| Autor: |
Bajorin, D. F. Witjes, J. A. Gschwend, J. E. Schenker, M. and Valderrama, B. P. Tomita, Y. Bamias, A. Lebret, T. and Shariat, S. F. Park, S. H. Ye, D. Agerbaek, M. Enting, D. McDermott, R. Gajate, P. Peer, A. Milowsky, I, M. and Nosov, A. Antonio Jr, J. N. Tupikowski, K. Toms, L. and Fischer, B. S. Qureshi, A. Collette, S. Unsal-Kacmaz, K. and Broughton, E. Zardavas, D. Koon, H. B. Galsky, M. D. |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Popis: |
Adjuvant Nivolumab for Invasive Urothelial Carcinoma In a prospective, randomized trial involving patients with urothelial carcinoma who had undergone radical surgery, adjuvant nivolumab was compared with placebo. The median disease-free survival was 20.8 months with nivolumab and 10.8 months with placebo. Treatment-related adverse events of grade 3 or higher were noted in 17.9% of patients in the nivolumab group. 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 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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