Guidelines for time-to-event endpoint definitions in sarcomas and gastro-intestinal stromal tumors (GIST) trials. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials).

Date publication

juillet 2014

Auteurs

Membres identifiés du Cancéropôle Est :
Dr COLLIN Françoise , Dr JOOSTE Valérie

Tous les auteurs :
Bellera CA, Penel N, Ouali M, Bonvalot S, Casalli PG, Nielsen OS, Delannes M, Litiere S, Bonnetain F, Dabakuyo TS, Benjamin R, Blay JY, Bui BN, Collin F, Delaney TF, 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, Sleijder S, Stoeckle E, Van Glabbeke M, Woll P, Gourgou-Bourgade S, Mathoulin-Pelissier S

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/25070543

Résumé

BACKGROUND: The use of potential surrogate endpoints for overall survival, such as disease-free-survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCT) in cancer. However, the definition of time-to-event (TTE) endpoints is rarely precise and lacks uniformity across trials. Endpoint 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 Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE endpoints. We report guidelines for RCT in sarcomas and gastro-intestinal-stromal tumors (GIST). METHODS: We first performed a literature review to identify TTE endpoints (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these endpoints. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. RESULTS: Recommended guidelines for the definition of TTE endpoints 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.

Référence

Ann Oncol. 2014 Jul 28. pii: mdu360.