Nanoparticle micellar formulation of paclitaxel in combination with carboplatin for women with recurrent platinum sensitive ovarian cancer (OAS07-OVA): Overall survival results of a phase 3 randomized trial.

Abstract

5560 Background: The primary objective in the pivotal trial OAS-07OVA was reached and it was demonstrated that Paclical, a nanoparticle micellar formulation of paclitaxel (Oasmia Pharmaceutical AB) is non-inferior to Cremophor-EL Paclitaxel in terms of progression free survival (PFS) in the treatment of recurrent platinum-sensitive ovarian, fallopian tube or peritoneal carcinoma. Paclical is given as 1-h infusion without standard use of premedication. The follow-up analyses presented here includes overall survival (OS) and subgroups of PFS and OS. Methods: In this open 1:1 randomized 2-armed phase 3 study, 789 patients were included 2009 - 2012 in 81 centers. Non-inferiority in terms of OS was included as a secondary objective, anddefined as the time between date of randomization and death. Following the end of study, information of the death of participating patients was collected on a special form until August 2016. The upper non-inferiority limit of the one-sided confidence interval of the hazard ratio of the two treatment arms was set to 1.185. Results: Non-inferiority of OS was showed as the hazard ratio estimated based on a Cox proportional hazards model stratified by CA125 and relapse was 0.95 (95% CI: 0.78; 1.16) in the PP population. The median overall survival time was 25.7 months in the Paclical arm and 24.8 months in the Taxol arm. Non-inferiority of OS was also seen in patients experiencing their first relapse, and patients with serous adenocarcinoma at diagnosis. In addition, sensitivity analyses as well as subgroup analyses showed a consistent tendency of favor for Paclical in terms of PFS. Conclusions: Paclical is non-inferior to Taxol with respect to OS and PFS for patients with recurrent platinum-sensitive ovarian cancer. Even though the pivotal study was not designed to show superiority, subgroup analyses show a consistent tendency of favor for Paclical in terms of OS and PFS indicating a benefit for the Paclical group. Clinical trial information: NCT00989131, Eudra CT: 2008-002668-32 Clinical trial information: 2008-002668-32.