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Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma

Robert J. Motzer, Bernard Escudier, David F. McDermott, Saby George, Hans J. Hammers, Sandhya Srinivas, Scott S. Tykodi, Jeffrey A. Sosman, Giuseppe Procopio, Elizabeth R. Plimack, Daniel Castellano, Toni K. Choueiri, Howard Gurney, Frede Donskov, Petri Bono, John Wagstaff, Thomas C. Gauler, Takeshi Ueda, Yoshihiko Tomita, Fabio A. Schutz, Christian Kollmannsberger, James Larkin, Alain Ravaud, Jason S. Simon, Li-An Xu, Ian M. Waxman, Padmanee Sharma

New England Journal of Medicine, Volume: 373, Issue: 19, Pages: 1803 - 1813

Swansea University Author: John Wagstaff

DOI (Published version): 10.1056/NEJMoa1510665

Abstract

This randomised phase III trial compared standard of care Everolimus with the anti-PD1 monoclonal antibody Nivolumab in previously treated patients with locally advanced inoperable or metastatic clear cell renal cancer. 810 patients were randomised to receive either Everolimus 10 mg orally daily or...

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Published in: New England Journal of Medicine
Published: 2015
URI: https://cronfa.swan.ac.uk/Record/cronfa25003
first_indexed 2015-12-10T01:57:47Z
last_indexed 2018-02-09T05:05:21Z
id cronfa25003
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Patients could be treated beyond progression if the investigator believed that the patient was gaining clinical benefit. The primary endpoint was overall survival. The median survival was 25 months for Nivolumab and 19.8 months for Everolimus (p=0.002). The objective response rate was higher for Nivolumab (25 versus 5%; p=&amp;#60;0.001).The median progression free survivals were 4.6 &amp; 4.4 months (p=0.11). Grade 3 &amp; 4 treatment related toxicities were observed in 19 &amp; 37% of patients on Nivolumab or Everolimus respectively. 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spelling 2017-12-26T13:25:20.8133078 v2 25003 2015-12-09 Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma fdab5e9e2fe06c93d3ffa19c816bdcf6 John Wagstaff John Wagstaff true false 2015-12-09 MEDS This randomised phase III trial compared standard of care Everolimus with the anti-PD1 monoclonal antibody Nivolumab in previously treated patients with locally advanced inoperable or metastatic clear cell renal cancer. 810 patients were randomised to receive either Everolimus 10 mg orally daily or 3 mg/kg of Nivolumab intravenously every two weeks. Patients were treated until unacceptable toxicity or disease progression. Patients could be treated beyond progression if the investigator believed that the patient was gaining clinical benefit. The primary endpoint was overall survival. The median survival was 25 months for Nivolumab and 19.8 months for Everolimus (p=0.002). The objective response rate was higher for Nivolumab (25 versus 5%; p=&#60;0.001).The median progression free survivals were 4.6 & 4.4 months (p=0.11). Grade 3 & 4 treatment related toxicities were observed in 19 & 37% of patients on Nivolumab or Everolimus respectively. In patients with previously treated renal cell carcinoma Nivolumab produced superior survival and more tolerable treatment than Everolimus. Journal Article New England Journal of Medicine 373 19 1803 1813 Renal Cancer, Nivolumab, Everolimus 25 9 2015 2015-09-25 10.1056/NEJMoa1510665 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University 2017-12-26T13:25:20.8133078 2015-12-09T16:06:19.3887593 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Robert J. Motzer 1 Bernard Escudier 2 David F. McDermott 3 Saby George 4 Hans J. Hammers 5 Sandhya Srinivas 6 Scott S. Tykodi 7 Jeffrey A. Sosman 8 Giuseppe Procopio 9 Elizabeth R. Plimack 10 Daniel Castellano 11 Toni K. Choueiri 12 Howard Gurney 13 Frede Donskov 14 Petri Bono 15 John Wagstaff 16 Thomas C. Gauler 17 Takeshi Ueda 18 Yoshihiko Tomita 19 Fabio A. Schutz 20 Christian Kollmannsberger 21 James Larkin 22 Alain Ravaud 23 Jason S. Simon 24 Li-An Xu 25 Ian M. Waxman 26 Padmanee Sharma 27 0025003-13072017143347.pdf nejmoa2015025renalpaper.pdf 2017-07-13T14:33:47.1730000 Output 529505 application/pdf Version of Record true 2017-07-13T00:00:00.0000000 true eng
title Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
spellingShingle Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
John Wagstaff
title_short Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
title_full Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
title_fullStr Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
title_full_unstemmed Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
title_sort Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
author_id_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6
author_id_fullname_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6_***_John Wagstaff
author John Wagstaff
author2 Robert J. Motzer
Bernard Escudier
David F. McDermott
Saby George
Hans J. Hammers
Sandhya Srinivas
Scott S. Tykodi
Jeffrey A. Sosman
Giuseppe Procopio
Elizabeth R. Plimack
Daniel Castellano
Toni K. Choueiri
Howard Gurney
Frede Donskov
Petri Bono
John Wagstaff
Thomas C. Gauler
Takeshi Ueda
Yoshihiko Tomita
Fabio A. Schutz
Christian Kollmannsberger
James Larkin
Alain Ravaud
Jason S. Simon
Li-An Xu
Ian M. Waxman
Padmanee Sharma
format Journal article
container_title New England Journal of Medicine
container_volume 373
container_issue 19
container_start_page 1803
publishDate 2015
institution Swansea University
doi_str_mv 10.1056/NEJMoa1510665
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
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description This randomised phase III trial compared standard of care Everolimus with the anti-PD1 monoclonal antibody Nivolumab in previously treated patients with locally advanced inoperable or metastatic clear cell renal cancer. 810 patients were randomised to receive either Everolimus 10 mg orally daily or 3 mg/kg of Nivolumab intravenously every two weeks. Patients were treated until unacceptable toxicity or disease progression. Patients could be treated beyond progression if the investigator believed that the patient was gaining clinical benefit. The primary endpoint was overall survival. The median survival was 25 months for Nivolumab and 19.8 months for Everolimus (p=0.002). The objective response rate was higher for Nivolumab (25 versus 5%; p=&#60;0.001).The median progression free survivals were 4.6 & 4.4 months (p=0.11). Grade 3 & 4 treatment related toxicities were observed in 19 & 37% of patients on Nivolumab or Everolimus respectively. In patients with previously treated renal cell carcinoma Nivolumab produced superior survival and more tolerable treatment than Everolimus.
published_date 2015-09-25T00:57:06Z
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