A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (GOG218)

Trial ID # NCT00262847; GOG-218
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, Paclitaxel
Eligible Participant

Newly Diagnosed, Stage III (suboptimally debulked) or Stage IV after primary surgery

Patients Enrolled

1,873

Therapy Setting

First-line, Maintenance

Study Design

Double Blind, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac+Bev vs CarboPt+Pac:

All:
PFS: 14.1 vs 11.2 vs 10.3 months, HR: 0.72 (0.63-0.82, p<0.001), 0.91 (0.80-1.04, p=0.16)
OS: 43.3 vs 40.8 vs 41.1 months, HR: 0.92 (0.73-1.15, p=0.45), 1.04 (0.83-1.30, p=0.76)

Exploratory analysis in patients with ascites:
CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac:

PFS: 15.2 vs 10.3 months, HR: 0.71 (0.62-0.81, p<0.001)
OS: 43.3 vs 39.9 months, HR: 0.82 (0.70-096, p=0.014)

Clinically Significant Adverse Events

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac+Bev vs CarboPt+Pac:
Serious AE: GI wall disruption (2.6 vs 2.8 vs 1.2%)
Grade 2-4 AE: hypertension (23 vs 16.5 vs 7%)

Conclusion

Improved PFS with addition of bevacizumab in high risk patients, particularly those with ascites

Reference

Burger RA et al. Final overall survival (OS) analysis of an international randomized trial evaluating bevacizumab (BEV) in the primary treatment of advanced ovarian cancer: A NRG oncology/Gynecologic Oncology Group (GOG) study. ASCO (2018) Abstract 5517 Poster
https://media4.asco.org/214/12975/160513/160513_poster_big_1.jpg

Ferriss J et al. Ascites predicts treatment benefit of bevacizumab in front-line therapy of advanced epithelial ovarian, fallopian tube and peritoneal cancers: an NRG Oncology/GOG study. Gynecol Oncol (2015) 139(1):17-22
https://www.ncbi.nlm.nih.gov/pubmed/26216729