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The adverse events of immunotherapy in the patients with thymic epithelial tumors: a pharmacovigilance study
ABSTRACT
Background:
Thymic epithelial tumors (TETs) have been identified with high PD-L1 expression, and immunotherapy has shown clinical benefits in patients with TETs. However, a higher incidence of immune-related adverse events (irAEs) was noted among patients suffering from TETs.
Objective:
Thus, we conducted a pharmacovigilance study to gain a comprehensive understanding of irAEs in patients with TETs with real-world data.
Methods:
We collected individual safety reports submitted to the FDA's Adverse Events Reporting System (FAERS) between January 2011 and September 2024. For quantifying the signal detection of immune-related adverse events (irAEs), we conducted a disproportionality analysis by computing the reporting odds ratio (ROR). Cumulative distribution curves were preformed to illustrate the event-to-onset data for ICI-related AEs in different groups.
Results:
A total 147 cases with TETs who experienced irAEs were identified, and 17 specific PTs were considered as valid and strongly associated with immune checkpoint inhibitors (ICIs) therapies, covering 11 SOCs. The frequent irAEs included myositis (ROR 104.54, 95%CI 24.50-446.06), myocarditis ROR 11.63, 95%CI 5.98-22.60), myasthenia gravis (ROR 3.18, ,95%CI 1.48-6.82) and febrile neutropenia ROR 2.66, ,95%CI 1.26-5.62). More than 70% of irAEs were emerged within the first two months of initiating ICIs therapies, with a median onset time of 21.0 days. Analyses of time-to-onset profile indicated that early failure-type profiles were found in all population with ICIs or subgroup of anti-PD-1 or anti-PD-L1 therapy. ICIs-related myocarditis was more predominantly observed in patients with thymoma, accounting for 75% of cases, and occurs in 25% of those with thymic carcinoma.
Conclusions:
Our study provided a deeper and broader understanding of ICIs safety proļ¬les in the patients with TETs, which would help to raise clinical awareness of close monitoring to detect severe immune-toxicity for TETs patients with immunotherapy. Clinical Trial: Unnecessary
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