Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.
Fiche publication
Date publication
mai 2015
Journal
Annals of oncology : official journal of the European Society for Medical Oncology
Auteurs
Membres identifiés du Cancéropôle Est :
Dr DABAKUYO-YONLI Sandrine
Tous les auteurs :
Gourgou-Bourgade S, Cameron D, Poortmans P, Asselain B, Azria D, Cardoso F, A'Hern R, Bliss J, Bogaerts J, Bonnefoi H, Brain E, Cardoso MJ, Chibaudel B, Coleman R, Cufer T, Dal Lago L, Dalenc F, De Azambuja E, Debled M, Delaloge S, Filleron T, Gligorov J, Gutowski M, Jacot W, Kirkove C, MacGrogan G, Michiels S, Negreiros I, Offersen BV, Penault Llorca F, Pruneri G, Roche H, Russell NS, Schmitt F, Servent V, Thürlimann B, Untch M, van der Hage JA, van Tienhoven G, Wildiers H, Yarnold J, Bonnetain F, Mathoulin-Pélissier S, Bellera C, Dabakuyo-Yonli TS,
Lien Pubmed
Résumé
Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer.
Mots clés
Breast Neoplasms, diagnosis, Consensus, Delphi Technique, Disease Progression, Disease-Free Survival, Endpoint Determination, classification, Female, Humans, Randomized Controlled Trials as Topic, classification, Research Design, standards, Terminology as Topic, Time Factors, Treatment Failure
Référence
Ann. Oncol.. 2015 May;26(5):873-9