厄洛替尼治疗晚期非小细胞肺癌

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

作者信息

Tang Chuan-hao, Liu Xiao-qing, Gao Hong-jun, Li Jian-jie, Guo Wan-feng, Li Xiao-yan, Wang Wei-xia, Liu Bing, Qu Li-li, Wang Wei-wei

机构信息

Department of Lung Cancer, Tumor Center of PLA, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.

出版信息

Zhonghua Zhong Liu Za Zhi. 2010 Feb;32(2):143-7.

PMID:20403247

Abstract

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 (HR 0.56, 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 < or = 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 > or = 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.

摘要

目的

厄洛替尼是一种表皮生长因子受体（EGFR）酪氨酸激酶小分子抑制剂，对于一线化疗失败后的非小细胞肺癌（NSCLC）患者，其生存期有显著改善。本研究旨在评估厄洛替尼治疗晚期NSCLC患者的抗肿瘤疗效及毒性。

方法

选取2006年12月至2008年11月期间在我科收治的104例晚期NSCLC患者纳入本研究。符合条件的患者口服厄洛替尼150mg/d，直至疾病进展或出现无法耐受的毒性反应。采用实体瘤疗效评价标准（RECIST）确定最佳临床疗效，依据美国国立癌症研究所（NCI）标准评估不良事件。

结果

总有效率为27.9%（29/104），临床获益率为76.0%（79/104）。中位无进展生存期为5.1个月（95%置信区间4.0 - 8.0）。中位生存时间为13.1个月（95%置信区间10.0 - 15.7）。1年生存率为61.5%。对于身体状况良好的患者（风险比[HR]0.56，P = 0.006）、腺癌患者（HR 0.43，P = 0.004）和出现皮疹的患者（HR 0.46，P = 0.005），观察到厄洛替尼治疗有显著的生存获益。但吸烟患者（HR 2.75，P < 0.001）和肝转移患者（HR 2.91，P = 0.002）死亡风险增加。不良事件为轻度（≤2级），最常见的毒性反应是皮疹，发生率为73.1%（76/104），腹泻发生率为41.3%（43/104）。仅6.7%（7/104）的患者出现≥3级不良事件。