厄洛替尼治疗晚期非小细胞肺癌的临床观察

Erlotinib in the treatment of advanced non-small-cell lung cancer （NSCLC）

目的观察厄洛替尼单药治疗晚期非小细胞肺癌（NSCLC）的疗效和不良反应。方法104例晚期NSCLC患者给予厄洛替尼150mg口服治疗，每日1次，服用至疾病进展或出现不可耐受的不良反应。采用实体瘤的疗效评价标准评价疗效。采用美国国家癌症研究所毒性评价标准评价不良反应。结果104例患者均可评价疗效，客观有效率为27．9％（29／104），疾病控制率为76．0％（79／104），中位无进展生存时间为5．1个月，中位生存时间为13．1个月，1年总生存率为61．5％。多因素生存分析显示，PS评分为0—1分、腺癌和治疗后出现皮疹的患者具有显著的生存优势（均P〈0．05）；而吸烟和肝转移则显著增加了死亡风险（均P〈0．05）。厄洛替尼治疗晚期NSCLC最常见的不良反应是皮疹和腹泻，发生率分别为73．1％和41．3％。不良反应多为1～2级，3～4级不良反应的发生率仅为6．7％。结论厄洛替尼治疗晚期NSCLC的疗效确切，患者耐受性良好，可作为化疗失败、不适合或拒绝接受化疗的晚期NSCLC患者的治疗选择。

Objective Erlotinib is a small-molecule inhibitor of EGFR tyrosine kinase, showing a significant improvement of survival in non-small-cell lung cancer （ NSCLC ） after the failure of front-line chemotherapy. The aim of this study was to evaluate the antitumor efficacy and toxicity of Erlotinib in the treatment of advanced NSCLC patients. Methods A total of 104 patients with advanced NSCLC admitted in our department during December 2006 to November 2008 were enrolled in this study. Eligible patients received oral Erlotinib 150 mg/d until disease progression or intolerable toxicity. Best clinical response was determined using RECIST criteria, the adverse events were evaluated according to the NCI criteria. Results The total effective rate was 27.9% （29/104） and the clinical benefit was 76.0% （79/104）. The median progression- free survival was 5.1 months （95% CI 4.0-8.0）. The median survival time was 13.1 months （95% CI 10. 0- 15.7 ）. The 1-year survival rate was 61.5%. Significant survival benefit from erlobinib therapy was observed for patients with good personal status （ HR0. 56, P = 0.006） , adenocarcinoma （ HR 0. 43, P = 0.004） and skin rash （HR 0.46, P = 0.005）. But patients with smoking （HR 2.75, P 〈 0. 001 ） and liver metastasis （HR 2.91, P = 0.002） add the risk of death. The adverse events were mild （grade ≤2）, most common toxicities were skin rash in 73. 1% （76/104） and diarrhea in 41.3% （43/104）. Only 6.7% （7/104） patients got adverse events of grade/〉3. Conclusion Erlotinib is an effective and well-tolerated treatment option for advanced NSCLC and could offer an alternative for patients after the failure of first-line chemotherapy, unsuitable for or not wishing to receive chemotherapy.