A real-world pharmacovigilance study of FDA Adverse Event Reporting System events for gefitinib and docetaxel.

IF 2.7 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-09-06 DOI:10.1007/s00228-025-03905-8

Chengqian Cui, Bingge Li, Xiaoxia Zhang

{"title":"A real-world pharmacovigilance study of FDA Adverse Event Reporting System events for gefitinib and docetaxel.","authors":"Chengqian Cui, Bingge Li, Xiaoxia Zhang","doi":"10.1007/s00228-025-03905-8","DOIUrl":null,"url":null,"abstract":"Background: In recent years, gefitinib and docetaxel, as targeted and chemotherapeutic agents, respectively, have been widely used in the treatment of non-small cell lung cancer (NSCLC). However, the safety of these drugs remains a significant concern in clinical practice. Comparative studies on the safety of these two drugs have yet to be fully explored. This study aimed to analyze adverse event (AE) signals associated with gefitinib and docetaxel in the treatment of NSCLC using the FDA Adverse Event Reporting System (FAERS), providing insights for clinical practice and package insert.Methods: Adverse events for gefitinib and docetaxel were retrieved from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 (2004 Q1) through the fourth quarter of 2024 (2024 Q4). The reporting odds ratio method was used to identify risk signals. The results were standardized and classified using the System Organ Class (SOC) and Preferred Terms (PT) in the 26.1 version of the Medical Dictionary for Regulatory Activities (MedDRA) and compared with the package insert.Results: The FAERS received 8214 and 42,453 AE reports for gefitinib and docetaxel, respectively. An analysis of the top 100 AEs ranked by signal strength revealed 64 positive PTs for gefitinib, spanning 14 SOCs, 45 of which were not mentioned in the package insert. For docetaxel, 61 positive PTs were identified, involving 15 SOCs, with 33 AEs not mentioned in the package insert. The top 5 PTs with the highest signal strength for gefitinib were PRIDE syndrome, drug resistance, lymphangiosis carcinomatosa, xeroderma, and skin disorder. For docetaxel, the top 5 PTs were lacrimal structure injury, madarosis, hair disorder, variations in hair color, and psychological trauma.Conclusion: The potential adverse reactions of gefitinib and docetaxel are not fully covered in their package insert. The newly identified AE signals provide critical evidence for the improvement of the package insert. These findings have significant implications for individualized clinical treatment.","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00228-025-03905-8","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: In recent years, gefitinib and docetaxel, as targeted and chemotherapeutic agents, respectively, have been widely used in the treatment of non-small cell lung cancer (NSCLC). However, the safety of these drugs remains a significant concern in clinical practice. Comparative studies on the safety of these two drugs have yet to be fully explored. This study aimed to analyze adverse event (AE) signals associated with gefitinib and docetaxel in the treatment of NSCLC using the FDA Adverse Event Reporting System (FAERS), providing insights for clinical practice and package insert.

Methods: Adverse events for gefitinib and docetaxel were retrieved from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 (2004 Q1) through the fourth quarter of 2024 (2024 Q4). The reporting odds ratio method was used to identify risk signals. The results were standardized and classified using the System Organ Class (SOC) and Preferred Terms (PT) in the 26.1 version of the Medical Dictionary for Regulatory Activities (MedDRA) and compared with the package insert.

Results: The FAERS received 8214 and 42,453 AE reports for gefitinib and docetaxel, respectively. An analysis of the top 100 AEs ranked by signal strength revealed 64 positive PTs for gefitinib, spanning 14 SOCs, 45 of which were not mentioned in the package insert. For docetaxel, 61 positive PTs were identified, involving 15 SOCs, with 33 AEs not mentioned in the package insert. The top 5 PTs with the highest signal strength for gefitinib were PRIDE syndrome, drug resistance, lymphangiosis carcinomatosa, xeroderma, and skin disorder. For docetaxel, the top 5 PTs were lacrimal structure injury, madarosis, hair disorder, variations in hair color, and psychological trauma.

Conclusion: The potential adverse reactions of gefitinib and docetaxel are not fully covered in their package insert. The newly identified AE signals provide critical evidence for the improvement of the package insert. These findings have significant implications for individualized clinical treatment.

查看原文本刊更多论文

FDA不良事件报告系统事件对吉非替尼和多西他赛的现实世界药物警戒研究。

背景：近年来，吉非替尼和多西他赛分别作为靶向和化疗药物被广泛应用于非小细胞肺癌（NSCLC）的治疗。然而，这些药物的安全性在临床实践中仍然是一个重要的问题。这两种药物的安全性比较研究尚未得到充分探讨。本研究旨在利用FDA不良事件报告系统（FAERS）分析吉非替尼和多西他赛治疗NSCLC的不良事件（AE）信号，为临床实践和说明书提供见解。方法：从2004年第一季度（2004 Q1）至2024年第四季度（2024 Q4）的FDA不良事件报告系统（FAERS）中检索吉非替尼和多西他赛的不良事件。采用报告优势比法识别风险信号。将结果标准化，并根据26.1版《药物调节活动医学词典》（MedDRA）中的系统器官分类（SOC）和首选术语（PT）进行分类，并与说明书进行比较。结果：FAERS分别收到吉非替尼和多西他赛的8214和42453例AE报告。对信号强度排名前100位ae的分析显示，吉非替尼有64个阳性PTs，涵盖14个soc，其中45个未在说明书中提及。对于多西紫杉醇，鉴定出61例阳性PTs，包括15例soc，其中33例ae未在说明书中提及。吉非替尼信号强度最高的前5位PTs分别是PRIDE综合征、耐药、癌性淋巴管病、干皮病和皮肤病。对于多西他赛，前5个PTs是泪道结构损伤、脱发、头发紊乱、发色变化和心理创伤。结论：吉非替尼和多西他赛的潜在不良反应未在说明书中完全说明。新识别的声发射信号为改进封装插件提供了重要证据。这些发现对个体化临床治疗具有重要意义。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.