The BEV1L study: Do real-world outcomes associated with the addition of bevacizumab to first-line chemotherapy in patients with ovarian cancer reinforce clinical trial findings?

Abstract

Background: In clinical trials, adding bevacizumab to first-line (1L) chemotherapy for Stage III/IV epithelial ovarian cancer significantly improved progression-free survival but not overall survival (OS). Post hoc analyses suggested potentially greater benefit from the addition of bevacizumab in patients with high-risk prognostic factors.

Methods: Eligible patients in this nationwide, deidentified, electronic health record-derived database study had Stage III/IV epithelial ovarian cancer and initiated 1L chemotherapy ± bevacizumab (January 1, 2017-May 31, 2023). High-risk prognostic factors were defined as having Stage IV disease or Stage III disease with either visible residual disease or no documentation of surgery. Median real-world time to next treatment and real-world OS, indexed to 1L initiation, were estimated by Kaplan-Meier methods. Cox proportional hazards models assessed associations between patient characteristics and 1L treatment received, with each real-world outcome.

Results: Among 1752 patients, median (interquartile range) age was 68 (60-75) years; median (interquartile range) follow-up time was 18.5 (8.0-36.6) months. Among patients with high-risk prognostic factors, median (95% CI) real-world time to next treatment was significantly longer with 1L chemotherapy plus bevacizumab (13.6 [12.7-15.9] months) than chemotherapy alone (11.7 [10.6-12.6] months; p = .032). There was a trend toward longer median (95% CI) real-world OS with 1L chemotherapy plus bevacizumab (31.1 [27.7-37.5] months) versus chemotherapy (27.4 [25.1-31.2] months; p = .052). For patients without high-risk prognostic factors, real-world outcomes did not differ with the addition of bevacizumab.

Conclusions: These real-world results support clinical trial data suggesting the benefit of adding bevacizumab to 1L chemotherapy may be limited to patients with high-risk prognostic factors.

Keywords: advanced ovarian cancer; bevacizumab; first‐line maintenance; first‐line treatment; high‐risk prognostic factors; real‐world outcomes.