| Source: |
Bajorin, D F, Witjes, J A, Gschwend, J E, Schenker, M, Valderrama, B P, Tomita, Y, Bamias, A, Lebret, T, Shariat, S F, Park, S H, Ye, D, Agerbaek, M, Enting, D, McDermott, R, Gajate, P, Peer, A, Milowsky, M I, Nosov, A, Antonio, J N, Tupikowski, K, Toms, L, Fischer, B S, Qureshi, A, Collette, S, Unsal-Kacmaz, K, Broughton, E, Zardavas, D, Koon, H B & Galsky, M D 2021, 'Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma', New England Journal of Medicine, vol. 384, no. 22, pp. 2102-2114. https://doi.org/10.1056/NEJMoa2034442 |
| 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 intention-to-treat population was 20.8 months (95% confidence interval [CI], 16.5 to 27.6) with nivolumab and 10.8 months (95% CI, 8.3 to 13.9) with placebo. The percentage of patients who were alive and disease-free at 6 months was 74.9% with nivolumab and 60.3% with placebo (hazard ratio for disease recurrence or death, 0.70; 98.22% CI, 0.55 to 0.90; P |