Department of Medical Laboratory Sciences, Student Research Committee, School of Allied Medical Science, Mazandaran University of Medical Sciences, Sari, Iran.
Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.
BMC Cancer. 2020 Oct 31;20(1):1049. doi: 10.1186/s12885-020-07545-2.
Measurement of serum human epidermal growth factor receptor-2 (HER-2/neu) levels might play an essential role as a diagnostic/screening marker for the early selection of therapeutic approaches and predict prognosis in breast cancer patients. We aimed to undertake a systematic review and meta-analysis focusing on the diagnostic/screening value of serum HER-2 levels in comparison to routine methods.
We performed a systematic search via PubMed, Scopus, Cochrane-Library, and Web of Science databases for human diagnostic studies reporting the levels of serum HER-2 in breast cancer patients, which was confirmed using the histopathological examination. Meta-analyses were carried out for sensitivity, specificity, accuracy, area under the ROC curve (AUC), positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR).
Fourteen studies entered into this investigation. The meta-analysis indicated the low sensitivity for serum HER2 levels (Sensitivity: 53.05, 95%CI 40.82-65.28), but reasonable specificity of 79.27 (95%CI 73.02-85.51), accuracy of 72.06 (95%CI 67.04-77.08) and AUC of 0.79 (95%CI 0.66-0.92). We also found a significant differences for PPV (PPV: 56.18, 95%CI 44.16-68.20), NPV (NPV: 76.93, 95%CI 69.56-84.31), PLR (PLR: 2.10, 95%CI 1.69-2.50) and NLR (NLR: 0.58, 95%CI 0.44-0.71).
Our findings revealed that although serum HER-2 levels showed low se nsitivity for breast cancer diagnosis, its specificity, accuracy and AUC were reasonable. Hence, it seems that the measurement of serum HER-2 levels can play a significant role as a verification test for initial negative screening test results, especially in low-income regions due to its cost-effectiveness and ease of implementation.
血清人表皮生长因子受体-2（HER-2/neu）水平的测量可能在选择早期治疗方法和预测乳腺癌患者预后方面作为诊断/筛查标志物发挥重要作用。我们旨在进行一项系统评价和荟萃分析，重点关注血清 HER-2 水平的诊断/筛查价值，与常规方法进行比较。
我们通过 PubMed、Scopus、Cochrane-Library 和 Web of Science 数据库进行了系统搜索，以查找报告乳腺癌患者血清 HER-2 水平的人类诊断研究，这些研究通过组织病理学检查得到证实。对敏感性、特异性、准确性、ROC 曲线下面积（AUC）、阳性预测值（PPV）、阴性预测值（NPV）、阳性似然比（PLR）和阴性似然比（NLR）进行了荟萃分析。
有 14 项研究纳入本研究。荟萃分析表明，血清 HER2 水平的敏感性较低（敏感性：53.05，95%CI 40.82-65.28），但特异性为 79.27（95%CI 73.02-85.51），准确性为 72.06（95%CI 67.04-77.08），AUC 为 0.79（95%CI 0.66-0.92）。我们还发现 PPV（PPV：56.18，95%CI 44.16-68.20）、NPV（NPV：76.93，95%CI 69.56-84.31）、PLR（PLR：2.10，95%CI 1.69-2.50）和 NLR（NLR：0.58，95%CI 0.44-0.71）有显著差异。
我们的研究结果表明，虽然血清 HER-2 水平对乳腺癌诊断的敏感性较低，但特异性、准确性和 AUC 较为合理。因此，由于其成本效益和易于实施，测量血清 HER-2 水平似乎可以作为初始阴性筛查试验结果的验证试验发挥重要作用，尤其是在低收入地区。
