Do trial benefits predict real-world gains in metastatic castration resistant prostate cancer.

ABSTRACT:

Background

It is important to understand the relationship between drug efficacy measured in randomized clinical trials (RCTs) and real-world drug effectiveness. We estimate how RCT overall survival (OS) and RCT radiographic progression-free survival (rPFS) benefits predict the association between treatments and real-world OS gains for metastatic castration-resistant prostate cancer (mCRPC) drugs.

Methods

Using the National Cancer Institute list of approved cancer drugs and the National Comprehensive Cancer Network Treatment Guidelines, we identified all pharmaceutical therapies for mCRPC approved between 2010 and 2019. We obtained RCT OS and rPFS hazard ratios from the pivotal trials used for Food and Drug Administration (FDA) approval, and we estimated real-world OS hazard

SUBMITTER: Axeen S 

PROVIDER: S-EPMC11879356 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature