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Article(id=1199688709160399397, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199688705905623579, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.1540.2023.0215, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1657814400000, receivedDateStr=2022-07-15, revisedDate=null, revisedDateStr=null, acceptedDate=1665763200000, acceptedDateStr=2022-10-15, onlineDate=1763957677401, onlineDateStr=2025-11-24, pubDate=1703692800000, pubDateStr=2023-12-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763957677401, onlineIssueDateStr=2025-11-24, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763957677401, creator=13701087609, updateTime=1763957677401, updator=13701087609, issue=Issue{id=1199688705905623579, tenantId=1146029695717560320, journalId=1189873630562394117, year='2023', volume='48', issue='12', pageStart='1359', pageEnd='1491', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1763957676626, creator=13701087609, updateTime=1763958367038, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1199691601774739748, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199688705905623579, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1199691601774739749, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199688705905623579, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1420, endPage=1426, ext={EN=ArticleExt(id=1199688709441417775, articleId=1199688709160399397, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Efficacy and safety of stereotactic body radiotherapy combined with karelizumab and apatinib in treatment of advanced hepatocellular carcinoma, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective To investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with camrelizumab and apatinib in treatment of advanced hepatocellular carcinoma (HCC). Methods The clinical data were retrospectively analyzed of 85 patients with advanced HCC treated in the Fifth Affiliated Hospital of Zhengzhou University and People's Hospital of Zhengzhou from January 2019 to September 2021. They were divided into observation group (n=31, SBRT combined with camrelizumab and apatinib) and control group (n=54, treated with camrelizumab and apatinib) according to whether they received SBRT. The propensity score matching (PSM) was used to balance the influence of confounding factors. The objective remission rate (ORR) and disease control rate (DCR) were compared between the two groups. The 6-month overall survival rate, 1-year overall survival rate and progression-free survival (PFS) were compared between the two groups by Kaplan-Meier method. The safety of the two groups was evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results Before PSM, there were significant differences in age (P=0.043), number of extrahepatic metastasis (P=0.028), and previous surgical treatment (P=0.038) between the two groups. After PSM, there was no significant difference in baseline characteristics between the two groups (P>0.05). After PSM, 27 cases were included in each groups, and three months after treatment, the ORR in observation group and control group were 66.7% and 29.6%, respectively, showed difference with statistically significant (P=0.006); and the DCR in the both groups were 96.3% and 85.2% respectively, showed no statistically significant difference (P=0.175). There were statistical differences in 6-month overall survival rate (96.3% vs. 80.9%, P=0.001), 1-year overall survival rate (75.0% vs. 61.4%, P=0.034) and median PFS (8 months vs. 5 months, P=0.003) between the observation group and control group. Multi-factor Cox regression analysis showed that baseline alpha-fetoprotein (AFP) ≥400 ng/ml was an independent risk factor for affecting the survival of patients with advanced HCC (HR>1, P<0.05), while the triple therapy and previous targeted drugs therapy were the protective factors for the survival of patients with advanced HCC (HR<1, P<0.05). In the observation group, 4 patients had grade 3 adverse reactions, and the common adverse reactions were dyspepsia (14.8%). One case of grade 3 adverse reactions occurred in control group, and there was no statistically significant difference in the incidence of adverse reactions between the two groups (P=0.639). Conclusion SBRT combined with camrelizumab and apatinib is a safe and effective treatment for advanced HCC with significant clinical effect and controllable adverse reactions.

, correspAuthors=Guang-Cheng Ding, authorNote=null, correspAuthorsNote=
E-mail:
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目的 探讨立体定向放射治疗(SBRT)联合卡瑞利珠单抗、阿帕替尼治疗晚期肝细胞癌(HCC)的疗效及安全性。方法 回顾性分析2019年1月-2021年9月郑州大学第五附属医院和郑州人民医院收治的85例晚期HCC患者的临床资料，根据是否接受SBRT治疗分为观察组(n=31，采用SBRT联合卡瑞利珠单抗和阿帕替尼治疗)与对照组(n=54，采用卡瑞利珠单抗和阿帕替尼治疗)。采用倾向性评分匹配(PSM)均衡混杂因素，比较两组客观缓解率(ORR)、疾病控制率(DCR)，采用Kaplan-Meier生存曲线比较两组6个月总生存率、1年总生存率、无进展生存期(PFS)；使用常见不良事件标准(CTCAE)5.0版评估两组治疗方法的安全性。结果 PSM前，两组年龄(P=0.043)、肝外转移数(P=0.028)和既往是否手术治疗(P=0.038)差异有统计学意义；PSM后，两组基线资料比较差异无统计学意义(P>0.05)，两组各纳入27例患者。治疗后3个月，观察组和对照组ORR分别为66.7%、29.6%，差异有统计学意义(P=0.006)，DCR分别为96.3%、85.2 %，差异无统计学意义(P=0.175)。观察组和对照组6个月总生存率(96.3% vs. 80.9%，P=0.001)、1年总生存率(75.0% vs. 61.4%，P=0.034)和中位PFS(8个月 vs. 5个月，P=0.003)差异有统计学意义。多因素Cox回归分析显示，基线甲胎蛋白(AFP)≥400 ng/ml是影响晚期HCC患者生存期的独立危险因素(HR>1，P<0.05)；而三联疗法、既往使用靶向药物是晚期HCC患者生存期的保护因素(HR<1，P<0.05)。观察组4例出现3级不良反应，常见不良反应为消化不良(14.8%)等；对照组1例发生3级不良反应。两组不良反应发生率比较差异无统计学意义(P=0.639)。结论 SBRT联合卡瑞利珠单抗、阿帕替尼治疗晚期HCC临床效果显著，不良反应可控，是一种安全、有效的治疗方法。

