title: Surrogate endpoints for overall survival in lung cancer trials: a review.
abstract: 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.
authors.affiliation: a Methodology and Quality of Life in Oncology Unit , University Hospital of Besançon , Besançon , France.|b Department of Medical Oncology , University Hospital of Besançon , Besançon , France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Fiteni
authors.affiliation: c Chest disease Department , University Hospital of Besançon , Besançon , France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Westeel
authors.affiliation: a Methodology and Quality of Life in Oncology Unit , University Hospital of Besançon , Besançon , France.|d EA 3181 University of Franche-Comté , Besançon , France.|e The French National clinical research Platform Quality of Life and Cancer , Besançon , France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D002986:Clinical Trials as Topic / Q000379:methods*; D018572:Disease-Free Survival; D023381:Endpoint Determination; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers
keywords: Lung cancer; surrogate endpoints