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Trabectedin for Women With Ovarian Carcinoma After Treatment With Platinum and Taxanes Fails

From the Istituto Oncologico della Svizzera Italiana, Bellinzona; Centre Pluridisciplinaire d'Oncologie, Lausanne, Switzerland; Istituto Europeo di Oncologia; Istituto Nazionale dei Tumori; Southern Europe New Drugs Organization Foundation; Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy; and PharmaMar SA, Madrid, Spain

Address reprint requests to Silvia Marsoni, Southern Europe New Drugs Organization Foundation, Via Visconti di Modrone 12, 20100 Milano, Italy; e-mail: marsonis{at}sendo-org.it

PURPOSE: To assess the efficacy and toxicity of the marine-derived alkaloid trabectedin (ET-743) in patients with advanced ovarian cancer refractory to or experiencing disease relapse after platinum- and taxane-based chemotherapy.

PATIENTS AND METHODS: Fifty-nine patients from four institutions either resistant (n = 30) or sensitive (n = 29) to prior platinum and taxanes were treated with a 3-hour infusion of trabectedin every 3 weeks. Patients were monitored weekly for toxicity and restaged every two cycles for response. Response was assessed according to Response Evaluation Criteria in Solid Tumors Group.

RESULTS: The peer-reviewed objective response rate in platinum-sensitive patients was 43% (95% CI, 23% to 65%) with an estimated median time to progression of 7.9 months (95% CI, 7.5 to 14.1 months); in platinum-resistant patients two partial responses were observed. Responses were durable for up to 12.9 months (median, 5 months). The predominant toxicities at the recommended dose of 1,300 µg/m² were neutropenia, asthenia, and self-limited increase of aminotransferases never requiring treatment interruption.

CONCLUSION: Trabectedin administered as a 3-hour infusion at 1,300 µg/m² is a safe new drug with promising activity in relapsed ovarian cancer, showing a 43% objective response rate in patients with platinum-sensitive disease, which favorably compares with other salvage treatments and warrants additional development either alone or in combination.

Supported by PharmaMar, Madrid, Spain.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, 2002, Orlando, FL.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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