HE4 and CA125 serum biomarker monitoring in women with epithelial ovarian cancer.

Q3 Biochemistry, Genetics and Molecular Biology Tumor Biology Pub Date : 2022-01-01 DOI:10.3233/TUB-220016

Alexandra Samborski, M Craig Miller, Alexandra Blackman, Shannon MacLaughlan-David, Amanda Jackson, Geralyn Lambert-Messerlian, Rachel Rowswell-Turner, Richard G Moore

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引用次数: 7

Abstract

Background: CA125 is the gold standard serum biomarker for monitoring patients with epithelial ovarian cancer (EOC). Human epididymal protein 4 (HE4) is a novel serum biomarker for EOC patients.

Objective: The objective of this trial was to examine the utility of measuring serum HE4 levels for monitoring EOC patients and to compare HE4 performance parameters to serum CA125.

Methods: A retrospective trial using residual longitudinal serum samples drawn during treatment and monitoring from EOC patients. Serum CA125 and HE4 levels were analyzed at each time point, and a velocity of change was calculated and correlated with clinical status. The null hypothesis was that HE4 is inferior to CA125, and this was tested using concordance and two-sided Fisher's exact testing. McNemar's test was used to assess the overall agreement of the two assays with the clinical status.

Results: A total of 129 patients with 272 separate clinical periods and 1739 events (serum samples) were evaluated. Using a 25% change in serum biomarker levels to indicate change in disease status, the accuracy and NPV determined for HE4 versus CA125 were 81.8% versus 82.6% (p = 0.846) and 87.4% versus 89.7% (p = 0.082), respectively. Concordance comparison of HE4 accuracy / CA125 accuracy was 0.990, indicating HE4 was not inferior to CA125 (McNemar's test p-value = 0.522). Performing a velocity of change analysis, the accuracy and NPV determined for HE4 versus CA125 were 78.3% versus 78.6% (p = 0.995) and 74.9% versus 76.3% (p = 0.815), respectively. Concordance comparison of HE4 velocity accuracy / CA125 velocity accuracy was 0.996, again indicating HE4 was not inferior to CA125 (McNemar's test p-value = 0.884). The combination of HE4 and CA125 velocity changes showed a similar accuracy of 81.3% (p = 0.797 compared to HE4 and CA125 alone) and NPV of 81.1% (p≥0.172 compared to HE4 and CA125 alone), and an increased sensitivity of 70.5% (p≤0.070 compared to HE4 and CA125 alone).

Conclusion: HE4 is equivalent to CA125 for monitoring of EOC patients. The combination of CA125 and HE4 velocities is superior to either marker alone.

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上皮性卵巢癌妇女HE4和CA125血清生物标志物监测。

背景:CA125是监测上皮性卵巢癌(EOC)患者的金标准血清生物标志物。人附睾蛋白4 (HE4)是一种新的EOC患者血清生物标志物。目的:本试验的目的是检验测定血清HE4水平对监测EOC患者的效用，并将HE4性能参数与血清CA125进行比较。方法:回顾性试验，使用治疗和监测期间EOC患者的残留纵向血清样本。分析各时间点血清CA125、HE4水平，计算其变化速度并与临床状态相关。原假设是HE4低于CA125，并使用一致性和双侧Fisher精确检验进行了检验。McNemar试验用于评估两种测定法与临床状态的总体一致性。结果:共评估了129例患者的272个独立临床期和1739个事件(血清样本)。使用25%的血清生物标志物水平变化来指示疾病状态的变化，HE4和CA125测定的准确性和净pv分别为81.8%和82.6% (p = 0.846)和87.4%和89.7% (p = 0.082)。HE4准确度与CA125准确度的一致性比较为0.990，表明HE4不低于CA125 (McNemar检验p值= 0.522)。通过变化速度分析，测定的HE4和CA125的准确性和净现值分别为78.3%和78.6% (p = 0.995)和74.9%和76.3% (p = 0.815)。HE4速度精度与CA125速度精度的一致性比较为0.996，再次表明HE4不低于CA125 (McNemar检验p值= 0.884)。HE4和CA125联合检测速度变化的准确率为81.3%(与HE4和CA125单独比较p = 0.797)， NPV为81.1%(与HE4和CA125单独比较p≥0.172)，敏感性增加70.5%(与HE4和CA125单独比较p≤0.070)。结论:HE4与CA125在EOC患者监测中的作用相当。CA125和HE4的结合速度优于单独使用任何一种标记物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Tumor Biology 医学-肿瘤学

CiteScore

5.40

自引率

0.00%

发文量

审稿时长

1 months

期刊介绍： Tumor Biology is a peer reviewed, international journal providing an open access forum for experimental and clinical cancer research. Tumor Biology covers all aspects of tumor markers, molecular biomarkers, tumor targeting, and mechanisms of tumor development and progression. Specific topics of interest include, but are not limited to: Pathway analyses, Non-coding RNAs, Circulating tumor cells, Liquid biopsies, Exosomes, Epigenetics, Cancer stem cells, Tumor immunology and immunotherapy, Tumor microenvironment, Targeted therapies, Therapy resistance Cancer genetics, Cancer risk screening. Studies in other areas of basic, clinical and translational cancer research are also considered in order to promote connections and discoveries across different disciplines. The journal publishes original articles, reviews, commentaries and guidelines on tumor marker use. All submissions are subject to rigorous peer review and are selected on the basis of whether the research is sound and deserves publication. Tumor Biology is the Official Journal of the International Society of Oncology and BioMarkers (ISOBM).