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
Biomarkers	Exploratory: Stage IV, CA125 KELIM score
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, 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 16.6 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) 37(26):2317-2328 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 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 https://pubmed.ncbi.nlm.nih.gov/36252167/

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