면역관문억제제 투여 환자의 간기능 이상반응 분석
Analysis of Hepatic Adverse Event in Patients Treated with Immune Checkpoint Inhibitor
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Background : Immune check point inhibitors can cause immune-related adverse events. Among them, hepatic adverse events are usually mild. However, in rare cases, fatal and severe adverse events might occur. The objective of this study was to evaluate the incidence, time of occurrence, and risk factors of hepatic adverse event in patients treated with immune check point inhibitors. Methods : Electronic medical records of patients aged 18 years or older who were treated with immune check point inhibitors in Samsung Medical Center Hematooncology from June 1, 2020 to November 31, 2020 were retrospectively reviewed. Results : In this study, a total of 702 patients were evaluated, including 526 (74.9%) males and 176 (25.1%) females. Hepatic adverse events were identified in 327 (46.6%) patients (Grade Ⅰ, 257 patients, 78.6%; Grade Ⅱ, 35 patients, 10.7%; Grade Ⅲ, 30 patients, 9.2%; Grade Ⅳ, 5 patients, 1.5%). The median time when AST/ALT reached the maximum level after first administration of immune checkpoint inhibitors was 94 days (range, 7-1211 days). In all hepatic adverse events, patients who were younger than 65 years-old had higher risk of hepatic adverse events (OR: 1.712; 95% CI: 1.265-2.317, p < 0.001). Risk factor for hepatic adverse events above grade Ⅱ were under 65 years-old (OR: 1.854; 95% CI: 1.090-3.352, p = 0.023), combined PPI (OR: 2.064; 95% CI: 1.183-3.600), and other cancers (i.e., bladder cancer) (OR: 2.988, 95% CI: 1.004-8.896, p = 0.049) based on classification criteria in this study. Conclusion : Based on this result, most hepatic adverse events were mild. However, in 10% of patients, moderate or higher hepatic adverse events were observed. The time of occurrence was about 3 months after first administration. In addition, the younger than 65 years-old age, the higher the likelihood of hepatic adverse events, and the severity of adverse events in the under 65-year-old, PPI coadministration group, and specific cancer may increase, requiring careful monitoring.
Abstract
Background : Immune check point inhibitors can cause immune-related adverse events. Among them, hepatic adverse events are usually mild. However, in rare cases, fatal and severe adverse events might occur. The objective of this study was to evaluate the incidence, time of occurrence, and risk factors of hepatic adverse event in patients treated with immune check point inhibitors. Methods : Electronic medical records of patients aged 18 years or older who were treated with immune check point inhibitors in Samsung Medical Center Hematooncology from June 1, 2020 to November 31, 2020 were retrospectively reviewed. Results : In this study, a total of 702 patients were evaluated, including 526 (74.9%) males and 176 (25.1%) females. Hepatic adverse events were identified in 327 (46.6%) patients (Grade Ⅰ, 257 patients, 78.6%; Grade Ⅱ, 35 patients, 10.7%; Grade Ⅲ, 30 patients, 9.2%; Grade Ⅳ, 5 patients, 1.5%). The median time when AST/ALT reached the maximum level after first administration of immune checkpoint inhibitors was 94 days (range, 7-1211 days). In all hepatic adverse events, patients who were younger than 65 years-old had higher risk of hepatic adverse events (OR: 1.712; 95% CI: 1.265-2.317, p < 0.001). Risk factor for hepatic adverse events above grade Ⅱ were under 65 years-old (OR: 1.854; 95% CI: 1.090-3.352, p = 0.023), combined PPI (OR: 2.064; 95% CI: 1.183-3.600), and other cancers (i.e., bladder cancer) (OR: 2.988, 95% CI: 1.004-8.896, p = 0.049) based on classification criteria in this study. Conclusion : Based on this result, most hepatic adverse events were mild. However, in 10% of patients, moderate or higher hepatic adverse events were observed. The time of occurrence was about 3 months after first administration. In addition, the younger than 65 years-old age, the higher the likelihood of hepatic adverse events, and the severity of adverse events in the under 65-year-old, PPI coadministration group, and specific cancer may increase, requiring careful monitoring.
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