Cisplatin as second-line therapy in ovarian carcinoma treated initially with single-agent paclitaxel: a Gynecologic Oncology Group study

Objectives. The platinum compounds are the most active agents in the treatment of ovarian carcinoma. Phase II trials demonstrated the activity of paclitaxel in patients with disease clinically resistant to platinum-based front-line therapy, and phase III studies confirmed that a combination of paclitaxel plus a platinum was superior to cyclophosphamide plus a platinum. This study evaluated the activity of platinum in patients with bulky advanced disease treated with single-agent paclitaxel as front-line therapy on a Gynecologic Oncology Group protocol. Those patients who had persistent (stable) or progressive disease while receiving paclitaxel, or a recurrence of disease within 6 months of completing six cycles of paclitaxel therapy, received single-agent cisplatin. Methods. Thirty-nine eligible patients with ovarian carcinoma persistent, progressive, or recurrent after initial treatment with paclitaxel 200 mg/m(2) over 24 It every 3 weeks received cisplatin 100 mg/m(2) every 3 weeks until disease progression or unacceptable toxicity. Results. Among 37 patients evaluable for response, 8 complete (22%) and 13 partial (35%) responses resulted. Twelve (32%) patients exhibited stable disease, while 4 (11%) had increasing disease. Median progression-free survival was 11.0 months. Median survival was 15.0 months. All but two patients were clinically resistant to paclitaxel (progression during or within 6 months after completion of paclitaxel). Grade 2 or worse adverse effects among 39 patients evaluable for toxicity included neutropenia (23), thrombocytopenia (3), anemia (10), nausea and vomiting (23), azotemia (7), neurotoxicity (9), fever (2), and tinnitus (1). Conclusion. These data provide evidence that cisplatin is active as second-line therapy in patients clinically resistant to paclitaxel. The overall response rate is high (57%) with excellent progression-free and overall survival in the second-line setting. (C) 2003 Elsevier Inc. All rights reserved.