作者
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
发表日期
2015/11/5
期刊
New England Journal of Medicine
卷号
373
期号
19
页码范围
1803-1813
出版商
Massachusetts Medical Society
简介
Background
Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment.
Methods
A total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily. The primary end point was overall survival. The secondary end points included the objective response rate and safety.
Results
The median overall survival was 25.0 months (95% confidence …
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RJ Motzer, B Escudier, DF McDermott, S George… - New England Journal of Medicine, 2015