Exploration of modified progression-free survival as a novel surrogate endpoint for overall survival in immuno-oncology trials.

ABSTRACT:

Background

Progression-free survival (PFS) exhibits suboptimal performance as the surrogate endpoint for overall survival (OS) in trials studying immune checkpoint inhibitors (ICIs). Here we propose a novel surrogate endpoint, modified PFS (mPFS), which omits the events of disease progression (but not deaths) within 3 months after randomization.

Methods

PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for randomized trials studying ICIs in advanced solid tumors with available PFS and OS data up to May 2020. Individual patient-level data (IPD) for PFS and OS were reconstructed for eligible trials. A simulation-based algorithm was used to match the reconstructed, disconnected PFS and OS IPD, and 1000 independent simulated datasets of matched

SUBMITTER: Wang ZX 

PROVIDER: S-EPMC8021890 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature