Department of Medical Oncology, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing Chest Hospital, Capital Medical University Beijing, China.
Thorac Cancer. 2014 May;5(3):243-9. doi: 10.1111/1759-7714.12085. Epub 2014 Apr 22.
To evaluate the efficacy and safety of Icotinib - an orally administered, highly potent selective inhibitor of epidermal growth factor receptor (EGFR) and its active mutations, in the treatment of patients with advanced non-small cell lung cancer (NSCLC).
A total of 101 patients with stage IIIb/IV NSCLC were treated with 125 mg Icotinib three times a day until disease progression or intolerable toxicity. Response rate was evaluated using response evaluation criteria in solid tumors and progression-free survival (PFS) was collected.
The overall response rate (ORR) and disease control rate (DCR) were 37.6% (38/101) and 79.2% (80/101), respectively. The median PFS was 6.5 months. Multivariate analysis showed that female gender (P= 0.048, 95% confidence interval [CI] 1.010-6.016) and occurrence of rash (P= 0.002, 95% CI 1.667-9.809) were the independent predictive factors for ORR, while a performance status (PS) score of 0-1 (P= 0.001, 95% CI 0.024-0.402) and rash (P= 0.042, 95% CI 1.089-76.557) were the independent predictive factors for DCR. In addition, PS scores of 0-1 (P <0.001, 95% CI 0.135-0.509), and non-smoking (P= 0.017, 95% CI 0.342-0.900) were found to be independent influencing factors for PFS. Moreover, patients with EGFR mutations had better PFS than patients with wild type EGFR, while patients with EGFR exon 19 deletion had better survival than those with EGFR exon 21 mutation. The most common adverse effects of Icotinib were rash (35.6%) and diarrhea (17.8%), which was tolerable.
Treatment of stage IIIb/IV NSCLC patients with Icotinib was effective and tolerable, specifically in patients with EGFR mutation.
评估口服、高选择性表皮生长因子受体（EGFR）及其活性突变体抑制剂埃克替尼在治疗晚期非小细胞肺癌（NSCLC）患者中的疗效和安全性。
共纳入 101 例Ⅲb/Ⅳ期 NSCLC 患者，接受 125mg 埃克替尼每日 3 次治疗，直至疾病进展或不能耐受毒性。采用实体瘤反应评价标准评估缓解率，收集无进展生存期（PFS）。
总缓解率（ORR）和疾病控制率（DCR）分别为 37.6%（38/101）和 79.2%（80/101）。中位 PFS 为 6.5 个月。多因素分析显示，女性（P=0.048，95%置信区间[CI]1.010-6.016）和皮疹（P=0.002，95%CI 1.667-9.809）是 ORR 的独立预测因素，而 PS 评分 0-1（P=0.001，95%CI 0.024-0.402）和皮疹（P=0.042，95%CI 1.089-76.557）是 DCR 的独立预测因素。此外，PS 评分 0-1（P<0.001，95%CI 0.135-0.509）和非吸烟（P=0.017，95%CI 0.342-0.900）是 PFS 的独立影响因素。此外，EGFR 突变患者的 PFS 优于野生型 EGFR 患者，而 EGFR 外显子 19 缺失患者的生存优于 EGFR 外显子 21 突变患者。埃克替尼最常见的不良反应是皮疹（35.6%）和腹泻（17.8%），均可耐受。
埃克替尼治疗Ⅲb/Ⅳ期 NSCLC 患者有效且可耐受，特别是 EGFR 突变患者。
