Docetaxel for metastatic breast cancer: two consecutive phase II trials.

Background: Docetaxel is the most active agent for metastatic breast cancer, but the optimal treatment regimen as a single agent has yet to be defined. Patients and Methods: Two consecutive monocentric phase II trials of docetaxel in metastatic breast cancer were carried out. In Trial I, 36 patients received docetaxel 35 mg/m 2 weekly for 6 weeks every 8 weeks and in Trial II, 29 patients received docetaxel 100 mg/m 2 day 1 every 21 days. Results: Patient characteristics were comparable. However, patients with liver involvement comprised 25% of cases in Trial I and 55% in Trial II. The overall response rate on an intention-to-treat basis was 19% vs. 45% in Trial I and II respectively; time to progression was 3.8 vs. 7.5 months respectively, and overall median survival was comparable in each trial. Conclusion: Docetaxel given at 100 mg/m 2 every three weeks appears to be a safe, effective regimen that can be applied in common clinical practice for the treatment of metastatic breast cancer.