Lifetime Data Analysis

, Volume 14, Issue 1, pp 54-64

First online:

Exploring and validating surrogate endpoints in colorectal cancer

  • Tomasz BurzykowskiAffiliated withCenter for Statistics, Hasselt UniversityMSOURCE Medical Development Email author 
  • , Marc BuyseAffiliated withCenter for Statistics, Hasselt UniversityIDDI (International Drug Development Institute)
  • , Greg YothersAffiliated withNSABP (National Surgical Adjuvant Breast and Bowel Project) Biostatistical Center
  • , Junichi SakamotoAffiliated withNagoya University Graduate School of Medicine
  • , Dan SargentAffiliated withMayo Clinic College of Medicine

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Sargent et al (J Clin Oncol 23: 8664–8670, 2005) concluded that 3-year disease-free survival (DFS) can be considered a valid surrogate (replacement) endpoint for 5-year overall survival (OS) in clinical trials of adjuvant chemotherapy for colorectal cancer. We address the question whether the conclusion holds for trials involving other classes of treatments than those considered by Sargent et al. Additionally, we assess if the 3-year cutpoint is an optimal one. To this aim, we investigate whether the results reported by Sargent et al. could have been used to predict treatment effects in three centrally randomized adjuvant colorectal cancer trials performed by the Japanese Foundation for Multidisciplinary Treatment for Cancer (JFMTC) (Sakamoto et al. J Clin Oncol 22:484–492, 2004). Our analysis supports the conclusion of Sargent et al. and shows that using DFS at 2 or 3 years would be the best option for the prediction of OS at 5 years.


Surrogate endpoint Colorectal cancer Surrogate threshold effect