Modification of cut-off values for HE4, CA125 and the ROMA algorithm for early-stage epithelial ovarian cancer detection: Results from 1021 cases in South China

Objectives: The purpose of this study was to evaluate the performance of human epididymis protein 4 (HE4) and the Risk of Ovarian Malignancy Algorithm (ROMA) in early stage epithelial ovarian cancer (EOC) detection in patients in southern China. Additionally, this study proposes a possible ideal cut-off value for each marker to its own population in South China. Design and methods: Serum HE4 and CA125 were measured in 756 patients with pelvic masses (275 malignancies, 53 borderline tumors and 428 benign diseases), and their ROMA values were calculated. Areas under the receiver operator characteristic (ROC) curves (AUC) were assessed for HE4, CA125, ROMA and combinations of these biomarkers. Results: Both HE4 and ROMA performed better diagnostically than CA125 alone for early stage EOC, with AUCs ranging from 0.714 for HE4, 0.699 for ROMA, and 0.463 for CA125 in premenopausal subjects, and 0.902 for ROMA, 0.880 for HE4, and 0.256 for CA125 in postmenopausal subjects. Conclusions: HE4 and ROMA alone were found to be better than CA125 for detecting borderline tumors and early-stage EOC. The optimal cut-off values (HE4: 70 pmol/l for all; CA125: 60 U/ml for pre- and 35 U/ml for postmenopausal women) could notably improve diagnostic performance in EOC detection in patients in southern China. (C) 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.