, correspAuthors=丁广成, authorNote=null, correspAuthorsNote=
丁广成，E-mail：
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雷艳文，硕士研究生，主要从事肿瘤放化疗结合治疗的临床研究

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雷艳文，硕士研究生，主要从事肿瘤放化疗结合治疗的临床研究

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雷艳文，硕士研究生，主要从事肿瘤放化疗结合治疗的临床研究

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Cancers (Basel), 2022, 14(19): 4647., articleTitle=Prognostic role of molecular and imaging biomarkers for predicting advanced hepatocellular carcinoma treatment efficacy, refAbstract=null)], funds=[Fund(id=1199700887183655159, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, awardId=2018ZX10303502-001, language=EN, fundingSource=National Science and Technology Major Project(2018ZX10303502-001), fundOrder=null, country=null), Fund(id=1199700888316117243, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, awardId=2018ZX10303502-001, language=CN, fundingSource=国家科技重大专项课题(2018ZX10303502-001), fundOrder=null, country=null), Fund(id=1199700888437752063, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, awardId=2018020256, language=EN, fundingSource=Henan Province Medical Science and Technology Research Program Joint Construction Project(2018020256), fundOrder=null, country=null), Fund(id=1199700888534221057, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, awardId=2018020256, language=CN, fundingSource=河南省医学科技攻关计划联合共建项目(2018020256), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1199700880464379939, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, xref=1, ext=[AuthorCompanyExt(id=1199700880472768548, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, companyId=1199700880464379939, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1Stereotactic Body Radiotherapy Center, the Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000, China), AuthorCompanyExt(id=1199700880485351461, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, companyId=1199700880464379939, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1郑州大学第五附属医院立体定向放射治疗中心，河南郑州 450000)]), AuthorCompany(id=1199700880636346409, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, xref=2, ext=[AuthorCompanyExt(id=1199700880648929322, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, companyId=1199700880636346409, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2Department of Oncology, the Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000, China), AuthorCompanyExt(id=1199700880665706538, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, companyId=1199700880636346409, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2郑州大学第五附属医院肿瘤内科，河南郑州 450000)]), AuthorCompany(id=1199700880745398319, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, xref=3, ext=[AuthorCompanyExt(id=1199700880753786927, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, companyId=1199700880745398319, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3Department of Radiation Oncology, People's Hospital of Zhengzhou, Zhengzhou, Henan 450000, China), AuthorCompanyExt(id=1199700880757981232, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, companyId=1199700880745398319, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3郑州人民医院放疗科，河南郑州 450000)])], figs=[ArticleFig(id=1199700886135079125, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=EN, label=Fig.1, caption=Kaplan-Meier OS and PFS for observation and control groups, figureFileSmall=KLX/edY5eAwRHYX/y4yczA==, figureFileBig=7up7FOqmLGddfSW6zpo/Pg==, tableContent=null), ArticleFig(id=1199700886256713943, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=CN, label=图1, caption=PSM后两组HCC患者OS和PFS生存曲线

PSM. 倾向性评分匹配；HCC. 肝细胞癌；OS. 总生存期；PFS. 无进展生存期

, figureFileSmall=KLX/edY5eAwRHYX/y4yczA==, figureFileBig=7up7FOqmLGddfSW6zpo/Pg==, tableContent=null), ArticleFig(id=1199700886407708891, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=EN, label=Fig.2, caption=Forest plot of multivariate Cox regression analysis after PSM, figureFileSmall=dWXHcgGspwePz2k+Z1MDng==, figureFileBig=wdEfr8bpJpdO/crFFEii/g==, tableContent=null), ArticleFig(id=1199700886491594974, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=CN, label=图2, caption=PSM后Cox回归多因素分析森林图

PSM. 倾向性评分匹配；TACE. 经导管肝动脉化疗栓塞术；ECOG评分. 美国东部肿瘤协作组表现状态评分

, figureFileSmall=dWXHcgGspwePz2k+Z1MDng==, figureFileBig=wdEfr8bpJpdO/crFFEii/g==, tableContent=null), ArticleFig(id=1199700886571286753, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=EN, label=Tab.1, caption=

