Abstract

BackgroundHuman epididymis protein 4 (HE4) is a novel and specific biomarker for ovarian cancer. The aim of this study is to evaluate a new tumor marker, HE4, in comparison with CA125 in diagnosis of epithelial ovarian cancer (EOC) and benign gynecological diseases.MethodsCA125 and HE4 serum levels were determined in 30 patients with epithelial ovarian cancer (21 serous, 6 endometrioid and 3 mucinous tumors), 20 patients with benign gynecological diseases (8 patients with ovarian cyst, 5 patients with endometriosis, 4 patients with fibroid and 3 patients with pelvic inflammatory disease) and 20 healthy women. CA125 and HE4 cut-offs were 35 U/ml and 150 pmol/l, respectively.ResultsSerum HE4 and CA125 concentrations were significantly higher in the ovarian cancer patients compared with those seen in patients with benign disease or in the healthy controls (p = 0.001 and p < 0.001 respectively). In the receiver operating characteristic analysis (ROC), the area under the curve (AUC) values for HE4 was 0.96 (95% confidence interval, 0.9-1.0) and CA125 was 0.82 (95% confidence interval, 0.7-0.94). Compared to CA125, HE4 had higher sensitivity (90% vs. 83.3%), specificity (95% vs. 85%), PPV (93.1% vs. 80.7%) and NPV (92.7% vs. 87.2%), the combination of HE4 + CA125 the sensitivity and PPV reached 96.7% and 97% respectively.ConclusionMeasuring serum HE4 concentrations along with CA125 concentrations may provide higher accuracy for detecting epithelial ovarian cancer.Virtual SlidesThe virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1060413168685759

Highlights

  • The annual incidence of ovarian cancer is 204,000, with 125,000 deaths

  • We investigated the role of Human epididymis protein 4 (HE4) alone and in combination with Carbohydrate antigen 125 (CA125) in assessing patients with epithelial ovarian cancer, regardless of the menopausal status

  • No false positive results for HE4 or CA125 were recorded on healthy women, the specificity was more evident among patients with benign gynecological lesions, since only 2 were positive for HE4, while 6 were positive for CA125 (10% vs 30%). we found a significant difference in CA125 values between the benign gynecological disease group and control group (p < 0.05)

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Summary

Introduction

The annual incidence of ovarian cancer is 204,000, with 125,000 deaths. Ovarian cancer remains the most lethal of all gynecologic malignancies. One of the reasons for the high fatality rate is that more than 70% of women with ovarian cancer are diagnosed with advanced disease. There is a close correlation between stage at presentation and survival; early detection of ovarian cancer represents the best hope for mortality reduction and long term disease control. Tumors are further described as benign, malignant, or borderline, and depending upon tumor subtype; classified as low or high-grade. The aim of this study is to evaluate a new tumor marker, HE4, in comparison with CA125 in diagnosis of epithelial ovarian cancer (EOC) and benign gynecological diseases

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