HE 4, CA 125, the Risk of Malignancy Algorithm and the Risk of Malignancy Index and complex pelvic masses ‐ a prospective comparison in the pre‐operative evaluation of pelvic masses in an Australian population

Background Human epididymis protein 4 ( HE 4) has been proposed as a novel biomarker for the diagnosis of epithelial ovarian cancer. Using HE 4 and CA 125, the risk of malignancy algorithm ( ROMA ) has been shown to be effective in the stratification of epithelial ovarian cancer risk. Aims To determine the effectiveness of HE 4 and ROMA in the diagnosis of malignancy of women presenting with a complex pelvic mass in an Australian population and to compare it with CA 125 and the risk of malignancy index ( RMI ). Materials and Methods Prospective recruitment of women was conducted between October 2012 and March 2014 ( n  = 50). CA 125 and HE 4 serum concentrations were collected and stored for subsequent analysis. Sensitivities, specificities, positive predictive values ( PPV ) and negative predictive values ( NPV ) were calculated for HE 4, CA 125, ROMA and the RMI . Receiver operating characteristic ( ROC ) area under the curves ( AUC ) were also calculated for comparison. Results There was a higher HE 4 level in women with ovarian cancer compared with women with benign pathology ( P  = 0.008), and this observation was seen in benign versus stage 1 ovarian cancer women ( P  = 0.025). HE 4 had a better specificity than CA 125 for the diagnosis of ovarian cancer in all women ( P  = 0.022), and this effect was also observed in premenopausal women ( P  = 0.012). Furthermore, the ROC ‐ AUC for HE 4 was superior than CA 125 in all women ( P  = 0.0451). The ROMA algorithm was not inferior to the RMI calculation in this population. Conclusions In an Australian population, HE 4 and ROMA are useful in the diagnosis of epithelial ovarian cancer.