恩度联合全脑放疗一线治疗非小细胞肺癌多发脑转移的临床研究  

Effect of Endostar Combined with Whole Brain Radiotherapy in the First-line Treatment of Multiple Brain Metastases of Non-small Cell Lung Cancer

作　　者：袁岳宏[1] 徐可[1] 郑文川 林连兴[1] YUAN Yue-hong;XU Ke;ZHENG Wen-chuan;LIN Lian-xing(Shantou Central Hospital,Guangdong Province,Shantou 515031,China)

机构地区：[1]广东省汕头市中心医院,广东汕头515031

出　　处：《肿瘤学杂志》2021年第9期722-727,共6页Journal of Chinese Oncology

基　　金：汕头市科技计划医疗卫生类别项目(181204224010641)。

摘　　要：[目的]探讨恩度联合全脑放疗(whole brain radiotherapy,WBRT)一线治疗非小细胞肺癌多发脑转移的疗效和安全性。[方法]收集2019年3月至2020年9月病理确诊的初治的驱动基因阴性或突变状态未明的非小细胞肺癌多发脑转移患者70例(脑转移灶>3个),随机分为试验组(先接受恩度联合WBRT,n=37)和对照组(先接受WBRT,n=33)。随后,试验组和对照组都接受多西他赛联合顺铂/卡铂方案序贯治疗4~6个周期。主要研究终点为颅内疾病无进展生存时间(intracranial progression-free survival,iPFS),次要研究终点有颅外疾病无进展生存时间(extracranial progressionfree survival,ePFS)、颅内缓解率(intracranial response rate,iRR)、颅外缓解率(extracranial response rate,e RR),总缓解率(overall response rate,ORR)、总生存期(overall survival,OS)、颅内疾病控制率(intracranial disease control rate,i DCR)、颅外疾病控制率(extracranial disease control rate,eDCR)和总疾病控制率(overall disease control rate,o DCR);并记录两组不良反应事件。[结果]中位随访时间为10.5个月(2.5~18.1个月)。两组中位i PFS、中位e PFS、中位OS、iRR、eRR、ORR和iDCR差异无统计学意义(P>0.05)。eDCR分别为75.7%和51.5%,oDCR分别为73.0%和45.5%,两组间差异具有统计学意义(P<0.05)。[结论]对于驱动基因阴性或突变状态未明的非小细胞肺癌多发脑转移患者,在全脑放疗序贯化疗的基础上联合使用恩度,并不能带来i PFS、e PFS或OS方面的获益以及iORR、eORR和OR提高,但提高了患者e DCR和o DCR。[Objective]To study the efficacy and safety of endostar combined with whole brain radiotherapy in the first-line treatment of multiple brain metastases of non-small cell lung cancer(NSCLC).[Methods]From March 2019 to September 2020,70 patients with multiple brain metastases(brain metastases>3)of newly diagnosed NSCLC with negative driver gene or unknown mutation status after pathological diagnosis were randomly divided into experimental group(n=37)with first received endostar combined with WBRT and control group(n=33)with first received WBRT.After that,both the experimental group and the control group received docetaxel combined with cisplatin/carboplatin regimen for4~6 cycles.The primary endpoint was the progression free survival time of intracranial diseases(i PFs).The secondary endpoints were the progression free survival time of extracranial disease(e PFS),intracranial response rate(i RR),extracranial response rate(e RR),overall response rate(ORR),overall survival(OS),intracranial disease control rate(i DCR),extracranial disease control rate(e DCR),overall disease control rate(o DCR)and adverse events.[Results]The median follow-up time was 10.5 months(2.5~18.1 months).The median i PFS,median e PFS,median OS,i RR,e RR,ORR and i DCR were not statistically significant between two groups(P>0.05).The e DCR were 75.7%and 51.5%,the o DCR were 73.0%and 45.5%respectively(P<0.05).[Conclusion]For patients with multiple brain metastases of non-small cell lung cancer with negative driver genes or unknown mutation status,combined endostar with whole brain radiotherapy and sequential chemotherapy will not bring i PFS,e PFS,OS,i ORR,e ORR or o ORR benefits,only increase e DCR and o DCR.

关 键 词：非小细胞肺癌 多发脑转移 全脑放疗 恩度 疗效 

分 类 号：R734.2[医药卫生—肿瘤]