Usefulness of the HE4 biomarker as a second-line test in the assessment of suspicious ovarian tumors

PURPOSE: The aim of our study was the evaluation of HE4 usefulness as a test in assessment of ovarian tumors which are suspicious and difficult to classify correctly via subjective ultrasound examination. METHODS: In this retrospective cohort study 253 women diagnosed with adnexal masses were examined preoperatively. Suspicious tumors (n = 145) were divided into groups of: “probably benign” (n = 70), “uncertain” (n = 34), and “probably malignant” (n = 41). “Uncertain” tumors were also assessed as “benign” (n = 11) or “malignant” (n = 23). The logistic regression model was performed to analyze if the serum marker improves the prediction of a malignant finding and net reclassification improvement (NRI) was calculated to measure diagnostic improvement. RESULTS: Within the analyzed group 85 (58.6 %) benign and 60 (41.4 %) malignant tumors were confirmed histopathologically. The comparison of HE4 with subjective ultrasound assessment showed lowered NRI in the entire analyzed group as well as in the groups of tumors classified as “probably benign” or “probably malignant” (NRI = −0.16; P = 0.0139 and NRI = −0.133; P = 0.0489, respectively). The analysis of logistic regression model confirmed that biomarkers do not improve diagnostic accuracy. The difference between areas under ROC for HE4 (0.891) and CA125 (0.902) was not statistically significant (P = 0.760). CONCLUSIONS: After subjective ultrasound assessment, the addition of the second-line test—HE4 as well as CA125 serum level does not improve diagnostic performance. However, HE4 evaluation satisfies the clinical expectations of diagnostic tools for ovarian tumors and, thus, may be useful to less experienced sonographers.