Tyrosine kinase inhibitors-associated interstitial lung disease used in non-small cell lung cancer: a pharmacovigilance analysis based on the FDA adverse event reporting system database

医学 不良事件报告系统 药物警戒 间质性肺病 内科学 不利影响 肺癌 酪氨酸激酶抑制剂 药理学 酪氨酸激酶 安全概况 疾病 重症监护医学 肿瘤科 癌症 受体
作者
Jing Zhang,Ting Qiu,Yiting Zhou,Shengjie Wu,Enguo Chen
出处
期刊:Expert Opinion on Drug Safety [Taylor & Francis]
卷期号:22 (9): 849-856 被引量:5
标识
DOI:10.1080/14740338.2023.2193392
摘要

Background Interstitial lung disease (ILD) was a relatively common cause of drug-induced mortality. However, the safety profile of the whole TKIs induced ILD was largely unknown.Research design and methods The reported cases of ILD associated with TKIs were downloaded from the FDA adverse event reporting system (FAERS) database between 1 January 2004 and 30 April 2022 to detect ILD signals by disproportionality analysis. Furthermore, the fatality rate and time to onset (TTO) of various TKIs were also calculated.Results The median age of total 2999 reported cases was 67. The largest reported cases came from osimertinib (n = 736, 24.5%). However, gefitinib had the highest ROR of 12.47 (11.4, 13.64) and IC of 3.53 (3.23, 3.86), means the strongest association with ILD. Trametinib, vemurafenib, larotectinib, selpercatinib, and cabozantinib did not show ILD signal. The median age of dead cases was 72 (Q1:62, Q3:83), and 53.02% (n = 579) were female and 41.11% (n = 449) were male. MET group showed the highest fatality rate of 55.17% with the shortest median TTO of 21 days (Q1: 8.5, Q3: 35.5).Conclusions TKIs were significantly associated with ILD. More attention should be paid to female, older, MET group with shorter TTO, as their prognosis might be worse.
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