Chen H, Wang H P, Zhang L, Si X Y
Department of Respiration, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.
Zhonghua Nei Ke Za Zhi. 2017 Jan 1;56(1):39-43. doi: 10.3760/cma.j.issn.0578-1426.2017.01.010.
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. 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. 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 overall response rate (ORR) of 48.9%, and a disease control rate (DCR) of 95.6%. The median PFS was 14.9 months (95% 13.5-16.3) and the OS was 37.0 weeks (95% 27.9-46.1). Patients with brain metastases showed higher ORR(=0.049). Patients with stage ⅢB had longer PFS than those with stage Ⅳ(=0.007). The most common adverse events were grade 1-2 skin rash (38 patients, 40.9%). Other adverse events included dry skin, oral mucositis, diarrhea and liver function injury. Three patients withdrew because of severe liver injury or skin rash. No treatment related mortality occurred. Icotinib is effective and safe as first-line treatment for Chinese advanced NSCLC patients with EGFR sensitive mutation.
评估埃克替尼作为一线治疗方案在中国表皮生长因子受体（EGFR）敏感突变的非小细胞肺癌（NSCLC）患者中的安全性和疗效。纳入ⅢB/Ⅳ期NSCLC且有EGFR敏感突变且未接受过治疗的患者进行本研究。分析缓解率、无进展生存期（PFS）、总生存期（OS）及安全性。本研究纳入90例晚期腺癌患者，44例部分缓解（PR），42例病情稳定（SD），4例疾病进展（PD），总缓解率（ORR）为48.9%，疾病控制率（DCR）为95.6%。中位PFS为14.9个月（95% 13.5 - 16.3），OS为37.0周（95% 27.9 - 46.1）。有脑转移的患者ORR较高（=0.049）。ⅢB期患者的PFS长于Ⅳ期患者（=0.007）。最常见的不良事件为1 - 2级皮疹（38例，40.9%）。其他不良事件包括皮肤干燥、口腔黏膜炎、腹泻及肝功能损伤。3例患者因严重肝损伤或皮疹退出研究。未发生与治疗相关的死亡。埃克替尼作为中国EGFR敏感突变的晚期NSCLC患者的一线治疗有效且安全。
