盐酸埃克替尼治疗EGFR突变状态明确的晚期非小细胞肺癌的临床观察

Clinical Observation of Icotinib Hydrochloride for Advanced Non-small Cell Lung Cancer Patients with EGFR Status Identified

背景与目的盐酸埃克替尼(icotinib hydrochloride)是我国第一个具有自主知识产权的小分子靶向抗癌新药,与吉非替尼和厄洛替尼相比,在化学结构、分子作用机理、疗效等方面相似。本研究观察盐酸埃克替尼治疗表皮生长因子受体突变状态明确的晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效和毒副反应。方法回顾性分析2009年3月-2014年12月间北京胸科医院收治的晚期NSCLC患者,表皮生长因子受体(epidermal growth factor receptor,EGFR)突变状态已知,均口服盐酸埃克替尼治疗,评价其疗效和毒副反应。结果 124例组织学证实的晚期NSCLC患者,其中EGFR突变型99例,野生型25例。全组客观有效率(objective response rate,ORR)为51.6%,疾病控制率(disease control rate,DCR)为79.8%。突变型和野生型患者的ORR:63.6%vs 4.0%,DCR:93.9%vs 24.0%,两者均有统计学差异(P<0.000,1)。突变型和野生型患者的无进展生存期(progression-free survival,PFS)(分别为10.5个月和1.0个月)(P<0.000,1)。治疗相关的毒副反应主要为皮疹38例(30.6%),腹泻20例(16.1%)。结论盐酸埃克替尼治疗EGFR突变的晚期NSCLC疗效肯定,耐受性好。

Background and objective Icotinib is the first self-developed small molecular drug in China for targeted therapy of lung cancer. Compared to the other two commercially available epidermal growth factor receptor （EGFR） tyrosine kinase inhibitors, gefitinib and erlotinib, icotinib is similar to them in chemical structure, mechanism of activity and therapeutic effects. To explore the efficacy and side effects oficotinib hydrochloride in the treatment of the advanced non-small cell lung cancer （NSCLC） patients with EGFR mutation and wild-type. Methods Patients with advanced NSCLC who were treated with icotinib hydrochloride in Beijing Chest Hospital were retrospective analyzed from March 2009 to December 2014. Results The clinical data of 124 patients （99 with EGFR mutation and 25 with wild type） with advanced NSCLC were enrolled in this study. The patients＇ overall objective response rate （ORR） was 51.6 % and the disease control rate （DCR） was 79.8%; The patients with EGFR mutation, ORR was 63.6%, DCR was 93.9%. The ORK was 4.0% and the DCR was 24.0% in the wild-type patients. Median progression-free survival （PFS） with icotinib treatment in EGFR mutation patients was 10.5 months and 1.0 month in wild-type patients. The major adverse events were mild skin rash （30.6%） and diarrhea （16.1%）. Conclusion Monotherapy with icotinib hydrochloride is effective and tolerable for the advanced NSCLC EGFR mutation patients.