Mefatinib as first-line treatment of patients with advanced EGFR-mutant non-small-cell lung cancer:a phase Ⅰb/Ⅱefficacy and biomarker study

科研成果详情

题名	Mefatinib as first-line treatment of patients with advanced EGFR-mutant non-small-cell lung cancer:a phase Ⅰb/Ⅱefficacy and biomarker study
作者	Pingli Wang 1; Yuping Li2; Dongqing Lv3; Lingge Yang 4; Liren Ding 1; Jianya Zhou 5; Wei Hong 6; Youfei Chen 1; Dongqing Zhang2; Susu He 3; Jianying Zhou 5; Kai Wang
发表日期	2021-12-30
发表期刊	信号转导与靶向治疗(英文) 影响因子和分区
语种	中文
原始文献类型	Periodical
摘要	EGFR inhibitors have revolutionized the treatment of advanced non-small-cell lung cancer(NSCLC).Mefatinib is a novel,bioavailable,second-generation,irreversible pan-EGFR inhibitor.This phase Ib/Ⅱ open-label,single-arm,multi-center study investigated the efficacy,safety,biomarker,and resistance mechanisms of mefatinib in the first-line treatment of patients with advanced EGFR-mutant NSCLC.This study included 106 patients with EGFR-mutant stage ⅢB-Ⅳ NSCLC who received first-line mefatinib at a daily dose of either 60 mg(n=51)or 80 mg(n=55).The primary endpoint was progression-free survival(PFS).Secondary endpoints were overall response rate(ORR),disease control rate(DCR),overall survival(OS),and safety.The cohort achieved an ORR of 84.9％and DCR of 97.2％.The median PFS was 15.4 months and the median OS was 31.6 months.Brain metastasis was detected in 29％of patients(n=31)at diagnosis and demonstrated an ORR of 87.1％,PFS of 12.8 months,and OS of 25.2 months.Adverse events primarily involved skin and gastrointestinal toxicities,which were well-tolerated and manageable.Analyses of mutation profiles were performed using targeted sequencing of plasma samples at baseline,first follow-up 6 weeks from starting mefatinib therapy(F1),and at progression.Patients with concurrent TP53 mutations had comparable PFS as wild-type TP53(14.0 vs 15.4 months;p=0.315).Furthermore,circulating tumor DNA clearance was associated with longer PFS(p=0.040)and OS(p=0.002).EGFR T790M was the predominant molecular mechanism of mefatinib resistance(42.1％,16/38).First-line mefatinib provides durable PFS and an acceptable toxicity profile in patients with advanced EGFR-mutant NSCLC.
期号	1 页码:3145-3153
页数	9
收录类别	万方
URL	查看原文
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/195484
专题	附属第一医院其他_附属台州医院（浙江省台州医院）
作者单位	1.Department of Respiratory and Critical Care Medicine,The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,China; 2.Department of Respiratory and Critical Care Medicine,The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China; 3.Department of Respiratory Medicine,Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University,Linhai,China; 4.Department of Respiratory and Critical Care Medicine,The Fourth Affiliated Hospital of Zhejiang University School of Medicine,Yiwu,China; 5.Department of Respiratory Diseases,Thoracic Disease Diagnosis and Treatment Center,The First Affiliated Hospital,College of Medicine,Zhejiang University,Hangzhou,China; 6.Department of Oncology and Chemotherapy,Zhejiang Cancer Hospital,Hangzhou,China
推荐引用方式 GB/T 7714	Pingli Wang,Yuping Li,Dongqing Lv,et al. Mefatinib as first-line treatment of patients with advanced EGFR-mutant non-small-cell lung cancer:a phase Ⅰb/Ⅱefficacy and biomarker study[J]. 信号转导与靶向治疗(英文),2021(1):3145-3153.
APA	Pingli Wang., Yuping Li., Dongqing Lv., Lingge Yang., Liren Ding., ... & Kai Wang. (2021). Mefatinib as first-line treatment of patients with advanced EGFR-mutant non-small-cell lung cancer:a phase Ⅰb/Ⅱefficacy and biomarker study. 信号转导与靶向治疗(英文)(1), 3145-3153.
MLA	Pingli Wang,et al."Mefatinib as first-line treatment of patients with advanced EGFR-mutant non-small-cell lung cancer:a phase Ⅰb/Ⅱefficacy and biomarker study".信号转导与靶向治疗(英文) .1(2021):3145-3153.