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Randomized Controlled Trial of Single-Agent Paclitaxel Versus Cyclophosphamide, Doxorubicin, and Cisplatin in Patients With Recurrent Ovarian Cancer Who Responded to First-Line Platinum-Based Regimens

From the Department of Gynaecology Oncology, Università degli Studi di Milano-Bicocca, Ospedale San Gerardo dei Tintori, Monza; Laboratory of Oncological Clinical Research, Istituto di Ricerche Farmacologiche "Mario Negri"; and Department of Gynaecology Oncology, European Institute of Oncology, Milan, Italy.

Address reprint requests to Valter Torri, MD, Laboratory of Oncological Clinical Research, Istituto di Ricerche Farmacologiche "Mario Negri," Via Eritrea 62-20157, Milan, Italy; email: torri{at}marionegri.it

PURPOSE: To assess the activity, efficacy, and tolerability of single-agent paclitaxel and a platinum-containing regimen in previously treated patients with recurrent ovarian cancer.

PATIENTS AND METHODS: Patients who achieved complete remission with platinum-based regimens and whose disease recurred after a progression-free interval of more than 12 months were included in the study. Every 21 days, patients received paclitaxel 175 mg/m² intravenously (IV) over 3 hours or cyclophosphamide 500 mg/m², doxorubicin 50 mg/m², and cisplatin 50 mg/m² (CAP) IV.

RESULTS: Between June 1992 and May 1995, 97 consecutive patients with assessable or measurable disease were randomized to paclitaxel (n = 50) or CAP (n = 47). The median number of cycles on each arm was six. Toxicities included grade 3/4 leukopenia (4% for paclitaxel v 34% for CAP), grade 3/4 neutropenia (13% v 36%), grade 1/2 myalgia (19% v 4%), allergic reactions (15% v 2%), and grade 2/3 nausea and vomiting (17% v 51%). Complete responses were achieved in 17% and 30% of patients receiving paclitaxel and CAP, respectively, and partial responses were achieved in 28% and 25%, respectively (P = .062). At a median follow-up time of 49 months, median progression-free intervals were 9 months for paclitaxel and 15.7 months for CAP (Cox analysis: hazards ratio [HR], 0.60; 95% confidence interval [CI], 0.37 to 0.97; P = .038); median overall survival times were 25.8 months for paclitaxel and 34.7 months for CAP (Cox analysis: HR, 0.58; 95% CI, 0.34 to 0.98; P = .043).

CONCLUSION: Rechallenge with either single-agent paclitaxel or platinum-based chemotherapy is effective in this patient population. Preliminary results suggest that single-agent paclitaxel may not be as active as platinum-based chemotherapy in recurrent ovarian cancer. Larger randomized trials are needed.

Supported in part by the Fondazione Nerina e Mario Mattioli, Milan, Italy.

Presented in part at the Thirty-Second Annual Meeting of the American Society of Clinical Oncology, Philadelphia, PA, May 18-21, 1996.

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