EGFR突变晚期NSCLC患者第1、2代EGFR-TKI治疗耐药后序贯奥希替尼或阿美替尼治疗的效果观察  

Efficacy of Sequential Osimertinib or Aumolertinib in the Treatment of Advanced NSCLC Patients with EGFR Mutations After Drug Resistance to the First and Second Generation EGFR-TKI

作　　者：孟新源[1] 张莉[1] 薛淑萍[2] MENG Xinyuan;ZHANG Li;XUE Shuping(Dept.of Pharmacy,Affiliated Cancer Hospital of Xinjiang Medical University,Urumqi 830011,China;Dept.of Pulmonary Medicine,Affiliated Cancer Hospital of Xinjiang Medical University,Urumqi 830011,China)

机构地区：[1]新疆医科大学附属肿瘤医院药学部,乌鲁木齐830011 [2]新疆医科大学附属肿瘤医院肺内一科,乌鲁木齐830011

出　　处：《中国医院用药评价与分析》2023年第9期1079-1081,1085,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：新疆维吾尔自治区自然科学基金资助项目(No.2022D01C286)。

摘　　要：目的:观察表皮生长因子受体(EGFR)突变晚期非小细胞肺癌(NSCLC)患者使用第1、2代表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKI)耐药后分别序贯奥西替尼、阿美替尼治疗的疗效及安全性。方法:选取2020年1月至2022年5月该院收治的EGFR突变的晚期NSCLC患者128例,随机分为奥西替尼组、阿美替尼组,每组64例。奥西替尼组患者口服甲磺酸奥希替尼80 mg/d,阿美替尼组患者口服甲磺酸阿美替尼110 mg/d。持续随访,比较两组患者的客观缓解率(ORR)、疾病控制率(DCR)以及无进展生存期(PFS),评估不良反应。结果:两组患者均无失访。奥西替尼组、阿美替尼组患者的总体DCR[75.00%(48/64)vs.82.81%(53/64)]、ORR[53.12%(34/64)vs.65.62%(42/64)]的差异无统计学意义(P>0.05)。阿美替尼组脑转移患者的DCR为80.77%(21/26),ORR为65.38%(17/26),均高于奥西替尼组的44.00%(11/25)、32.00%(8/25),差异均有统计学意义(P<0.05)。奥西替尼组患者的中位PFS为11.02个月,阿美替尼组为11.76个月,两组的差异无统计学意义(χ^(2)=0.083,P=0.773)。两组患者各级不良反应发生率的差异无统计学意义(P>0.05)。结论:第1、2代EGFR-TKI耐药后EGFR T790M突变的晚期NSCLC患者序贯奥西替尼、阿美替尼治疗的近期疗效和不良反应接近,合并脑转移的患者选用阿美替尼能获得更好的疾病控制率。OBJECTIVE:To observe the efficacy and safety of sequential osimertinib or almonertinib in the treatment of patients with advanced non-small cell lung cancer(NSCLC) with epidermal growth factor receptor(EGFR) mutation after drug resistant to the first and second generation EGFR tyrosine kinase inhibitors(EGFR-TKI).METHODS:Totally 128 advanced NSCLC patients with EGFR-positive mutations admitted into the hospital from Jan.2020 to May 2022 were selected as research subject,which were randomly divided into osimertinib group and almonertinib group,with 64 cases in each group.The osimertinib group was given oral administration of 80 mg/d of osimertinib mesylate,the almonertinib group was given oral administration of 110 mg/d of almonertinib mesylate.Continuous follow-up was conducted to compare the objective response rate(ORR),disease control rate(DCR) and progression-free survival(PFS) between two groups,and the adverse drug reactions was evaluated.RESULTS:No patients were lost to follow-up in either group.There were no statistically significance in differences in overall DCR [75.00%(48/64) vs.82.81%(53/64)] and ORR [53.12%(34/64) vs.65.62%(42/64)] between osimertinib group and almonertinib group(P>0.05).The DCR was 80.77%(21/26) and the ORR was 65.38%(17/26) of patients with brain metastasis in osimertinib group,which were higher than those in almonertinib group [44.00%(11/25) and 32.00%(8/25)],with statistically significant differences(P<0.05).The mPFS of osimertinib group was 11.02 months,and that of almonertinib group was 11.76 months,the difference was not statistically significant(χ^(2)=0.083,P=0.773).There was no statistically significant difference in the incidence of adverse drug reactions at all levels between two groups(P>0.05).CONCLUSIONS:Sequential osimertinib and almonertinib in the treatment of advanced NSCLC patients with EGFR T790M mutations after drug resistance to the first and second generation EGFR-TKI have similar short-term efficacy and adverse drug reactions,and almonertinib is a better choice

关 键 词：非小细胞肺癌 表皮生长因子受体-酪氨酸激酶抑制剂 耐药 奥希替尼 阿美替尼 

分 类 号：R979.1[医药卫生—药品]