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, Qian D Shi, R. G. Gray, M. J. O'Connell, D. J. Sargent

Research output: Contribution to journalArticle

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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

Fingerprint

Disease-Free Survival
Databases
Survival
Fluorouracil
Proportional Hazards Models
Colonic Neoplasms
Drug Approval
Recurrence
Kaplan-Meier Estimate
United States Food and Drug Administration
Clinical Trials
Drug Therapy

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Chapman, J. W., O'Callaghan, C. J., Hu, N., Ding, K., Yothers, G. A., Catalano, P. 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

Innovative estimation of survival using log-normal survival modelling on ACCENT database. / Chapman, J. W.; O'Callaghan, C. J.; Hu, N.; Ding, K.; Yothers, G. A.; Catalano, P. J.; Shi, Qian D; Gray, R. G.; O'Connell, M. J.; Sargent, D. J.

In: British Journal of Cancer, Vol. 108, No. 4, 05.03.2013, p. 784-790.

Research output: Contribution to journalArticle

Chapman, JW, O'Callaghan, CJ, Hu, N, Ding, K, Yothers, GA, Catalano, PJ, Shi, QD, Gray, RG, O'Connell, MJ & Sargent, DJ 2013, 'Innovative estimation of survival using log-normal survival modelling on ACCENT database', British Journal of Cancer, vol. 108, no. 4, pp. 784-790. https://doi.org/10.1038/bjc.2013.34
Chapman JW, O'Callaghan CJ, Hu N, Ding K, Yothers GA, Catalano PJ et al. Innovative estimation of survival using log-normal survival modelling on ACCENT database. British Journal of Cancer. 2013 Mar 5;108(4):784-790. https://doi.org/10.1038/bjc.2013.34
Chapman, J. W. ; O'Callaghan, C. J. ; Hu, N. ; Ding, K. ; Yothers, G. A. ; Catalano, P. J. ; Shi, Qian D ; Gray, R. G. ; O'Connell, M. J. ; Sargent, D. J. / Innovative estimation of survival using log-normal survival modelling on ACCENT database. In: British Journal of Cancer. 2013 ; Vol. 108, No. 4. pp. 784-790.
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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.",
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AU - Yothers, G. A.

AU - Catalano, P. J.

AU - Shi, Qian D

AU - Gray, R. G.

AU - O'Connell, M. J.

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