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Trabectedin combination benefits certain patients with advanced ovarian cancer
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Patients with recurrent ovarian cancer who carry the BRCA1 mutation may experience improved survival when treated with a chemotherapeutic combination containing the orphan drug trabectedin.
Bradley J. Monk, MD, of the division of gynecologic oncology at St. Joseph’s Hospital and Medical Center in Phoenix, and colleagues conducted an exploratory analysis of a randomized phase 3 trial to determine whether a BRCA1 mutation or an XPG mutation could affect the clinical benefit patients with advanced ovarian cancer derive from trabectedin plus pegylated liposomal doxorubicin (PLD).
Bradley J. Monk
Researchers analyzed germline DNA samples from 264 patients who participated in a multicenter, open-label, phase 3 study from April 2005 to May 2007. Women in the study were randomly assigned to trabectedin plus PLD or PLD alone.
BRCA1 mutations were identified in 18% of women assigned to the combination vs. 13% of women assigned PLD alone. XPG mutations were identified in 6% of women assigned the trabectedin combination and 7% of those assigned PLD alone.
Overall, researchers reported a higher response rate in women with BRCA1 mutations than those with BRCA1 wild-type disease (49% vs. 28%).
Among women with BRCA1 mutations, patients treated with trabectedin plus PLD had longer PFS (13.5 months vs. 5.5 months; P = .0002) and longer OS (23.8 months vs. 12.5 months; P = .0086) than those treated with PLD alone.
However, among the BRCA1 wild-type patients, researchers observed no statistically significant difference in OS among those who received the combination vs. those who received PLD alone (19.1 months vs. 19.3 months).
Among women with XLG mutations, those assigned the trabectedin combination demonstrated shorter median PFS (1.9 months vs. 7.5 months) and OS (14.5 months vs. 20.7 months), but the survival differences were not statistically significant.
“These results are interesting because they add to the importance of BRCA1 status as a marker to optimize treatment with trabectedin and other DNA damaging agents,” Monk said in a press release. “Identifying potential genetic and molecular biomarkers in these patients can provide invaluable information for the clinician that can be brought back to the bench to better understand how trabectedin works in ovarian cancer.” – by Anthony SanFilippo
Disclosure: The study was funded by Janssen Pharmaceuticals. The researchers report research funding and honoraria from, employment relationships with and stock options with Janssen, Johnson & Johnson and Pharma Mar.
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