postmenopausal patients (p=0.04) than in premenopausal (p=0.12). The advantage of CMFVP in disease-free survival is not yet apparent in overall survival.