NEWS FROM ESMO

A Promising New Option for Relapsed/Recurrent Ovarian Cancer

Trabectedin (Yondelis®) is a novel agent originally extracted from sea squirts and now prepared by a semi-synthetic process. A phase III study of a trabectedin (T) combined with pegylated liposomal doxorubicin (PLD) vs PLD alone in relapsed, recurrent ovarian cancer (OC) has demonstrated that the PLD + T combination is superior to PLD in both the primary endpoint PFS, and secondary endpoint of response rate (RR). The trial enrolled 672 patients whose disease progressed after response to first-line therapy. The patients’ median age was 57, and 64% had a platinum-free interval (PFI) > 6 months. Results: Median PFS for PLD + T was 7.3 months and for PLD 5.8 months (HR=0.79; p=0.019). For patients with a PFI > 6 months, the median PFS was 9.2 months for PLD + T vs 7.5 months for PLD alone (HR=0.73; p=0.017). RR for all patients: 28% vs 19% (p=0.008) and if PFI > 6 months: 35% vs 23%. Adverse events were manageable with appropriate monitoring.

This is one of the largest studies designed to establish clinical activity of a non-platinum doublet in second-line treatment of OC. Positive trials in recurrent OC are rare, so these results are quite encouraging.

Monk BJ, et al. LBA4 Annals of Oncology 19 (Supplement 8) 2008.

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