Background: Targeted therapy has become an indispensable therapy method in advanced non-small cell lung cancer (NSCLC) treatment. Epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) can significantly prolong the survival of patients harboring EGFR gene mutation. Icotinb is China's first EGFR-TKI with independent intellectual property rights. The aim of this study is to investigate the clinical characteristics about the beneficiary of advanced NSCLC patients with EGFR Common mutation who were treated with Icotinib. Retrospectively collect the data about beneficiary [progression-free survival (PFS)≥6 months] and analysis of the related risk factors for prognosis.
Methods: From September 1, 2011 to September 30, 2015, 231 cases of advanced NSCLC beneficiary with EGFR common mutation were enrolled for treatment with icotinib in Zhejiang Cancer Hospital.
Results: The one year benefit rate was 67.9% in the group treated with Icotinib as first line, and in the groupas second line or above was 53.6%, which is statisticallysignificant. The two years benefit rate was 18.7% and 9.3%, respectively. The median PFS of first line group and the second line or above was 16.7 and 12.4 months, respectively. The presence of brain metastasis (P=0.010), Prior chemotherapy (P=0.001), Eastern Cooperative Oncology Group (ECOG) score (P=0.001) were the main factors influencing the prognosis. The most common adverse were skin rashes (51 cases, 22.1%) and diarrhea (27 cases, 11.7%).
Conclusions: Icotinib offers long-term clinical benefit and good tolerance for advanced NSCLC harboring EGFR gene mutation. Its advantage groups in addition to the patients with brain metastases and better ECOG score, the curative effect of patients with the first-line treatment is superior to second or further line. .
背景与目的 靶向治疗已经成为晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）治疗中不可或缺的重要手段，表皮生长因子受体（epithelial growth factor receptor, EGFR）的酪氨酸激酶抑制剂（tyrosine kinase inhibitor, TKI）可显著延长晚期携带EGFR基因突变肺癌患者生存期。埃克替尼是我国第一个拥有自主知识产权的EGFR-TKI。本研究旨在探讨埃克替尼治疗EGFR敏感突变的晚期NSCLC获益患者的临床特点，对获益患者[无进展生存时间（progression-free survival, PFS）≥6个月]进行回顾性资料收集并分析相关影响因素。方法 收集2011年9月1日-2015年9月30日浙江省肿瘤医院经埃克替尼片治疗的231例EGFR敏感突变的晚期NSCLC获益患者的生存情况。结果 经埃克替尼治疗后，一线治疗组1年获益率达67.9%，二线及以上组为53.6%，具有统计学意义（P=0.027）；一线治疗组2年获益率对比二线及以上组亦有统计学差异（18.7%和9.3%，P=0.047）。一线患者和二线及以上患者的中位PFS分别为16.7个月和12.4个月，且差异具有统计学意义（P=0.006）。其中有无脑转移（P=0.010）、埃克替尼治疗时机（P=0.001）、美国东部肿瘤协作组（Eastern Cooperative Oncology Group, ECOG）评分（P=0.001）为影响预后的主要因素。主要不良反应为皮疹51例（22.1%），腹泻27例（11.7%）。结论 埃克替尼是EGFR基因敏感突变的晚期NSCLC患者有效的治疗方案，其优势人群除无脑转移者及ECOG评分好的患者外，一线治疗患者疗效明显优于二线及以上者。敏感突变患者采用埃克替尼可得到较好的临床获益，并具有较好的耐受性。.