Comparison of the baseline data of HCC patients in both groups before and after PSM [n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
项目PSM前PSM后
观察组(n=31)对照组(n=54)P观察组(n=27)对照组(n=27)P
年龄(岁)0.0430.761
<6523(74.2)28(51.9)19(70.4)20(74.1)
≥658(25.8)26(48.1)8(29.6)7(25.9)
性别0.9701.000
男24(77.4)42(77.8)20(74.1)20(74.1)
女7(22.6)12(22.2)7(25.9)7(25.9)
肝外转移数(个)0.0281.000
<226(83.9)33(61.1)22(81.5)23(85.2)
≥25(16.1)21(38.9)5(18.5)4(14.8)
ECOG评分(分)0.6631.000
110(32.3)15(27.8)8(29.6)8(29.6)
221(67.7)39(72.2)19(70.4)19(70.4)
Child-Pugh分级0.7840.776
A21(67.7)35(64.8)18(66.7)17(63.0)
B10(32.3)19(35.2)9(33.3)10(37.0)
门脉癌栓21(67.7)33(61.1)0.54117(63.0)18(66.7)0.776
血清AFP水平(ng/ml)0.9410.776
<40021(67.7)37(68.5)18(66.7)17(63.0)
≥40010(32.3)17(31.5)9(33.3)10(37.0)
乙肝病史29(93.5)46(85.9)0.24925(92.6)24(88.9)0.639
既往治疗
手术10(32.2)30(55.6)0.03810(37.0)12(44.4)0.580
TACE18(58.1)31(57.4)0.95316(59.3)15(55.6)0.783
射频消融10(32.2)16(29.6)0.8009(33.3)7(25.9)0.551
靶向药物14(45.2)14(25.9)0.06911(40.7)9(33.3)0.573
), ArticleFig(id=1199700886692921572, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=CN, label=表1, caption=

PSM前后两组HCC患者基线资料比较[例(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
项目PSM前PSM后
观察组(n=31)对照组(n=54)P观察组(n=27)对照组(n=27)P
年龄(岁)0.0430.761
<6523(74.2)28(51.9)19(70.4)20(74.1)
≥658(25.8)26(48.1)8(29.6)7(25.9)
性别0.9701.000
男24(77.4)42(77.8)20(74.1)20(74.1)
女7(22.6)12(22.2)7(25.9)7(25.9)
肝外转移数(个)0.0281.000
<226(83.9)33(61.1)22(81.5)23(85.2)
≥25(16.1)21(38.9)5(18.5)4(14.8)
ECOG评分(分)0.6631.000
110(32.3)15(27.8)8(29.6)8(29.6)
221(67.7)39(72.2)19(70.4)19(70.4)
Child-Pugh分级0.7840.776
A21(67.7)35(64.8)18(66.7)17(63.0)
B10(32.3)19(35.2)9(33.3)10(37.0)
门脉癌栓21(67.7)33(61.1)0.54117(63.0)18(66.7)0.776
血清AFP水平(ng/ml)0.9410.776
<40021(67.7)37(68.5)18(66.7)17(63.0)
≥40010(32.3)17(31.5)9(33.3)10(37.0)
乙肝病史29(93.5)46(85.9)0.24925(92.6)24(88.9)0.639
既往治疗
手术10(32.2)30(55.6)0.03810(37.0)12(44.4)0.580
TACE18(58.1)31(57.4)0.95316(59.3)15(55.6)0.783
射频消融10(32.2)16(29.6)0.8009(33.3)7(25.9)0.551
靶向药物14(45.2)14(25.9)0.06911(40.7)9(33.3)0.573
), ArticleFig(id=1199700886810362088, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=EN, label=Tab.2, caption=

Comparison of short-term efficacy between the two groups of HCC patients after PSM [n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
组别CRPRSDPDORRDCR
P0.0060.175
观察组(n=27)1(3.7)17(63.0)8(29.6)1(3.7)18(66.7)26(96.3)
对照组(n=27)08(29.6)15(55.6)4(14.8)8(29.6)23(85.2)
), ArticleFig(id=1199700886877470956, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=CN, label=表2, caption=

PSM后两组HCC患者近期疗效比较[例(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
组别CRPRSDPDORRDCR
P0.0060.175
观察组(n=27)1(3.7)17(63.0)8(29.6)1(3.7)18(66.7)26(96.3)
对照组(n=27)08(29.6)15(55.6)4(14.8)8(29.6)23(85.2)
), ArticleFig(id=1199700886944579822, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=EN, label=Tab.3, caption=

