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Title: Trabectedin Produces Progression-Free Survival Benefits in Relapsed Ovarian Cancer: Presented at ESMO
URL: http://www.pslgroup.com/dg/22C7FA.htm
Doctor's Guide
September 16, 2008

By Janet Fricker

STOCKHOLM, Sweden -- September 16, 2008 -- Adding trabectedin to pegylated liposomal doxorubicin (PLD) significantly improves progression-free survival (PFS) in women with relapsed ovarian cancer, according to a study presented here at the 33rd European Society for Medical Oncology Congress (ESMO).

In a presentation on September 15, Bradley Monk, MD, University of California Irvine Medical Center, Orange, California, presented the results of the multicentre, phase 3 OVA-301 study of 672 women whose ovarian cancer had progressed after responding to a platinum-based therapy and who had measurable disease on radiology review.

The women were a median of 58 years old and were randomised to receive either trabectedin in combination with PLD or PLD alone. PFS was assessed by an independent radiologist.

Results showed that median length PFS for women taking trabectedin and PLD was 7.3 months and it was 5.8 months for those taking PLD alone (hazard ratio 0.79, P = .0190). In the case of women who had relapsed more than 6 months after receiving first-line therapy, median PFS was 9.2 months for trabectedin and PLD versus 7.5 months for PLD alone.

Dr. Monk said that the findings suggest that trabectedin is more active in patients who have gone a longer time since receiving initial chemotherapy.

"Overall survival is a secondary endpoint, but results can not be expected until 520 events have occurred," said Dr. Monk.

Neutropenia was the most common toxicity and occurred in 77% of the combination arm compared with 38% of patients taking PLD alone, but there was a low incidence of toxicity with clinical consequences, such as febrile neutropenia (8%) and sepsis (1%).

Trabectedin is currently approved for treatment of soft tissue sarcoma in Europe.


[Presentation title: A Randomized Phase III Study of Trabectedin With Pegylated Liposomal Doxorubicin (PLD) Versus PLD in Relapsed, Recurrent Ovarian Cancer (OC). Abstract LBA4]

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