中国药业2025，Vol.34Issue(15)：94-99,6.DOI:10.3969/j.issn.1006-4931.2025.15.018
奥希替尼致表皮生长因子受体基因突变阳性非小细胞肺癌患者心脏毒性的危险因素与转归分析
Risk Factors and Outcomes of Cardiotoxicity in Non-Small Cell Lung Cancer Patients with Epidermal Growth Factor Receptor Gene Mutation-Positive Induced by Osimertinib
摘要
Abstract
Objective To investigate the risk factors and outcomes of cardiotoxicity in non-small cell lung cancer(NSCLC)patients with epidermal growth factor receptor(EGFR)gene mutation-positive induced by osimertinib.Methods A retrospective study was conducted on 99 NSCLC patients with EGFR gene mutation-positive treated with osimertinib in the hospital from January 2022 to September 2023.All patients were orally administered Osimertinib Mesylate Tablets,and they were divided into the normal group(61 cases)and the adverse drug reaction(ADR)group(38 cases)based on whether cardiotoxicity occurred.The cardiac monitoring indexes[myoglobin(Mb),high-sensitivity troponin I(hs-cTnI),creatine kinase isoenzyme(CK-MB),N-terminal pro-brain natriuretic peptide(NT-proBNP),electrocardiogram QT interval,and left ventricular ejection fraction(LVEF)]after treatment in the two groups were compared.The patients' clinical data were collected,including gender,age,smoking history,hypertension history,diabetes history,dosage of osimertinib,duration of administration,creatinine,urea nitrogen,potassium,sodium,chlorine,liver injury,performance status(PS)score of the Eastern Cooperative Oncology Group(ECOG),tumor stage,and drug combination.Univariate analysis and Logistic multivariate regression analysis were used to screen independent risk factors.A receiver operating characteristic(ROC)curve was draw based on the selected independent risk factors to calculate the area under the curve(AUC),and to calculate the Youden(YI)index based on the sensitivity and 1-specificity in the ROC curve.The incidence and outcome of cardiotoxicity in the ADR group were analyzed.Results After treatment,the Mb,hs-cTnI,CK-MB,NT-proBNP levels in the ADR group were significantly higher than those in the normal group(P<0.05).Univariate analysis showed that there were significant differences between the two groups in age,history of diabetes,duration of administration,creatinine,tumor T stage,and tumor M stage(P<0.05).Logistic multiple regression analysis showed that the duration of administration and tumor T stage were independent risk factors for cardiotoxicity in NSCLC patients with EGFR gene mutation positive induced by osimertinib(P<0.05).The AUC(95%CI)of the ROC curves of the duration of administration and tumor T stage were[0.655(0.542,0.768),P=0.000]and[0.662(0.546,0.777),P=0.007],with YI of 0.347 and 0.293,respectively.In the ADR group,there were three patients with association evaluations of"positive",thirty-three patients with"likely",and two patients with"possible".The Common Terminology Criteria for Adverse Events(CTCAE)grades 1-2 and 3-4 were 28 cases(73.68%)and 10 cases(26.32%),respectively.After discontinuation of drugs and symptomatic treatment,25 cases(65.79%)improved,and no deaths reported.Conclusion The duration of administration and tumor T stage are risk factors for cardiotoxicity in NSCLC patients with EGFR gene mutation-positive induced by osimertinib.During clinical treatment,patients'myocardial enzymes,electrocardiogram,and cardiac function indicators should be regularly monitored,especially for patients with administration duration≥23 d and tumor T stage>3.If cardiotoxicity occurs,medication should be stopped in time and symptomatic treatment should be carried out.关键词
奥希替尼/心脏毒性/非小细胞肺癌/表皮生长因子受体/基因突变/危险因素Key words
osimertinib/cardiotoxicity/non-small cell lung cancer/epidermal growth factor receptor/gene mutation/risk factors分类
医药卫生引用本文复制引用
金忆婷,马维娜,剧素贞,蒲旭辉..奥希替尼致表皮生长因子受体基因突变阳性非小细胞肺癌患者心脏毒性的危险因素与转归分析[J].中国药业,2025,34(15):94-99,6.基金项目
中国医药教育协会科研基金(康哲专项)[CMEA2024004] （康哲专项）
上海健康医学院附属嘉定区中心医院中青年骨干培养项目[ZQN202016]. （）
