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 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: 43.4 vs 40.8 vs 41.1 months, HR: 0.96 (0.85-1.09, p=0.53), 1.06 (0.94-1.20, p=0.34)

Exploratory analysis stage IV patients:
CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac+Bev vs CarboPt+Pac:

OS: 42.8 vs 34.5 vs 32.6 months, HR: 0.75 (0.59-0.95), HR: 0.99

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 16.6 vs 7.2%)

Conclusion

Improved PFS, but no OS difference with addition of bevacizumab to carboplatin+paclitaxel; potential benefit for patients with stage IV disease

Reference

Tewari KS et al. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. J Clin Oncol (2019)
https://www.ncbi.nlm.nih.gov/pubmed/31216226

Burger RA et al. Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer. NEJM (2011) 365: 2473-83
https://www.ncbi.nlm.nih.gov/pubmed/22204724