Phase I-II studies of docetaxel as a single agent in the treatment of metastatic breast cancer.

Docetaxel (Taxotere, Rhône-Poulenc Rorer, Antony, France) is highly effective in the first-line treatment of metastatic breast cancer, achieving an objective response rate of 61% (95% confidence interval, 52% to 69%). This rate of response is seen in patients with poor prognostic factors such as liver metastases and multiple organ involvement. In previously treated metastatic disease, docetaxel is also highly active, with an overall objective response rate of 41% in patients with strictly defined anthracycline-resistant disease. Phase II data suggest that docetaxel is the most active agent yet available in the treatment of advanced breast cancer; this conclusion is now supported by the results of randomized phase III trials. These data justify the further investigation of docetaxel alone and in combination chemotherapy.