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

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 3rd June 2015 to 31st 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.