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

American Society of Clinical Oncology (ASCO) - Tập 17 Số 5 - Trang 1413-1413 - 1999
Jean‐Marc Nabholtz1, H.-J. Senn1, W.R. Bezwoda1, David Melnychuk1, L Deschênes1, J. Douma1, Ted Vandenberg1, Bernardo L. Rapoport1, R. Rosso1, V. Trillet-Lenoir1, J Drbal1, A. Molino1, J. W. R. Nortier1, D. J. Richel1, Tomas Nagykalnai1, P Siedlecki1, N. Wilking1, J.Y. Génot1, P. Hupperets1, F Pannuti1, Dimosthenis Skarlos1, Eva Tomiak1, M Murawsky1, May Alakl1, A. Riva1, Matti Aapro1
1From the cross-Cancer Institute, Edmonton, Alberta; the S.M.B.D. Jewish General Hospital, Montreal, Quebec; Oncolocy Department Hopital du ST Sacrement, Quebec, Quebec; London Regional Cancer Centre, London, Ontation; Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada; Zentrum fur Tumordiagnostik und Pravention, St Gallen; Division D'Oncologie, Hopital Cantonal Universitaire, Geneva, Switzerland; Department of Medicine, University of the Witwaterstrand, Parktown, Johannesburg; Medical Centre of...

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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.

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Tài liệu tham khảo

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American Society of Clinical Oncology (ASCO)

Tập 17 Số 5

1413-1413

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