Mining and analysis of signals of lurbinectedin-induced adverse events based on FAERS database
ZHUO Yuhua
LIANG Juewen
WANG Bin
Abstract：Objective To mine and analyze the lurbinectedin-related adverse drug event(ADE)signals in the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)so as to provide references for the rational and safe clinical use of lurbinectedin.Methods All ADE report data were retrieved from the FAERS database,with lurbinectedin as the primary suspect drug,covering a total of 15 quarters from the 4th quarter of 2020 to the 2nd quarter of 2024.The reporting odds ratio(ROR)analysis and the Bayesian confidence propagation neural network(BCPNN)analysis were performed to mine the ADE signals.Results A total of 686 ADE reports related to lurbinectedin were included,with a male-to-female ratio of 1.25:1,and most of the reports were from the USA(accounting for 45.48%(312/686)).46 ADE risk signals were identified,involving 10 system organ classes(SOCs),mainly including systemic diseases and various reactions at the administration site,blood and lymphatic system diseases,and respiratory system,chest,and mediastinal diseases.Among them,death,disease progression,neutropenia,thrombocytopenia and weakness ranked the top 5 ADE signals with the highest frequency of occurrence.The top 5 ADE signals in terms of ADE signal intensity(ranked by ROR and BCPNN)were extravasation,extravasation at the adminis-tration site,vesicles at the infusion site,phlebitis,and vascular pain.In addition,new ADE signals related to lurbinectedin were discovered,such as acute kidney injury,phlebitis,respiratory failure,colitis,hypoxia,hyponatremia,hemoptysis,respiratory depression,and vascular pain,which were not mentioned in the lurbinectedin instructions.Conclusion The ADE signals of lur-binectedin identified through signal mining in this study are basically consistent with the main adverse events listed in the drug instructions in terms of types,but there are differences in occurrence frequency and severity.Before the clinical use of lurbinec-tedin,a comprehensive risk assessment should be carried out,involving infection risk,tumor progression risk and drug interac-tion risk,and personalized treatment plans should be developed according to the specific conditions of patients.
Keywords：lurbinectedinFAERSadverse drug eventsignal miningROR methodBCPNN method
Publication Date：2025-11-25
Online Publishing Date：2025-12-04(First online date of this platform, not the publication date of the document)
Pages：6( 1446-1451 )