FIRST-LINE CHEMOTHERAPY WITH PACLITAXEL BY 3-HOUR INFUSION AND CARBOPLATIN IN ADVANCED BREAST-CANCER (FINAL REPORT) - A PHASE-II STUDY CONDUCTED BY THE HELLENIC COOPERATIVE ONCOLOGY GROUP

Purpose: To evaluate the activity and toxicity of the combination of p aclitaxel given by three-hour infusion, and carboplatin as first-line chemotherapy in patients with advanced breast cancer (ABC). Background : Paclitaxel is an active agent in ABC. Furthermore, our group has sho wn that the combination of paclitaxel and carboplatin is effective in anthracycline-resistant ABC. Patients and methods: From January 1996 u ntil March 1997, 66 women with ABC were treated with paclitaxel (175 m g/m(2)) by three-hour infusion followed by carboplatin at an AUC of 6 mg x min/ml every three weeks. The median age of the patients was 56 y ears (range 28-75). A total of 39 patients had received adjuvant chemo therapy and 22 of them were treated with an anthracycline or mitoxantr one-containing regimen. Results: A total. of 324 cycles (median: six) were administered, 273 (85%) of them at full dose. The median number o f delivered cycles was six. The median delivered dose intensity (DI) o f paclitaxel was 55.1 mg/m(2)/week (range 30.5-69.3) and the relative DI was 0.95 (range 0.5-1.2). Eight patients (12%, 95% confidence inter val (CI): 5%-22%) achieved complete and 28 (42%, 95% CI: 30%-55%) part ial responses. Grade 3-4 toxicities included anemia (5%), granulocytop enia (24%), thrombocytopenia, nausea/vomiting and allergic reaction (3 % each), myalgias/arthralgias and neurotoxicity (1,5% each). Febrile n eutropenia occurred in eight (12%) patients. Alopecia was universal. A fter a median follow-up of 17.3 (range 0.07-24.5) months, 48 (72%) pat ients have demonstrated tumor progression and 24 (36%) have died. Medi an time to progression was 8.6 (range 0.07-23+) months and median surv ival 20.4 (range 0.07-24.5+) months. Conclusions. The combination of p aclitaxel and carboplatin has moderate activity in ABC and can be easi ly delivered on an outpatient basis with manageable toxicity. This reg imen may be useful especially in patients to whom anthracyclines or ci splatin administration is precluded because of other concomitant disea ses.