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The validity of progression‐free survival 2 as a surrogate trial end point for overall survival

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Overall survival (OS) is the gold‐standard end point for oncology trials. However, the availability of multiple therapeutic options after progression and crossover to receive investigational agents confound and delay OS… Click to show full abstract

Overall survival (OS) is the gold‐standard end point for oncology trials. However, the availability of multiple therapeutic options after progression and crossover to receive investigational agents confound and delay OS data maturation. Progression‐free survival 2 (PFS‐2), defined as the time from randomization to progression on first subsequent therapy, has been proposed as a surrogate for OS. Using a meta‐analytic approach, the authors aimed to assess the association between OS and PFS‐2 and compare this with progression‐free survival 1 (PFS‐1) and the objective response rate (ORR).

Keywords: free survival; end point; progression free; survival; progression; overall survival

Journal Title: Cancer
Year Published: 2022

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