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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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DOI (Published version): 10.1016/j.ejca.2012.12.010

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
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URI: https://cronfa.swan.ac.uk/Record/cronfa14028
first_indexed 2013-07-23T12:11:32Z
last_indexed 2018-02-12T19:38:40Z
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recordtype SURis
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spelling 2018-02-12T13:17:09.1437826 v2 14028 2013-01-24 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 fdab5e9e2fe06c93d3ffa19c816bdcf6 John Wagstaff John Wagstaff true false 2013-01-24 MEDS 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. Journal Article European Journal of Cancer 49 6 1287 1296 0959-8049 Renal cell carcinoma, Pazopanib, Overall survival 31 12 2013 2013-12-31 10.1016/j.ejca.2012.12.010 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University 2018-02-12T13:17:09.1437826 2013-01-24T14:43:58.5241064 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Cora N Sternberg 1 Robert E Hawkins 2 John Wagstaff 3 Pamela Salman 4 Jozef Mardiak 5 Carlos H Barrios 6 Juan J Zarba 7 Oleg A Gladkov 8 Eunsik Lee 9 Cezary Szczylik 10 Lauren McCann 11 Stephen D Rubin 12 Mei Chen 13 Ian D Davis 14
title 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
spellingShingle 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
John Wagstaff
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6
author_id_fullname_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6_***_John Wagstaff
author John Wagstaff
author2 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
format Journal article
container_title European Journal of Cancer
container_volume 49
container_issue 6
container_start_page 1287
publishDate 2013
institution Swansea University
issn 0959-8049
doi_str_mv 10.1016/j.ejca.2012.12.010
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 0
active_str 0
description 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.
published_date 2013-12-31T06:26:10Z
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score 11.047501

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