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Background <p>Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of advanced renal cell carcinoma (RCC), but their use is associated with immune-related adverse events, including hepatic adverse events (irHAEs).</p> Methods <p>We retrospectively analysed 105 RCC patients treated with ICIs as first-line therapy between 2018 and 2023 at the University Hospital of Essen. Patients were categorized by the development of irHAE, defined per CTCAE grading v5.0. Multivariable logistic regression was used to identify risk factors, while Kaplan-Meier survival analyses evaluated PFS and OS.</p> Results <p>Among the cohort, 16.19% (<i>n</i> = 17) developed irHAE, while 8.57% (<i>n</i> = 9) experienced higher-grade events. Combination therapy with tyrosine kinase inhibitors (TKIs) was associated with a higher likelihood of irHAE (OR: 7.69, <i>p</i> = 0.037) compared to ICI-only regimens, with cabozantinib showing a significantly shorter time to onset (35 vs. 84 days; <i>p</i> &lt; 0.001). Patients with a BMI ≥ 25 had a significantly increased risk (<i>p</i> = 0.011). Differences in PFS (18.63 vs. 19.87 months; <i>p</i> = 0.099) and OS (27.80 vs. 23.87 months; <i>p</i> = 0.36) were not statistically significant.</p> Conclusions <p>The combination of ICI with TKI posed higher risks for irHAE in RCC patients. While survival outcomes were unaffected, the results underscore the need for tailored monitoring and management. Prospective studies are warranted to refine therapeutic approaches.</p>

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Immune-related hepatic adverse events in renal cell carcinoma patients treated with immune checkpoint inhibitors: a retrospective study

  • 期刊论文

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  • 发表日期：

    2025年9月16日

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  • Amer Saleh,
  • Viktor Grünwald,
  • Thomas Hilser,
  • Christopher Darr

摘要

Background

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of advanced renal cell carcinoma (RCC), but their use is associated with immune-related adverse events, including hepatic adverse events (irHAEs).

Methods

We retrospectively analysed 105 RCC patients treated with ICIs as first-line therapy between 2018 and 2023 at the University Hospital of Essen. Patients were categorized by the development of irHAE, defined per CTCAE grading v5.0. Multivariable logistic regression was used to identify risk factors, while Kaplan-Meier survival analyses evaluated PFS and OS.

Results

Among the cohort, 16.19% (n = 17) developed irHAE, while 8.57% (n = 9) experienced higher-grade events. Combination therapy with tyrosine kinase inhibitors (TKIs) was associated with a higher likelihood of irHAE (OR: 7.69, p = 0.037) compared to ICI-only regimens, with cabozantinib showing a significantly shorter time to onset (35 vs. 84 days; p < 0.001). Patients with a BMI ≥ 25 had a significantly increased risk (p = 0.011). Differences in PFS (18.63 vs. 19.87 months; p = 0.099) and OS (27.80 vs. 23.87 months; p = 0.36) were not statistically significant.

Conclusions

The combination of ICI with TKI posed higher risks for irHAE in RCC patients. While survival outcomes were unaffected, the results underscore the need for tailored monitoring and management. Prospective studies are warranted to refine therapeutic approaches.