Taxol (paclitaxel) in patients with metastatic breast carcinoma who have failed prior chemotherapy: interim results of a multinational study.

A multinational, randomized study has been conducted to compare the effectiveness and safety of two doses of Taxol (paclitaxel) (135 and 175 mg/m2, given as a 3-hour intravenous infusion every 3 weeks) in patients with metastatic breast carcinoma who had previously undergone treatment with one or two chemotherapeutic regimens. A total of 471 patients were enrolled in the study; the first 117 were included in an interim analysis that was planned in the protocol to identify any extreme efficacy differences between the treatment arms. Most (85%) of these initial patients were ambulatory with a performance status of 0 or 1 and multiple sites of disease. Duration of treatment ranged from 1 to 7 courses (median, 4). Of the 113 patients who received Taxol 135 mg/m2 (n = 56) or 175 mg/m2 (n = 57), 111 were evaluable for an overall response rate of 27%, with 3 complete and 27 partial responses. In this interim analysis no significant difference in response rate between the two treatment groups was detected. The primary toxicity encountered was neutropenia that was rapidly reversible and not associated with treatment delays. It was concluded that at these doses Taxol is an effective and well-tolerated treatment option for the management of metastatic breast cancer in previously treated patients.