厄罗替尼治疗晚期非小细胞肺癌19例临床疗效

Efficacy of erlotinib on advanced non-small-cell lung cancer

目的评价厄罗替尼治疗ⅢB～Ⅳ期非小细胞肺癌（NSCLC）的疗效和患者不良反应。方法19例患者均为经病理证实的、至少接受过一种方案全身化疗的晚期NSCLC患者。厄罗替尼150mg／次，1次／d，口服，直至病情进展或出现不能耐受的不良反应。采用实体瘤疗效评价标准（RECIST）评价疗效，美国国立癌症研究所毒性评价标准（CTCAE）评价不良反应。结果19例患者客观缓解率（ORR）为21．1％（4／19）。疾病控制率（完全缓解＋部分缓解＋稳定）为84．2％（16／19），疾病无进展生存时间（PFS）3～36个月，中位PFS7．5个月；生存时间9～39个月，中位生存时间15．9个月。不良反应主要是皮疹16例（84．2％），腹泻11例（57．9％），多为Ⅰ～Ⅱ度；Ⅲ度丙氨酸氨基转移酶升高1例；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NSCLC患者有较好的疗效和安全性。

Objective To evaluate the efficacy of erlotinib on advanced NSCLC, and observe its adverse events. Methods An open labeled, expanded access program （EAP） was conducted on 19 pathologically confirmed advanced NSCLC patients who had received at least one regimen chemotherapy. Erlotinib （150 mg） was orally administered daily till disease progression or intolerable adverse events developed. The efficacy was evaluated according to RECIST criteria; the adverse events were evaluated according to NCI criteria. Results In 19 patients, the objective response rate was 21.1% （4/19）, and the disease control rate was 84.2 % （16/19）; the median progression-free survival time was 7.5 months （3-36 months）, and the median survival time was 15.9 months （9-39 months）. Adverse events were generally mild （grade Ⅰ or Ⅱ ）, including skin rash （84.2 %） and diarrhea （57.9 %）. One （5.3 %） patient developed grade Ⅲ elevation of serum glutamate pyruvate transaminase. 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.