Objectives: Immune checkpoint inhibitor (ICI)-related hepatotoxicity (ICH) occurs in 1–17% of patients treated with ICIs. Although most cases are grade 1–2, ICH remains a clinically significant cause of morbidity. This study aimed to characterize the clinicopathological features of patients who developed ICH and to identify factors influencing survival. Methods: Patients treated with ICIs for metastatic solid malignancies at our center between January 2018 and May 2023 were retrospectively analyzed. Thirty-six patients who developed ICH during this period were included. Results: The median age at ICH onset was 62 years (range, 23–83), and the median number of ICI cycles before ICH was four (range, 1–44). The median progression-free survival (PFS) was 5.96 months (95% CI, 0.23–11.69), and the median overall survival (OS) was 11.26 months (95% CI, 2.85–19.67). In multivariate Cox regression analysis, baseline hemoglobin level and the number of ICI cycles before ICH were independent predictors of both PFS and OS. Conclusion: Patients who developed ICH after four or more ICI cycles had significantly better PFS and OS. ICH occurred earlier in those with liver metastases. Larger, multicenter prospective studies are warranted to validate these findings and improve management strategies. Keywords: Cancer, Hepatotoxicity, Immune Checkpoint Inhibitor, Immunotherapy, Survival
Corresponding Author: Alper Coskun