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Review
. 2015 May;26(5):873-879.
doi: 10.1093/annonc/mdv106. Epub 2015 Feb 27.

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)†

S Gourgou-Bourgade  1 , D Cameron  2 , P Poortmans  3 , B Asselain  4 , D Azria  5 , F Cardoso  6 , R A'Hern  7 , J Bliss  7 , J Bogaerts  8 , H Bonnefoi  9 , E Brain  10 , M J Cardoso  6 , B Chibaudel  11 , R Coleman  12 , T Cufer  13 , L Dal Lago  14 , F Dalenc  15 , E De Azambuja  14 , M Debled  9 , S Delaloge  16 , T Filleron  15 , J Gligorov  17 , M Gutowski  18 , W Jacot  19 , C Kirkove  20 , G MacGrogan  9 , S Michiels  21 , I Negreiros  22 , B V Offersen  23 , F Penault Llorca  24 , G Pruneri  25 , H Roche  15 , N S Russell  26 , F Schmitt  27 , V Servent  28 , B Thürlimann  29 , M Untch  30 , J A van der Hage  31 , G van Tienhoven  32 , H Wildiers  33 , J Yarnold  34 , F Bonnetain  35 , S Mathoulin-Pélissier  36 , C Bellera  36 , T S Dabakuyo-Yonli  37
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Free article
Review

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)†

S Gourgou-Bourgade et al. Ann Oncol. 2015 May.
Free article

Erratum in

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.

Keywords: breast cancer; efficacy measure; guidelines; randomized, controlled trial; time-to-event end point.

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