Department of Laboratory Medicine, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Clin Chim Acta. 2018 Dec;487:6-14. doi: 10.1016/j.cca.2018.09.015. Epub 2018 Sep 8.
Serum-based tumor biomarkers are used to monitor cancer treatment, while clear guidance on the clinical usage is often lacking. We describe a graphical presentation to support diagnostic accuracy studies and clinical interpretation of longitudinal biomarker data.
A biomarker response characteristic (BReC) plot was designed. To allow demonstration of the BReC plot application, software was developed that supported 1) dynamic generation of BReC plots, and 2) diagnostic accuracy studies of biomarker response-based medical tests. The BReC plot application was demonstrated using serial carcinoembryonic antigen (CEA) and Cyfra 21.1 results from 216 patients with metastasized non-small cell lung cancer, treated with Nivolumab in routine clinical practice.
The developed software supported the generation of BReC plots and diagnostic validation of biomarker response-based medical tests by generating the sensitivity, specificity and predictive values. Obtained BReC plots showed a clear relationship between clinical outcome and CEA and Cyfra 21.1 responses. Furthermore, using BReC plots, CEA and Cyfra 21.1 based medical tests were designed with a sensitivity for detection of treatment failure of 0.34 and 0.35 and a specificity of 0.96.
The BReC plot appears to support diagnostic validation studies and the interpretation of longitudinal biomarkers though further validation is warranted.
基于血清的肿瘤标志物用于监测癌症治疗，但通常缺乏对其临床应用的明确指导。我们描述了一种图形表示方法，以支持诊断准确性研究和对纵向生物标志物数据的临床解释。
设计了生物标志物反应特征（BReC）图。为了能够展示 BReC 图的应用，开发了软件，该软件支持 1）BReC 图的动态生成，2）基于生物标志物反应的医学测试的诊断准确性研究。使用来自 216 名转移性非小细胞肺癌患者的连续癌胚抗原（CEA）和细胞角蛋白 21.1 结果演示了 BReC 图的应用，这些患者在常规临床实践中接受了 Nivolumab 治疗。
开发的软件通过生成敏感性、特异性和预测值，支持 BReC 图的生成和基于生物标志物反应的医学测试的诊断验证。获得的 BReC 图清楚地显示了临床结果与 CEA 和 Cyfra 21.1 反应之间的关系。此外，使用 BReC 图，设计了基于 CEA 和 Cyfra 21.1 的医疗测试，其检测治疗失败的敏感性分别为 0.34 和 0.35，特异性为 0.96。
BReC 图似乎支持诊断验证研究和对纵向生物标志物的解释，但需要进一步验证。
