HE-4 A Novel Tumour Marker for Ovarian Mass and Its Comparison with CA 125

IARC released on 14th December the updated Globocan 2020 with new estimates on the global cancer burden, indicating that it has risen to 19.3 million cases and 10 million cancer deaths in 2020. Ovarian cancer is the 8th most commonly occurring cancer in women and the 18th most common cancer overall. There were more than 313,000 new cases of ovarian cancer in 2020 as per the Globocan 2020. Despite advances in the diagnosis and treatment, there has been little change in the mortality rate of ovarian cancer as most of patients were diagnosed at advanced stage. Tumour markers are the biochemical substances which are detected in the presence of tumours.Usually they are either the products of tumour tissues or secreted from the normal cells which are in the close with tumour tissue (2). Serum CA125 assay has low sensitivity in the early stages and also can be increased in certain conditions such as menstruation or endometriosis. Many studies reported that HE4 is absent in normal ovarian surface epithelium but is expressed specifically in 100% of endometroid and serous epithelial ovarian cancers (2). Furthermore, this combined measure can correct the variations in HE4 and CA125 which are due to other pathology.

1. To evaluate HE4 and CA125 in ovarian tumour patients preoperatively. 2. To compare the utility of HE4 and CA 125 for diagnosing and distinguishing malignant ovarian tumour.

In this prospective study, 149 patients of ovarian tumour were evaluated for serum CA125 and HE4. Out of which, 18 patients were lost to follow-up. Their levels were determined by the electrochemiluminescence (ECLIA) technique. Positive cut-off of CA 125 was taken > 35 U/mL. The HE4 positive cut-off values for premenopausal and postmenopausal women were > 70 pmol/l and > 140 pmol/l, respectively. Sensitivity, specificity and predictive value were calculated for each tumour marker.

In patients with benign diseases, abnormal serum levels of HE4 and CA125 were found in 0.86% and 9.4% of patients, respectively. Specificity of HE4 and CA125 of diagnosing benign tumour were 99.03% and 81.55%, respectively. Tumour marker sensitivity in ovarian cancer was 100% for HE4 and 85.71% for CA 125. Among patients with ovarian epithelial cancer, HE4 (in contrast to CA 125) had significantly higher concentrations than in other malignancies (p < 0.001). In differentiating benign gynaecological diseases from malignant ovarian cancer, HE4 was found to be more positive predictive than CA125 (96.55% and 55.81%, respectively).

In this study, HE4 was found to be more sensitivity and specificity (p < 0.001) for ovarian malignancyas compare to CA 125. HE4 is better in diagnosing and distinguishing ovarian cancer from benign ovarian tumour as compare to CA125 preoperatively. It may be considered as novel ovarian tumour marker.