Novel association with gemcitabine and docetaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracyclines: results of a multicenter phase II study.

The goals of this study were to evaluate the efficacy and toxicity of the gemcitabine/docetaxel combination in metastatic breast cancer previously treated with anthracyclines. Fifty-three patients with metastatic breast cancer who had failed or relapsed after anthracycline-based chemotherapy entered the study and were evaluable. Patients received gemcitabine (1,000 mg/m(2) days 1 and 8) and docetaxel (80 mg/m(2) day 8), every 3 weeks. The regimen was generally well tolerated with good feasibility. A complete response occurred in six patients (9.4%) and partial response in 23 (43.4%) for an overall response rate of 53% (95% confidence interval, 38.9% to 66.7%). Median survival rate was 70%; and the duration of response, time to progression, and overall survival were 6, 7.5, and 16.5 months, respectively. We conclude that the gemcitabine/docetaxel combination constitutes a manageable and tolerable combination as salvage chemotherapy in metastatic breast cancer and may represent a valid treatment option in patients previously treated with anthracyclines.