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)

Sophie Gourgou-Bourgade 1 D. Cameron 2 P. Poortmans B. Asselain 3 D. Azria 4, 5 F. Cardoso R. A'Hern 6 J. Bliss 6 J. Bogaerts 7 H. Bonnefoi 8 E. Brain 9 M. Cardoso B. Chibaudel 10 R. Coleman T. Cufer L. Dal Lago 11 F. Dalenc 12 E. de Azambuja 11 M. Debled 8 S. Delaloge 13 T. Filleron 14 J. Gligorov 15 M. Gutowski William Jacot 16 C. Kirkove G. Macgrogan 17 S. Michiels 18 I. Negreiros B. Offersen F. Penault Llorca 19 G. Pruneri 20 H. Roche 14 N. Russell F. Schmitt V. Servent 21 B. Thürlimann M. Untch J. van der Hage G. van Tienhoven H. Wildiers J. Yarnold F. Bonnetain 22 S. Mathoulin-Pélissier 23 C. Bellera 8 T. Dabakuyo-Yonli 24
Abstract : BACKGROUND: 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. PATIENTS AND METHODS: A 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. RESULTS: Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. CONCLUSION: The 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.
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Soumis le : jeudi 12 septembre 2019 - 10:55:35
Dernière modification le : jeudi 19 septembre 2019 - 10:07:32

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Sophie Gourgou-Bourgade, D. Cameron, P. Poortmans, B. Asselain, D. Azria, et al.. 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). Annals of Oncology, Oxford University Press (OUP), 2015, 26 (5), pp.873-879. ⟨10.1093/annonc/mdv106⟩. ⟨hal-02284722⟩

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