• 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 Nortier, D J Richel, T Nagykalnai, P Siedlecki, N Wilking, J Y Genot, P S Hupperets, F Pannuti, D Skarlos, E M Tomiak, M Murawsky, M Alakl, and M Aapro.
• Cross-Cancer Institute, Edmonton, Alberta, Canada. jmarkn@cancerboard.ab.ca
• J. Clin. Oncol. 1999 May 1; 17 (5): 1413-24.

PurposeThis 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 MethodsPatients (n=392) were randomized to receive either docetaxel 100 mg/m2 intravenously (i.v.) every 3 weeks (n=203) or mitomycin 12 mg/m2 i.v. every 6 weeks plus vinblastine 6 mg/m2 i.v. every 3 weeks (n=189), for a maximum of 10 3-week cycles.ResultsIn 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 1 weeks, P=.001, and 1 1.4 v 8.7 months, P=.0097, respectively). Neutropenia grade 3/4 was more frequent with docetaxel (93.1 % v62.5%; 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.ConclusionDocetaxel 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.

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