Occurrence of adverse reactions in the two groups of HCC patients [n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应观察组(n=27)对照组(n=27)
任何等级3级任何等级3级
合计27(100.0)4(14.8)27(100.0)1(3.7)
消化不良4(14.8)02(7.4)0
转氨酶升高4(14.8)2(7.4)1(3.7)0
白细胞减少4(14.8)1(3.7)4(14.8)0
腹泻4(14.8)03(11.1)0
血小板减少3(11.1)1(3.7)2(7.4)0
乏力3(11.1)02(7.4)0
皮疹2(7.4)04(14.8)0
手足综合征1(3.7)05(18.5)0
血压升高1(3.7)03(11.1)1(3.7)
RCCEP1(3.7)01(3.7)0
), ArticleFig(id=1199700887024271602, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199688709160399397, language=CN, label=表3, caption=

两组HCC患者不良反应发生情况[例(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应观察组(n=27)对照组(n=27)
任何等级3级任何等级3级
合计27(100.0)4(14.8)27(100.0)1(3.7)
消化不良4(14.8)02(7.4)0
转氨酶升高4(14.8)2(7.4)1(3.7)0
白细胞减少4(14.8)1(3.7)4(14.8)0
腹泻4(14.8)03(11.1)0
血小板减少3(11.1)1(3.7)2(7.4)0
乏力3(11.1)02(7.4)0
皮疹2(7.4)04(14.8)0
手足综合征1(3.7)05(18.5)0
血压升高1(3.7)03(11.1)1(3.7)
RCCEP1(3.7)01(3.7)0
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SBRT联合卡瑞利珠单抗和阿帕替尼治疗晚期肝细胞癌的疗效及安全性
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雷艳文 1 , 丁广成 1, * , 秦德华 1 , 郭彦伟 2 , 王海霞 3 , 张剑 2 , 陈家富 1 , 罗青竹 1 , 郭文静 1
解放军医学杂志 | 临床研究 2023,48(12): 1420-1426
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解放军医学杂志 | 临床研究 2023, 48(12): 1420-1426
SBRT联合卡瑞利珠单抗和阿帕替尼治疗晚期肝细胞癌的疗效及安全性
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雷艳文1, 丁广成1, * , 秦德华1, 郭彦伟2, 王海霞3, 张剑2, 陈家富1, 罗青竹1, 郭文静1
作者信息
  • 1郑州大学第五附属医院立体定向放射治疗中心，河南郑州 450000
  • 2郑州大学第五附属医院肿瘤内科，河南郑州 450000
  • 3郑州人民医院放疗科，河南郑州 450000

    • 雷艳文，硕士研究生，主要从事肿瘤放化疗结合治疗的临床研究

通讯作者:

丁广成，E-mail：
Efficacy and safety of stereotactic body radiotherapy combined with karelizumab and apatinib in treatment of advanced hepatocellular carcinoma
Yan-Wen Lei1, Guang-Cheng Ding1, * , De-Hua Qin1, Yan-Wei Guo2, Hai-Xia Wang3, Jian Zhang2, Jia-Fu Chen1, Qing-Zhu Luo1, Wen-Jing Guo1
Affiliations
  • 1Stereotactic Body Radiotherapy Center, the Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000, China
  • 2Department of Oncology, the Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000, China
  • 3Department of Radiation Oncology, People's Hospital of Zhengzhou, Zhengzhou, Henan 450000, China
出版时间: 2023-12-28 doi: 10.11855/j.issn.0577-7402.1540.2023.0215
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摘要
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目的 探讨立体定向放射治疗(SBRT)联合卡瑞利珠单抗、阿帕替尼治疗晚期肝细胞癌(HCC)的疗效及安全性。方法 回顾性分析2019年1月-2021年9月郑州大学第五附属医院和郑州人民医院收治的85例晚期HCC患者的临床资料，根据是否接受SBRT治疗分为观察组(n=31，采用SBRT联合卡瑞利珠单抗和阿帕替尼治疗)与对照组(n=54，采用卡瑞利珠单抗和阿帕替尼治疗)。采用倾向性评分匹配(PSM)均衡混杂因素，比较两组客观缓解率(ORR)、疾病控制率(DCR)，采用Kaplan-Meier生存曲线比较两组6个月总生存率、1年总生存率、无进展生存期(PFS)；使用常见不良事件标准(CTCAE)5.0版评估两组治疗方法的安全性。结果 PSM前，两组年龄(P=0.043)、肝外转移数(P=0.028)和既往是否手术治疗(P=0.038)差异有统计学意义；PSM后，两组基线资料比较差异无统计学意义(P>0.05)，两组各纳入27例患者。治疗后3个月，观察组和对照组ORR分别为66.7%、29.6%，差异有统计学意义(P=0.006)，DCR分别为96.3%、85.2 %，差异无统计学意义(P=0.175)。观察组和对照组6个月总生存率(96.3% vs. 80.9%，P=0.001)、1年总生存率(75.0% vs. 61.4%，P=0.034)和中位PFS(8个月 vs. 5个月，P=0.003)差异有统计学意义。多因素Cox回归分析显示，基线甲胎蛋白(AFP)≥400 ng/ml是影响晚期HCC患者生存期的独立危险因素(HR>1，P<0.05)；而三联疗法、既往使用靶向药物是晚期HCC患者生存期的保护因素(HR<1，P<0.05)。观察组4例出现3级不良反应，常见不良反应为消化不良(14.8%)等；对照组1例发生3级不良反应。两组不良反应发生率比较差异无统计学意义(P=0.639)。结论 SBRT联合卡瑞利珠单抗、阿帕替尼治疗晚期HCC临床效果显著，不良反应可控，是一种安全、有效的治疗方法。

