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[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%,m PFS为11.8个月。21外显子L858R突变患者ORR为57.9%,DCR为94.7%,m PFS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m PFS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。
[Objective] To observe the efficacy and adverse reactions of icotinib in the treatment of advanced lung adenocarcinoma with EGFR mutation. [Method] A total of 134 patients with stage Ⅲb / Ⅳ EGFR mutation positive advanced lung adenocarcinoma were treated with Icitinib 125mg three times a day until disease progression or intolerable adverse reactions. [Results] Among the 134 patients with EGFR mutation positive advanced lung adenocarcinoma, 6 cases (4.5%) had complete remission (CR), 90 cases (67.2%) had partial remission (PR), 32 cases (23.9% ), Disease progression (PD) in 6 cases (4.5%). The objective response rate (ORR) was 71.6% (96/134) and the disease control rate (DCR) was 95.5% (128/134). The median progression-free time (mPFS) was 11.2 months (95% CI: 9.8 to 12.5 months), with OS not yet available. The ORR of exon 19 deletion mutations was 81.8%, DCR was 93.5% and m PFS was 11.8 months. 21 patients with exon L858R mutation had ORR of 57.9%, DCR of 94.7% and m PFS of 10.2 months. The ORR of exon 19 deletions was significantly better than that of exon 21 L858R (81.8% vs 57.9%, P = 0.002). Patients with non-smoking had better ORR than smokers (77.4% vs 58.5%, P = 0.025). There was no significant difference in m PFS and DCR between different sex, age, stage of lung cancer, type of EGFR mutation and smoking status. The main adverse reactions were rashes (44.8%) and diarrhea (25.3%) of grade Ⅰ ~ Ⅱ. After symptomatic treatment, patients were more tolerable. [Conclusion] The first-line treatment with imatinib in patients with advanced lung adenocarcinoma positive EGFR mutation has achieved good results, the incidence of adverse reactions is low, and the patients are more tolerable.