Influence of tumor control on tumor-related events (TRE) in relapsed ovarian cancer (ROC): Results from OVA-301, a randomized phase III study of trabectedin (Tr) with pegylated liposomal doxorubicin (PLD) versus PLD alone.

Abstract

e15529 Background: OVA-301 was an open-label, multicenter, randomized phase III study comparing Tr+PLD to PLD alone in 672 patients (pts) with ROC. The combination of Tr+PLD demonstrated significantly improved progression free survival and response rates, manageable noncumulative toxicity, fewer PLD-associated adverse events and no adverse effect on patient-reported outcome data (Monk, Ann Oncol. 2008). We studied the impact of the combination of Tr+PLD on TRE. Methods: TRE present at study entry and end of treatment were compared. These included analgesic use including narcotics, weight gain or loss, increase or decrease of ascites or pleural fluid and abdominal pain. Results: Among the pts with pleural fluid at baseline 11 of 28 (39%) in the Tr+ PLD arm had complete resolution compared with 4 of 27 (15 %) in the PLD arm. Resolution usually occurred over 5 cycles in both arm. Among the pts with evaluable disease who had resolution of pleural fluid, 4/7 (57%) in Tr+PLD and 1/4 (25%) in PLD alone arm had CR/PR by independent radiologist. Thirty percent of pts in the Tr+ PLD arm compared with 27% in the PLD arm showed resolution of ascites. The new onset of ascities was observed in 5% of pts in the Tr+ PLD arm compared with 8% in the PLD arm. The incidence of grade 3-4 AEs related to abdominal pain was 1% in the Tr+ PLD arm compared with 5% in the PLD arm. No other differences were observed based on the clinical parameters that were examined. Conclusions: Consistent with the findings from OVA-301, Tr+PLD results in reduced incidence of TRE compared with the PLD alone in patients with relapsed ovarian cancer. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Johnson & Johnson, PharmaMar Johnson & Johnson, Zeltia Johnson & Johnson