Department of Medical and Surgical Sciences, University of Bologna, via Massarenti 9, Bologna, Italy.
Radiology Unit, S.Orsola-Malpighi Bologna Authority Hospital, Bologna, Italy.
Eur Radiol. 2018 Sep;28(9):3611-3620. doi: 10.1007/s00330-018-5393-3. Epub 2018 Apr 9.
To assess the inter-operator concordance and the potential sources of discordance in defining response to sorafenib in hepatocellular carcinoma (HCC).
All patients who received sorafenib between September 2008 and February 2015 were scrutinised for this retrospective study. Images were evaluated separately by three radiologists with different expertise in liver imaging (operator 1, >10 years; operator 2, 5 years; operator 3, no specific training in liver imaging), according to: response evaluation radiological criteria in solid tumours (RECIST) 1.1, modified RECIST (mRECIST) and response evaluation criteria in cancer of the liver (RECICL).
The overall response concordance between the more expert operators was good, irrespective of the criteria (RECIST 1.1, ĸ = 0.840; mRECIST, ĸ = 0.871; RECICL, ĸ = 0.819). Concordance between the less expert operator and the other colleagues was lower. The most evident discordance was in target lesion response assessment, with expert operators disagreeing mostly on lesion selection and less expert operators on lesion measurement. As a clinical correlate, overall survival was more tightly related with "progressive disease" as assessed by the expert compared to the same assessment performed by operator 3.
Decision on whether a patient is a responder or progressor under sorafenib may vary among different operators, especially in case of a non-specifically trained radiologist. Regardless of the adopted criteria, patients should be evaluated by experienced radiologists to minimise variability in this critical instance.
• Inter-operator variability in the assessment of response to sorafenib is poorly known. • The concordance between operators with expertise in liver imaging was good. • Target lesions selection was the main source of discordance between expert operators. • Concordance with non-specifically trained operator was lower, independently from the response criteria. • The non-specifically trained operator was mainly discordant in measurements of target lesions.
评估在肝细胞癌（HCC）中定义索拉非尼反应的观察者间一致性和潜在的不一致来源。
对 2008 年 9 月至 2015 年 2 月期间接受索拉非尼治疗的所有患者进行了这项回顾性研究。根据实体瘤反应评估标准（RECIST）1.1、改良 RECIST（mRECIST）和肝癌反应评估标准（RECICL），由三位具有不同肝脏成像专业知识的放射科医生（医生 1，>10 年；医生 2，5 年；医生 3，无肝脏成像特定培训）分别单独评估图像。
无论采用何种标准（RECIST 1.1，κ=0.840；mRECIST，κ=0.871；RECICL，κ=0.819），更有经验的医生之间的总体反应一致性较好。与其他同事相比，经验较少的医生的一致性较低。最明显的差异是在靶病灶反应评估方面，专家医生主要在病灶选择上存在分歧，经验较少的医生则在病灶测量上存在分歧。作为临床相关性，与由医生 3进行的相同评估相比，专家医生评估的“进展性疾病”与总生存期的相关性更紧密。
在索拉非尼治疗下，患者是否为应答者或进展者的决定可能因不同的医生而异，特别是在没有接受过特定培训的放射科医生的情况下。无论采用何种标准，为了最大限度地减少这种关键情况下的变异性，都应让有经验的放射科医生对患者进行评估。
评估索拉非尼反应的观察者间变异性知之甚少。
具有肝脏成像专业知识的医生之间的一致性较好。
靶病灶选择是专家医生之间差异的主要来源。
与未接受特定培训的医生相比，一致性较低，与反应标准无关。
未接受特定培训的医生主要在靶病灶的测量上存在差异。
