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)†

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, Hans; Yarnold, J; Bonnetain, F; Mathoulin-Pélissier, S; Bellera, C; Dabakuyo-Yonli, TS

doi:10.1093/annonc/mdv106

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)†

Author:

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, Hans ; Yarnold, J ; Bonnetain, F ; Mathoulin-Pélissier, S ; Bellera, C ; Dabakuyo-Yonli, TS

Keywords:

Science & Technology, Life Sciences & Biomedicine, Oncology, guidelines, randomized, controlled trial, time-to-event end point, efficacy measure, breast cancer, POSTMENOPAUSAL WOMEN, CLINICAL-TRIALS, TAMOXIFEN, SURVIVAL, randomized, controlled trial, Breast Neoplasms, Consensus, Delphi Technique, Disease Progression, Disease-Free Survival, Endpoint Determination, Female, Humans, Randomized Controlled Trials as Topic, Research Design, Terminology as Topic, Time Factors, Treatment Failure, 1112 Oncology and Carcinogenesis, Oncology & Carcinogenesis, 3202 Clinical sciences, 3211 Oncology and carcinogenesis

Abstract:

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.