泌尿道上皮細胞癌術後輔助免疫與化學治療之療效與安全性比較：多中心回顧性研究

林仁傑¹、劉凡維²、李高漢^1*、江亭易^1*、蔡育賢³、黃冠華¹、邱文祥⁴

¹外科部泌尿外科，奇美醫學中心；²教學部，奇美醫學中心；³泌尿部，國立成功大學附設醫院；⁴泌尿外科，新光吳火獅紀念醫院

Adjuvant Immunotherapy Compared to Conventional Adjuvant Modalities in Upper Tract Urothelial Carcinoma: A Multi-Center Retrospective Cohort Study

Jen-Chieh Lin¹、Fan-Wei Liu²、Kau-Han Lee^1*、Ting-Yi Chiang^1*、Yuh-Shyan Tsai³、Steven K. Huang¹、Allen W.Chiu⁴

¹Division of Urology, Department of Surgery, Chi Mei Medical Center, Tainan, Taiwan; ²Department of General Medicine , Chi Mei Medical Center, Tainan, Taiwan; ³Department of Urology, College of Medicine, National Cheng Kung University, Tainan, Taiwan; ⁴Department of Urology, Shin Kong Wu Ho-Su Memorial Hospital

Purpose: Adjuvant therapy guidelines for upper tract urothelial carcinoma (UTUC) rely heavily on trials predominantly featuring bladder cancer. Furthermore, post-surgical renal impairment frequently renders UTUC patients cisplatin-ineligible, limiting the feasibility of standard chemotherapy. This multicenter, retrospective study aims to compare the real-world efficacy and safety of adjuvant immunotherapy versus traditional chemotherapy in patients with UTUC following radical nephroureterectomy (RNU).

Materials and Methods: We analyzed 242 UTUC patients treated at two tertiary centers in Taiwan between 2018 and 2025. Patients were categorized into observation, adjuvant chemotherapy, and adjuvant immunotherapy (nivolumab) groups. A 1:2 propensity score matching (PSM) was utilized to balance baseline covariates. The primary endpoint was non-bladder recurrence-free survival (NBRFS), and the secondary endpoint was overall survival (OS). Survival was analyzed using Kaplan-Meier methods and multivariable Cox proportional hazards regression.

Results: Baseline characteristics revealed the immunotherapy group had a significantly higher proportion of pre-existing chronic kidney disease (72.0%) compared to the chemotherapy group (38.4%, p<0.001). Following PSM, no significant differences in OS (HR 1.783, p=0.275) or NBRFS (HR 1.714, p=0.276) were observed between the immunotherapy and chemotherapy cohorts. Multivariable analysis identified pathological T stage and preoperative end-stage renal disease (ESRD) as independent predictors of NBRFS. In subgroup analysis, adjuvant intervention yielded the most pronounced clinical benefit at the pT2 stage, identifying a critical therapeutic window. Safety profiles significantly favored immunotherapy, demonstrating a lower overall incidence of adverse events (42.1% vs. 71.1%, p=0.046), primarily driven by a marked reduction in hematologic toxicity (21.1% vs. 60.5%, p=0.006).

Conclusions: Adjuvant immunotherapy demonstrates oncological efficacy comparable to traditional chemotherapy while offering a significantly superior safety profile. It represents a vital, viable alternative for high-risk UTUC patients with compromised renal function, particularly when intervened at the pT2 stage before systemic disease escape