A LATE-PHASE-II STUDY OF RP56976 (DOCETAXEL) IN PATIENTS WITH ADVANCED OR RECURRENT BREAST-CANCER

A late phase II clinical trial of RP56976 (docetaxel), derived from Ta xus baccata was performed to evaluate anti-tumour activity, time to pr ogression and clinical toxicity in patients with advanced or recurrent breast cancer. The patients, between 15 and 80 years old with perform ance status (PS) of 0-2, received at least two cycles of docetaxel 60 mg m(-2) intravenously at 3-4 week intervals. Of the 81 patients enrol led, the 72 eligible for the study were given a total of 327 cycles, w ith a median of four cycles each. Five patients obtained a complete re sponse (CR) and 27 a partial response (PR); the response rate (RR) was 44.4% (95% confidence interval 32.7-56.6%). A relatively high RR of 9 /28 (32.1%) was observed in patients who had received prior chemothera py involving anthracyclines. The dose-limiting toxicity was grade 3-4 leucocytopenia or neutropenia, found in 78.9% and 85.9% patients respe ctively. Other severe (grade, 3) toxicities included alopecia (38%), a norexia (18.3%), nausea/vomiting (11.3%), and fatigue (9.9%). Hypersen sitivity reactions, oedema and skin toxicity were not severe and were reversible. One therapy-related death occurred 10 days after the dose was given. These findings indicate that docetaxel has potent activity against metastatic breast cancer, and that the dose of 60 mg m(-2) is safe.