Lifetime Data Analysis

, Volume 14, Issue 1, pp 54–64

Exploring and validating surrogate endpoints in colorectal cancer


    • Center for StatisticsHasselt University
    • MSOURCE Medical Development
  • Marc Buyse
    • Center for StatisticsHasselt University
    • IDDI (International Drug Development Institute)
  • Greg Yothers
    • NSABP (National Surgical Adjuvant Breast and Bowel Project) Biostatistical Center
  • Junichi Sakamoto
    • Nagoya University Graduate School of Medicine
  • Dan Sargent
    • Mayo Clinic College of Medicine

DOI: 10.1007/s10985-007-9079-4

Cite this article as:
Burzykowski, T., Buyse, M., Yothers, G. et al. Lifetime Data Anal (2008) 14: 54. doi:10.1007/s10985-007-9079-4


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 endpointColorectal cancerSurrogate threshold effect
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© Springer Science+Business Media, LLC 2008