Z. Wang, H. Bi, Y.D. Wang, Q. Liu, B. Shao, C.Q. Li, C. Fu, S. Fu, G.Y. Shan, A. Chen, C.C. Lv, Y. Zeng
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Outcomes included an objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.</p></div><div><h3>Results</h3><p>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. 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Zeng\",\"doi\":\"10.1016/j.acuro.2023.10.010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>Between March 2020 and December 2022, 33 patients were enrolled. The median follow-up was 10.17 (IQR 5.73-12.47) months. 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引用次数: 0
摘要
目的针对程序性死亡蛋白-1（PD-1）的单克隆抗体替斯利珠单抗在尿路癌中显示出令人鼓舞的抗肿瘤活性。本研究旨在评估替斯利珠单抗在真实世界环境中治疗尿路癌的疗效和安全性。方法本研究是一项真实世界回顾性研究，在中国辽宁省肿瘤医院& 研究所进行。符合条件的患者年龄≥18岁。患者接受200毫克替斯利珠单抗单药治疗，每3周静脉注射一次，直至病情发展到无法耐受毒性。结果包括客观反应率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性。中位随访时间为 10.17 个月（IQR 5.73-12.47 个月）。在所有33名患者中，ORR和DCR分别为30.30%（95% CI 15.6-48.7%）和42.42%（95% CI 25.48-60.78%）。中位 PFS 为 5.73 个月（95% CI 3.27-13.00），12 个月的 PFS 率为 31.90%（95% CI 19.20-53.00%）。中位OS为17.7个月（95% CI为12.80个月，未达标），12个月OS率为67.50%（95% CI为52.70-86.40%）。分别有11人（33.33%）和8人（24.24%）出现≥3级的治疗相关不良事件（TRAE）和免疫相关不良事件。结论 tislelizumab对局部晚期或转移性尿路上皮癌具有卓越的疗效和可控的安全性，这表明它可能是这一人群的一种有前途的治疗选择。
Tislelizumab, un nuevo anticuerpo monoclonal anti-PD-1 para el cáncer urotelial: estudio de vida real
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.
Conclusion
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.
期刊介绍：
Actas Urológicas Españolas is an international journal dedicated to urological diseases and renal transplant. It has been the official publication of the Spanish Urology Association since 1974 and of the American Urology Confederation since 2008. Its articles cover all aspects related to urology.
Actas Urológicas Españolas, governed by the peer review system (double blinded), is published online in Spanish and English. Consequently, manuscripts may be sent in Spanish or English and bidirectional free cost translation will be provided.
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