Progression‐free survival and overall survival in the first‐line treatment of BRCA wild‐type advanced epithelial ovarian cancer: An analysis of patient‐level data pooled from historical clinical trials
Le Su, Mehmet Burcu, Kayleen Ports, Vlad Gradinariu, Yahav Itzkovich, Rahul Jain, Karin Yamada, Cumhur Tekin, Lei ChenABSTRACT
Background
Progression‐free survival (PFS) is a common primary endpoint in first‐line epithelial ovarian cancer (EOC) trials; however, its relationship with overall survival (OS) remains uncertain. The patient‐level PFS‐OS association among individuals with BRCA wild‐type advanced EOC treated with first‐line platinum‐based chemotherapy was evaluated.
Methods
This retrospective analysis pooled patient‐level data from first‐line advanced EOC historical trials sourced from the Medidata Enterprise Data Store. Eligible patients had BRCA wild‐type disease and initiated platinum‐based chemotherapy (index date) after primary debulking surgery or as neoadjuvant therapy before planned interval debulking surgery. The PFS‐OS association was evaluated using Spearman's correlation (ρ) and landmark analyses at prespecified timepoints (9, 12, 15, and 18 months after index).
Results
Among 487 patients (50.1% aged ≥65 years; 90.1% White; 63.7% International Federation of Gynecology and Obstetrics stage III; 54.6% ECOG‐PS 0; 37.3% primary debulking surgery; 53.0% interval debulking surgery; median follow‐up 3.4 years), the median PFS and OS were 15.6 months (95% CI, 13.8–16.8) and 42.1 months (95% CI, 37.8–45.7), respectively. The PFS‐OS correlation (ρ) was 0.7 (95% CI, 0.6–0.8). Across all landmarks, progression‐free patients experienced longer subsequent OS; at 15 months, the unadjusted HR was 0.29 (95% CI, 0.22–0.37). Associations remained after covariate adjustment and did not vary by best overall response, bevacizumab use, or surgical type/outcomes.
Conclusion
In this patient population, PFS demonstrated a consistently moderate, positive association with OS across multiple analytical approaches. These findings provide patient‐level evidence that PFS is an informative early endpoint, although additional trial‐level evaluations are needed to confirm PFS as a validated surrogate for OS in first‐line EOC.