A phase II study of Yondelis® (trabectedin, ET-743) as a 24-h continuous intravenous infusion in pretreated advanced breast cancer

• DOI: 10.1038/sj.bjc.6603142
• Publication Date: 2006-05-31T13:35:29Z
• Authors: L Zelek; A Yovine; E Brain; F Turpin; A Taamma; M Riofrio; M Spielmann; J Jimeno; J L Misset
• Keywords: Trabectedin

Yondelis® (trabectedin, ET-743) is a novel marine-derived anticancer compound found in the ascidian Ecteinascidia turbinata. It currently under phase II/III development breast cancer, hormone refractory prostate sarcomas and ovarian cancer. Activity cancer experimental models has been reported, preliminary evidence of activity this setting during I programme also observed. The present study assessed feasibility trabectedin women with advanced previously treated conventional therapies. Patients disease at least one but not more than two regimens that included taxanes or anthracyclines as palliative therapy were eligible. Trabectedin 1.5 mg m−2 was administered 24-h continuous infusion every 3 weeks. kept on until progression, unacceptable toxicity patient refusal. Twenty-seven patients between April 1999 September 2000. Their median age 54 years (range: 36–67) 63% them had metastatic sites. Twenty-two performance status 1. All received anthracyclines, 23 out 27 taxanes. Of 21 measurable disease, three confirmed partial responses, unconfirmed response minor responses (49 32% tumour shrinkage) observed; six stable disease. Median survival 10 months (95% confidence interval: 4.88–15.18). Transient noncumulative transaminitis observed most patients. pharmacokinetic profile patient's population line overall data available schedule. policy dose adjustments based intercycle peaks bilirubin alkaline phosphatase appears to have positive impact therapeutic index trabectedin. can induce control manageable toxicity, thus warranting further single agent combination regimens.