Phase II study of weekly paclitaxel for advanced or metastatic breast cancer in Japan.

BACKGROUND The efficacy and safety of weekly paclitaxel was evaluated in Japanese women with advanced or metastatic breast cancer. PATIENTS AND METHODS Paclitaxel was given by single weekly intravenous infusion at 100 mg/m2 on days 1, 8, 15, 22, 29 and 36 of a 49-day cycle to women with advanced or metastatic breast cancer not responding to other chemotherapy. RESULTS A total of 69 enrolled patients received a median of 3 (range 1-13) cycles of treatment. The overall response rate was 44.9%, comprising 3 complete responses (CRs) and 28 partial responses (PRs). Median durations of CR and PR were 64.0 (range 57-499) and 113.0 (range 29-590) days, respectively. Grade 3 or greater adverse reactions included neutropenia in 37.7%, leukopenia in 31.9% and neuropathy in 5.8%. CONCLUSION A weekly regimen of paclitaxel was well tolerated and achieved a relatively high response rate in Japanese breast cancer patients with advanced or metastatic disease.