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


Therapy Setting

First-line, Maintenance

Study Design

Double Blind, Randomized


PFS, OS, evaluated per RECIST


Exploratory: Stage IV, CA125 KELIM score


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

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, high/low risk, CA125 KELIM score:
CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac+Bev vs CarboPt+Pac:
stage IV patients: OS: 42.8 vs 34.5 vs 32.6 months, HR: 0.75 (0.59-0.95), HR: 0.99

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac:
high risk KEL unfav: OS: 35.1 vs 29.1 months, HR: 0.79 (0.65-0.97, p=0.023)
high risk KEL fav: OS: 59.6 vs 49.4 months, HR: 1.05 (0.79-1.39)
low risk KEL unfav: OS: 38.2 vs 37.8 months, HR: 1.08 (0.79-1.48)
low risk KEL fav: OS: 51.3 vs 68.6 months, HR: 1.18 (0.83-1.69) 

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%)


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


Tewari KS et al. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. J Clin Oncol (2019) 37(26):2317-2328

You B et al. Identification of Patients With Ovarian Cancer Experiencing the Highest Benefit From Bevacizumab in the First-Line Setting on the Basis of Their Tumor-Intrinsic Chemosensitivity (KELIM): The GOG-0218 Validation Study. J Clin Oncol (2022) 40(34):3965-3974

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