Intermediate endpoints as surrogates for long-term outcomes in breast cancer adjuvant chemotherapy trials.

ABSTRACT:

Importance and objective

Several definitions of efficacy endpoints have been proposed for clinical trials in early breast cancer (EBC). Invasive disease-free survival (IDFS) and other endpoints have been used as surrogates for overall survival (OS) in adjuvant trials. The aim was to evaluate these endpoints in a comparative way in a large cohort of patients to assess whether they are appropriate surrogates for OS.

Participants and design

Individual patient data from 8 phase III randomized adjuvant chemotherapy (CT) trials for EBC were analyzed. Trial-level surrogacy analyses were conducted using weighted least squares regression to assess the association between treatment effects on surrogates at different time points-IDFS and other defined endpoints (by STEEP v2.0)-and OS.

SUBMITTER: Blasco A 

PROVIDER: S-EPMC12450318 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature