Aims: To assess whether replacing CA125 with HE4 in the classical formulas of risk of malignancy indices (RMIs) can improve diagnostic performance.
Methods: For each of 312 patients with an adnexal mass, classical RMIs 1-4 were computed based on ultrasound score, menopausal status, and serum CA125 levels. Additionally, modified RMIs (mRMIs) 1-4 were recalculated by replacing CA125 with HE4.
Results: Malignant pathology was diagnosed in 52 patients (16.67%). There was no significant difference in diagnostic performance (area under the receiver operating characteristic curve [AUC]) between each classical RMI and its corresponding mRMI. In the entire sample, the AUC was 0.899, 0.900, 0.895, and 0.908 for classical RMIs 1-4 compared to 0.903, 0.929, 0.930, and 0.931 for mRMIs 1-4. In premenopausal patients, the AUC was 0.818, 0.798, 0.795, and 0.802 for classical RMIs 1-4 compared to 0.839, 0.875, 0.876, and 0.856 for mRMIs 1-4. In postmenopausal patients, the AUC was 0.906, 0.895, 0.896, and 0.906 for classical RMIs 1-4 compared to 0.907, 0.923, 0.924, and 0.930 for mRMI 1-4.
Conclusions: Use of HE4 instead of CA125 did not significantly improve diagnostic performance of RMIs 1-4 in patients with an adnexal mass.