Abstract

10547 Background: Alternative endpoints to overall survival (OS) such as progresion-free survival (PFS), time-to-progression (TTP) or time-to-treatment failure (TTF) are increasingly used to assess treatment efficacy in randomized controlled trials (RCT) to reduce inclusions and trials’ duration. Their properties in terms of surrogate markers need to be assessed to ensure that they can adequately replace OS. Methods: We conducted a literature review to summarize by cancer type studies evaluating surrogate endpoints for OS. In the absence of data for soft-tissue sarcoma (STS), we assessed surrogate properties for OS of PFS, TTP and TTF in advanced STS. We relied on a meta-analytical framework to estimate individual-level association (association between the candidate surrogate endpoint and OS) and trial-level association (association between the treatment effects on the candidate surrogate and on OS). Statistical methods included weighted linear regression (WLR) and the two-stage method introduced by Burzy...

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