Quantifying treatment benefit in molecular subgroups to assess a predictive biomarker Journal Article


Authors: Iasonos, A.; Chapman, P. B.; Satagopan, J. M.
Article Title: Quantifying treatment benefit in molecular subgroups to assess a predictive biomarker
Abstract: An increased interest has been expressed in finding predictive biomarkers that can guide treatment options for both mutation carriers and noncarriers. The statistical assessment of variation in treatment benefit (TB) according to the biomarker carrier status plays an important role in evaluating predictive biomarkers. For time-to-event endpoints, the hazard ratio (HR) for interaction between treatment and a biomarker from a proportional hazards regression model is commonly used as a measure of variation in TB. Although this can be easily obtained using available statistical software packages, the interpretation of HR is not straightforward. In this article, we propose different summary measures of variation in TB on the scale of survival probabilities for evaluating a predictive biomarker. The proposed summary measures can be easily interpreted as quantifying differential in TB in terms of relative risk or excess absolute risk due to treatment in carriers versus noncarriers. We illustrate the use and interpretation of the proposed measures with data from completed clinical trials. We encourage clinical practitioners to interpret variation in TB in terms of measures based on survival probabilities, particularly in terms of excess absolute risk, as opposed to HR. © 2016 American Association for Cancer Research.
Journal Title: Clinical Cancer Research
Volume: 22
Issue: 9
ISSN: 1078-0432
Publisher: American Association for Cancer Research  
Date Published: 2016-05-01
Start Page: 2114
End Page: 2120
Language: English
DOI: 10.1158/1078-0432.ccr-15-2517
PROVIDER: scopus
PMCID: PMC4856220
PUBMED: 27141007
DOI/URL:
Notes: Article -- Export Date: 2 June 2016 -- Source: Scopus
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  1. Jaya M Satagopan
    141 Satagopan
  2. Alexia Elia Iasonos
    362 Iasonos
  3. Paul Chapman
    326 Chapman