Exploring and validating surrogate endpoints in colorectal cancer

Tomasz Burzykowski, Marc Buyse, Greg Yothers, Junichi Sakamoto, Dan Sargent

Research output: Contribution to journalArticle

24 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)54-64
Number of pages11
JournalLifetime Data Analysis
Volume14
Issue number1
DOIs
StatePublished - Mar 1 2008

Keywords

  • Colorectal cancer
  • Surrogate endpoint
  • Surrogate threshold effect

ASJC Scopus subject areas

  • Applied Mathematics

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    Burzykowski, T., Buyse, M., Yothers, G., Sakamoto, J., & Sargent, D. (2008). Exploring and validating surrogate endpoints in colorectal cancer. Lifetime Data Analysis, 14(1), 54-64. https://doi.org/10.1007/s10985-007-9079-4