目标：Tislelizumab，一种针对程序性死亡蛋白-1（PD-1）的单克隆抗体，在尿路上皮癌中显示出令人鼓舞的抗肿瘤活性。这项研究旨在评估tislelizumab在现实世界环境中在卵巢癌中的疗效和安全性。
方法：该研究是在辽宁省肿瘤医院和研究所进行的一项现实世界的回顾性研究，中国。符合条件的患者≥18岁。患者每3周静脉内接受200-mgtislelizumab单药治疗，直到疾病发展为无法耐受的毒性。结果包括客观反应率(ORR)，疾病控制率（DCR），无进展生存期（PFS），总生存率（OS）和安全性。
结果：在2020年3月至2022年12月之间，招募了33名患者。中位随访时间为10.17(IQR5.73-12.47)个月。在所有33名患者中，ORR和DCR分别为30.30%（95%CI15.6-48.7%）和42.42%（95%CI25.48-60.78%），分别。中位PFS为5.73(95%CI3.27-13.00)个月,12个月PFS率为31.90%（95%CI19.20-53.00%）。中位OS为17.7个月（95%CI12.80-未达到），12个月OS率为67.50%（95%CI52.70-86.40%）。11人（33.33%）和8人（24.24%）经历了≥3级治疗相关不良事件（TRAEs）和免疫相关Aes，分别。无治疗相关死亡发生。
结论：tislelizumab在局部晚期或转移性尿路上皮癌中的优异疗效和可控制的安全性表明，它可能是该人群的有希望的治疗选择。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
