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 vs CarboPt+PLD+Bev:

PFS: 11.7 vs 13.3 months (HR: 0.80, 0.68-0.96, p=0.0128)
OS: 28.2 vs 33.5 months (HR = 0.833, p=0.0787)

Exploratory analysis; patients with previous 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 provided a significant PFS improvement compared to CarboPt+Gem+Bev

Reference

Pfisterer J et al., Carboplatin/pegylated liposomal doxorubicin/bevacizumab (CD-BEV) vs. carboplatin/gemcitabine/bevacizumab (CG-BEV) in patients with recurrent ovarian cancer: A prospective randomized phase III ENGOT/GCIG-Intergroup study (AGP study group, AGO-Austria, ANZGOG, GINECO, SGCTG) Ann Oncol (2018) 29 (suppl_8 abstr 933O)
https://academic.oup.com/annonc/article/29/suppl_8/mdy285.142/5141721

Helwick C, "Study Identifies Suitable Partner for Bevacizumab in Recurrent Ovarian Cancer," ASCO Post, 11/25/18
http://www.ascopost.com/issues/november-25-2018/study-identifies-suitable-partner-for-bevacizumab-in-recurrent-ovarian-cancer/?email=3765099c6418f856b604555d5c951496613127a5b67bf12667a9ec27bee4f5c5&utm_medium=Email&utm_campaign=TAP%20EN