PHASE-II STUDY OF PACLITAXEL (BMS-181339) INTRAVENOUSLY INFUSED OVER 3 HOURS FOR ADVANCED OR METASTATIC BREAST-CANCER IN JAPAN

A Phase II study of paclitaxel in patients with primary advanced or me tastatic breast cancer was conducted by a cooperative study group cons isting of 16 institutions in Japan. Paclitaxel at a dose of 210 mg/m(2 ) was intravenously infused over 3 hours, along with premedication to prevent hypersensitivity reactions. The course was repeated at 21-day intervals. Of 62 eligible patients, 60 were evaluable for toxicity and 59 were evaluable for efficacy. Forty-five patients were previously t reated with anthracyclines. Twenty-one of 59 patients (35.6%) had a ma jor objective response including 2 CRs and 19 PRs (95% confidence inte rval, 23.6-49.1%). A response rate of 35.5% (CR1, PR10) was observed i n 31 patients refractory to the anthracyclines containing prior metast atic chemotherapy. Median (range) rime was 41 (6-100) days to onset of and median duration of response was 125 (36-305) days. Toxicities inc luded leukopenia (grade 3, 4: 67%), anemia (grade 1-3, 80%), thrombocy topenia (grade 1: 8%), alopecia (grade 3: 43%), peripheral neuropathy (grade 1-3. 93%), arthralgia (59%), myalgia (46%), nausea and vomiting (40%), fever (33%), allergic reaction (grade 3. 2%) and hypotension ( grade 3: 5%). All toxicities were tolerable and manageable. Paclitaxel intravenously infused over 3 hours demonstrated a significant antitum or activity for metastatic breast cancer. Furthermore, paclitaxel exhi bited non-cross resistance to anthracycline. Paclitaxel administered a s a convenient 3-hour infusion is effective for patients with metastat ic breast cancer and has an acceptable toxicity profile.