Pulse Brain · Growing Health Evidence Index
Peer-reviewed

Nivolumab plus Gemcitabine–Cisplatin in Advanced Urothelial Carcinoma

Michiel S. van der Heijden, Guru Sonpavde, Thomas Powles, Andrea Necchi, Mauricio Burotto, Michael Schenker, Juan Pablo Sade, Aristotelis Bamias, Philippe Beuzeboc, Jens Bedke, Jan Oldenburg, Gurkamal Chatta, Yüksel Ürün, Dingwei Ye, Zhisong He, Begoña P. Valderrama, Ja Hyeon Ku, Yoshihiko Tomita, Jeiry Filian, Lily Wang, Daniela Purcea, M. PATEL, Federico Nasroulah, Matthew D. Galsky

New England Journal of Medicine · 2023

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Summary

BACKGROUND: No new agent has improved overall survival in patients with unresectable or metastatic urothelial carcinoma when added to first-line cisplatin-based chemotherapy. METHODS: In this phase 3, multinational, open-label trial, we randomly assigned patients with previously untreated unresectable or metastatic urothelial carcinoma either to receive intravenous nivolumab (at a dose of 360 mg) plus gemcitabine-cisplatin (nivolumab combination) every 3 weeks for up to six cycles, followed by nivolumab (at a dose of 480 mg) every 4 weeks for a maximum of 2 years, or to receive gemcitabine-cisplatin alone every 3 weeks for up to six cycles. The primary outcomes were overall and progression-free survival. The objective response and safety were exploratory outcomes. RESULTS: A total of 608 p

Subject
Other / interdisciplinary
Source type
Peer-reviewed study
System type
Other
DOI
10.1056/nejmoa2309863
Catalogue ID
BFmokjoc86-lj05wr
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