A correlation analysis to assess event-free survival as a trial-level surrogate for overall survival in early breast cancer.

ABSTRACT:

Background

Event-free survival (EFS) has been listed on the FDA Table of Surrogate Endpoints as a surrogate measure that can be considered for accelerated or traditional approval in breast cancer. However, no studies have evaluated the correlation between the treatment effects on EFS and treatment effects on overall survival (OS).

Methods

We performed a systematic search of the literature until May 2020 according to the PRISMA guideline for all published randomized controlled trials (RCTs) in early breast cancer in the neoadjuvant setting. Data on EFS and OS, including the hazard ratio (HR) and 95% confidence intervals (CI), were extracted from each study and the association between the trial-level EFS HR and the trial-level OS HR was estimated using a linear mixed-effects m

SUBMITTER: Gyawali B 

PROVIDER: S-EPMC7910654 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature