biostudies-literatureWang ZXNational Key R&amp;D Program of Chinae002114https://www.ebi.ac.uk/biostudies/studies/S-EPMC8021890biostudies-literatureUnknown9(4)<h4>Background</h4>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.<h4>Methods</h4>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 matchedJournal for immunotherapy of cancerExploration of modified progression-free survival as a novel surrogate endpoint for overall survival in immuno-oncology trials.PMC80218902018YFC1313300Liang FLi JXu RHXie LWang ZXLin WHYang ZMWu HXfalseExploration of modified progression-free survival as a novel surrogate endpoint for overall survival in immuno-oncology trials.<h4>Background</h4>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.<h4>Methods</h4>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 matched2021-01-01T00:00:00Z2021 Apr2026-07-16T10:02:45.221Z2026-07-09T10:48:12.896ZS-EPMC80218903379538510.1136/jitc-2020-002114