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Prospective Randomized Trial Of Docetaxel Versus Mitomycin Plus Vinblastine In Patients With Metastatic Breast Cancer Progressing Despite Previous Anthracycline-Containing Chemotherapy

J.-M. Nabholtz, H. J. Senn, W. R. Bezwoda, D. Melnychuk, L. Deschênes, J. Douma, T. A. Vandenberg, B. Rapoport, R. Rosso, V. Trillet-Lenoir, J. Drbal, A. Molino, J.W.R. Nortier, D. J. Richel, T. Nagykalnai, P. Siedlecki, N. Wilking, J. Y. Genot, P.S.G.J. Hupperets, F. Pannuti, D. Skarlos, E. M. Tomiak, M. Murawsky, M. Alakl, A. Riva, M. Aapro

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PURPOSE: This phase III study compared docetaxel 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 10 3-week cycles. RESULTS: In an intention-to-treat analysis, docetaxel produced significantly higher response rates than MV overall (30.0% v 11.6%; P < .0001), as well as in patients with visceral involvement (30% v 11%), liver metastases (33% v 7%), or resistance to previous anthracycline agents (30% v 7%). Median time to progression (TTP) and overall survival were significantly longer with docetaxel than MV (19 v 11 weeks, P = .001, and 11.4 v 8.7 months, P = .0097, respectively). Neutropenia grade 3/4 was more frequent with docetaxel (93.1% v 62.5%; P < .05); thrombocytopenia grade 3/4 was more frequent with MV (12.0% v 4.1%; 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 for patients with MBC progressing despite previous anthracycline-containing chemotherapy.