解放军医学院学报2025，Vol.46Issue(6)：531-538,8.DOI:10.12435/j.issn.2095-5227.25021401
EGFR 20外显子插入突变非小细胞肺癌的分子亚型和预后比较研究
Clinical characteristics and treatment strategies in non-small cell lung cancer patients with EGFR exon 20 insertion mutations:A retrospective study
摘要
Abstract
Background Epidermal growth factor receptor(EGFR)exon 20 insertion(ex20ins)mutations represent the most common non-classical EGFR mutations in non-small cell lung cancer(NSCLC),yet effective treatment options have long been lacking.Objective To investigate the clinical characteristics and evaluate the efficacy and survival outcomes of different therapies in Chinese patients with advanced EGFR ex20ins-mutant NSCLC to optimize clinical strategies.Methods Clinical data about patients with advanced EGFR ex20ins-mutant NSCLC treated at the First and the Fifth Medical Centers of PLA General Hospital from January 1,2015 to November 1,2024 were retrospectively analyzed.Next-generation sequencing(NGS)and polymerase chain reaction(PCR)were used to identify insertion subtypes and confirm mutation status.Patients received first-line or subsequent chemotherapy,targeted therapy,or immunotherapy.Treatment response was assessed using RECIST version 1.1.Kaplan-Meier analysis was employed to calculate median progression-free survival(PFS)and overall survival(OS),and Cox regression models were used to evaluate prognostic factors.Results Totally 62 patients with advanced EGFR ex20ins mutant NSCLC were included.The median age of the patients was 60 years,with 38(61.7%)females.Twenty-one distinct molecular subtypes were identified,among which EGFR exon 20 p.A767-V769dup was the most prevalent(12/39,30.8%).Patients receiving first-line treatment achieved a median PFS of 9.4 months(95%CI:7.4-11.5 months).Targeted therapy demonstrated superior efficacy(median PFS:10.5 months)compared to chemotherapy(median PFS:8.7 months)and immunotherapy(median PFS:5.8 months),though the differences were not statistically significant(Plog-rank=0.792).The OS was 28.7 months(95%CI:19.5-37.9 months).Patients receiving targeted therapy exhibited longer OS(median OS:31.7 months vs 19.3 months);HR=0.79,95%CI:0.26-2.45,P=0.684),but the difference was not statistically significant(Plog-rank=0.683).Notably,patients with near-loop insertion mutations had significantly better prognosis than those with far-loop insertion mutations(median OS:45.7 months vs 24.9 months;HR=0.19,95%CI:0.06-0.59,P=0.004)(Plog-rank=0.001).Among patients receiving targeted therapy,those with near-loop insertion mutations exhibited significantly longer OS compared to those with far-loop insertion mutations(51.3 months vs 6.4 months;HR=0.10,95%CI:0.03-0.35,P＜0.001)(Plog-rank＜0.001).Conclusion Targeted therapy demonstrates superior efficacy over chemotherapy and immunotherapy in NSCLC patients with EGFR ex20ins mutations,particularly benefiting those with near-loop insertions by improving OS.Insertion sites serve as a critical determinant of treatment response and OS,and should be a key consideration in clinical decision-making.关键词
非小细胞肺癌/EGFR 20外显子插入突变/靶向治疗/免疫治疗/真实世界研究Key words
non-small cell lung cancer/EGFR exon 20 insertion mutation/targeted therapy/immunotherapy/real-world study分类
医药卫生引用本文复制引用
盛舒,翟今朝,卯云烨,葛祥伟,贾杨洋,秦博宇,吕东来,汪进良..EGFR 20外显子插入突变非小细胞肺癌的分子亚型和预后比较研究[J].解放军医学院学报,2025,46(6):531-538,8.基金项目
国家科技重大专项(2024ZD0520201) （2024ZD0520201）
