于晓露,王慧敏,王韡旻.埃克替尼一线治疗134例EGFR突变阳性的晚期肺腺癌的疗效分析[J].肿瘤学杂志,2017,23(9):772-775.
埃克替尼一线治疗134例EGFR突变阳性的晚期肺腺癌的疗效分析
Efficacy of Icotinib as First-Line Therapy for 134 Patients with Advanced Lung Adenocarcinoma of Positive EGFR Mutation
投稿时间:2017-05-01  
DOI:10.11735/j.issn.1671-170X.2017.09.B006
中文关键词:  埃克替尼  腺癌  一线治疗  疗效
英文关键词:icotinib  adenocarcinoma  first-line therapy  efficacy
基金项目:
作者单位
于晓露 上海交通大学附属胸科医院 
王慧敏 上海交通大学附属胸科医院 
王韡旻 上海交通大学附属胸科医院 
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中文摘要:
      摘 要:[目的] 观察埃克替尼一线治疗EGFR突变阳性的晚期肺腺癌患者的疗效及不良反应。[方法] 对134例Ⅲb/Ⅳ期EGFR突变阳性的晚期肺腺癌患者应用埃克替尼125mg 每天三次治疗,直至疾病进展或出现不可耐受的不良反应。[结果] 134例EGFR基因突变阳性晚期肺腺癌患者中,完全缓解(CR)6例(4.5%),部分缓解(PR)90例(67.2%),疾病稳定(SD)32例(23.9%),疾病进展(PD)6例(4.5%)。客观缓解率(ORR)为71.6%(96/134),疾病控制率(DCR)为95.5%(128/134)。中位无进展时间(mPFS)为11.2个月(95%CI:9.8~12.5个月),OS尚未获得。19外显子缺失突变的ORR 为81.8%,DCR为93.5%,mPFS为11.8个月。21外显子L858R突变患者ORR 为 57.9%,DCR为94.7%,mPFS为10.2个月。19外显子缺失突变的ORR明显优于21外显子L858R突变(81.8% vs 57.9%,P=0.002)。不吸烟患者的ORR优于吸烟患者(77.4% vs 58.5%,P=0.025)。不同性别、年龄、肺癌分期、EGFR突变类型、吸烟状态对mPFS和DCR的影响无统计学差异。主要不良反应为Ⅰ~Ⅱ度的皮疹(44.8%)和腹泻(25.3%),经对症处理后,患者多可耐受。[结论] 埃克替尼一线治疗EGFR突变阳性的晚期肺腺癌患者取得了很好的疗效,不良反应的发生率低,且患者多可耐受。
英文摘要:
      Abstract:[Objective] To investigate the efficacy and adverse effect of icotinib as first-line therapy in treatment of patients with EGFR-mutation positive advanced lung adenocarcinoma. [Methods] One hundred and thirty four patients with EGFR-mutation positive advanced lung adenocarcinoma received oral icotinib(125mg,tid) as first-line therapy until disease progression or intolerable toxicity appeared. [Results] Among 134 patients,complete response(CR) was achieved in 6 cases(4.5%),partial response(PR) in 90 cases(67.2%),stable disease(SD) in 32 cases(23.9%) and progressive disease(PD) in 6 cases(4.5%). The ORR was 71.6%(96/134),DCR was 95.5%(128/134),mPFS was 11.2 months(95%CI:9.8~12.5months),and OS was not obtained yet. The ORR,DCR and mPFS of 19 exon muntation positive patients were 81.8%,93.5%,11.8months,respectively. The ORR,DCR and mPFS of 21 exon muntation positive patients were 57.9%,94.7%,10.2months,respectively. Patients with 19 exon mutation showed better ORR than those with 21 L858R mutation(81.8% vs 57.9%,P=0.002). Non-smoking patients showed better ORR than smokers(77.4% vs 58.5%,P=0.025). There were no significant differences in mPFS and DCR among patients of different gender,age,clinical stage,EGFR mutation state and smoking state. The main adverse effects wereⅠ~Ⅱ degrees of rash(44.8%) and diarrhea(25.3%),which were generally tolerated after symptomatic treatment. [Conclusion] The results suggest that icotinib is effective for patients with EGFR-mutation positive advanced lung adenocarcinoma as first-line therapy with low and tolerated adverse effects.
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