COMET Initiative | Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) 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 sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)

BACKGROUND: The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). METHODS: We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. RESULTS: Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. CONCLUSION: Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities.

Contributors

Bellera, C. A. Penel, N. Ouali, M. Bonvalot, S. Casali, P. G. Nielsen, O. S. Delannes, M. Litiere, S. Bonnetain, F. Dabakuyo, T. S. Benjamin, R. S. Blay, J. Y. Bui, B. N. Collin, F. Delaney, T. F. Duffaud, F. Filleron, T. Fiore, M. Gelderblom, H. George, S. Grimer, R. Grosclaude, P. Gronchi, A. Haas, R. Hohenberger, P. Issels, R. Italiano, A. Jooste, V. Krarup-Hansen, A. Le Pechoux, C. Mussi, C. Oberlin, O. Patel, S. Piperno-Neumann, S. Raut, C. Ray-Coquard, I. Rutkowski, P. Schuetze, S. Sleijfer, S. Stoeckle, E. Van Glabbeke, M. Woll, P. Gourgou-Bourgade, S. Mathoulin-Pelissier, S.

Publication

Journal: Ann Oncol
Volume:
Issue:
Pages: 1 - 8
Year: 2014
DOI: 10.1093/annonc/mdu360

Further Study Information

Current Stage: Not Applicable
Date: November 2010 - 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; financial support for organizing the in-person meeting held in Chicago).

Health Area

Disease Category: Cancer

Disease Name: Gastric Cancer, Sarcoma

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Epidemiologists
- Statisticians

Study Type

- Definition

Method(s)

- Consensus meeting
- Delphi process
- Literature review