COMET Initiative | 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)

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)

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.

Contributors

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, M. J. 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, B. V. Penault Llorca, F. Pruneri, G. Roche, H. Russell, N. S. Schmitt, F. Servent, V. Thurlimann, B. Untch, M. van der Hage, J. A. van Tienhoven, G. Wildiers, H. Yarnold, J. Bonnetain, F. Mathoulin-Pelissier, S. Bellera, C. Dabakuyo-Yonli, T. S.

Publication

Journal: Ann Oncol
Volume: 26
Issue: 5
Pages: 873 - 879
Year: 2015
DOI: 10.1093/annonc/mdv106

Further Study Information

Current Stage: Not Applicable
Date: January 2011 - June 2012
Funding source(s): This work was supported by grants from the French National League against Cancer (Ligue Nationale Contre le Cancer, 2009 National Grant for Clinical Research) and the French National Cancer Institute (Institut National du Cancer - INCa, financial support for organizing the in-person meeting held in Chicago) (no grant number).

Health Area

Disease Category: Cancer

Disease Name: Breast cancer

Target Population

Age Range: Unknown

Sex:

Nature of Intervention:

Stakeholders Involved

- Clinical experts
- Methodologists
- Statisticians

Study Type

- Definition

Method(s)

- Delphi process
- Literature review
- Semi structured discussion

The consensus process was constituted of two rounds of rating (first round: January 2011 to January 2012; second round: February 2012 to May 2012) and one face-to-face meeting (3 June 2012, Chicago).