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Background <p>Immunological checkpoint inhibitors (ICIs) have shown promise in treating various malignancies but are understudied in genitourinary cancers among patients with advanced chronic kidney disease (CKD), who are typically excluded from clinical trials. We evaluated the efficacy and safety of ICIs in this high-risk patient group.</p> Methods <p>This retrospective cohort study included patients with CKD diagnosed with renal cell carcinoma and urothelial carcinoma, utilizing data from 63 healthcare organizations in the TriNetX US Collaborative Network database between January 2015 and December 2023. Patients with advanced CKD (aCKD) and early CKD (eCKD) receiving ICIs were compared after 1:1 propensity score matching. Outcomes were assessed using Kaplan–Meier and Cox proportional hazards models. The primary outcome was all-cause mortality, and secondary outcomes included immune-related adverse events (irAEs).</p> Results <p>The study involved 2213 patients with aCKD and 9784 with eCKD who received ICIs. After matching, 2196 patients remained in each cohort. Patients with aCKD had higher 2-year all-cause mortality than those with eCKD (44.7% vs. 35.5%; HR = 1.372, 95% CI: 1.248–1.507). They also had a modestly higher risk of overall coded irAEs (HR = 1.141, 95% CI: 1.058–1.231), mainly driven by AKI (HR = 1.662, 95% CI: 1.500–1.840). Increased risks of mortality and AKI were evident from 3&#xa0;months and persisted through 60&#xa0;months.</p> Conclusions <p>In this large retrospective database study, aCKD was associated with worse survival and greater renal vulnerability among ICI-treated patients with genitourinary cancers. CKD alone should not automatically preclude ICI use in carefully selected patients, but close renal monitoring and multidisciplinary management are warranted, particularly for patients with aCKD.</p> <p>Trial registration number: Not applicable.</p>

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Efficacy of checkpoint inhibitors in genitourinary cancers with advanced chronic kidney disease

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月10日

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  • Yin-Shen Chen,
  • Chia-Cheng Yu,
  • Renin Chang,
  • Sheng-Hua Wu,
  • Cheuk-Kwan Sun,
  • Shu-Hung Huang

摘要

Background

Immunological checkpoint inhibitors (ICIs) have shown promise in treating various malignancies but are understudied in genitourinary cancers among patients with advanced chronic kidney disease (CKD), who are typically excluded from clinical trials. We evaluated the efficacy and safety of ICIs in this high-risk patient group.

Methods

This retrospective cohort study included patients with CKD diagnosed with renal cell carcinoma and urothelial carcinoma, utilizing data from 63 healthcare organizations in the TriNetX US Collaborative Network database between January 2015 and December 2023. Patients with advanced CKD (aCKD) and early CKD (eCKD) receiving ICIs were compared after 1:1 propensity score matching. Outcomes were assessed using Kaplan–Meier and Cox proportional hazards models. The primary outcome was all-cause mortality, and secondary outcomes included immune-related adverse events (irAEs).

Results

The study involved 2213 patients with aCKD and 9784 with eCKD who received ICIs. After matching, 2196 patients remained in each cohort. Patients with aCKD had higher 2-year all-cause mortality than those with eCKD (44.7% vs. 35.5%; HR = 1.372, 95% CI: 1.248–1.507). They also had a modestly higher risk of overall coded irAEs (HR = 1.141, 95% CI: 1.058–1.231), mainly driven by AKI (HR = 1.662, 95% CI: 1.500–1.840). Increased risks of mortality and AKI were evident from 3 months and persisted through 60 months.

Conclusions

In this large retrospective database study, aCKD was associated with worse survival and greater renal vulnerability among ICI-treated patients with genitourinary cancers. CKD alone should not automatically preclude ICI use in carefully selected patients, but close renal monitoring and multidisciplinary management are warranted, particularly for patients with aCKD.

Trial registration number: Not applicable.