中国现代医生2019，Vol.57Issue(10)：29-33,37,6.
盐酸埃克替尼联合全脑放疗治疗非小细胞肺癌脑转移的随机对照研究
A randomized controlled trial of ectatinib hydrochloride combined with whole brain radiotherapy for brain metastasis of non-small cell lung cancer
摘要
Abstract
Objective To investigate the efficacy and safety of whole brain radiotherapy combined with ectatinib hydrochloride in the treatment of non-small cell lung cancer (NSCLC) brain metastases. Methods A total of 44 patients with brain metastases from NSCLC from June 2013 to June 2017 were randomly divided into combination therapy group and radiotherapy group. The efficacy and safety between the two groups were compared. Results The median follow-up was 18.5 months. The mPFS of the combination therapy group and the radiotherapy group were 9.3 months and 6.6 months, respectively (log-rank P=0.006). The mPFS of the EGFR mutant and wild type in the combination group were12.2 months and 6.5 months (log-rank P=0.002). The mPFS of EGFR mutants and wild-type patients in the radiotherapy group were 6.4 months and 6.8 months, respectively (log-rank P=0.933). The mOS in the combination therapy group and the radiotherapy group were 14.2 months and 12.6 months, respectively (log-rank P=0.035). The mOS of the EGFR mutant and wild type in the combination group were 19.1 months and 12.7 months, respectively (log-rank P=0.006). The mOS of EGFR mutants and wild-type patients in the radiotherapy group were 12.6 months and 10.4 months, respectively (log-rank P=0.449).The ORR of the two groups was 78.3％ and 47.6％, respectively (log-rank P=0.035), and the DCR was 91.3％ and 85.7％, respectively (χ2=0.341, P=0.560).In terms of adverse reactions, the incidence of rash in the combined group was 56.5％, of which 3 cases were grade 3-4. The adverse reactions such as fatigue, nausea and vomiting, diarrhea, liver and kidney damage, and leukopenia were all grade 1-2, and there was no statistically significant difference between the two groups. Conclusion Ectinib hydrochloride combined with whole brain radiotherapy can improve the objective response rate of patients with non-small cell lung cancer with brain metastases, prolong the median local progression-free survival and median overall survival, and the patient's adverse reaction tolerance is good.关键词
盐酸埃克替尼/非小细胞肺癌/表皮生长因子受体/全脑放疗Key words
Ectinib hydrochloride/Non-small cell lung cancer/Epidermal growth factor receptor/Whole brain radiotherapy分类
医药卫生引用本文复制引用
纪蓉,王建芳,孙彩萍,刘建江,陈遐林..盐酸埃克替尼联合全脑放疗治疗非小细胞肺癌脑转移的随机对照研究[J].中国现代医生,2019,57(10):29-33,37,6.基金项目
浙江省公益技术研究社会发展项目(2016C33224) （2016C33224）
浙江省卫生厅一般计划项目(2014KYB278) （2014KYB278）
浙江省绍兴市公益性技术应用研究计划项目(2015B70067) （2015B70067）