立体定向放射治疗  /  卡瑞利珠单抗  /  阿帕替尼  /  肝细胞癌  /  倾向性评分匹配

Objective To investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with camrelizumab and apatinib in treatment of advanced hepatocellular carcinoma (HCC). Methods The clinical data were retrospectively analyzed of 85 patients with advanced HCC treated in the Fifth Affiliated Hospital of Zhengzhou University and People's Hospital of Zhengzhou from January 2019 to September 2021. They were divided into observation group (n=31, SBRT combined with camrelizumab and apatinib) and control group (n=54, treated with camrelizumab and apatinib) according to whether they received SBRT. The propensity score matching (PSM) was used to balance the influence of confounding factors. The objective remission rate (ORR) and disease control rate (DCR) were compared between the two groups. The 6-month overall survival rate, 1-year overall survival rate and progression-free survival (PFS) were compared between the two groups by Kaplan-Meier method. The safety of the two groups was evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results Before PSM, there were significant differences in age (P=0.043), number of extrahepatic metastasis (P=0.028), and previous surgical treatment (P=0.038) between the two groups. After PSM, there was no significant difference in baseline characteristics between the two groups (P>0.05). After PSM, 27 cases were included in each groups, and three months after treatment, the ORR in observation group and control group were 66.7% and 29.6%, respectively, showed difference with statistically significant (P=0.006); and the DCR in the both groups were 96.3% and 85.2% respectively, showed no statistically significant difference (P=0.175). There were statistical differences in 6-month overall survival rate (96.3% vs. 80.9%, P=0.001), 1-year overall survival rate (75.0% vs. 61.4%, P=0.034) and median PFS (8 months vs. 5 months, P=0.003) between the observation group and control group. Multi-factor Cox regression analysis showed that baseline alpha-fetoprotein (AFP) ≥400 ng/ml was an independent risk factor for affecting the survival of patients with advanced HCC (HR>1, P<0.05), while the triple therapy and previous targeted drugs therapy were the protective factors for the survival of patients with advanced HCC (HR<1, P<0.05). In the observation group, 4 patients had grade 3 adverse reactions, and the common adverse reactions were dyspepsia (14.8%). One case of grade 3 adverse reactions occurred in control group, and there was no statistically significant difference in the incidence of adverse reactions between the two groups (P=0.639). Conclusion SBRT combined with camrelizumab and apatinib is a safe and effective treatment for advanced HCC with significant clinical effect and controllable adverse reactions.

