A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Trial ID #	NCT01837251
Phase	III
Drug Class	Angiogenesis Inhibitors: VEGF
Drug Name	Bevacizumab
Alternate Drug Names	immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial	Carboplatin, Liposomal doxorubicin, Bevacizumab, Gemcitabine
Eligible Participant	Platinum sensitive ovarian cancer at first recurrence
Patients Enrolled	682
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	PFS
Efficacy	CarboPt+Gem+Bev (n=337) vs CarboPt+PLD+Bev (n=345): PFS: 11.6 vs 13.3 months (HR: 0.81, 0.68-0.96, p=0.012) OS: 27.8 vs 31.9 months (HR = 0.81, 0.67-0.98, p=0.032) Exploratory analysis; patients with prior bevacizumab: PFS: 10.1 vs 11.3 months (HR: 0.73, 0.57-0.94, p=0.0126)
Clinically Significant Adverse Events	CarboPt+Gem+Bev vs CarboPt+PLD+Bev: Serious AEs: 8.5 vs 9.9% Grade 3-4 AE: neutropenia (22.2 vs 12.0%), hypertension (20.7 vs 27.7%)
Conclusion	CarboPt+PLD+Bev provides a significant PFS and OS improvement compared to CarboPt+Gem+Bev
Reference	Pfisterer J et al. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol (2020) 21(5):699-709 https://www.ncbi.nlm.nih.gov/pubmed/32305099