| アブストラクト | INTRODUCTION: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are first-line treatments for hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer. With their increasing clinical use, infection-related adverse events (AEs) associated with CDK4/6 inhibitors have been widely reported in recent years. This study aimed to analyze the occurrence of infections associated with the CDK4/6 inhibitors (palbociclib, ribociclib and abemaciclib) based on the real-world data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: Data were extracted from the FAERS database between 2015Q1 and 2022Q3. The clinical characteristics of patients with primary suspected infection-related AEs were analyzed. A disproportionality analysis was performed to investigate the potential association between AEs and CDK4/6 inhibitors. The influencing factors were evaluated using Pearson's chi-square test. RESULTS: Reports of infection-related AEs associated with ribociclib accounted for 8.58% of the total reports of AEs associated with ribociclib, followed by palbociclib (2.72%) and abemaciclib (1.24%). Ribociclib (67.65%) was associated with more serious outcome events than palbociclib (30%) or abemaciclib (48.08%). The sex and age were not associated with outcome severity. Disproportionality analysis showed that fourteen, sixteen and two infection-related preferred terms were detected for palbociclib, ribociclib and abemaciclib, respectively. CONCLUSION: Infection-related AEs were highly associated with three CDK4/6 inhibitors, especially palbociclib and ribociclib, based on the real-world data from the FAERS database. However, further causality assessment is required. |
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| ジャーナル名 | Frontiers in pharmacology |
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| 投稿日 | 2024/7/16 |
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| 投稿者 | Chen, Jinhua; Tang, Linlin; Song, Wenping; Sun, Cuicui; Zhang, Wenzhou |
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| 組織名 | Department of Pharmacy, The Affiliated Cancer Hospital of Zhengzhou University;and Henan Cancer Hospital, Henan Engineering Research Center for Tumor Precision;Medicine and Comprehensive Evaluation, Henan Provincial Key Laboratory of;Anticancer Drug Research, Zhengzhou, China.;Department of Pharmacy, Affiliated Hospital of Weifang Medical University,;Weifang, China.;Department of Pharmacy, Qilu Hospital of Shandong University, Ji'nan, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39011505/ |
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