Endocrine adverse events related to immune checkpoint inhibitors in gastric cancer

This study aimed to systematically assess the endocrine adverse reactions associated with Immune checkpoint inhibitors (ICIs) in the treatment of gastric cancer. Data from the FDA Adverse Event Reporting System (FAERS) spanning from Q1 2013 to Q3 2024 were analyzed. The association between ICIs use and endocrine adverse events in gastric cancer was evaluated using the report odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) methods. A total of 326 cases of endocrine system-related adverse events were identified in association with ICIs therapy for gastric cancer. These events included common disorders such as thyroid dysfunction and adrenal insufficiency, as well as less frequently reported conditions, including the syndrome of inappropriate antidiuretic hormone secretion, hyperparathyroidism, thyroid nodules, and Cushing’s syndrome. Analysis of patient demographics revealed a higher reporting frequency of these adverse events in male patients and in those aged 65–85 years. The spectrum of endocrine adverse reactions exhibited significant variability across different ICIs agents, with distinct differences in reporting frequency and onset timing. Weibull distribution analysis revealed that the occurrence of ICI-related endocrine adverse events did not follow a temporal trend, exhibiting an overall random occurrence pattern. Endocrine system-related adverse events are significantly associated with the use of ICIs in the treatment of gastric cancer. This study provides a comprehensive overview of the spectrum of endocrine adverse events and their temporal characteristics, which may inform the safe clinical application of ICIs.