Clinical features, diagnosis, and outcome of anaplastic lymphoma kinase tyrosine kinase inhibitors associated interstitial lung disease.

Background To investigate the clinical features of anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKI) -associated interstitial lung disease (ILD), and to provide a reference for the rational use of ALK TKI. Methods Cases of ALK TKI-associated ILD before December 31, 2025 were collected by searching the database and clinical data were collected for retrospective analysis. Result Fifty patients were included, with a median age of 54.5 years (range 33, 86). The median time of ILD occurrence was 50 days (range 2, 630). Dyspnea (56.0%), hypoxemia (38.0%), cough (36.0%) and fever (26.0%) were the main clinical symptoms, and there may also be no symptoms. Computed tomography mainly showed ground-glass opacities (98.0%). After the patients discontinued ALK-TKI and received systemic steroid treatment, 90.0% of the patients had symptom relief and improved imaging, and 10.0% of the patients died. Conclusion ILD is a rare and fatal adverse event of ALK-TKI. The possibility of ILD should be considered if dyspnea, hypoxemia, and cough occur during ALK-TKI use. After ILD recovery, patients could switch to the same ALK-TKI or another ALK-TKI under the protection of glucocorticoid.