摘要
目的评价埃克替尼一线治疗表皮生长因子受体（EGFR）敏感突变的晚期非小细胞肺癌（NSCLC）的疗效与安全性。方法回顾性分析2011年9月至2016年3月北京协和医院呼吸科一线使用埃克替尼治疗EGFR敏感突变93例晚期NSCLC患者的临床资料、疗效与安全性。结果93例EGFR敏感突变的晚期NSCLC患者中，3例因出现Ⅲ度及Ⅲ度以上药物相关毒副反应而终止治疗，余90例进行疗效评估。90例患者中，部分缓解44例，疾病稳定42例，疾病进展4例，客观有效率48．9％，疾病控制率95．6％。中位无进展生存期（PFS）为14．9个月（95％CI13．5-16．3个月），中位总生存期（OS）为37．0个月（95％CI27．9-46．1个月）。肿瘤TNM分期为ⅢB期患者PFS优于Ⅳ期（32．07个月比14．6个月；P=0．007），性别、年龄〉70岁、吸烟史、EGFR突变位点、基线有无脑转移、最佳疗效为部分缓解或疾病稳定与PFS无关。基线脑转移患者客观有效率高于无脑转移患者（73．3％比44．0％；P=0．049），性别、年龄、吸烟史、肿瘤TNM分期、ECOG评分、EGFR突变为19外因子缺失或21外因子L858突变与客观有效率及疾病控制率无关。常见毒副反应为皮疹（38例，40．9％）、皮肤干燥、腹泻、乏力、口腔黏膜炎、肝功能异常等。Ⅲ-Ⅳ度毒副反应包括Ⅲ度皮疹4例，Ⅲ度口腔黏膜炎2例，Ⅳ度肝损害1例。3例因毒副反应停药。结论埃克替尼一线治疗EGFR敏感突变的晚期NSCLC患者疗效突出且安全性好。
Objective To evaluate the safety and efficacy of icotinib as first-line therapy in Chinese non-small cell lung cancer （NSCLC） patients harboring epidermal growth factor receptor （EGFR） sensitive mutations. Methods Patients with stage ⅢB/Ⅳ NSCLC who had EGFR sensitive mutation and had no previous treatment were enrolled into this study. The response rates, progress free survival （PFS） , overall survival （OS）, and the safety were analyzed. Results Ninety advanced adenocarcinoma patients were enrolled in this study, 44 patients had partial response （PR） , 42 patients had stable disease （ SD ）, 4 patients had progressive disease （PD）, with an ovcral] response rate （ORR） of 48.9%, and a disease control rate （DCR） of 95.6%. The median PFS was 14. 9 months （95%CI 13.5 - 16. 3） and the OS was 37.0 weeks （ 95% CI 27. 9 - 46. 1 ）. Patients with brain metastases showed higher ORR （ P = 0. 049 ）. Patients with stage llI B had longer PFS than those with stage 1V （ P = 0. 007 ）. The most common adverse events were grade 1 - 2 skin rash （38 patients, 40. 9% ）. Other adverse events included dry skin, oral mueositis, diarrhea and liver function injury. Three patients withdrew because of severe liver injury or skin rash. No treatment related mortality occurred. Conclusions Icotinib is effective and safe as first-line treatment for Chinese advanced NSCLC patients with EGFR sensitive mutation.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2017年第1期39-43,共5页
Chinese Journal of Internal Medicine
关键词
埃克替尼
癌
非小细胞肺
治疗结果
安全
Icotinib
Carcinoma, non-small cell lung
Treatment outcome
Safety
