[The trade-off and selection of efficacy endpoints: controversies and challenges between progression-free survival and overall survival in clinical trials of gynecological tumors].

Progression-free survival (PFS) is widely used as an alternative endpoint for overall survival (OS) due to its ability to shorten clinical trial cycles and reduce interference with subsequent treatments. However, PFS based on tumor measurements is susceptible to evaluation bias, insufficient statistical power, and confounding effects of subsequent treatments, leading to doubts about its clinical value, especially in the field of ovarian cancer where controversy is significant. Although the benefits of PFS may not necessarily translate into extended OS or improved quality of life, it is not advisable to completely negate the clinical value of the drug simply because the secondary endpoint OS did not show significant benefits. This article explains the disconnect between PFS and OS in gynecological tumors, proposes the necessityofoptimizing endpoint selection to reduce statistical bias, and emphasizes the importance of precision medicine as the guide to promote clinical trial design innovation. The aim is to provide a strategic framework for balancing accelerated approval and clinical benefit verification, guiding future research to focus more on the dual improvement of endpoint selection scientificity and patient survival improvement.