A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Newly diagnosed stage II-IV epithelial ovarian cancer

1560

First-line

Open-Label, Randomized

PFS, OS, evaluated per RECIST

Regimens:
IV CarboPt+Pac: IV paclitaxel 80 mg/m2 once per week with intravenous (IV) carboplatin area under the curve 6
IP CarboPt+Pac: IV paclitaxel 80 mg/m2 once per week with IP carboplatin area under the curve 6
IP CisPt+Pac: once every 3 weeks IV paclitaxel 135 mg/m2 over 3 hours day 1, IP cisplatin 75 mg/m2 day 2, and IP paclitaxel 60 mg/m2 day 8
--all regimens also received bevacizumab 15mg/kg IV every 3 weeks in cycles 2 to 22.

IV CarboPt+Pac+Bev w/ Bev maint vs IP CarboPt+Pac+Bev w/ Bev maint vs IP CisPt+Pac+Bev w/ Bev maint:
PFS: 24.9 vs 27.4 vs 26.2 months, HR: 0.925 (0.802-1.07, n.s.), 0.977 (0.847-1.13, n.s.)
OS: 75.5 vs 78.9 vs 72.9 months, HR: 0.949 (0.799-1.128, n.s.), 1.05 (0.884-1.24, n.s.)

Exploratory analysis stage II/III disease and optimally resected (residual disease of 1 cm or less) (n=1,380):
PFS: 26.9 vs 28.7 vs 27.8 months, HR: 0.921 (0.789-1.07, n.s.) and HR: 0.966 (0.828-1.13, n.s.)
OS: 80.0 vs 84.7 vs 76.3 months (n.s.)

Exploratory analysis stage II/III disease with no residual disease (n=870)
PFS: 35.9 vs 38.8 vs 35.5 months
OS: 108.6 vs 114.2 vs 107.9 months

Exploratory analysis stage II/III disease optimally resected (residual disease of 1 cm or less)  by CA125 nadir prior to the 4th cycle of treatment:
CA125≤10 vs CA125>10: PFS: 44.2 vs 28.5 months; OS: NR vs 89.0 months

IV CarboPt+Pac+Bev w/ Bev maint vs IP CarboPt+Pac+Bev w/ Bev maint vs IP CisPt+Pac+Bev w/ Bev maint:
Serious AE: 25 deaths, due to toxicity (8 vs 7 vs 10)
Grade 3-4 AE: hypertension (11.9 vs 14.3 vs 20.5%), infections (11.5 vs 17.2 vs 17.7%), nausea and vomiting (5.1 vs 4.7 vs 11.0%)

Compared to the IV reference arm, PFS was not significantly increased with either IP regimen

Walker JL et al. Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol (2019) 37(16):1380-1390
https://www.ncbi.nlm.nih.gov/pubmed/31002578

Long Term Survival of GOG 252 Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/GOG Study, SGO 2022 Scientific Plenary II, abstract 20
https://www.clearityfoundation.org/wp-content/uploads/2022/03/GOG252-abstract-20-SGO-2022.pdf