Immunotherapy Safety in Thymic Epithelial Tumors: Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System

This large-scale pharmacovigilance study delineates a distinct and severe irAEs profile for ICIs in patients with TETs, characterized by robust disproportionality signals for myositis, cardiotoxicity, and myasthenia gravis. As a hypothesis-generating analysis, these findings underscore the need for vigilant monitoring and early detection strategies to mitigate irAE risks, particularly in high-risk subgroups such as patients with thymoma. The results provide clinically relevant evidence to guide risk-benefit evaluation and inform tailored surveillance protocols during ICI therapy in this population.