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A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: Final overall survival results and safety update

Cora N Sternberg, Robert E Hawkins, John Wagstaff, Pamela Salman, Jozef Mardiak, Carlos H Barrios, Juan J Zarba, Oleg A Gladkov, Eunsik Lee, Cezary Szczylik, Lauren McCann, Stephen D Rubin, Mei Chen, Ian D Davis

European Journal of Cancer, Volume: 49, Issue: 6, Pages: 1287 - 1296

Swansea University Author: John Wagstaff

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Abstract

435 treatment naive or cytokine pre-treated patients with metastatic clear cell carcinoma of the kidney were randomised 2:1 to receive either pazopanib or placebo. The median overall survivals (22.9 vs 20.5) were not significantly different (p=0.224). However crossover from placebo to active drug oc...

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Published in: European Journal of Cancer
ISSN: 0959-8049
Published: 2013
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa14028
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Abstract: 435 treatment naive or cytokine pre-treated patients with metastatic clear cell carcinoma of the kidney were randomised 2:1 to receive either pazopanib or placebo. The median overall survivals (22.9 vs 20.5) were not significantly different (p=0.224). However crossover from placebo to active drug occurred early and frequently confounding the overall survival analysis. Inverse probability of censoring weighted (IPCW) did demonstrated that pazopanib did decrease mortality (HR = 0.504; 95% CI, 0.315– 0.762; two-sided P = .002). Cumulative exposure to pazopanib was 30% higher now than when this trial was first published in 2010. Despite this no new safety signals were detected. In 2016 this paper was one of the most cited papers in the European Journal of Cancer.
Keywords: Renal cell carcinoma, Pazopanib, Overall survival
College: Faculty of Medicine, Health and Life Sciences
Issue: 6
Start Page: 1287
End Page: 1296