mRECIST与iRECIST标准评价肝细胞癌免疫治疗疗效的对比研究  

Comparison of mRECIST and iRECIST criteria in evaluating the efficacy of immunotherapy for hepatocellular carcinoma

作　　者：卢红 陈伟 王健 吴宗乾 刘赫 胡晓飞 王田 LU Hong;CHEN Wei;WANG Jian;WU Zongqian;LIU He;HU Xiaofei;WANG Tian(Department of Radiology,the First Affiliated Hospital of Army Medical University,Chongqing 400038,China;Department of Nuclear Medicine,the First Affiliated Hospital of Army Medical University,Chongqing 400038,China;Department of Burn and Plastic Surgery,the Affiliated Hospital of Sergeant School,Army Medical University,Shijiazhuang 050047,China)

机构地区：[1]中国人民解放军陆军军医大学第一附属医院放射科,重庆400038 [2]中国人民解放军陆军军医大学第一附属医院核医学科,重庆400038 [3]中国人民解放军陆军军医大学士官学校附属医院烧伤整形科,河北石家庄050047

出　　处：《中国普通外科杂志》2023年第7期1023-1031,共9页China Journal of General Surgery

摘　　要：背景与目的:目前免疫治疗逐渐成为肝细胞癌(HCC)患者新的全身治疗方法之一,其治疗效果得到了临床肯定,但是其治疗效果的影像学评估方法仍在不断摸索中,并且影像学评估能有效为临床确定免疫新辅助治疗的主要临床终点提供充足的证据。本研究分析对比实体瘤免疫治疗疗效评价标准(iRECIST)和修订后实体瘤疗效评价标准(mRECIST)对HCC免疫治疗疗效的评价,以期找到更适合HCC免疫治疗疗效的影像学评估方法,便于临床医生制订个体化精准治疗方案。方法:回顾性分析2017—2021年间中国人民解放军陆军军医大学第一附属医院收治行PD-L1单抗免疫治疗HCC患者临床资料,其中男性58例,女性9例。CT或MRI动态增强扫描临床影像学资料包括治疗前1周内及治疗后2、4个月3个时间点。分别采用iRECIST和mRECIST标准进行疗效评估,对比检测两种疗效标准评估结果的差异。结果:PD-L1单抗免疫治疗后2、4个月复查,两种标准疗效评估结果差异有统计学意义(P<0.01);两种评估方法差异主要体现在客观缓解率(ORR),两次复查结果,mRECIST标准ORR所占比例均明显大于iRECIST标准的ORR所占比例,差异有统计学意义(P<0.01);大部分mRECIST标准评估为完全缓解或部分缓解的患者采用iRECIST标准评估为稳定;这两种不同的评估方法均有50%左右患者在初次评定为进展的情况下继续治疗而达到稳定状态或者部分缓解状态。结论:mRECIST标准测量时避开液化坏死区,以“存活肿瘤”对靶病灶进行疗效评价的方式更加客观、科学,避免因肿瘤大小变化不明显但肿瘤负荷明显减少而低估治疗效果。而iRECIST标准提出了未确认的疾病进展和确认的疾病进展的概念,更适用于免疫治疗过程中出现的假性进展等特有反应,故建议在采用mRECIST标准评估“存活肿瘤”的同时应该借鉴iRECIST标准的循环持续评估的模式,对使用mRECIST标�Background and Aims:Immunotherapy is emerging as a new systemic treatment method for patients with hepatocellular carcinoma(HCC),with its clinically recognized therapeutic effects.However,imaging evaluation methods for assessing treatment response are still being explored.Imaging assessment is crucial in providing sufficient evidence for determining the primary clinical endpoints of immunotherapy in clinical practice.This study analyzes and compares the efficacy evaluation of immunotherapy in HCC using the Immune-Related Response Evaluation Criteria in Solid Tumors(iRECIST)and the modified Response Evaluation Criteria in Solid Tumors(mRECIST),aims to find a more suitable imaging assessment method for immunotherapy efficacy in HCC and facilitate the development of individualized and precise treatment plans by clinical physicians.Methods:A retrospective analysis of clinical data from HCC patients who received PD-L1 monoclonal antibody immunotherapy at the First Affiliated Hospital of the Army Medical University from 2017 to 2021 was conducted.Of the patients,58 were males,and 9 were females.Clinical imaging data from CT or MRI dynamic contrast-enhanced scans were collected at three time points:one week before treatment and two and four months after treatment initiation.The efficacy evaluations were performed using both iRECIST and mRECIST criteria,and the differences in the evaluation results between the two criteria were compared.Results:Evaluation of immunotherapy efficacy using iRECIST and mRECIST criteria two and four months after PD-L1 monoclonal antibody treatment showed statistically significant differences(P<0.01).The main discrepancy between the two evaluation methods was observed in the objective response rate(ORR),with mRECIST showing a significantly higher ORR compared to iRECIST(P<0.01).Many patients who were classified as achieving complete or partial response using mRECIST were categorized as stable diseases according to iRECIST.Both evaluation methods indicated that approximately 50%of patients init

关 键 词：癌 肝细胞 免疫疗法 诊断显像 实体肿瘤疗效评价标准 

分 类 号：R735.7[医药卫生—肿瘤]