索拉非尼治疗患者中欧洲肝脏研究学会标准和改良实体瘤反应评估标准的重现性。
Reproducibility of European Association for the Study of the Liver criteria and modified Response Evaluation Criteria in Solid Tumors in patients treated with sorafenib.
机构信息
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Yonsei Liver Cancer, Severance Hosipital, Seoul, Korea.
出版信息
Liver Int. 2018 Sep;38(9):1655-1663. doi: 10.1111/liv.13731. Epub 2018 Mar 31.
BACKGROUND & AIMS: The European Association for the Study of the Liver criteria and the modified Response Evaluation Criteria in Solid Tumors are used for assessing the treatment outcomes of hepatocellular carcinoma. We investigated the inter- and intra-observer reproducibility of the European Association for the Study of the Liver criteria and modified Response Evaluation Criteria in Solid Tumors in patients with advanced hepatocellular carcinoma treated with sorafenib.
METHODS
A total of 99 patients with treatment-naive advanced hepatocellular carcinoma receiving sorafenib were included. The κ-values for the inter- and intra-observer agreement of the treatment response were calculated.
RESULTS
Inter-observer agreement for baseline tumour number was excellent, as reflected by the high κ-value. The κ-statistics showed "excellent" concordance between the 2 sets of measurements by observer A regarding the overall responses using the European Association for the Study of the Liver criteria (κ = .948, agreement rate = 84.8%) and modified Response Evaluation Criteria in Solid Tumors (κ = .944, agreement rate = 83.8%; all P < .001). In addition, high κ-values indicated concordance between the first sets of measurements by observers A and B (κ = .991 by the European Association for the Study of the Liver criteria and .988 by modified Response Evaluation Criteria in Solid Tumors, all P < .001). When agreements in radiological overall responses between the 2 sets of measurements by observer B and between the second sets of measurements by observers A and B were calculated, similar results regarding high κ-values (>.8) were obtained.
CONCLUSIONS
The reproducibility of the European Association for the Study of the Liver criteria and modified Response Evaluation Criteria in Solid Tumors in assessing treatment outcomes was high in patients with advanced hepatocellular carcinoma treated with sorafenib.
背景与目的
欧洲肝脏研究学会标准和改良实体瘤反应评价标准用于评估肝细胞癌的治疗效果。我们研究了索拉非尼治疗的晚期肝细胞癌患者中欧洲肝脏研究学会标准和改良实体瘤反应评价标准的观察者内和观察者间的可重复性。
方法
共纳入 99 例接受索拉非尼治疗的初治晚期肝细胞癌患者。计算了治疗反应的观察者内和观察者间一致性 κ 值。
结果
基线肿瘤数量的观察者间一致性极好，反映出 κ 值很高。观察者 A 对使用欧洲肝脏研究学会标准（κ=0.948，一致性率=84.8%）和改良实体瘤反应评价标准（κ=0.944，一致性率=83.8%；均 P<0.001）的整体反应的两组测量之间的 κ 统计显示“极好”的一致性。此外，观察者 A 和 B 的第一组测量之间的高 κ 值表明一致性（欧洲肝脏研究学会标准为 κ=0.991，改良实体瘤反应评价标准为 κ=0.988，均 P<0.001）。当计算观察者 B 的两组测量之间和观察者 A 和 B 的第二组测量之间的影像学整体反应的一致性时，获得了关于高 κ 值（>.8）的类似结果。
结论
在接受索拉非尼治疗的晚期肝细胞癌患者中，欧洲肝脏研究学会标准和改良实体瘤反应评价标准评估治疗效果的可重复性很高。
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