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Journal Articles British Journal of Cancer Year : 2020

Progression-Free Survival as a Surrogate for Overall Survival in Oncology Trials: A Methodological Systematic Review

Abstract

Abstract Background Progression-free survival (PFS) is a surrogate endpoint widely used for overall survival (OS) in oncology. Validation of PFS as a surrogate must be done for each indication and each intervention. We aimed to identify all studies evaluating the validity of PFS as a surrogate for OS in oncology, and to describe their methodological characteristics. Methods We conducted a systematic review by searching MEDLINE via PubMed and the Cochrane Library with no limitation on time, selected relevant studies and extracted data in duplicate on how surrogacy was evaluated (meta-analytic approach, assessment of correlation and level of evaluation). Results We identified 91 studies evaluating the validity of PFS as a surrogate for OS in 24 cancer localisations. Although a meta-analytic approach was used in 83 (91%) studies, the methods used to validate PFS as a surrogate of OS were heterogeneous across studies. Of the 47 studies concluding that PFS is a good surrogate for OS, for 15 (32%), there was no quantitative argument for surrogacy. Conclusions Although most studies used a meta-analytic approach as recommended, our methodological review highlights heterogeneity in methods and reporting, which stresses the importance of developing and applying clear recommendations in this area.

Dates and versions

hal-03892148 , version 1 (09-12-2022)

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Lisa Belin, Aidan Tan, Yann De Rycke, Agnès Dechartres. Progression-Free Survival as a Surrogate for Overall Survival in Oncology Trials: A Methodological Systematic Review. British Journal of Cancer, 2020, 122 (11), pp.1707--1714. ⟨10.1038/s41416-020-0805-y⟩. ⟨hal-03892148⟩
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