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Ab s t r Ac t Introduction: Ovarian cancer is the third leading site of cancer among women in India. 70% of ovarian cancers are diagnosed with advanced disease leading to high fatality rate. Human epididymis protein 4 (HE4), also known as WAP four disulphide core 2 (WFDC2), is a novel protein and is one of the more promising biomarkers for improving diagnostic performance in ovarian cancer detection. Aim: To evaluate a new tumor marker, HE4, in comparison with CA-125 in diagnosis of ovarian cancer and benign gynecological diseases. Material and Methods: Pre-operative serum HE4 and CA-125 were determined in 146 patients with benign gynecologic diseases and 100 patients with malignant gynecologic cancers (64 were epithelial ovarian cancers patients). HE4 and CA-125 cutoffs were 140 pmol/L and 35 kU/L, respectively. Sandwich Elisa, biotin-labelled antibody kit was used for HE4. Results: HE4 demonstrated better specificity than CA 125 in benign gynecologic disease patients, with abnormal concentrations in 1.3% and 33.6% , respectively. A significantly higher area under the ROC curve was obtained with HE4 than with CA 125 in the differential diagnosis of gynecologic diseases (0.875 vs 0.723; p=0.0001). Both markers were clearly related to stage (HE4:p=0.004; CA-125: p=0.001).) and histopathological type (HE4: p =0.003 and CA-125:p =0.009 in serous papillary ovarian cancer). Conclusion: HE4 has significantly higher diagnostic specificity than CA 125, and the combination of CA-125 and HE4 improved the detection of ovarian cancer in all stages and histological types. HE4 use may be important in the differential diagnosis of ovarian cancer.

Serum Human Epididymus Protein-4 (HE4) as a Biomarker in Ovarian Cancer and its Comparison with CA-125 in Benign and Malignant Cases