First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial

Abstract

Objective: First-line bevacizumab plus carboplatin and paclitaxel (CP) is approved for stage III/IV ovarian cancer treatment following initial surgical resection, based on global phase III GOG-0218 and ICON7 trials. This study evaluated the efficacy and safety of bevacizumab + CP as first-line ovarian cancer therapy in Chinese patients.

Methods: Patients with newly diagnosed, International Federation of Gynecology and Obstetrics (FIGO) stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer post-primary surgery were randomized 1:1 to receive 6 cycles of CP with bevacizumab/placebo, followed by bevacizumab/placebo maintenance until unacceptable toxicity or disease progression. Primary endpoint was investigator-assessed progression-free survival (PFS). Stratification factors were FIGO stage and debulking status (stage III optimally debulked vs stage III suboptimally debulked vs stage IV) and Eastern Cooperative Oncology Group performance status (0 vs 1 or 2).

Results: Of randomized patients, 51 received bevacizumab + CP and 49 received placebo + CP. Median PFS was 22.6 months with bevacizumab + CP (95% confidence interval [CI]=18.6, not estimable) and 12.3 months (95% CI=9.5, 15.0) with placebo + CP (stratified hazard ratio=0.30; 95% CI=0.17, 0.53). Treatment-related grade 3/4 adverse events occurred in 46 of 49 (94%) patients receiving bevacizumab + CP, and 34 of 50 (68%) receiving placebo + CP.

Conclusion: Bevacizumab + CP showed clinically meaningful improvement in PFS vs placebo + CP, consistent with GOG-0218 results. Safety data were aligned with the known bevacizumab safety profile. These results support first-line bevacizumab + CP therapy in Chinese patients with ovarian cancer.

Trial registration: ClinicalTrials.gov Identifier: NCT03635489.

Keywords: Bevacizumab; Chemotherapy; Chinese; Ovarian Cancer.

Fig. 1. PFS per investigator-assessed RECIST v1.1 in the ITT population. (A) Kaplan–Meier curves and (B) forest plots for primary and subgroup analyses.

Bev, bevacizumab; CA, cancer antigen; CI, confidence interval; CP, carboplatin plus paclitaxel; ECOG PS, Eastern Cooperative Oncology Group performance status; FIGO, International Federation of Gynecology and Obstetrics; HR, hazard ratio; ITT, intention-to-treat; NE, not estimable; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumours. ^*All patients were Chinese. ^†Per electronic case report form, not interactive voice/web response system. ^‡Includes those with mixed and mucinous histology.

Fig. 2. Kaplan–Meier curves for OS in the ITT population.

HRs were measured by unstratified Cox regression. Bev, bevacizumab; CI, confidence interval; CP, carboplatin plus paclitaxel; HR, hazard ratio; ITT, intention-to-treat; NE, not estimable; OS, overall survival.