作者
Robert J Motzer, Bernard Escudier, Saby George, Hans J Hammers, Sandhya Srinivas, Scott S Tykodi, Jeffrey A Sosman, Elizabeth R Plimack, Giuseppe Procopio, David F McDermott, Daniel Castellano, Toni K Choueiri, Frede Donskov, Howard Gurney, Stéphane Oudard, Martin Richardet, Katriina Peltola, Ajjai S Alva, Michael Carducci, John Wagstaff, Christine Chevreau, Satoshi Fukasawa, Yoshihiko Tomita, Thomas C Gauler, Christian K Kollmannsberger, Fabio A Schutz, James Larkin, David Cella, M Brent McHenry, Shruti Shally Saggi, Nizar M Tannir
发表日期
2020/9/15
期刊
Cancer
卷号
126
期号
18
页码范围
4156-4167
简介
Background
CheckMate 025 has shown superior efficacy for nivolumab over everolimus in patients with advanced renal cell carcinoma (aRCC) along with improved safety and tolerability. This analysis assesses the long‐term clinical benefits of nivolumab versus everolimus.
Methods
The randomized, open‐label, phase 3 CheckMate 025 trial (NCT01668784) included patients with clear cell aRCC previously treated with 1 or 2 antiangiogenic regimens. Patients were randomized to nivolumab (3 mg/kg every 2 weeks) or everolimus (10 mg once a day) until progression or unacceptable toxicity. The primary endpoint was overall survival (OS). The secondary endpoints were the confirmed objective response rate (ORR), progression‐free survival (PFS), safety, and health‐related quality of life (HRQOL).
Results
Eight hundred twenty‐one patients were randomized to nivolumab (n = 410) or everolimus (n = 411); 803 …
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RJ Motzer, B Escudier, S George, HJ Hammers… - Cancer, 2020