肿瘤药学2016，Vol.6Issue(3)：193-197,5.DOI:10.3969/j.issn.2095-1264.2016.03.08
单中心单臂 II 期临床研究：沙利度胺治疗一代 TKI 继发性耐药的晚期非小细胞肺癌的临床疗效及安全性
A Single-center, Single-arm Phase II Trail：Efficacy and Safety of Thalidomide on Advanced NSCLC Patients with Secondary Drug Resistance of First Generation EGRF-TKI
摘要
Abstract
Objective To observe the clinical efficacy and safety of thalidomide in treatment of advanced non-small cell lung cancer patients with secondary drug resistance to first generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). Methods In this study, 52 cases of non-small cell lung cancer patients were recruited from January 2010 to December 2015 in Huangshan City Peo-ple’s Hospital. Thalidomide was added for the treatment of patients with imaging-confirmed disease progression after taking first generation EGFR-TKI. Thalidomide was taken at a draught from 100 mg to 300 mg with an increase of 50 mg every four days, 1 h before bedtime. The efficiency and toxicity of thalidomide and the survival of patients were analyzed. Results In all patients, there were 4 cases of partial re-sponse (PR) and 16 cases of stability of disease (SD). The effective rate was 7.7%, and the disease control rate was 38.5%. There was no se-rious adverse reaction in all patients. After treatment, the progress free survival (PFS) ranged between 3 weeks and 44 weeks, and the median PFS was 7 weeks. The overall survival (OS) was from 52 weeks to 240 weeks, and the median OS was 108 weeks. After thalidomide and TKI combination therapy, there was statistical difference to overall survival between subgroups (male vs. female and PFS < 44w vs. PFS ≥ 44w) (P<0.05). Conclusion Thalidomide is helpful in a certain extent to the reversal of first generation TKI resistance.关键词
沙利度胺/表皮生长因子受体酪氨酸激酶抑制剂/非小细胞肺癌/贝伐单抗/厄洛替尼Key words
Thalidomide/Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors/Non-small Cell Lung Cancer/Bevacizumab/Erlotinib分类
医药卫生引用本文复制引用
王根和,吴鹏飞,方平,陈雍,左刚,吴怡青,汪曙红,章隆辉..单中心单臂 II 期临床研究：沙利度胺治疗一代 TKI 继发性耐药的晚期非小细胞肺癌的临床疗效及安全性[J].肿瘤药学,2016,6(3):193-197,5.基金项目
黄山市科技局科技攻关课题（2013KN-01）。 （）
