Utility of HE4 in the Evaluation of Adnexal Masses Among Premenopausal and Postmenopausal Women.

Adnexal masses, encompassing a spectrum of benign and malignant conditions, present a diagnostic challenge in clinical practice. The timely and accurate assessment of these masses is paramount for guiding appropriate management strategies and ensuring optimal patient outcomes. In this context, Human Epididymis Protein 4 (HE4) has emerged as a promising biomarker, offering valuable insights into the differential diagnosis and risk stratification of adnexal masses. This study aims to elucidate the evolving role of HE4 in the evaluation of adnexal masses by delineating the diagnostic accuracy, prognostic significance, and clinical implications of HE4 alone or as a part of an algorithm in this context. This study was conducted in the Department of Obstetrics and Gynaecology of JIPMER from September 2017 to January 2019 among women who presented with adnexal mass to gynaecological OPD and were planned for surgery. CA-125 levels were estimated using the direct chemiluminescence method, and HE4 levels were estimated using the ELISA method. RMI and ROMA scores were calculated, and results were compared with the final histopathological report. In the present study, among 160 patients studied, the average age of the study population was 45 years. On histopathology, 59% were reported as benign, whereas 5% and 35% of patients were borderline and malignant, respectively. Among malignant tumours, the majority were epithelial tumours (92%), and among epithelial, the majority were serous (67.6%). In the present study, the sensitivity and specificity of the RMI and ROMA models in the prediction of malignancy was 87.7%, 71.6% and 93.8%, 81.1%, respectively. HE4 independently predicted malignancy in the adnexal masses when used with a cut-off of 70 pmol/L for premenopausal women and 140 pmol/L for post-menopausal women. The ROMA had good diagnostic power in predicting the risk of malignancy in an adnexal mass, with high sensitivity and AUC curve compared to RMI in this study. HE4 independently proved to be useful for predicting ovarian malignancy.