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 Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin
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

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