Docetaxel for metastatic breast cancer: two consecutive phase II trials

Docetaxel is the most active agent for metastatic breast cancer, but the optimal treatment regimen as a single agent has yet to be defined.

Two consecutive monocentric phase II trials of docetaxel in metastatic breast cancer were carried out. In Trial I, 36 patients received docetaxel 35 mg/m2 weekly for 6 weeks every 8 weeks and in Trial II, 29 patients received docetaxel 100 mg/m2 day 1 every 21 days.

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.

Docetaxel given at 100 mg/m2 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.