Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy

Abstract

Purpose: This phase III study compared docetoxel with mitomycin plus vinblastine (MV) in patients with metastatic breast cancer (MBC) progressing despite previous anthracycline-containing chemotherapy. Patients and Methods: Patients (n = 392) were randomized to receive either docetaxel 100 mg/m2 intravenously (IV) every 3 weeks (n = 203) or mitomycin 12 mg/m2 IV every 6 weeks plus vinblastine 6 mg/m2 IV every 3 weeks (n = 189), for a maximum of 103-week cycles. Results: In an intention-to-treat analysis, docetaxel produced significantly higher response rates than MV overall (30.0% v 11.6%; P < .05). Severe acute or chronic nonhematologic adverse events were infrequent in both groups. Withdrawal rates because of adverse events (MV, 10.1%; docetaxel, 13.8%) or toxic death (MV, 1.6%; docetaxel, 2.0%) were similar in both groups. Quality-of-life analysis was limited by a number of factors, but results were similar in both groups. Conclusion: Docetaxel is significantly superior to MV in terms of response, TTP, and survival. The safety profiles of both therapies are manageable and tolerable. Docetaxel represents a clear treatment option far patients with MBC progressing despite previous anthracycline-containing chemotherapy.