Risk analysis of regorafenib related hepatobiliary system injury based on the US Food and Drug Administration Adverse Event Reporting System
10.3760/cma.j.cn114015-20190615-00491
- VernacularTitle:基于美国FDA不良事件报告系统数据库的瑞戈非尼肝胆系统损伤风险分析
- Author:
Xia LONG
1
;
Xiaohuan ZENG
;
Xiaohong GAN
Author Information
1. 成都市第五人民医院药剂科 611130
- Publication Type:Journal Article
- Keywords:
Angiogenesis inhibitors;
Antineoplastic agents;
Adverse drug reaction reporting systems;
Chemical and drug induced liver injury;
Regorafenib
- From:
Adverse Drug Reactions Journal
2020;22(4):227-232
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the risks and influencing factors of regorafenib related hepatobiliary system injury.Methods:Reports of regorafenib related hepatobiliary system adverse events received from 4th quarter, 2012 to 3rd quarter, 2018 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were collected. The signal intensity of hepatobiliary system adverse events related to regorafenib was screened and statistically analyzed by report odds ratio ( ROR) and proportional report ratio ( PRR), and their influencing factors were analyzed by logistic regression analysis. Results:A total of 26 013 adverse event reports related to regorafenib were retrieved, and 28 preferred terms were screened as suspicious hepatobiliary system related adverse event signals. Results from sorting the signal intensity of adverse events using ROR, PRR and their lower limit of 95% confidence interval ( CI) showed that elevation of jaundice and bilirubin had the strongest signal ( ROR=8.56, 95 %CI lower limit: 7.66; PRR=8.46, 95 %CI lower limit: 7.58), followed by other laboratory abnormalities ( ROR=6.05, 95 %CI lower limit: 4.95; PRR=6.03, 95 %CI lower limit: 4.94) and then liver related diseases ( ROR=5.46, 95 %CI lower limit: 4.71; PRR=5.43, 95 %CI lower limit: 4.69). Logistic regression analysis showed that the risk of hepatobiliary system adverse events was higher when the regorafenib dose was>80~<160 mg/d, compared with the dose of ≤80 mg/d ( OR=1.702, 95 %CI: 1.230-2.356, P=0.001), and was lower in patients with gastrointestinal stromal tumors, compared with other tumors ( OR=0.436, 95 %CI: 0.240-0.792, P=0.006). Conclusion:Regorafenib has the risk of hepatobiliary system injury, and a higher dose may be related to the increased risk.
