Abstract
OBJECTIVES: To evaluate the validity of serum CA-125, Human Epididymis protein 4 (HE4) and Risk of Malignancy Algorithm (ROMA) at standard and optimal cut-offs, in preoperative prediction of epithelial ovarian carcinoma (EOC) in Vietnam. SUBJECTS AND METHODS: Cross-sectional, descriptive study on 277 patients with ovarian masses hospitalized at the OBGYN Departments, Hue University Hospital and Hue Central Hospital, Vietnam, from 01/2016 to 11/2017. All patients had measurements of serum CA-125 by Elecsys 2010 system and HE4 by immunoassay ARCHITECT® HE4 kits; ROMA calculated, and preoperative malignancy risk estimated. Matching these values to postoperative histopathology resulted in the preoperative prediction values. RESULTS: There were 30 (10.8%) cases of EOC. Median values of CA 125, HE4, and ROMA of EOC and benign tumors were 214.20 U/ml, 18.91 U/ml; 90.00 pmol/l, 39.80 pmol/l; and 55.20%, 4.80%, respectively. The sensitivities and specificity of CA125, HE4, and ROMA to distinguish between malignant and benign tumors at standard cut-offs were 83.3% and 78.5%; 50% and 98.38%; 80.0% and 84,6%, and those at optimal cut-offs were 83.3% and 86.6%; 80.0% and 91.5%, 86.7% and 88.7%, respectively. AUCs of CA-125, HE4, and ROMA were 0.872, 0.894, 0.912; and those for the post-menopausal group were 0.900, 0.894 and 0.924, respectively. CONCLUSION: Serum CA 125 and HE4 levels and ROMA have good validity in the diagnosis of EOC, of which ROMA gives the best result. The ROMA index should be applied in clinical practice to help in the assessment and management of patients with suspected ovarian cancer.