Surrogate endpoints for overall survival in lung cancer trials: a review.
Fiche publication
Date publication
mai 2017
Journal
Expert review of anticancer therapy
Auteurs
Membres identifiés du Cancéropôle Est :
Pr WESTEEL Virginie
Tous les auteurs :
Fiteni F, Westeel V, Bonnetain F
Lien Pubmed
Résumé
Intermediate endpoints are often used as primary endpoints instead of overall survival (OS) in lung cancer trials but they are not systematically validated as surrogate endpoints for OS. Areas covered: The aim of the study was to review the studies which assessed potential surrogate endpoints for OS in lung cancer trials. Expert commentary: Twenty studies were identified. In operable non-small cell lung cancer (NSCLC) (adjuvant trials) and locally advanced NSCLC (radiotherapy trials), one individual-patient data meta-analysis found a high correlation of disease-free survival (DFS) and progression-free survival (PFS) with OS at patient and trial level. In trials of adjuvant chemotherapy, correlation between disease-free survival DFS and OS were 0.83 at the individual level (95% CI 0.83-0.83) and 0.92 at trial level (95% CI 0.88-0.95). In locally advanced disease, correlation between PFS and OS was 0.77 to 0.85 at the individual level, and 0.89 to 0.97 at trial level. This study provides a 'proof' of the surrogacy of PFS and DFS on OS according to the IQWiG framework and the surrogacy of PFS and DFS on OS was classified level 2 according to Fleming hierarchy. In all the other setting, no endpoint was judged to be valid surrogate for OS.
Mots clés
Lung cancer, surrogate endpoints
Référence
Expert Rev Anticancer Ther. 2017 May;17(5):447-454