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)†

Publication

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)†

Journal Paper/Review - Feb 27, 2015

Dabakuyo-Yonli T S, Russell N S, Roché H, Pruneri G, Penault Llorca F, Offersen B V, Negreiros I, Michiels S, Macgrogan G, Kirkove C, Schmitt F, Servent V, Bellera C, Mathoulin-Pélissier S, Bonnetain F, Yarnold J, Wildiers H, van Tienhoven G, van der Hage J A, Untch M, Thürlimann Beat, Jacot W, Gutowski M, Gligorov J, Bonnefoi H, Bogaerts J, Bliss J, A'Hern R, Cardoso F, Azria D, Asselain B, Poortmans P, Cameron D, Brain E, Cardoso M J, Filleron T, Delaloge S, Debled M, De Azambuja E, Dalenc F, Dal Lago L, Cufer T, Coleman R, Chibaudel B, Gourgou-Bourgade S

Citation

Dabakuyo-Yonli T, Russell N, Roché H, Pruneri G, Penault Llorca F, Offersen B, Negreiros I, Michiels S, Macgrogan G, Kirkove C, Schmitt F, Servent V, Bellera C, Mathoulin-Pélissier S, Bonnetain F, Yarnold J, Wildiers H, van Tienhoven G, van der Hage J, Untch M, Thürlimann B, Jacot W, Gutowski M, Gligorov J, Bonnefoi H, Bogaerts J, Bliss J, A'Hern R, Cardoso F, Azria D, Asselain B, Poortmans P, Cameron D, Brain E, Cardoso M, Filleron T, Delaloge S, Debled M, De Azambuja E, Dalenc F, Dal Lago L, Cufer T, Coleman R, Chibaudel B, Gourgou-Bourgade S. 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)†. Ann Oncol 2015; 26:873-9.

Type

Journal Paper/Review (English)

Journal

Ann Oncol 2015; 26

Publication Date

Feb 27, 2015

Issn Electronic

1569-8041

Pages

873-9

Brief description/objective

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.