Measurement of serum human epidermal growth factor receptor-2 (HER-2/neu) levels for breast cancer is still controversial and not recommended in any clinical procedures. However, it seems that HER-2 measuring can plays an important role as a diagnostic marker for early selection of therapeutic approach as well as predict of prognosis in breast cancer patients. We aimed to undertake a systematic review and meta-analysis focuses on the diagnostic value of serum HER-2 level measures by ELISA in compare to other methods due to its ease of implementation and cost-effectiveness for HER-2 positive two plus in IHC.
We performed a systematic search via PubMed, Scopus, Cochrane Library and Web of Science databases for human diagnostic studies reported the levels of serum HER2 in breast cancer patients, which was confirmed using histopathological examination such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Meta-analyses were carried out for sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR).
Fourteen studies entered into the study. The meta-analysis indicated that serum HER2 levels had sensitivity 53.05 (95%CI 40.82-65.28), specificity 79.27 (95%CI 73.02-85.51), accuracy 72.06 (95%CI 67.04-77.08), PPV 56.18 (95%CI 44.16-68.20), NPV 76.93 (95%CI 69.56-84.31), PLR 2.10 (95%CI 1.69-2.50) and NLR 0.58 (95%CI 0.44-0.71).
Our findings revealed that, although serum HER2 levels showed a low sensitivity for breast cancer diagnosis, its specificity is significantly high in this regard. Hence, it seems that measurement of serum HER2 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 in comparison with monitoring of tissue HER-2.
Clinical trial identification
Legal entity responsible for the study
Amir Shamshirian and Reza Alizadeh-Navaei.
Has not received any funding.
All authors have declared no conflicts of interest.