Authors
Dean F Bajorin, J Alfred Witjes, Jürgen E Gschwend, Michael Schenker, Begoña P Valderrama, Yoshihiko Tomita, Aristotelis Bamias, Thierry Lebret, Shahrokh F Shariat, Se Hoon Park, Dingwei Ye, Mads Agerbaek, Deborah Enting, Ray McDermott, Pablo Gajate, Avivit Peer, Matthew I Milowsky, Alexander Nosov, João Neif Antonio Jr, Krzysztof Tupikowski, Laurence Toms, Bruce S Fischer, Anila Qureshi, Sandra Collette, Keziban Unsal-Kacmaz, Edward Broughton, Dimitrios Zardavas, Henry B Koon, Matthew D Galsky
Publication date
2021/6/3
Journal
New England Journal of Medicine
Volume
384
Issue
22
Pages
2102-2114
Publisher
Massachusetts Medical Society
Description
Background
The role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma after radical surgery is not clear.
Methods
In a phase 3, multicenter, double-blind, randomized, controlled trial, we assigned patients with muscle-invasive urothelial carcinoma who had undergone radical surgery to receive, in a 1:1 ratio, either nivolumab (240 mg intravenously) or placebo every 2 weeks for up to 1 year. Neoadjuvant cisplatin-based chemotherapy before trial entry was allowed. The primary end points were disease-free survival among all the patients (intention-to-treat population) and among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or more. Survival free from recurrence outside the urothelial tract was a secondary end point.
Results
A total of 353 patients were assigned to receive nivolumab and 356 to receive placebo. The median disease-free survival in the …
Total citations
Scholar articles
DF Bajorin, JA Witjes, JE Gschwend, M Schenker… - New England Journal of Medicine, 2021