国家一类新药盐酸埃克替尼片大规模人群用药的疗效与安全性评价

Safety and Efficacy of Icotinib Hydrochloride for Non-small Cell Lung Cancer (NSCLC) Patient in A Large Population

目的：评价盐酸埃克替尼片（凯美纳）大规模人群用药的安全性与疗效。方法：通过专门设计的反馈表和随访表收集患者信息，不良反应按照WHO抗癌药物毒性分级标准分为Ⅰ-Ⅳ度；疗效按照实体瘤疗效评价标准Recistl．1进行评估，并统计总体客观缓解率（ORR）和疾病控制率（DCR）。结果：共收集1156例患者用药后的相关资料，总不良反应发生率为41．3％，其中皮疹23．2％，腹泻10．1％，转氨酶升高1．0％，其他不良反应81例，间质性肺炎1例：最佳疗效结果显示：ORR与DCR分别为34．5％和79．4％。结论：盐酸埃克替尼片在大样本应用中的安全性和疗效与Ⅲ期临床试验结果一致或更优。

Objective ： To evaluate the safety and efficacy of Icotinib Hydrochloride （ Conmana） for non-small cell lung cancer （NSCLC） patient in a large population. Methods ： Information from patients including demographic characteristics, adverse reactions and efficacy, etc., was collected by specially designed forms. Adverse reactions （ADR） were assessed by NCI CTC. Efficacy including objective responses was judged according to Recistl.1. Results ：From August 2011 to February 2012 , a total of 1 981 patients were enrolled. Of which 1 156 patients who had used icotinib were recorded with efficacy and ADR information. The overall ADR rate was 41.3%, the most frequent AEs were rash （23.2%） and diarrhea （10.1%）. The incidence of transaminase elevation was 1.0%. One interstitial lung disease was reported. Objective response rate was 34.5% while disease control rate was 79.4%. Currently, the collection of efficacy and safety data as well as study enrollment is still undergoing. Conclusion ： Icotinib Hydrochloride was proved as a safe and effective therapy for NSCLC in a regular clinical practice setting and large population.