Clinical value of serum human epididymis protein 4 assay in the diagnosis of ovarian cancer: a meta-analysis

Objective: Human epididymis protein 4 (HE4) has been approved for diagnosing ovarian cancer. The goal of this meta-analysis was to evaluate the clinical value of the serum HE4 in the diagnosis of ovarian cancer. Methods: The PubMed and Embase databases were searched to identify suitable studies. The sensitivity (SEN), specificity (SPE), and positive and negative likelihood ratios (PLR and NLR, respectively) of HE4 for the diagnosis of ovarian cancer were commonly used as bivariates. Summary receiver operating characteristic curves were used to summarize overall test performances. Meta-Disc 1.4 software was used to analyze the data. Results: A total of 6,269 patients from 31 trials were subjected to meta-analysis. The summary estimates of HE4 for ovarian cancer diagnosis were as follows: SEN 0.73 (95% confidence interval [CI] 0.71-0.75); SPE 0.89 (95% CI 0.88-0.90); PLR 7.30 (95% CI 5.42-9.84); and NLR 0.15 (95% CI 0.10-0.23). SEN 0.74 (95% CI 0.72-0.76); SPE 0.89 (95% CI 0.88-0.90); PLR 7.35 (95% CI 5.55-9.73); NLR 0.14 (95% CI 0.09-0.21). Conclusion: Our study demonstrates that the sensitivity and specificity of HE4 was higher than that of cancer antigen 125. The results indicated that HE4 could be a useful tumor marker for ovarian cancer diagnosis. However, the results of this meta-analysis should be interpreted with caution, due to the heterogeneity among study designs. Further study should pay more attention to the possibility that HE4 can be a marker for monitoring recurrence of ovarian cancer.