【摘要】 目的:表皮生长因子受体(epidermal growth factor receptor,EGFR) 20号外显子插入(exon 20 insertion,exon20ins)突变发生率低，且有效治疗手段少。本研究对合并EGFR exon20ins突变的晚期NSCLC患者进行了回顾性分析，旨在对比不同疗法的疗效和安全性，从而优化患者的一线治疗选择。方法:我们多中心收集了接受单纯化疗、靶向治疗和化疗联合抗血管治疗的exon20ins突变晚期NSCLC患者。通过观察无进展生存期(progression-free survival,PFS)、客观缓解率(objective response rate,ORR)和疾病控制率评估临床反应，并对影响PFS的因素进行Cox回归分析。结果:在121例入组的患者中，单纯化疗组的中位PFS 8.1个月(95%CI:6.0～10.2个月)，ORR为26.2%(11/42);靶向治疗组中位PFS 7.0个月，ORR 29.7%(11/37);化疗联合抗血管治疗组中位PFS 6.9个月(95%CI:6.0～7.7个月)，ORR 35.7%(15/42)。多因素分析显示，区域淋巴结转移是中位PFS的独立影响因素，有区域淋巴结转移表现为更低的中位PFS(6.5 vs 7.3个月，P=0.026)。结论:化疗、化疗联合抗血管治疗、三代EGFR酪氨酸激酶抑制剂均是EGFR exon20ins晚期肺癌患者一线治疗的可选策略。化疗联合抗血管治疗可能会带来更为深度的肿瘤缓解。患者是否合并区域淋巴结转移可能与PFS存在一定的相关性。更多还原

【Abstract】 Objective: Advanced non-small cell lung cancer( NSCLC) harboring epidermal growth factor receptor exon20 insertion( EGFR exon20 ins) mutations is characterized by low incidence and limited effective treatments. This retrospective study was conducted to compare the efficacy and safety of different first-line regimens in advanced patients with EGFR exon20 ins-mutant NSCLC,aiming to optimize treatment strategies. Methods: Patients with advanced lung cancer harboring EGFR exon20 ins who received chemotherapy alone,targeted therapy,or chemotherapy plus antiangiogenic therapy were collected from multiple centers. Clinical responses were evaluated by observing progression-free survival( PFS),objective response rate( ORR),and disease control rate. Cox regression analysis was performed to identify factors influencing PFS.Results: Among the 121 enrolled patients,the median PFS in the chemotherapy-alone group was 8. 1 months( 95% CI:6. 0 ～ 10.2 months),with an ORR of 26.2%( 11/42); in the targeted therapy group,the median PFS was 7.0 months,with an ORR of 29.7%( 11/37); and in the chemotherapy combined with anti-angiogenic therapy group,the median PFS was 6. 9 months( 95% CI: 6.0 ～ 7.7 months),with an ORR of 35.7%( 15/42). Multivariate analysis revealed that regional lymph node metastasis was an independent factor affecting median PFS,with patients having regional lymph node metastasis showing a shorter median PFS( 6. 5 vs 7. 3 months,P = 0. 026). Conclusion: For advanced NSCLC patients with EGFRex20 ins mutations,first-line treatment options include chemotherapy,chemotherapy combined with anti-angiogenic therapy,and third-generation EGFR tyrosine kinase inhibitors. Chemotherapy combined with anti-angiogenic therapy may lead to a deeper tumor response. Furthermore,regional lymph node metastasis serves as a correlative factor for PFS.更多还原