厄罗替尼单药治疗晚期非小细胞肺癌的疗效和安全性分析

目的 研究厄罗替尼单药治疗晚期非小细胞肺癌(NSCLC)的疗效和安全性.方法 50例晚期NSCLC患者接受了厄罗替尼治疗,其中19例进行了表皮生长因子受体基因检测.中位生存期采用Kaplan-Meier方法计算.结果 最常见的不良反应为皮疹(96%)和腹泻(32%).中位生存期为21.8月,95%可信区间(CI)为17.1～26.4月.中位无疾病进展生存期为7.0月,95%CI为3.9～10.1月.19例接受表皮生长因子受体基因检测的患者中,突变型8例、野生型11例.突变型和野生型患者的客观有效率分别为62.5%和9.1%,差异具有显著性(X2=6.631,P=0.036);无疾病进展生存期分别为16.330(95%CI2.803～29.857)和5.570月(95%CI2.441～8.699),两者差异具有显著性(X2=8.799,P=0.003).结论 晚期NSCLC患者接受厄罗替尼治疗安全有效.

Efficacy and Safety of Erlotinib as Monotherapy for Advanced Non-small Cell Lung Cancer

Objective To explore the efficacy and safety of erlotinib monotherapy for advanced non-small cell lung cancer (NSCLC). Methods Totally 50 patients with advanced NSCLC received oral erlotinib 150 mg/d treatment, and tumor specimen in 19 patients were collected for epidermal growth factor receptor (EGFR) gene mutation tests. Median survival (MS) was calculated using the Kaplan-Meier method. Results The most common adverse events ( AEs) were skin rash (96% ) and diarrhea (32% ). The overall survival (OS) of all patients was 21. 8 months [95% confidential interval (CI) : 17. 1-26. 4 months] and the median progression-free survival (PFS) of all patients was 7. 0 months (95% CI: 3.9-10. 1 months). EGFR mutation analysis showed gene mutation in 8 cases and wild type in 11 cases. The objective response rate in patients with or without EGFR gene mutations were 62. 5% and 9. 1% , respectively (X2 =6. 631, P =0.036). PFS in pa-tients with or without EGFR gene mutations were 16.330 (95% CI: 2.803-29.857 months) and 5.570 months (95% CI: 2.441-8.699 months), respectively (X2 =8.799, P= 0.003). Conclusion Erlotinib monotherapy is safe and effective for some Chinese NSCLC patients after failure of prior chemotherapy.