盐酸埃克替尼治疗晚期非小细胞肺癌的临床观察

Clinical observation of icotinib hydrochloride for patients with advanced non-small cell lung cancer

目的观察盐酸埃克替尼治疗晚期非小细胞肺癌（NSCLC）的近期疗效和毒副反应。方法回顾性分析2009年3月至2012年1月间收治的晚期NSCLC患者59例，均口服盐酸埃克替尼单药治疗，评价其近期疗效和毒副反应。全组有25例患者行表皮生长因子受体（EGFR）基因检测，其中19外显子缺失突变13例，21外显子错义突变9例，20和21外显子双突变1例，EGFR野生型2例。结果59例NSCLC患者中，部分缓解27例（45．8％），疾病稳定17例（28．8％），疾病进展15例（25．4％），客观有效率为45．8％（27／59），疾病控制率为74．6％（44／59）。EGFR突变患者的客观有效率为73．9％（17／23），疾病控制率为95．7％（22／23）。59例患者中，有36例（61．0％）患者在治疗后有不同程度的症状缓解，主要缓解的症状为咳嗽、喘憋、疼痛和声嘶等。治疗相关毒副反应主要为皮疹21例（35．6％），其中I度18例，Ⅱ度2例，Ⅲ度1例；腹泻9例（15．3％），其中Ⅰ度7例，Ⅱ度2例；其他不良反应为皮肤干燥、恶心和胃部不适等。盐酸埃克替尼治疗的疗效与美国东部肿瘤协作组（ECOG）评分、治疗方式、吸烟史、EGFR突变、皮疹有关，差异有统计学意义（P〈0．05）。结论盐酸埃克替尼单药治疗晚期NSCLC近期疗效肯定，对于EGFR突变患者有效率更高，治疗相关的毒副反应较轻，患者耐受性好，为晚期NSCLC患者治疗的新选择。

Objective To explore the efficacy and side effects of icotinib hydrochloride in the treatment of patients with advanced non-small cell lung cancer （NSCLC）. Methods The efficacy and side effects of ieotinib hydrochloride in treatment of 59 cases with stage 1V NSCIC and followed-up from March 2009 to January 2012 were retrospectively analyzed. Results Twenty seven patients （45.8%） showed partial response （PR） , 17 patients （28.8%） achieved SD, and 15 （25.4%） had progressive disease. The objective response rate （ORR） was 45.8 % （ 27/59 ）, and disease control rate （DCR） was 74.6% （44/59）. Among the 23 patients with EGFR mutation, ORR was 73.9 % （ 17/23 ）, and DCR was 95.7% （22/23）. Thirty six patients （ 61.0% ） achieved remission of symptoms to varying degrees. The main symptoms relieved were cough, asthmatic suffocating, pain and hoarseness. The major adverse events were mild skin rash （35.6%） and diarrhea （15.3%）. Others were dry skin, nausea and stomach problems. The efficacy of icotinib hydrochloride were related to the ECOG performance status, smoking history, EGFR mutation and rash significantly （ P 〈 0. 05 ）. Conclusions Monotherapy with icotinib hydrochloride is effective and tolerable for patients with advanced NSCLC, especially with EGFR mutation.