%0 Journal Article
%T Tislelizumab, a novel PD-1 monoclonal antibody in urothelial cancer: A real-world study.
%A Wang Z
%A Bi H
%A Wang YD
%A Liu Q
%A Shao B
%A Li CQ
%A Fu C
%A Fu S
%A Shan GY
%A Chen A
%A Lv CC
%A Zeng Y
%J Actas Urol Esp (Engl Ed)
%V 48
%N 4
%D 2024 May 29
%M 38160794
暂无%R 10.1016/j.acuroe.2023.12.006
%X <B>OBJECTIVE: </B>Tislelizumab, a monoclonal antibody against programed death protein-1 (PD-1), has shown encouraging antitumor activity in urothelial cancer. This study was designed to assess the efficacy and safety of tislelizumab in urotelial cancer in a real-world setting.<BR><B>METHODS: </B>The study was a real-world retrospective study undertaken at Liaoning Cancer Hospital & Institute, China. Eligible patients were ≥18 years. Patients received 200-mg tislelizumab monotherapy intravenously every 3 weeks until the disease progressed to intolerable toxicity. Outcomes included an objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.<BR><B>RESULTS: </B>Between March 2020 and December 2022, 33 patients were enrolled. The median follow-up was 10.17 (IQR 5.73-12.47) months. Of all 33 patients, ORR and DCR were 30.30% (95% CI 15.6%-48.7%) and 42.42% (95% CI 25.48%-60.78%), respectively. The median PFS was 5.73 (95% CI 3.27-13.00) months, with a 12-month PFS rate of 31.90% (95% CI 19.20%-53.00%). The median OS was 17.7 (95% CI 12.80-not reach) months, with a 12-month OS rate of 67.50% (95% CI 52.70%-86.40%). Eleven (33.33%) and 8 (24.24%) experienced ≥grade 3 treatment-related adverse events (TRAEs) and immune-related Aes, respectively. No treatment-related deaths occurred.<BR><B>CONCLUSIONS: </B>The excellent efficacy and controllable safety of tislelizumab in locally advanced or metastatic urothelial cancer suggest that it may be a promising therapeutic option for this population.