Why post-progression survival and post-relapse survival are not appropriate measures of efficacy in cancer randomized clinical trials

Int J Cancer. 2015 May 15;136(10):2444-7. doi: 10.1002/ijc.29278. Epub 2014 Nov 3.

Abstract

Comparisons of post-relapse survival (PRS) and post-progression survival have been used to measure efficacy in some cancer clinical trials. These comparisons are an attempt to account for second-line therapies and to identify benefits that do not translate in longer overall survival. However, the use of PRS comparisons can be misleading (either a longer or shorter PRS may indicate a benefit, depending on the circumstances) and can result in biased estimates (because of selection). Here, we describe the problems surrounding PRS comparisons and propose alternative approaches to deal with non-randomized therapies administered after progression to the experimental treatment.

Keywords: bias; clinical trials; post-progression survival; post-relapse survival.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Disease Progression
  • Humans
  • Models, Statistical
  • Neoplasm Recurrence, Local / mortality*
  • Neoplasms / mortality*
  • Neoplasms / pathology
  • Randomized Controlled Trials as Topic*
  • Survival Analysis