The Incidence of Immune Checkpoint Inhibitor-Related Hepatotoxicity (ICH) in a Real-World Setting: A Retrospective Cohort Study
Recent meta-analyses of clinical trials have identified liver injury as a common adverse event among cancer patients treated with immune checkpoint inhibitors (ICIs). This study aims to estimate the incidence and risk factors of ICH among cancer patients between those with normal and abnormal liver function at baseline. We utilized electronic health records from Pusan National University Hospital transformed to OMOP-CDM, involving adult patients treated with ICIs between January 2011 and June 2022. Of 840 ICI-treated adult patients, 803 were eligible for this study. Mean age was 67.1 years (SD: 10.1) and the majority were male (n=563, 70.1%). The most common ICIs were atezolizumab (n=275, 34.2%) and pembrolizumab (n=264, 32.9%). About 32.4% (n=260) received a chemotherapy during follow-up, primarily carboplatin (n=141, 54.2%) and etoposide (n=57, 21.9%). The incidence of ICH was 19.0 cases / 100 person-years overall, with higher rates in the abnormal group (9.1 vs 45.4 cases / 100 person-years). Baseline characteristics were significantly different between groups except for the type of chemotherapy. Compared to males, females were more likely to develop ICH in the normal group (HR: 2.54, p-value: 0.045); and patients with liver cancer (HR: 2.99, p-value: 0.034) or receiving etoposide (HR: 24.0, p-value: 0.039) were more likely to develop ICH in the abnormal group. Abnormal liver function at baseline exhibited a higher ICH rate. These results underscore the importance of tailoring ICH prevention strategies to the baseline liver function of patients treated with ICIs.
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