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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
Abstract
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/m 2 intravenously (IV) every 3 weeks (n = 203) or mitomycin 12 mg/m 2 IV every 6 weeks plus vinblastine 6 mg/m 2 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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Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., Filiberti, A., Flechtner, H., Fleishman, S. B., Haes, J. C. J. M. D., et al. (1993) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/85.5.365 · Cited by 16,005
Cited by
Cortes, J., O'Shaughnessy, J., Loesch, D., Blum, J. L., Vahdat, L. T., Petrakova, K., Chollet, P., Manikas, A., Diéras, V., Delozier, T., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60070-6 · Cited by 1,094
Extending Survival with Chemotherapy in Metastatic Breast Cancer
O'Shaughnessy, J. (2005) · The Oncologist · doi:10.1634/theoncologist.10-90003-20 · Cited by 668
Nabholtz, J.-M., Falkson, C., Campos, D., Szanto, J., Martin, M., Chan, S., Pienkowski, T., Zaluski, J., Pinter, T., Krzakowski, M., et al. (2003) · Journal of Clinical Oncology · doi:10.1200/jco.2003.04.040 · Cited by 384
Self-citationTaxane resistance in breast cancer: mechanisms, predictive biomarkers and circumvention strategies.
Murray, S., Briasoulis, E., Linardou, H., Bafaloukos, D., & Papadimitriou, C. (2012) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2012.02.011 · Cited by 261
Andreopoulou, E., & Sparano, J. A. (2013) · Current Breast Cancer Reports · doi:10.1007/s12609-012-0097-1 · Cited by 65
Metadata
- Authors
- Nabholtz, J.-M., Senn, H. J., Bezwoda, W. R., Melnychuk, D., Deschênes, L., Douma, J., Vandenberg, T. A., Rapoport, B., Rosso, R., Trillet-Lenoir, V., Drbal, J., Molino, A., Nortier, J. W. R., Richel, D. J., Nagykalnai, T., Siedlecki, P., Wilking, N., Genot, J. Y., Hupperets, P. S. G. J., Pannuti, F., Skarlos, D., Tomiak, E. M., Murawsky, M., Alakl, M., Riva, A., & Aapro, M.
- Venue
- Journal of Clinical Oncology
- Published
- 1999-05
- Volume
- 17
- Issue
- 5
- Pages
- 1413-1413
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W1841504999
- Cited by
- 508
- References
- 1
- FWCI
- 15.19
- Type
- journal article
- Language
- en
- Open access
- closed
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- The paper
- Nabholtz, J.-M., Senn, H. J., Bezwoda, W. R., Melnychuk, D., Deschênes, L., Douma, J., Vandenberg, T. A., Rapoport, B., Rosso, R., Trillet-Lenoir, V., Drbal, J., Molino, A., Nortier, J. W. R., Richel, D. J., Nagykalnai, T., Siedlecki, P., Wilking, N., Genot, J. Y., Hupperets, P. S. G. J., . . . Aapro, M. (1999). Prospective Randomized Trial of Docetaxel Versus Mitomycin Plus Vinblastine in Patients With Metastatic Breast Cancer Progressing Despite Previous Anthracycline-Containing Chemotherapy. Journal of Clinical Oncology. https://doi.org/10.1200/jco.1999.17.5.1413
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.