Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: a meta-analysis

J Natl Cancer Inst. 2013 Nov 6;105(21):1667-70. doi: 10.1093/jnci/djt269. Epub 2013 Oct 9.

Abstract

The traditional endpoint for assessing efficacy of chemotherapies for advanced/recurrent gastric cancer is overall survival (OS), but OS requires prolonged follow-up. We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC meta-analysis, surrogacy of PFS was assessed through the correlation between the endpoints and through the correlation between the treatment effects on the endpoints. External validation of the prediction based on PFS was also evaluated. Individual data from 4069 patients in 20 randomized trials were analyzed. The rank correlation coefficient between PFS and OS was 0.853 (95% confidence interval [CI] = 0.852 to 0.854). The R (2) between treatment effects on PFS and on OS was 0.61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomarkers
  • Disease-Free Survival
  • Humans
  • Neoplasm Recurrence, Local / mortality*
  • Neoplasm Recurrence, Local / therapy*
  • Odds Ratio
  • Predictive Value of Tests
  • Randomized Controlled Trials as Topic
  • Stomach Neoplasms / mortality*
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / therapy*
  • Treatment Outcome

Substances

  • Biomarkers