Endpoint selection in HER2-positive early breast cancer
A partir d'une revue systématique de la littérature (8 essais incluant au total 21 480 patientes), cette méta-analyse évalue la validité de la survie sans maladie comme critère de substitution à la survie globale dans les essais évaluant un traitement adjuvant par anticorps anti-HER2 chez les patientes atteintes d'un cancer du sein HER2+ de stade précoce
Compared with definitive endpoints such as overall survival, the use of intermediate endpoints such as disease-free survival improves the efficiency of trial design, resulting in studies requiring smaller sample sizes and shorter follow-up. In oncology, the validation of intermediate endpoints as adequate surrogates of definitive outcomes is challenging. In early-stage breast cancer, evidence supporting the surrogacy of intermediate endpoints and definitive outcomes such as overall survival is scarce. Disease-free survival is a composite endpoint typically comprising locoregional and distant recurrences as well as new contralateral breast cancers, second cancers, and death from any cause. Disease-free survival has been used frequently as a primary endpoint in trials of early-stage breast cancer despite scarce data supporting its adequacy as a surrogate for overall survival.
The Lancet Oncology , commentaire, 2018