新型多重免疫测定和自动化荧光偏振免疫分析技术平台上乳腺癌肿瘤标志物的方法比较及临床性能

Method Comparison and Clinical Performance of Breast Cancer Tumor Markers on Novel Multiplex Immunoassay and Automatized LOCI Technology Platforms.

作者信息

Schröder Lars, Mallmann Michael R, Domroese Christian M, Wefers Natalie, Dolscheid-Pommerich Ramona, Stoffel-Wagner Birgit, Trulson Inga, Vahldiek Kai, Klawonn Frank, Holdenrieder Stefan

机构信息

Department of Gynecology, Ketteler-Hospital Offenbach, 63071 Offenbach, Germany.

Department of Gynecology, University Hospital Bonn, 53127 Bonn, Germany.

出版信息

Diagnostics (Basel). 2023 Sep 30;13(19):3101. doi: 10.3390/diagnostics13193101.

DOI:10.3390/diagnostics13193101

PMID:37835844

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10572608/

Abstract

Tumor marker determinations are valuable tools for the guidance of breast cancer patients during the course of disease. They are assessed on diverse analytical platforms that may be associated with differences according to the methods applied and the clinical performance. To investigate the method dependency and clinical significance of breast cancer protein tumor markers, CEA, CA 15-3, CA 125, CA 19-9 and AFP were measured in a total of 154 biobanked samples from 77 patients with breast cancer, 10 with DCIS, 31 with benign breast diseases and 36 healthy controls using a Millipore multiplex biomarker panel (MP) and an automized version of the routinely used Vista LOCI technology. The markers were compared between methods and investigated for diagnostic performance. CEA, CA 15-3 and AFP showed good correlations between both platforms with correlation coefficients of R = 0.85, 0.85 and 0.92, respectively, in all samples, but similarly also in the various subgroups. CA 125 and CA 19-9 showed only moderate correlations (R = 0.71 and 0.56, respectively). Absolute values were significantly higher for CEA, CA 15-3, CA 125 and AFP in the Vista LOCI as compared with the MP method and vice versa for CA 19-9. The diagnostic performance for discrimination of breast cancer from healthy controls was similar for both methods with AUCs in ROC curves for CEA (MP 0.81, 95% CI 0.72-0.91; LOCI 0.81; 95% CI 0.72-0.91) and CA-15-3 (MP 0.75, 95% CI 0.65-0.86; LOCI 0.67, 95% CI 0.54-0.79). Similar results were obtained for the comparison of breast cancer with benign breast diseases regarding CEA (AUC MP 0.62, 95% CI 0.51-0.73; LOCI 0.64, 95% CI 0.53-0.74) and CA-15-3 (MP 0.70, 95% CI 0.6-0.81; LOCI 0.66, 95% CI 0.54-0.77). Both platforms show moderate to good method comparability for tumor markers with similar clinical performance. However, absolute levels in individual patients should be interpreted with care.

摘要

肿瘤标志物检测是指导乳腺癌患者病程的重要工具。它们在不同的分析平台上进行评估，这些平台可能因应用的方法和临床性能而存在差异。为了研究乳腺癌蛋白质肿瘤标志物的方法依赖性和临床意义，使用密理博多重生物标志物检测板（MP）和常规使用的Vista LOCI技术的自动化版本，对来自77例乳腺癌患者、10例导管原位癌患者、31例乳腺良性疾病患者和36例健康对照的总共154份生物样本库样本中的癌胚抗原（CEA）、糖类抗原15-3（CA 15-3）、糖类抗原125（CA 125）、糖类抗原19-9（CA 19-9）和甲胎蛋白（AFP）进行了检测。对两种方法的标志物进行了比较，并研究了其诊断性能。在所有样本中，CEA、CA 15-3和AFP在两个平台之间显示出良好的相关性，相关系数分别为R = 0.85、0.85和0.92，在各个亚组中也是如此。CA 125和CA 19-9仅显示出中等相关性（分别为R = 0.71和0.56）。与MP方法相比，Vista LOCI中CEA、CA 15-3、CA 125和AFP的绝对值显著更高，而CA 19-9则相反。两种方法区分乳腺癌与健康对照的诊断性能相似，CEA的ROC曲线下面积（AUC）在MP法中为0.81（95%可信区间0.72 - 0.91），在LOCI法中为0.81（95%可信区间0.72 - 0.91）；CA-15-3在MP法中为0.75（95%可信区间0.65 - 0.86），在LOCI法中为0.67（95%可信区间0.54 - 0.79）。在比较乳腺癌与乳腺良性疾病时，CEA（AUC MP 0.62，95%可信区间0.51 - 0.73；LOCI 0.64，95%可信区间0.53 - 0.74）和CA-15-3（MP 0.70，95%可信区间0.6 - 0.81；LOCI 0.66，95%可信区间0.54 - 0.77）也得到了类似结果。两个平台对肿瘤标志物显示出中等至良好的方法可比性，临床性能相似。然而，对个体患者的绝对水平应谨慎解读。