Abstract: Objective To investigate the clinical characteristics of and risk factors for liver injury induced by anaplastic lymphoma kinase (ALK) inhibitors in patients with non-small cell lung cancer (NSCLC). Methods The clinical data of NSCLC patients treated with ALK inhibitors at the First Affiliated Hospital of Soochow University between January 2019 and July 2024 was collected. Patients were divided into a liver injury group and a non-liver injury group based on the occurrence of liver injury. Demographics, disease diagnosis, baseline biochemical indicators of livers, and other clinical data were compared between the two groups. Univariate and multivariate logistic regression analyses were used to identify risk factors for liver injury. Results A total of 75 NSCLC patients treated with ALK inhibitors were included in this study, with an overall incidence of liver injury of 42.7% (32/75). There were no significant differences in clinical characteristics such as demographic information, lung cancer stage, or baseline biochemical indicators of the liver between the two groups. Logistic regression analysis revealed that pre-existing diseases [P=0.047, hypertension P=0.006, 95%CI (1.691, 21.312)] and concomitant medications [P=0.008, concomitant use of proton pump inhibitors P=0.022, 95%CI (1.274, 23.761)] might be independent risk factors for ALK inhibitor-induced liver injury. Conclusion The results of this study suggest that the risk of liver injury in NSCLC patients receiving ALK inhibitor treatment is potentially associated with comorbid underlying diseases such as hypertension, or concurrent use of drugs like proton pump inhibitors during treatment. For such patients, close monitoring of liver function is essential in clinical practice to ensure the safe and rational use of ALK inhibitors.

Key words: Anaplastic Lymphoma Kinase Inhibitor, Non-Small Cell Lung Cancer, Liver Injury, Risk Factors