经肝动脉区域性治疗原发性肝癌的影像反应与临床结果。

Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma.

机构信息

Department of Radiology, Northwestern Memorial Hospital, Robert H. Lurie Comprehensive Cancer Center, Chicago, IL, USA.

出版信息

JAMA. 2010 Mar 17;303(11):1062-9. doi: 10.1001/jama.2010.262.

DOI:10.1001/jama.2010.262

PMID:20233824

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3117395/

Abstract

CONTEXT

Response Evaluation Criteria in Solid Tumors (RECIST) (unidimensional), World Health Organization (WHO) (bidimensional), and European Association for Study of the Liver (EASL) (necrosis) guidelines are commonly used to assess response following therapy for hepatocellular carcinoma (HCC). No universally accepted standard exists.

OBJECTIVES

To evaluate intermethod agreement between these 3 imaging guidelines and to introduce the concept of the "primary index lesion" as a biomarker for response.

DESIGN, SETTING, AND PARTICIPANTS: Single-center comprehensive imaging analysis including 245 consecutive patients with HCC who were treated with chemoembolization or radioembolization between January 2000 and December 2008. Computed tomography and magnetic resonance imaging scans (N = 1065) were reviewed to assess response in the "primary index lesion," defined as the largest tumor targeted during first treatment.

MAIN OUTCOME MEASURES

Intermethod agreement (kappa statistics) between RECIST, WHO, and EASL guidelines response; correlation of WHO and EASL response in the primary index lesion with time to progression and survival.

RESULTS

Kappa coefficients were 0.86 (95% confidence interval [CI], 0.80-0.92) between the WHO and RECIST guidelines, 0.24 (95% CI, 0.16-0.33) between RECIST and EASL, and 0.28 (95% CI, 0.19-0.36) between WHO and EASL. Disease progressed in 96 patients; 113 died. The hazard ratio for time to progression in responders compared with nonresponders was 0.36 (95% CI, 0.23-0.57) for WHO, 0.38 (95% CI, 0.24-0.58) for RECIST, and 0.38 (95% CI, 0.22-0.64) for EASL. Hazard ratios for survival in responders compared with nonresponders in univariate and multivariate analyses were 0.46 (95% CI, 0.32-0.67) and 0.55 (95% CI, 0.35-0.84) for WHO and 0.36 (95% CI, 0.22-0.57) and 0.54 (95% CI, 0.34-0.85) for EASL. Hazard ratios for survival in responders vs nonresponders in patients with solitary and multifocal HCC were 0.39 (95% CI, 0.19-0.77) and 0.51 (95% CI, 0.32-0.82) for WHO and 0.26 (95% CI, 0.10-0.67) and 0.47 (95% CI, 0.28-0.79) for EASL.

CONCLUSIONS

Among a group of patients with HCC, agreement for classification of therapeutic response was high between the RECIST and WHO guidelines but low between each of these and EASL. Application of these methods to measure response in a primary index lesion resulted in statistically significant correlations with disease progression and survival.

摘要

背景

实体瘤反应评估标准（RECIST）（单维）、世界卫生组织（WHO）（二维）和欧洲肝脏研究协会（EASL）（坏死）指南常用于评估肝癌（HCC）治疗后的反应。目前尚无普遍接受的标准。

目的

评估这 3 种影像学指南之间的方法间一致性，并引入“主要指标病变”的概念作为反应的生物标志物。

设计、地点和参与者：对 2000 年 1 月至 2008 年 12 月期间接受化疗栓塞或放射栓塞治疗的 245 例 HCC 连续患者进行了单中心综合影像学分析。回顾了计算机断层扫描和磁共振成像扫描（N=1065），以评估首次治疗中靶向的最大肿瘤“主要指标病变”的反应。

主要观察指标

RECIST、WHO 和 EASL 指南反应之间的方法间一致性（kappa 统计）；WHO 和 EASL 在主要指标病变中的反应与进展时间和生存的相关性。

结果

WHO 和 RECIST 指南间的kappa 系数为 0.86（95%置信区间[CI]，0.80-0.92），RECIST 和 EASL 指南间为 0.24（95% CI，0.16-0.33），WHO 和 EASL 指南间为 0.28（95% CI，0.19-0.36）。96 例患者疾病进展，113 例患者死亡。与非应答者相比，应答者的进展时间风险比为 WHO 为 0.36（95% CI，0.23-0.57），RECIST 为 0.38（95% CI，0.24-0.58），EASL 为 0.38（95% CI，0.22-0.64）。在单因素和多因素分析中，与非应答者相比，应答者的生存风险比为 WHO 为 0.46（95% CI，0.32-0.67）和 0.55（95% CI，0.35-0.84），EASL 为 0.36（95% CI，0.22-0.57）和 0.54（95% CI，0.34-0.85）。在单发和多发 HCC 患者中，与非应答者相比，应答者的生存风险比为 WHO 为 0.39（95% CI，0.19-0.77）和 0.51（95% CI，0.32-0.82），EASL 为 0.26（95% CI，0.10-0.67）和 0.47（95% CI，0.28-0.79）。