摘要
目的评价免疫检查点抑制剂(ICIs)联合抗血管生成治疗不可切除或中晚期肝癌的临床效果及安全性。方法检索Pubmed、Embase、Web of science、ClinicalTrails.gov、中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普中文科技期刊系统数据库(VIP)、万方数据资源系统等数据库及中国临床实验注册中心,纳入评价ICIs联合抗血管生成方案治疗不可切除肝癌的随机对照研究或回顾性研究。检索时限为建库至2022年2月10日,文献资料经过筛选、提取及偏倚风险评价后,采用RevMan 5.3软件及Stata 14.0软件进行meta分析。结果共纳入9项研究,包括1707例肝细胞癌患者。meta分析结果显示,联合治疗组的无进展生存期[危险比值(HR)=0.46,95%置信区间(95%CI)=0.35~0.60,P<0.01]、总生存期(HR=0.52,95%CI=0.41~0.64,P<0.05)较对照组明显延长,客观缓解率[相对危险度(RR)=1.72,95%CI=1.28~2.30,P<0.01]、疾病控制率(RR=1.36,95%CI=1.14~1.63,P<0.01)明显高于对照组。联合治疗组的不良反应发生率与对照组相似(RR=0.99,95%CI=0.95~1.03,P=0.59),其中高血压(RR=1.58,95%CI=1.14~2.18,P<0.01)和甲状腺功能减退(RR=6.79,95%CI=2.31~20.01,P<0.01)的发生率高于对照组,而两组在胃肠道反应(恶心、呕吐、腹泻)、皮疹、食欲减退、肝功能损伤(转氨酶升高)等方面的发生率无差异(P>0.05)。结论免疫检查点抑制剂联合抗血管新生治疗不可切除肝癌的临床效果显著,安全性可接受。
Objective To evaluate the clinical efficacy and safety of immune checkpoint inhibitors(ICIs)combined with anti-angiogenesis in the treatment of unresectable or advanced liver cancer.Methods Databases such as Pubmed,Embase,Web of science,ClinicalTrails.gov,CBM,CNKI,VIP,Wanfang Data Resource System and China Clinical Experiment Registration Center were searched.Randomized controlled studies or retrospective studies evaluating ICIs combined with anti-angiogenic regimen in the treatment of unresectable liver cancer were included.The search time limit was from the establishment of the database to February 10,2022.After the literature was screened,extracted,and assessed for risk of bias,Rev Man5.3 software and STATA14 software were used for meta-analysis.Results A total of nine studies including 1707 patients with hepatocellular carcinoma were included.The results of meta-analysis showed that the progression-free survival(HR=0.46,95%CI=0.35-0.60,P<0.01)and overall survival(HR=0.52,95%CI=0.41-0.64,P<0.01)of the combination therapy group were significantly longer than those of the single-drug group,and the objective response rate(RR=1.72,95%CI=1.28-2.30,P<0.01)and disease control rate(RR=1.36,95%CI=1.14-1.63,P<0.01)were significantly higher than those of the single-drug group.The incidence of adverse reactions(RR=0.99,95%CI=0.95-1.03,P=0.59)in the combined treatment group was similar to that in the control group,and the incidence of hypertension(RR=1.58,95%CI=1.14-2.18,P<0.01)and hypothyroidism(RR=6.79,95%CI=2.31-20.01,P<0.01)were higher than those in the control group.However,there were no differences between the two groups in terms of gastrointestinal reactions(nausea,vomiting,diarrhea),rash,loss of appetite,and liver function damage(transaminase elevation)were higher than those in the control group(P>0.05).Conclusion Immune checkpoint inhibitors combined with anti-angiogenesis have a significant clinical effect and acceptable safety in the treatment of unresectable liver cancer.
作者
鲜枫
张弛
许国辉
XIAN Feng;ZHANG Chi;XU Guohui(Nanchong Central Hospital Tumor Center,Nanchong,Sichuang 637000,China;School of Medicine,University of Electronic Science and Technology of China,Chengdu,Sichuan 611731,China;Department of Intervention,Sichuan Cancer Hospital,Chengdu,Sichuan 610042,China)
出处
《重庆医学》
CAS
2023年第4期569-575,共7页
Chongqing medicine
基金
北京医学奖励基金会课题(YXJL-2020-0972-0424)。
