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, et al.
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 1, 2001

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Reviewers: Li Liu, MD
Source: Journal of Clinical Oncology, Vol 17, Issue 5 (May), 1999: 1413-1424

Introduction

It is clear that chemotherapy provides clinical benefit to many women with metastatic breast cancer (J Clin Oncol. 1996 Aug;14(8):2197-205). However, metastatic breast cancer remains essentially incurable and almost all women with such dignosis will eventually die from their disease. Anthracycline-based combination chemotherapy has been the standard first-line chemotherapy for patients with metastatic breast cancer. Recently, several new drugs have demonstrated promising anti-tumor activity against breast cancer. In this randomized phase III study, the researchers compared docetaxel with mitomycin plus vinblastine (MV) in patients with metastatic breast cancer.

Materials and Methods

A total of 392 patients with metastatic breast cancer previously treated with anthracycline-based chemotherapy were included. Of them, 203 were randomized to treatment with docetaxel of 100mg/m2 every 3 weeks and 189 patients to the mitomycin 12 mg/m2 every 6 weeks plus vinblastine 6 mg/m2 every 3 weeks for a maximum of 10 cycles.

Results

  • The overall response rate was significantly higher in the docetaxel group than in the MV group, 30% vs. 11.6% (p<0.001).
  • Median time to progression was significantly longer in the docetaxel group than in the MV group, 19 weeks vs. 11 weeks (p=0.001).
  • The median overall survival of all randomized patients was significantly longer in the docetaxel group than in the MV group, 11.9 months vs. 8.7 months (p=0.0097).
  • The overall toxicity was comparable between the two groups.
  • The quality of life analysis was not significantly different between the groups but compliance with the surveys was poor, making this result somewhat suspect.

Discussion

This study showed the superiority of docetaxel over mytomycin plus vinblastine in terms of response rate, time to progression, and overall survival in patients with metastatic breast cancer previously treated with anthracycline-based chemotherapy. Because the goal of treatment is to improve the quality of life of patients, any comparison of survival between these palliative chemotherapy regimens should be adjusted for patient quality of life during the treatment period.