stereotactic body radiotherapy  /  camrelizumab  /  apatinib  /  hepatocellular carcinoma  /  propensity score matching
雷艳文, 丁广成, 秦德华, 郭彦伟, 王海霞, 张剑, 陈家富, 罗青竹, 郭文静. SBRT联合卡瑞利珠单抗和阿帕替尼治疗晚期肝细胞癌的疗效及安全性. 解放军医学杂志, 2023 , 48 (12) : 1420 -1426 . DOI: 10.11855/j.issn.0577-7402.1540.2023.0215
Yan-Wen Lei, Guang-Cheng Ding, De-Hua Qin, Yan-Wei Guo, Hai-Xia Wang, Jian Zhang, Jia-Fu Chen, Qing-Zhu Luo, Wen-Jing Guo. Efficacy and safety of stereotactic body radiotherapy combined with karelizumab and apatinib in treatment of advanced hepatocellular carcinoma[J]. Medical Journal of Chinese People’s Liberation Army, 2023 , 48 (12) : 1420 -1426 . DOI: 10.11855/j.issn.0577-7402.1540.2023.0215
正文
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2020年全球癌症统计数据显示，肝癌是全球第六常见癌症，也是癌症相关第四位死亡原因[1]。我国原发性肝细胞癌(hepatocellular carcinoma，HCC)发病率位居恶性肿瘤第4位，肿瘤致死病因居第2位，严重影响民众的生命和健康[2-3]。HCC发病较隐匿，多数患者发现时已处于晚期[4-5]。免疫联合抗血管生成药物治疗给晚期HCC患者带来了新的希望，已成为晚期HCC的一线治疗方法[6]。我国自主研发的PD-1抑制剂—卡瑞利珠单抗被用于治疗晚期HCC，研究表明，卡瑞利珠单抗联合阿帕替尼治疗晚期HCC显示出良好的疗效[7-9]。放射治疗是HCC治疗的重要手段，多项研究发现，局部放射治疗尤其是大分割立体定向放射治疗(stereotactic body radiotherapy，SBRT)可增强抗肿瘤免疫反应[10-11]。放射治疗、免疫检查点抑制剂(immune checkpoint inhibitors，ICIs)和抗血管生成药物三者相互作用，在提高非小细胞肺癌、胶质瘤等疗效方面具有潜力[12-16]。但目前三者联合治疗晚期HCC的相关研究较少，因此，本研究探讨SBRT联合卡瑞利珠单抗、阿帕替尼治疗晚期HCC的疗效及安全性，以期为三联疗法的应用提供临床依据。
1 资料与方法
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1.1 一般资料
回顾性分析2019年1月-2021年9月郑州大学第五附属医院和郑州人民医院收治的85例晚期原发性HCC患者的临床资料。纳入标准：年龄≥18岁；根据《原发性肝癌诊疗规范(2019年版)》[2]诊断为BCLC分期C期HCC；美国东部肿瘤协作组(Eastern Cooperative Oncology Group，ECOG)活动状态评分为0~2分；Child-Pugh评分为A、B。排除标准：既往有免疫系统相关疾病；有严重消化道出血、胃肠道穿孔或肠梗阻；有中枢神经系统转移；肝移植史；资料不完整或失访。根据治疗方式不同将患者分为观察组(n=31，采用SBRT联合卡瑞利珠单抗、阿帕替尼治疗)与对照组(n=54，采用卡瑞利珠单抗和阿帕替尼治疗)。本研究经郑州大学第五附属医院伦理委员会批准(Y2021034)，患者均签署知情同意书。
1.2 治疗方法
观察组患者进行全身评估，排除SBRT禁忌证后，进行定位：(1)根据患者治疗部位距体表距离选择仰卧或俯卧于负压袋上，在三维坐标的立体定向体架中进行精准定位；(2)双手上举，平静呼吸下进行CT增强双期扫描，层厚3~5 mm；(3)将CT图像上传至治疗计划系统，计划靶区(planning target volume，PTV)围绕大体肿瘤靶区扩展3~5 mm，根据正常器官限量制订治疗计划，周围正常器官受照剂量参照美国医学物理师协会(AAPM)TG101报告；(4)使用OUR-QGD型体部SBRT系统对病灶进行放射治疗，治疗剂量为36~50 Gy/6~10 f，1次/d，5次/周；(5)卡瑞利珠单抗(200 mg，每3周注射1次)与阿帕替尼(500 mg，1次/d)均在SBRT治疗首日后1周内给予，SBRT治疗结束后患者继续卡瑞利珠单抗和阿帕替尼治疗，直至疾病进展、不可耐受毒性，或因其他原因终止治疗。对照组采用卡瑞利珠单抗与阿帕替尼治疗，剂量用法同观察组。
1.3 随访与评估
治疗后1个月进行疗效评估，此后每3个月对患者进行增强CT或MRI随访1次，门诊及电话随访，时间截至2022年1月31日。甲胎蛋白(alpha fetoprotein，AFP)基线水平>20 ng/ml定义为AFP阳性；AFP较基线水平下降≥20%为AFP应答。
1.3.1 近期疗效
采用改良实体肿瘤疗效评价标准(mRECIST)评估客观缓解率(objective response rate，ORR)和疾病控制率(disease control rate，DCR)。ORR(%)=[完全缓解(complete response，CR)+部分缓解(partial response，PR)]/总例数×100%；DCR(%)=[CR+PR+疾病稳定(stable disease，SD)]/总例数×100%。
