文献类型：期刊文献

中文题名：安罗替尼联合全脑放疗治疗无驱动基因突变非小细胞肺癌多发脑转移患者的效果及安全性

英文题名：Efficacy and safety of anlotinib combined with whole brain radiation therapy in treatment of driver gene mutation-negative non-small cell lung cancer patients with multiple brain metastases

作者：杨杰[1];刘建江[2];毛绩伟[2];吴东平[2]

机构：[1]绍兴文理学院医学院临床医学系,绍兴312000;[2]绍兴文理学院附属第一医院绍兴市人民医院放疗科,绍兴312000

年份：2023

卷号：35

期号：9

起止页码：664

中文期刊名：肿瘤研究与临床

外文期刊名：Cancer Research and Clinic

收录：CSTPCD、、Scopus

基金：浙江省卫生健康科技计划(2021KY1149);白求恩医学科学研究基金(B19083FT)。

语种：中文

中文关键词：癌,非小细胞肺;安罗替尼;全脑放疗;脑转移;治疗结果

外文关键词：Carcinoma,non-small-cell lung;Anlotinib;Whole brain radiation therapy;Brain metastasis;Treatment outcome

中文摘要：目的探讨安罗替尼联合全脑放疗治疗无驱动基因突变的非小细胞肺癌(NSCLC)多发脑转移患者的效果和安全性。方法纳入2018年3月至2022年3月绍兴市人民医院收治的42例无驱动基因突变NSCLC多发脑转移患者,其中21例安罗替尼联合全脑放疗组患者来源于前瞻性单臂研究(临床试验注册号:ChiCTR1900027769);单独全脑放疗组患者来源于同期回顾性研究,按1∶1倾向性评分匹配后最终纳入21例患者。比较两组颅内客观缓解率(iORR)、颅内疾病控制率(iDCR)、颅内无进展生存(iPFS),总生存(OS)及不良反应等情况。结果21例安罗替尼联合全脑放疗组中,完全缓解(CR)1例(4.8%),部分缓解(PR)13例(61.9%),疾病稳定(SD)6例(28.6%),疾病进展(PD)1例(4.8%);21例单独全脑放疗组中,CR 0例,PR 10例(47.6%),SD 7例(33.3%),PD 4例(19.0%);安罗替尼联合全脑放疗组和单独全脑放疗组iORR分别为66.7%(14/21)和47.6%(10/21)(P=0.212),iDCR分别为95.2%(20/21)和81.0%(17/21)(P=0.343)。安罗替尼联合全脑放疗组和单独全脑放疗组中位iPFS时间分别为10.4、5.3个月,两组iPFS差异有统计学意义(P=0.049);1年OS率分别为50.5%、39.5%,2年OS率分别为29.9%、26.3%,中位OS时间分别为13.4、6.6个月,两组OS差异无统计学意义(P=0.452)。安罗替尼联合全脑放疗组治疗相关不良反应主要有食欲减退(13/21,61.9%)、高血压(11/21,52.4%)、乏力(10/21,47.6%)、腹泻(6/21,28.6%)、呕吐(6/21,28.6%)、头晕(9/21,42.9%)和头痛(8/21,38.1%),未观察到4级或以上不良反应,与单独全脑放疗组不良反应比较,差异均无统计学意义(均P>0.05)。结论安罗替尼联合全脑放疗可以延长无驱动基因突变的NSCLC多发脑转移患者的iPFS时间,且安全性良好。

外文摘要：ObjectiveTo investigate the efficacy and safety of anlotinib combined with whole brain radiation therapy in the treatment of driver gene mutation-negative non-small cell lung cancer(NSCLC)patients with multiple brain metastases.MethodsForty-two driver gene mutation-negative NSCLC patients with multiple brain metastases who were admitted to Shaoxing People's Hospital from March 2018 to March 2022 were included.Among them,21 patients in the anlotinib combined with whole brain radiation therapy group were enrolled from a prospective single-arm study(clinical trial registration number:ChiCTR1900027769),and the patients in the whole brain radiation therapy-alone group were enrolled from a concurrent retrospective study,and after 1∶1 propensity score matching,a total of 21 patients were finally included.The intracranial objective response rate(iORR),intracranial disease control rate(iDCR),intracranial progression-free survival(iPFS),overall survival(OS),and adverse events were compared between the two groups.ResultsAmong 21 patients in the arotinib combined with whole brain radiation therapy group,there were 1 case(4.8%)of complete remission(CR),13 cases(61.9%)of partial remission(PR),6 cases(28.6%)of stable disease(SD),and 1 case(4.8%)of progressive disease(PD).Among 21 patients in the whole brain radiation therapy-alone group,there were 0 case of CR,10 cases(47.6%)of PR,7 cases(33.3%)of SD,and 4 cases(19.0%)of PD.The iORR was 66.7%(14/21)and 47.6%(10/21)in the anlotinib combined with whole brain radiation therapy group and whole brain radiation therapy-alone group,respectively(P=0.212),and the iDCR was 95.2%(20/21)and 81.0%(17/21),respectively(P=0.343).The median iPFS time was 10.4 and 5.3 months in the anrotinib combined with whole brain radiation therapy group and the whole brain radiation therapy-alone group,respectively,and the difference in iPFS between the two groups was statistically significant(P=0.049);the 1-year OS rate was 50.5%and 39.5%,and the 2-year OS rate was 29.9%and 26.3%,respectively,with the median OS time of 13.4 and 6.6 months,respectively.The difference in OS between the two groups was not statistically significant(P=0.452).The most common treatment-related adverse effects in the anlotinib combined with whole brain radiation therapy group were loss of appetite(13/21,61.9%),hypertension(11/21,52.4%),fatigue(10/21,47.6%),diarrhea(6/21,28.6%),vomiting(6/21,28.6%),dizziness(9/21,42.9%),and headache(8/21,38.1%).No≥grade 4 adverse effects were observed,and there were no significant differences in adverse effects between the two groups(all P>0.05).ConclusionsAnlotinib combined with whole brain radiation therapy can prolong the iPFS time of driver gene mutation-negative NSCLC patients with multiple brain metastases,and it is well-tolerated in terms of safety.