厄罗替尼治疗晚期非小细胞肺癌患者的疗效及安全性研究

Efficacy and Safety of Erlotinib on Advanced Non-small Cell Lung Cancer

目的评价厄罗替尼治疗晚期非小细胞肺癌(NSCLC)患者的疗效和安全性。方法23例经病理证实的晚期NSCLC患者入组,均为经化疗失败的或不能耐受化疗及不愿接受化疗的。厄罗替尼150mg/次,每天口服1次。采用RECIST实体瘤疗效评价标准评价疗效,美国国家癌症研究院(NCI)制定的毒性评价标准评价不良反应。结果23例患者均可评价毒性及疗效。部分缓解(PR)6例,客观缓解率为26.1%(6/23),稳定(SD)10例,疾病控制率为69.6%(16/23),疾病进展(PD)7例。中位无进展生存期为6.8个月(2.6～10.2个月),中位生存时间为13.1个月(3.5～18.0个月)。不良反应主要是皮疹(78.3%)及腹泻(60.9%),多为Ⅰ～Ⅱ度,Ⅲ度腹泻有1例(4.3%),未出现Ⅳ度药物相关不良反应。结论厄罗替尼治疗晚期非小细胞肺癌患者安全、有效。

Objective To evaluate the efficacy and safety of Erlotinib on advanced non - small lung cell cancer （NSCLC） . Methods Totally 23 patients, who were pathologically confirmed to have advanced NSCLC and had failed or not tolerated or refused chemotherapy, were enrolled. Erlotinib （150 ng） was orally administered daily. The efficacy was evaluated according to Response Evaluation Criteria in Solid Tumors （RECIST） criteria, the adverse events were evaluated according to the National Cancer Institute （NCI） criteria. Results All patients were eligible for toxicity and efficacy analysis. There were 6 patients who got partial response, with an objective response rate of 26. 1% （6/23） ; 10 patients whose condition got stable, with a disease control rate of 69. 6% （ 16/23 ） ; and 7 patients whose disease got progressive. The median progression - free survival time was 6. 8 months （2. 6 - 10. 2 months） , and the median survival time was 13.1 months （3.5-18.0 months）. The adverse reactions included skin rash （78.3%） and diarrhea （60. 9% ）, which were mostly in Ⅰ - Ⅱ degree, only 1 case （4. 3% ） was in Ⅲ degree, and no IV degree occurred. Conclusion Erlotinib is effective and safe for advanced NSCLC patients.