アブストラクト | INTRODUCTION: Although immune checkpoint inhibitors (ICIs) combined with angiogenesis inhibitors (AGIs) has become increasingly used for cancers, the impact of combination therapy on immune-related adverse events (irAEs) in real-world settings has not been well elucidated to date. METHODS: The FDA Adverse Event Reporting System (FAERS) database from 2014 to 2022 was retrospectively queried to extract reports of irAEs referred as standardized MedDRA queries (SMQs), preferred terms (PTs) and system organ classes (SOCs). To perform disproportionality analysis, information component (IC) and reporting odds ratio (ROR) were calculated and lower limit of 95 % confidence interval (CI) for IC (IC(025)) > 0 or ROR (ROR(025)) > 1 with at least 3 reports was considered statistically significant. RESULTS: Compared to ICIs alone, ICIs + AGIs demonstrated a lower IC(025)/ROR(025) for irAEs-SMQ (2.343/5.082 vs. 1.826/3.563). Regarding irAEs-PTs, there were fewer irAEs-PTs of significant value in ICIs + AGIs than ICIs alone (57 vs. 150 PTs) and lower signal value for most PTs (88 %) in ICIs + AGIs. Moreover, lower IC(025) for most of irAEs-SOCs in ICIs + AGIs (11/13) compared with ICIs alone was observed. As for outcomes of irAEs, ICIs + AGIs showed a lower frequency of "fatal" for irAEs-SMQ than ICIs alone (4.88 % vs. 7.83 %), so as in cardiac disorder (SOC) (15.45 % vs. 26.37 %), and respiratory, thoracic and mediastinal disorders (SOC) (13.74 % vs. 20.06 %). Similarly, there were lower occurrence and fewer fatality of irAEs in ICIs + AGIs + chemotherapy (CT) than ICIs + CT. CONCLUSION: ICIs combined with AGIs may reduce incidence and mortality for most of irAEs compared to ICIs alone whether or not with CT. |
ジャーナル名 | International immunopharmacology |
投稿日 | 2024/6/6 |
投稿者 | Ren, Xiayang; Wang, Haijun; Deng, Lei; Wang, Wenqing; Wang, Yanfeng |
組織名 | Department of Pharmacy, National Cancer Center/National Clinical Research Center;for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union;Medical College, Beijing 100021, China. Electronic address: erxia100@163.com.;Department of Intensive Care Unit, National Cancer Center/National Clinical;Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences;and Peking Union Medical College, Beijing 100021, China. Electronic address:;haijun99@126.com.;Department of Radiation Oncology, National Cancer Center/National Clinical;dengleipumc@163.com.;wwq4350524@163.com.;Department of Comprehensive Oncology, National Cancer Center/National Clinical;wangyf@cicams.ac.cn. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38838553/ |