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甲磺酸阿帕替尼治疗驱动基因未明的晚期非小细胞肺癌的观察性研究

范少泷,邹玉环,房芳,宋文广,王毅峰   

  1. 唐山市工人医院,唐山市开滦总医院,唐山市工人医院,唐山市工人医院,唐山市工人医院
  • 收稿日期:2017-08-15 修回日期:2017-08-15 出版日期:2017-11-25
  • 基金资助:
    唐山市科技局科技攻关计划项目(项目编号:10130215a;项目名称:磁共振增强扫描在脑肿瘤非手术治疗中的应用研究)

Observational Study in Treatment of Unknown Driving Genes Advanced Non-Small Cell Lung Cancer with Apatinb

Fan Shaoshuang,Zou Yuhuan,Fang Fang,Song Wenguang and Wang Yifeng   

  1. Tangshan Gongren hospital,Kailuan General hospital,Tangshan Gongren hospital,Tangshan Gongren hospital,Tangshan Gongren hospital
  • Received:2017-08-15 Revised:2017-08-15 Online:2017-11-25

摘要: 目的:探讨非干预性观察甲磺酸阿帕替尼对表皮生长因子受体(EGFR)野生或未明的晚期非小细胞肺癌(NSCLC)的疗效及安全性。方法:选取2015年8月至2017年4月某院就诊化疗失败的34例EGFR野生或未明的晚期NSCLC患者,以口服甲磺酸阿帕替尼(425mg·d-1)为主要治疗,观察其无进展生存期(PFS)、客观缓解率(ORR)和疾病控制率(DCR),随访相关不良事件。结果:34例患者中可评价疗效者30例,中位PFS(mPFS)为3.75个月(95%CI:0.648~6.852),ORR为20%,其中部分缓解(PR)6例(20.00%),疾病稳定(SD)16例(53.33%),进展(PD)7例(23.33%),DCR为73.33%。不良反应主要有高血压18例(52.94%)、手足综合征18例(52.94%)、蛋白尿15例(44.12%)和乏力14例(41.18%),无药物相关性死亡。疗效相关性分析显示ECOG评分0~1分和联合化疗是延长PFS的因素,联合化疗为独立预后因子。结论:甲磺酸阿帕替尼治疗化疗失败的晚期NSCLC有良好疗效,不良反应可期可控,有进一步开展大规模临床研究的价值。

Abstract: Objective:To investigate the efficacy and safety of apatinib with non-interfered in patients with EGFR gene wild type or unknown of advanced non-small cell lung cancer(NSCLC), and explore the possible related factors of the effect.Methods:All the patients come from our hospital which is chemotherapy-faild advanced NSCLC of EGFR genes wild type or unknown from August 2015 to April 2017.All the patients received apatinib 425 mg once daily orally in 4-weeks cycle and adverse events were followed up.The end point was progress free survival(PFS), objective response rate(ORR),disease control rate(DCR).Results:Thirty-four patients were enrolled,of which the efficacy can be evaluated in 30 patients while the other 4 can not because of severe adverse events. The total median PFS was 3.75months(95%CI:0.648~6.852).The number of response were: partial remission(PR) 6 cases(20.00%), stead disease(SD) 16 cases(53.33%), progress disease(PD) 7 cases (23.33%). The overall response rate(ORR) and the disease control rate(DCR) were 20%,73.33% respectively.The most frequently observed adverse event were 18 cases hypertension(52.94%), 18 cases hand-foot syndrome(52.94%), 15 cases proteinuria(44.12%), and 14 cases fatigue(41.18%). No medicine-related death were found. Correlation analysis showed ECOG 0~1 and combination chemotherapy were two affecting factors of PFS,and the latteris independent predictor.Conclusion:The treatment of chemotherapy-faild advanced non-small lung cancer with apatinib have better exact affect, and toxicity could be controlled.So it has certain value of clinical application or large-scale clinical research.