厄罗替尼治疗晚期非小细胞肺癌患者的临床疗效

Efficacy of Erlotinib on Advanced Non-small Cell Lung Cancer

背景与目的:厄罗替尼是一种表皮生长因子受体酪氨酸激酶的选择性抑制剂,临床常用于治疗晚期非小细胞肺癌。本研究旨在评价厄罗替尼治疗ⅢB/Ⅳ期非小细胞肺癌患者的疗效和不良反应。方法:本研究为开放的,记名供药计划。44例患者均为经病理证实的、至少接受过一个方案全身化疗的晚期非小细胞肺癌患者。厄罗替尼每次150mg每天口服一次直至病情进展或出现不能耐受的不良反应。采用RECIST实体瘤疗效评价标准评价疗效,NCI毒性评价标准评价不良反应。结果:44例患者客观有效率为27.3%(12/44),疾病控制率为65.9%(27/44),中位无疾病进展时间4.5个月(0.9～8.1个月),中位生存时间13.7个月(9.2～18.2个月)。不良反应主要是皮疹(81.8%)及腹泻(56.8%),多为Ⅰ～Ⅱ度。Ⅲ度转氨酶升高有1例(2.3%)。未出现Ⅳ度药物相关不良反应。结论:厄罗替尼对既往化疗失败的局部晚期或转移性非小细胞肺癌患者有较好的疗效和安全性。

BACKGROUND ＆ OBJECTIVE： Erlotinib is a selective inhibitor of epidermal growth factor receptor （EGFR） tyrosine kinase, and has been used in treating advanced non-small cell lung cancer （NSCLC）. This study was to evaluate the efficacy of erlotinib on advanced NSCLC, and observe the adverse events. METHODS. An open labeled, expanded access program （EAP） was conducted on 44 pathologically confirmed advanced NSCLC patients who had received at least one regimen. Erlotinib （150 mg） was orally administered daily till disease progression or intolerable adverse events developed. The efficacy was evaluated according to RECIS criteria; the adverse events were evaluated according to NCI criteria. RESULTS, In the 44 patients, the objective response rate was 27.3%, and the disease control rate was 65.9%; the median progression-free survival time was 4.5 months （0.9-8.1 months）, and the median survival time was 13.7 months （9.2-18.2 months）. Adverse events were generally mild （grade Ⅰ or Ⅱ ）, including skin rash （81.8%） and diarrhea （56.8%）. One （2.3%） patient developed grade Ⅲ elevation of serum glutamate pyruvate transaminase （SGPT）. No grade Ⅳ drug-related adverse event occurred. CONCLUSION. Erlotinib is effective and safe for locally advanced or metastatic NSCLC patients who have failed previous chemotherapy.