The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses

This review of meta-analyses of oncology RCTs assessing the relationship between a surrogate endpoint (SE) and survival reports most found low correlation; all were based on a subset of trial evidence. The authors question widespread use of SE as a basis for treatment decisions.

A related editorial notes that many oncology drugs have not been shown to improve overall survival, and are approved on the basis of surrogate endpoints (such as progression-free survival). These surrogate endpoints do not necessarily translate into mortality benefits – and they cite the example case of bevacizumab for metastatic breast cancer.

 

The editorial author comments that “We must reduce drug approvals based on unreliable surrogates and change practice when clinical studies show no survival benefit... In our rush to find new effective treatments, we should not harm our patients with ineffective toxic ones.”