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Adjuvant nivolumab vs placebo in muscle-invasive urothelial carcinoma

New England Journal of Medicine Jun 09, 2021

Bajorin DF, Witjes A, Gschwend JE, et al. - Researchers aimed at determining the role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma after radical surgery in a phase 3, multicenter, double-blind, randomized, controlled trial. Patients with muscle-invasive urothelial carcinoma who had undergone radical surgery were assigned to receive either nivolumab (240 mg intravenously) or placebo every 2 weeks for up to 1 year. Neoadjuvant cisplatin-based chemotherapy before trial entry was allowed; 353 patients received nivolumab and 356 received placebo. Outcomes revealed longer disease-free survival in correlation with receiving adjuvant nivolumab than with receiving placebo in the intention-to-treat population and among patients with a PD-L1 expression level of 1% or more.

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