1.3.2 长期疗效
通过无进展生存期(progression-free survival，PFS)、6个月总生存率、1年总生存率等评估。
1.3.3 安全性
采用常见不良事件评价标准(Common Terminology Criteria for Adverse Events，CTCAE)5.0版评估。
1.4 资料收集
根据电话、门诊随访及住院病历资料，收集患者治疗前年龄、性别、肝外转移瘤个数、ECOG评分、Child-Pugh评分、是否有门脉癌栓、AFP水平、是否存在乙肝病毒感染、既往治疗情况，以及治疗后AFP水平、肿瘤大小(增强CT)、不良反应发生情况(包括不良反应类型、严重程度、处理后是否好转)、无进展生存时间、总生存期等。
1.5 倾向性评分匹配(propensity score matching，PSM)分析
使用PSM校正抽样偏差和混杂因素，采用多因素logistic回归分析年龄、性别、肝外转移部位、ECOG评分、Child-Pugh分级、是否有门脉癌栓、AFP水平、既往治疗方法的倾向性评分，按1:1邻近匹配法对两组患者进行匹配，卡钳值取0.05，最终匹配得到27对病例。
1.6 生存分析
采用Kaplan-Meier法绘制生存曲线，log-rank检验比较两组总生存期(overall survival，OS)、PFS差异。采用Cox比例风险模型分析晚期HCC患者生存期的影响因素。
1.7 统计学处理
采用SPSS 26.0软件进行统计分析。计数资料以率(%)表示，两组间比较采用χ2检验或Fisher精确检验。P<0.05为差异有统计学意义。
2 结果
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2.1 PSM前后两组基线资料比较及匹配结果
PSM前后，两组基线资料如表1所示。PSM前共纳入85例HCC患者，其中观察组31例，对照组54例；PSM后，两组各纳入27例患者。PSM前，两组年龄(P=0.043)、肝外转移数(P=0.028)和既往是否手术治疗(P=0.038)差异有统计学意义；PSM后，两组基线资料比较差异均无统计学意义(P>0.05)。
2.2 PSM后两组肿瘤标志物AFP阳性率和应答率
治疗后1个月，观察组AFP阳性率为66.7%(18/27)，对照组为70.4%(19/27)。观察组治疗后1、3个月AFP应答率分别为38.8%(7/18)、83.3%(15/18)，对照组分别为47.3%(9/19)、73.7%(14/19)。
2.3 PSM后两组近期疗效比较
治疗后3个月，观察组ORR高于对照组，差异有统计学意义[66.7%(95%CI 46.0%~83.5%) vs. 29.6%(95%CI 13.8%~50.2%)，P=0.006]；两组DCR比较差异无统计学意义[96.3%(95%CI 81.0%~99.9%) vs. 85.2%(95%CI 66.3%~95.8%)，P=0.175，表2]。
2.4 PSM后两组长期疗效比较
截至2022年1月31日，观察组与对照组中位随访时间均为14个月。Kaplan-Meier生存曲线(图1)分析显示，观察组和对照组中位OS分别为18(95%CI 12.4~23.6)个月、15(95%CI 13.2~16.8)个月，中位PFS分别为8个月、5个月，差异均有统计学意义(P=0.007、0.003)；观察组和对照组6个月总生存率分别为96.3%、80.9%，1年总生存率分别为75.0%、61.4%，差异均有统计学意义(P=0.001、0.034)。
Cox回归分析显示，基线AFP≥400 ng/ml是影响晚期HCC患者生存期的独立危险因素(HR=4.091，95%CI 1.694~9.879)，而三联疗法、既往使用靶向药物是晚期HCC患者生存期的保护因素(HR<1，P<0.05，图2)。
2.5 PSM后两组不良反应发生情况
观察组中较多见的不良反应为消化不良(14.8%)、转氨酶升高(14.8%)、白细胞减少(14.8%)、腹泻(14.8%)、血小板减少(11.1%)、乏力(11.1%)等，其中4例出现3级不良反应(2例转氨酶升高，1例白细胞减少，1例血小板减少)，其余23例不良反应均小于3级。对照组中较多见的不良反应为手足综合征(18.5%)、白细胞减少(14.8%)、皮疹(14.8%)等，1例出现3级不良反应(血压升高)。观察组消化道反应(消化不良、腹泻、转氨酶升高)发生率较对照组增高(P=0.024、0.024、0.043)。两组患者2级及以上不良反应经治疗后均得到控制。两组不良反应发生率差异无统计学意义(P=0.639) (表3)。
3 讨论
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放射治疗是治疗晚期HCC的重要手段。SBRT是一种先进的放疗技术，在计算机控制及医学影像技术引导下，使得高剂量区域分布的形状在三维方向上与靶区的形状一致，在靶区周围放射剂量陡降，可最大程度地保护正常组织，具有精准定位、精准治疗、大分割、低分次的特点[17]。放射治疗可直接造成肿瘤细胞死亡，释放肿瘤抗原，诱导免疫反应；还可通过增加白细胞黏附因子和促炎趋化因子的释放促进免疫细胞向肿瘤部位的运输，增强免疫治疗的疗效[10,18]。大剂量照射可引起血管退化和塌陷，导致组织缺氧，激活血管内皮生长因子，诱导血管生成，进而产生血管反弹效应，这为抗血管生成药物提供了治疗契机。氧是有效的放射增敏剂，抗血管生成药物通过诱导血管正常化，增强肿瘤的血流和氧合，可提高放射治疗的疗效[19]。免疫治疗可导致具有血管调节活性的免疫亚群的招募，这可能成为抗血管生成治疗的靶点，而抗血管生成治疗可以增加免疫细胞对肿瘤的浸润，减轻肿瘤缺氧和肿瘤免疫微环境抑制状态[12]。由此推测，免疫治疗、放射治疗、抗血管生成药物三者在肿瘤治疗过程中互相影响，协同发挥作用。
