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J Clin Oncol. 2005 Mar 20;23(9):1867-74.

Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails.

Author information

1
Southern Europe New Drugs Organization Foundation, Via Visconti di Modrone 12, 20100 Milano, Italy. marsonis@sendo-org.it

Abstract

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 microg/m(2) were neutropenia, asthenia, and self-limited increase of aminotransferases never requiring treatment interruption.

CONCLUSION:

Trabectedin administered as a 3-hour infusion at 1,300 microg/m(2) 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.

PMID:
15774779
DOI:
10.1200/JCO.2005.09.032
[Indexed for MEDLINE]
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