KEY TAKEAWAYS
- The phase III trial aimed to compare the efficacy of C/P/bevacizumab/PARPi versus carboplatin/paclitaxel/PARPi in advanced OC pts, irrespective of biomarker status.
- The primary objective is PFS, and secondary objectives include PFS, OS, PFS2, safety/tolerability, and QoL. The trial is currently recruiting.
Standard chemotherapy for advanced ovarian cancer (AOC) is a combination of carboplatin and paclitaxel (C/P). Maintaining this treatment with niraparib or a combination of olaparib and bevacizumab has shown significant benefits in patients(pts) with AOC. The role and benefit of adding bevacizumab to PARPi in maintenance therapy is still unclear.
Researchers aimed to compare the efficacy of C/P/bevacizumab/PARP-inhibitor(PARPi) versus C/P/PARPi in advanced OC pts, irrespective of biomarker status.
The study includes adult pts with newly diagnosed high-grade epithelial ovarian cancer, fallopian tube cancer FIGO III/IV (except FIGO IIIA2 without nodal involvement), or primary peritoneal cancer. Patients who have completed cycle 1 of chemotherapy as part of the Study-Run-In-Period are eligible for randomization.
Before day 1 of cycle 2, 970 pts with a central tumor BRCA (tBRCA) test outcome will be randomized 1:1 into either Arm 1, receiving 5 additional cycles of chemotherapy followed by niraparib for up to 3 years or into Arm 2, receiving 5 additional cycles of chemotherapy plus bevacizumab followed by bevacizumab therapy for up to 1 year, along with niraparib for up to 3 years.
Enrolment is also open for pts scheduled for neoadjuvant chemotherapy and interval debulking surgery.
The study’s primary objective is progression-free survival(PFS). Secondary objectives include various endpoints, including but not limited to progression-free survival (PFS) based on tBRCA-status, OS, PFS2, safety/tolerability, and quality of life. The trial actively enrolls pts, with the initial patient randomization in October 2022.
Source: https://www.emma.events/site/programme/?sessiondetail=4534566&trackid=0&a=esgo2023#!
Clinical Trial: https://clinicaltrials.gov/study/NCT05009082
Heitz F, Petru E, Henry S, Reuss A, Cibula D, Gaba L, Colombo N, Polleis S, Harter P; AGO-OVAR 28 / ENGOT-Ov57 Study Group. Niraparib Vs Niraparib In Combination With Bevacizumab In Patients With Carboplatin-Taxane Based Chemotherapy In Advanced Ovarian Cancer: A Multicentre Randomised Phase III Trial
