摘要
目的 评价信迪利单抗治疗晚期肝细胞癌(hepatocellular carcinoma,HCC)的疗效及其安全性。方法 收集2018年1月至2021年5月巴州人民医院收治的晚期不可切除HCC患者70例,随机分为对照组38例和联合组32例。对照组采用TACE+索拉非尼方案;联合组采用TACE+索拉非尼+信迪利单抗,于TACE术后第3天静脉滴注信迪利单抗200 mg,每3周给药1次。观察无进展生存时间(progression-free survival,PFS)、总生存期(overall survival,OS)、客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、不良反应、甲胎蛋白(AFP)及生活质量(quality of life, QOL)评分。结果 联合组的PFS为11.90(6.46,17.34)个月,高于对照组的4.70(0,11.34)个月,差异有统计学意义(Z=4.013,P=0.045)。联合组的OS未到达足够50%死亡的数据,对照组为11.90(0,23.83)个月,差异有统计学意义(Z=4.511,P=0.045)。联合组ORR和DCR分别为34.3%和75.0%,均高于对照组的31.6%和71.1%,但差异无统计学意义(χ^(2)=0.062、0.137,P=0.804、0.711)。联合组中甲状腺功能减低、低蛋白血症、白细胞减少的比例分别为28.1%、34.4%、34.4%,高于对照组的7.9%、10.5%、13.2%,差异有统计学意义(χ^(2)=5.005、5.868、4.435,P=0.025、0.015、0.035)。随访2~24周,两组患者QOL评分有逐渐增高的趋势,但是组内比较,差异均无统计学意义(F=1.437、1.495,P=0.201、0.181);AFP逐渐下降,组内比较差异均有统计学意义(Z=29.474、51.195,均P<0.01)。随访第0、2、4、6周时,对照组与联合组的AFP比较,差异均无统计学意义(P>0.05),但随访第8、16、24周时,联合组低于对照组,且差异均有统计学意义(Z=-2.247、-2.665、-3.130,P=0.025、0.008、0.002)。结论 TACE+索拉非尼+信迪利单抗方案对晚期HCC的疗效优于TACE+索拉非尼方案,且安全性较好。
Objective To evaluate the clinical efficacy and safety of sintilimab in the treatment of advanced hepatocellular carcinoma(HCC).Methods A total of 70 patients with unresectable advanced HCC,who were admitted to the People's Hospital of Bayingolin Mongolian Autonomous Prefecture of China between January 2018 and May 2021,were collected.The patients were randomly divided into the control group(n=38)and combination group(n=32).Transarterial chemoembolization(TACE)+sorafenib regimen was employed for the patients of the control group,while TACE+sorafenib+sintilimab regimen was adopted for the patients of the combination group.Intravenous infusion of sintilimab 200 mg was started on the third day after TACE,which was repeated administered once every 3 weeks.The progression-free survival(PFS),overall survival(OS),objective response rate(ORR),disease control rate(DCR),adverse reactions,AFP level and quality of life(QOL)score were recorded.ResultsTThe median PFS in the combination group was 11.90(6.46,17.34)months,which was longer than 4.70(0,11.34)months in the control group,and the difference between the two groups was statistically significant(Z=4.013,P-0.045).The median OS in the combination group didn't reach enough data of 50%deaths,which in the control group was 11.90(0,23.83)months,and the difference between the two groups was statistically significant(Z-4.511,P=0.045).The ORR and DCR in the combination group were 34.3%and 75.0%respectively,which were higher than 31.6%and 71.1%respectively in the control group,but the differences between the two groups were not statistically significant(=0.062,P=0.804 and χ^(2)=0.137,P=0.711,respectively).In the combination group,the incidences of hypothyroidism,hypoproteinemia and leukopenia were 28.1%,34.4%and 34.4%respectively,which were remarkably higher than 7.9%,10.5%and 13.2%respectively in the control group,and the differences between the two groups were statistically significant(χ^(2)=5.005 and P=-0.025,χ^(2)=5.868 and P=0.015,χ^(2)=4.435 and P=0.035,respectively).Dur
作者
谭永华
蔡江霞
刘慧利
刘煜
张静
TAN Yonghua;CAI Jiangxia;LIU Huili;LIU Yu;ZHANG Jing(Interventional Department,People’s Hospital of Bayingolin Mongolian Autonomous Prefecture,Korla,Xinjiang Uygur Autonomous Region 841099,China)
出处
《介入放射学杂志》
CSCD
北大核心
2023年第8期750-754,共5页
Journal of Interventional Radiology
基金
新疆维吾尔自治区卫生健康青年医学科技人才专项研究项目(WJWY-202108)
巴州科学技术研究项目(202018)。
关键词
肝细胞癌
信迪利单抗
免疫治疗
hepatocellular carcinoma
sintilimab
immunotherapy
