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,

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