本研究回顾性分析PSM后54例晚期HCC患者，观察组采用SBRT联合卡瑞利珠单抗、阿帕替尼三联疗法，对照组采用卡瑞利珠单抗和阿帕替尼二联疗法，结果初步表明SBRT可增强卡瑞利珠单抗和阿帕替尼的抗肿瘤作用。Chen等[13]评估大剂量照射、抗PD-L1和抗血管生成治疗对小鼠肺肿瘤的治疗效果，证实了三联疗法较二联疗法效果更佳，为三联疗法的临床研究提供了依据。一项关于帕博利珠单抗联合贝伐珠单抗及放射治疗胶质瘤的Ⅰ期临床试验显示，放射治疗联合抗血管生成药物可以提高ICIs治疗复发性胶质瘤的疗效，较单一免疫治疗疗效高，且不良反应可耐受[15]。既往晚期HCC的ORR控制不佳，索拉菲尼的ORR不到10%，但二联疗法的应用显著提高了HCC治疗效果，一项卡瑞利珠单抗联合阿帕替尼治疗晚期HCC的Ⅱ期多中心临床研究(RESCUE研究)结果显示，一线治疗的ORR达到34.3%[8]。本研究近期疗效结果显示，观察组ORR、DCR均明显高于对照组，表明以二联疗法为基础联合SBRT可显著提高晚期HCC的局部控制率和近期疗效。
虽然本研究OS未达到终点，但结果表明三联疗法可提高晚期HCC患者的1年总生存率，中位PFS也有所提高。Cox多因素回归分析显示，三联疗法是晚期HCC患者生存期的保护因素，进一步证实三联疗法可使患者受益。Zhong等[20]回顾性探讨了PD-1/PD-L1抑制剂联合姑息性放射治疗和抗血管生成治疗中晚期HCC的安全性，6个月和1年总生存率分别为96.3%和75.0%，与本研究结果基本一致；但ORR和DCR较本研究低，其原因可能为Zhong等[20]的研究中放射治疗方式较多，包括常规放射治疗、低分割放射治疗和SBRT，而本研究患者均采用大分割SBRT，治疗方式较单一，减少了因治疗方式差异而对结果造成的影响，且经过PSM处理混杂因素，结果更接近实际疗效。
AFP常用于HCC的诊断和预后监测。本研究多因素Cox回归分析结果显示，治疗前AFP≥400 ng/ml是导致晚期HCC患者死亡的危险因素之一，这可能与AFP可以刺激HCC细胞的增殖、迁移和侵袭有关，阻断AFP可以促进癌细胞凋亡[21]。AFP并非在HCC患者中均升高，约1/3的HCC患者无AFP升高，与本研究检测的31.5%相符。AFP水平在治疗前升高，在治疗后下降，可作为治疗有效的指标，若AFP水平在治疗前未升高，则不能用于监测治疗反应[22]。本研究分析两组AFP阳性患者治疗后1、3个月AFP应答率，结果显示，两组患者治疗后AFP应答率均升高，表明两组治疗均有效，治疗后1个月观察组AFP应答率低于对照组，但治疗后3个月高于对照组，其原因可能为SBRT对肝脏辐射损伤导致肝组织修复和肝细胞再生，致使血清AFP水平暂时升高，故起初观察组AFP应答率低于对照组，具体原因有待进一步研究。
本研究结果显示，观察组主要不良反应为消化不良(14.8%)、腹泻(14.8%)，均为0~2级不良反应；14.8%的患者出现转氨酶升高，其中2例为3级。三联疗法较二联疗法消化道反应(消化不良、腹泻、转氨酶升高)发生率增高(P=0.024、0.024、0.043)。但所有不良反应均可控，经治疗后可缓解，未造成治疗相关性死亡，初步表明三联疗法的不良反应可耐受。
综上所述，本研究结果表明，SBRT联合卡瑞利珠单抗、阿帕替尼治疗晚期HCC临床疗效显著，安全性可控。但本研究样本量较少，该结果仍需更多前瞻性、大样本研究加以验证。
基金
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  • 国家科技重大专项课题(2018ZX10303502-001)
  • 河南省医学科技攻关计划联合共建项目(2018020256)
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2023年第48卷第12期
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文章信息
doi: 10.11855/j.issn.0577-7402.1540.2023.0215
  • 接收时间：2022-07-15
  • 首发时间：2025-11-24
  • 出版时间：2023-12-28
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出版历史
  • 收稿日期：2022-07-15
  • 录用日期：2022-10-15
基金
National Science and Technology Major Project(2018ZX10303502-001)
国家科技重大专项课题(2018ZX10303502-001)
Henan Province Medical Science and Technology Research Program Joint Construction Project(2018020256)
河南省医学科技攻关计划联合共建项目(2018020256)
作者信息
    1郑州大学第五附属医院立体定向放射治疗中心，河南郑州 450000
    2郑州大学第五附属医院肿瘤内科，河南郑州 450000
    3郑州人民医院放疗科，河南郑州 450000

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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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