Innovative estimation of survival using log-normal survival modelling on ACCENT database

J. W. Chapman, C. J. O'Callaghan, N. Hu, K. Ding, G. A. Yothers, P. J. Catalano, Q. Shi, R. G. Gray, M. J. O'Connell, D. J. Sargent

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

Background:The ACCENT database, with individual patient data for 20 898 patients from 18 colon cancer clinical trials, was used to support Food and Drug Administration (FDA) approval of 3-year disease-free survival as a surrogate for 5-year overall survival. We hypothesised substantive differences in survival estimation with log-normal modelling rather than standard Kaplan-Meier or Cox approaches.Methods:Time to relapse, disease-free survival, and overall survival were estimated using Kaplan-Meier, Cox, and log-normal approaches for male subjects aged 60-65 years, with stage III colon cancer, treated with 5-fluorouracil-based chemotherapy regimens (with 5FU), or with surgery alone (without 5FU).Results:Absolute differences between Cox and log-normal estimates with (without) 5FU varied by end point. The log-normal model had 5.8 (6.3)% higher estimated 3-year time to relapse than the Cox model; 4.8 (5.1)% higher 3-year disease-free survival; and 3.2 (2.2)% higher 5-year overall survival. Model checking indicated greater data support for the log-normal than the Cox model, with Cox and Kaplan-Meier estimates being more similar. All three model types indicate consistent evidence of treatment benefit on both 3-year disease-free survival and 5-year overall survival; patients allocated to 5FU had 5.0-6.7% higher 3-year disease-free survival and 5.3-6.8% higher 5-year overall survival.Conclusion:Substantive absolute differences between estimates of 3-year disease-free survival and 5-year overall survival with log-normal and Cox models were large enough to be clinically relevant, and warrant further consideration.

Original languageEnglish (US)
Pages (from-to)784-790
Number of pages7
JournalBritish journal of cancer
Volume108
Issue number4
DOIs
StatePublished - Mar 5 2013

Keywords

  • ACCENT database
  • Cox
  • Kaplan-Meier
  • colon cancer
  • log-normal
  • survival

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Chapman, J. W., O'Callaghan, C. J., Hu, N., Ding, K., Yothers, G. A., Catalano, P. J., Shi, Q., Gray, R. G., O'Connell, M. J., & Sargent, D. J. (2013). Innovative estimation of survival using log-normal survival modelling on ACCENT database. British journal of cancer, 108(4), 784-790. https://doi.org/10.1038/bjc.2013.34