作者
Robert J Motzer, Konstantin Penkov, John Haanen, Brian Rini, Laurence Albiges, Matthew T Campbell, Balaji Venugopal, Christian Kollmannsberger, Sylvie Negrier, Motohide Uemura, Jae L Lee, Aleksandr Vasiliev, Wilson H Miller Jr, Howard Gurney, Manuela Schmidinger, James Larkin, Michael B Atkins, Jens Bedke, Boris Alekseev, Jing Wang, Mariangela Mariani, Paul B Robbins, Aleksander Chudnovsky, Camilla Fowst, Subramanian Hariharan, Bo Huang, Alessandra Di Pietro, Toni K Choueiri
发表日期
2019/3/21
期刊
New England Journal of Medicine
卷号
380
期号
12
页码范围
1103-1115
出版商
Massachusetts Medical Society
简介
Background
In a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase 3 trial involving previously untreated patients with advanced renal-cell carcinoma compared avelumab plus axitinib with the standard-of-care sunitinib.
Methods
We randomly assigned patients in a 1:1 ratio to receive avelumab (10 mg per kilogram of body weight) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were progression-free survival and overall survival among patients with programmed death ligand 1 (PD-L1)–positive tumors. A key secondary end point was progression-free survival in the overall population; other end points included objective response and safety.
Results
A total of 886 patients were assigned to receive …
学术搜索中的文章
RJ Motzer, K Penkov, J Haanen, B Rini, L Albiges… - New England Journal of Medicine, 2019