Quan Penghe, Zhang Longlong, Yang Bo, Hou Haozhong, Wu Ningli, Fan Xiaozheng, Yu Changjiang, Zhu He, Feng Tianxi, Zhang Yifan, Qu Kejun, Yang Xiaojian
Department of Urology, Xijing Hospital of Air Force Military Medical University, No. 127, Changle West Road, Xincheng District, Xi'an, 710032, China.
Department of Urology, The 986 Hospital of the Air Force Military Medical University, Xi'an, 710054, China.
Clin Transl Oncol. 2025 Mar;27(3):1221-1231. doi: 10.1007/s12094-024-03659-2. Epub 2024 Aug 22.
Upper tract urothelial carcinoma (UTUC) is a rare subset of urothelial cancers with poor prognosis. No consensus exists on the benefit of adjuvant immunotherapy for patients with UTUCs after nephroureterectomy with curative intent and the existing studies are limited. Herein, this study aimed to evaluate the effectiveness and safety of adjuvant treatment of tislelizumab with or without chemotherapy in patients with high-risk UTUC.
A retrospective study was conducted on 63 patients with high-risk UTUC who received tislelizumab with or without gemcitabine-cisplatin (GC) chemotherapy regimen after surgery between January 2020 and December 2022. Data on demographic and clinical characteristics, surgical, outcomes, prognostic factors, and safety were collected and analyzed.
Among the 63 patients with high-risk UTUC, the median age was 66 years (interquartile range 57-72), with 33 (52%) being male. The majority of patients with staged pT3 (44%) and pN0 (78%) disease. Fifty-one patients (81%) received tislelizumab plus GC chemotherapy, and 12 (19%) were treated with tislelizumab monotherapy. After the median follow-up of 26 months (range 1-47), 49 (78%) patients achieved stable disease. The 2-year disease-free survival (DFS) and 2-year overall survival were 78.68% (95% CI: 60.02-87.07%) and 81.40% (95% CI: 68.76-89.31%), respectively. The cycles of GC chemotherapy were independent prognostic factors for survival, with higher DFS (hazard ratio = 0.68, 95% CI, 0.50-0.93; p = 0.016) observed in the subgroup undergoing ≥ 3 cycles versus < 3 cycles of GC chemotherapy. Fifty-eight patients (92%) experienced at least one treatment-related adverse event (TRAE), with grade 3-4 TRAEs occurring in 13%. The most common grade 3-4 TRAEs were decreased white blood cells, thrombocytopenia, and ulcers.
The study demonstrates promising clinical benefits and a manageable safety profile of the tislelizumab-based adjuvant regimen for patients with high-risk UTUC. This suggests that adjuvant immunotherapy represents a potential therapeutic strategy for this population.
上尿路尿路上皮癌（UTUC）是尿路上皮癌中预后较差的罕见亚型。对于接受根治性肾输尿管切除术的UTUC患者，辅助免疫治疗的益处尚无共识，且现有研究有限。在此，本研究旨在评估替雷利珠单抗联合或不联合化疗对高危UTUC患者进行辅助治疗的有效性和安全性。
对2020年1月至2022年12月期间63例高危UTUC患者进行回顾性研究，这些患者术后接受了替雷利珠单抗联合或不联合吉西他滨-顺铂（GC）化疗方案。收集并分析了人口统计学和临床特征、手术情况、结局、预后因素及安全性等数据。
63例高危UTUC患者中，中位年龄为66岁（四分位间距57 - 72岁），男性33例（52%）。大多数患者分期为pT3（44%）和pN0（78%）。51例患者（81%）接受替雷利珠单抗联合GC化疗，12例（19%）接受替雷利珠单抗单药治疗。中位随访26个月（范围1 - 47个月）后，49例（78%）患者病情稳定。2年无病生存率（DFS）和2年总生存率分别为78.68%（95%CI：60.02 - 87.07%）和81.40%（95%CI：68.76 - 89.31%）。GC化疗周期是生存的独立预后因素，与接受<3周期GC化疗的亚组相比，接受≥3周期GC化疗的亚组DFS更高（风险比 = 0.68，95%CI，0.50 - 0.93；p = 0.016）。58例患者（92%）经历了至少1次治疗相关不良事件（TRAE），3 - 4级TRAE发生率为13%。最常见的3 - 4级TRAE为白细胞减少、血小板减少和溃疡。
该研究表明，基于替雷利珠单抗的辅助治疗方案对高危UTUC患者具有良好的临床获益和可控的安全性。这表明辅助免疫治疗是该人群的一种潜在治疗策略。
