• S Gourgou-Bourgade, D Cameron, P Poortmans, B Asselain, D Azria, F Cardoso, R A'Hern, J Bliss, J Bogaerts, H Bonnefoi, E Brain, M J Cardoso, B Chibaudel, R Coleman, T Cufer, L Dal Lago, F Dalenc, E De Azambuja, M Debled, S Delaloge, T Filleron, J Gligorov, M Gutowski, W Jacot, C Kirkove, G MacGrogan, S Michiels, I Negreiros, B V Offersen, F Penault Llorca, G Pruneri, H Roche, N S Russell, F Schmitt, V Servent, B Thürlimann, M Untch, J A van der Hage, G van Tienhoven, H Wildiers, J Yarnold, F Bonnetain, S Mathoulin-Pélissier, C Bellera, T S Dabakuyo-Yonli, and Definition for the Assessment of Time-to-event Endpoints in Cancer Trials Initiative.
• Biostatistic Unit, Montpellier Cancer Institute, Montpellier Data Center for Cancer Clinical Trials, CTD-INCa, Montpellier, France sophie.gourgou@icm.unicancer.fr.
• Ann. Oncol. 2015 May 1; 26 (5): 873-9.

BackgroundUsing 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.Patients And MethodsA literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts.ResultsRecommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings.ConclusionThe use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT.© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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