| アブストラクト | BACKGROUND: Immune checkpoint inhibitors (ICIs) have exhibited remarkable clinical benefits in the treatment of lung cancer, yet a large-scale pharmacovigilance investigation on ICI-related thyroid dysfunction (ICI-TD) remained limited. This study aimed to comprehensively analyze the demographic characteristics of ICI-TD in lung cancer patients and the pharmacovigilance signal patterns of the adverse events (AEs) using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: All existing data ranging from January 1(st) 2014 to March 31(st) 2026 were retrieved from the FAERS database. In descriptive analysis, the demographic characteristics of ICI-TD in lung cancer patients were collected and categorized. Disproportionality analysis was conducted to evaluate the signal characteristics of ICI-TD by employing three disproportional algorithms, namely reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC). RESULTS: A total of 2,001 reports of ICI-TD during treatment of lung cancer were identified after data processing, involving 1,758 patients and 10 ICIs. In general, ICI-TD were mainly reported in male patients (n = 959, 54.55%) and patients aged >/= 65 years (n = 856, 48.69%; median [lower quartile (Q1), upper quartile (Q3)] = 67 [60, 73]). After data cleaning, we found that reports from 752 patients had valid time-to-onset (TTO) values. The median TTO of ICI-TD was 42 days [Q1, Q3] = [14, 98], and ICI-TD was predominantly reported within 30 days after ICI administration (n = 323, 42.95% of all 752 patients). The vast majority of patients were reported as having serious reaction outcome (n = 1,690, 96.13%). Among all ICIs, nivolumab had the greatest number of ICI-TD reports (a = 655, 32.73% of all 2,001 reports, ROR(025) = 2.97, IC(025) = 1.32, PRR = 3.21, chi(2) = 782.34). The most frequently reported ICI-TD was "hypothyroidism" (a = 901, 45.03% of all 2,001 reports, ROR(025) = 4.83, IC(025) = 1.22, PRR = 5.36, chi(2) = 1,138.77). CONCLUSIONS: The present study provided a comprehensive overview of the demographic features of patients and pharmacovigilance signal patterns of ICI-TD during the treatment of lung cancer. Our findings would offer a referential perspective for the clinical understanding of the pharmacovigilance signals of ICI-TD. |
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| 組織名 | Department of Pharmacy, The Affiliated Brain Hospital, Guangzhou Medical;University, Guangzhou, China.;Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and The;Ministry of Education of China, Guangzhou Medical University, Guangzhou, China.;Department of Pharmacy, Guangzhou Institute of Cancer Research, the Affiliated;Cancer Hospital, Guangzhou Medical University, Guangzhou, China. |
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