Hu Xingsheng, Han Baohui, Gu Aiqin, Zhang Yiping, Jiao Shun Chang, Wang Chang-Li, He Jintao, Jia Xueke, Zhang Li, Peng Jiewen, Wu Meina, Ying Kejing, Wang Junye, Ma Kewei, Zhang Shucai, You Changxuan, Tan Fenlai, Wang Yinxiang, Ding Lieming, Sun Yan
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.
Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.
Lung Cancer. 2014 Nov;86(2):207-12. doi: 10.1016/j.lungcan.2014.08.014. Epub 2014 Sep 16.
The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China.
This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125 mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients.
Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively.
The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting.
3期ICOGEN试验证实，在非小细胞肺癌（NSCLC）患者的无进展生存期（PFS）方面，埃克替尼不劣于吉非替尼，这使得中国食品药品监督管理总局批准埃克替尼用于NSCLC的治疗。开展了一项4期研究，以评估埃克替尼在中国广大晚期NSCLC患者中的安全性和疗效。
本研究回顾性分析了接受口服埃克替尼125mg每日3次的不可切除、复发和/或晚期NSCLC患者的数据。主要终点为安全性。次要终点包括客观缓解率（ORR）和疾病控制率（DCR），对总体人群以及如表皮生长因子受体（EGFR）突变患者和老年患者等亚组进行了研究。
在2011年8月至2012年8月期间，本研究共纳入6087例晚期NSCLC患者，其中5549例可评估安全性和肿瘤反应。中位年龄为63岁（范围21 - 95岁），1571例（28.3%）患者年龄超过70岁。大多数患者为非吸烟者，患有腺癌且为IV期疾病。任何级别的药物不良反应（ADR）总体发生率为31.5%。最常见的ADR包括皮疹（17.4%）和腹泻（8.5%），3例患者发生间质性肺疾病（ILD）。总体人群的ORR和DCR分别为30.0%和80.6%，一线、二线以及三线或多线亚组的ORR和DCR分别为33.4%和81.2%、30.3%和80.3%、30.4%和89.3%。在665例可评估肿瘤反应的EGFR突变患者中，ORR和DCR分别为49.2%（327/665）和92.3%（614/665）。
超过6000例患者的数据与ICOGEN研究结果一致。埃克替尼在常规临床环境中显示出良好的毒性特征和疗效。
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