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. 2011 Oct;18 Suppl 2(Suppl 2):S5-S10.
doi: 10.3747/co.v18is2.941.

Progression-free survival as a primary endpoint in clinical trials of metastatic colorectal cancer

S Gill  1 , S Berry, J Biagi, C Butts, M Buyse, E Chen, D Jonker, C Mărginean, B Samson, J Stewart, M Thirlwell, R Wong, J A Maroun
Affiliations

Progression-free survival as a primary endpoint in clinical trials of metastatic colorectal cancer

S Gill et al. Curr Oncol. 2011 Oct.

Abstract

In recent years, significant advances have been made in the management of metastatic colorectal cancer. Traditionally, an improvement in overall survival has been considered the "gold standard"-the most convincing measure of efficacy. However, overall survival requires larger patient numbers and longer follow-up and may often be confounded by other factors, including subsequent therapies and crossover. Given the number of active therapies for potential investigation, demand for rapid evaluation and early availability of new therapies is growing. Progression-free survival is regarded as an important measure of treatment benefit and, compared with overall survival, can be evaluated earlier, with fewer patients and no confounding by subsequent lines of therapy. The present paper reviews the advantages, limitations, and relevance of progression-free survival as a primary endpoint in randomized trials of metastatic colorectal cancer.

Keywords: Progression-free survival; metastatic colorectal cancer; randomized clinical trials; surrogate endpoints; targeted therapies.

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Conflict of interest statement

9. CONFLICT OF INTEREST DISCLOSURES

MB holds stock in iddi. JAM has received research funding from Roche and Sanofi–Aventis, and has received honoraria for participation on boards and as a speaker for Roche, Novartis, Amgen, and Sanofi–Aventis. The remaining authors have no conflicts of interest pertinent to the topic of this manuscript to declare.

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