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. 2011 Oct;18 Suppl 2(Suppl 2):S11-9.
doi: 10.3747/co.v18is2.958.

Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma

S J Hotte  1 , G A Bjarnason, D Y C Heng, M A S Jewett, A Kapoor, C Kollmannsberger, J Maroun, L A Mayhew, S North, M N Reaume, J D Ruether, D Soulieres, P M Venner, E W Winquist, L Wood, J H E Yong, F Saad
Affiliations

Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma

S J Hotte et al. Curr Oncol. 2011 Oct.

Abstract

Traditionally, overall survival (os) has been considered the "gold standard" for evaluating new systemic oncologic therapies, because death is easy to define, is easily compared across disease sites, and is not subject to investigator bias. However, as the available options for continuing therapy increase, the use of os as a clinical trial endpoint has become problematic because of the increasing crossover and contamination of trials. As a result, the approval of promising new therapies may be delayed.Many clinicians believe that progression-free survival (pfs) is a more viable option for evaluating new therapies in metastatic and advanced renal cell carcinoma. As with all endpoints, pfs has inherent biases, and those biases must be addressed to ensure that trial results are not compromised and that they will be accepted by regulatory authorities. In this paper, we examine the issues surrounding the use of pfs as a clinical trial endpoint, and we suggest solutions to ensure that data integrity is maintained.

Keywords: Kidney cancer; clinical trial endpoints; overall survival; progression-free survival; regulatory approval.

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Conflict of interest statement

5. CONFLICT OF INTEREST DISCLOSURES

Six authors (SJH, AK, LAM, SN, JDR, JHEY) declared no conflicts. Five authors (DYCH, DS, CK, LW, JAM) declared sitting on an advisory board for one or more pharmaceutical companies, five (GAB, MASJ, PMV, FS, MNR) declared receiving honoraria from pharmaceutical companies, and four (MASJ, PMV, FS, CK) declared serving as a consultant for a pharmaceutical company. In addition, three authors (GAB, PMV, MNR) declared grant or research monies received from a pharmaceutical company. Pharmaceutical companies included Pfizer, Novartis, Roche, GlaxoSmithKline, Wyeth, Amgen, AstraZeneca, Janssen, Sanofi–Aventis, and Bayer. One further author (EWW) declared a conflict of interest only with Sanofi–Aventis, which has no renal cancer drugs.

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