Diagnostic Value of Novel Biomarker Human Epididymis Protein 4 (HE4) in Detecting Endometrial Cancer

Abstract

Objectives: Endometrial cancer (EC) is the most common malignancy of the female reproductive system. To date, no good marker for screening or disease monitoring of EC is available. The objective of this study was to investigate the sensitivity and specificity of CA125 and human epididymis protein 4 (HE4) in detection of EC. Materials and Methods: This case-control study was carried out on 40 women with EC and 60 women without cancer. Serum samples were prospectively obtained from all patients. Cut-off points for HE4 and CA125 were considered 70 pmol/L and 35 U/mL, respectively. The level of statistical significance is set at P < 0.05. Results: The ROC-AUC, for HE4 was 0.82 and CA125 was 0.73 and for combination of HE4 and CA125 was 0.89. Compared to CA125, HE4 had higher sensitivity (57.7% vs. 40%), equal specificity (93.3% vs. 95%), equal positive predictive value (PPV) (85% vs. 84.2%) and higher negative predictive value (NPV) (76.71% vs. 70.37%) and in combination of two tumor markers sensitivity, specificity, PPV and NPV were 62.5%, 93.3%, 86.2% and 78.9%, respectively. It was clear that combination of two markers had higher sensitivity and higher NPV to detect EC, than each marker alone. HE4 and CA125 were significantly elevated in EC compared to controls (P < 0.001). There was significant correlation between median HE4 and age of the patients (r = 0.48, P = 0.002) and stage of the disease (r = 0.50, P = 0.001). There was no significant correlation between CA125 and age, stage or grade of the disease (P = 0.39, P = 0.08 and P = 0.9, respectively). Conclusion: Our study showed that serum HE4 levels alone and in combination with CA125 are sensitive markers in diagnosing EC.