A phase II study of paclitaxel plus carboplatin as first‐line chemotherapy for women with metastatic breast carcinoma

Abstract

BACKGROUND This Phase II multicenter study evaluated the efficacy and toxicity of paclitaxel (200 mg/m² by 3‐hour infusion) with carboplatin (area under the curve 6 mg/mL per minute) administered every 3 weeks as first‐line therapy for women with metastatic breast carcinoma. METHODS Eligible patients had measurable metastatic disease and an Eastern Cooperative Oncology Group performance status of 0–2. Prior adjuvant chemotherapy, including anthracycline‐based therapy, was allowed, as was prior hormonal therapy as part of either adjuvant treatment or treatment for metastasis. Prior therapy with taxanes or platinum was not allowed. RESULTS A total of 53 patients were enrolled in this study, with 50 patients evaluable for response and toxicity. The overall response rate was 62% (95% confidence interval [CI], 48–75%); 16% of patients had complete responses and 46% had partial responses. The median time to progression was 7.3 months (95% CI, 5.9–12.9), and the 12‐month survival estimate was 72% (95% CI, 61–86%). Therapy was generally well tolerated. Grade 3–4 neutropenia was the predominant toxicity, observed in 82% of patients, but there were no episodes of febrile neutropenia or sepsis. Hematopoietic growth factors were not routinely necessary. Grade 3 peripheral neuropathy occurred in 16% of patients. CONCLUSIONS Paclitaxel (200 mg/m²) with carboplatin (area under the curve 6 mg/mL per minute) demonstrated substantial efficacy in patients with metastatic breast carcinoma, and the 12‐month survival rate of 72% was encouraging. This therapy represents a viable option for patients with metastatic disease. Cancer 2000;88:124–31. © 2000 American Cancer Society.