Back to Journals » OncoTargets and Therapy » Volume 5

Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology

Authors Sherrill B, Kaye J , Sandin R, Cappelleri J , Chen C

Received 3 August 2012

Accepted for publication 18 August 2012

Published 23 October 2012 Volume 2012:5 Pages 287—296


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Beth Sherrill,1 James A Kaye,2 Rickard Sandin,3 Joseph C Cappelleri,4 Connie Chen5

1RTI Health Solutions, Biometrics, Research Triangle Park, NC, USA; 2RTI Health Solutions, Epidemiology, Research Triangle Park, NC, USA; 3Pfizer, Global Outcomes Research Sollentuna, Sweden; 4Pfizer, Biostatistics, Groton, CT, USA; 5Pfizer, Global Outcomes Research New York, NY, USA

Abstract: Overall survival (OS) is the gold standard in measuring the treatment effect of new drug therapies for cancer. However, practical factors may preclude the collection of unconfounded OS data, and surrogate endpoints are often used instead. Meta-analyses have been widely used for the validation of surrogate endpoints, specifically in oncology. This research reviewed published meta-analyses on the types of surrogate measures used in oncology studies and examined the extent of correlation between surrogate endpoints and OS for different cancer types. A search was conducted in October 2010 to compile available published evidence in the English language for the validation of disease progression-related endpoints as surrogates of OS, based on meta-analyses. We summarize published meta-analyses that quantified the correlation between progression-based endpoints and OS for multiple advanced solid-tumor types. We also discuss issues that affect the interpretation of these findings. Progression-free survival is the most commonly used surrogate measure in studies of advanced solid tumors, and correlation with OS is reported for a limited number of cancer types. Given the increased use of crossover in trials and the availability of second-/third-line treatment options available to patients after progression, it will become increasingly more difficult to establish correlation between effects on progression-free survival and OS in additional tumor types.

Keywords: progression endpoints, correlation, cancer

Creative Commons License © 2012 The Author(s). This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.