Assessment of Diagnostic Values among CA-125, RMI, HE4, and ROMA for Cancer Prediction in Women with Nonfunctional Ovarian Cysts.

Abstract

Objectives: To evaluate the diagnostic performance among CA-125, RMI, HE4, and ROMA for cancer detection in women with nonfunctional ovarian cysts at King Chulalongkorn Memorial Hospital (KCMH). Secondary objective is to reconsider the proper cutoff value of HE4.

Methods: This is a prospective analytic study in women with nonfunctional ovarian cysts larger than 3 cm who scheduled for surgery at KCMH during 3^rd June 2015 to 31^st May 2016. Ultrasonogram and blood sample collection were completed before the operation. Patients' demographic information and pathologic results were obtained. SPSS software version 17 was used for statistical evaluation.

Results: A total of 281 participants were evaluated. 19.9% of them were malignant. Compared with CA-125, HE4 had lower sensitivity (53.4% vs. 87.9%) and NPV (89% vs. 93.6%) but higher specificity (97.8% vs. 46.2%) and PPV (86.1% vs. 29.8%). ROMA had slightly lower sensitivity (79.3% vs. 87.9%) and similar NPV (93.7% vs. 93.6%), but higher specificity (79.8% vs. 46.2%) and PPV (50.5% vs. 29.8%) compared with CA-125. The model that achieves the highest area under the ROC curve in differentiating benign versus malignant ovarian tumor was ROMA. Cutoff value of HE4 at 70 pMol/L (from 150 pMol/L) would give sensitivity 74.1% and specificity 86.5% that are comparable with ROMA.

Conclusions: HE4 and ROMA had better performance (higher specificity, PPV) compared to CA-125 and RMI. HE4 at 70 pMol/L could be the new cutoff value for Thai women with ovarian cysts, giving higher sensitivity and specificity.