Comparing and combining O-RADS ultrasound, serum CA125, and HE4 for the preoperative diagnosis of ovarian tumors.

BackgroundAccurate preoperative differentiation between benign and malignant ovarian tumors is critical for optimal patient management. The Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound risk stratification and serum biomarkers like CA125 and HE4 are key diagnostic tools, but their comparative and combined efficacy, especially when stratified by menopausal status, warrants further investigation.PurposeThis study aimed to evaluate and compare the individual diagnostic performance of O-RADS US, CA125, HE4, and the ROMA index, and to assess the added value of combining O-RADS US with serum biomarkers for preoperative ovarian tumor diagnosis.Materials and methodsA retrospective analysis was conducted on 367 patients with pathologically confirmed ovarian tumors. All patients underwent preoperative transvaginal ultrasound for O-RADS classification and serum testing for CA125 and HE4. The ROMA score was calculated. Multivariable logistic regression analysis was performed to identify independent predictors of ovarian malignancy. Diagnostic performance was assessed using receiver operating characteristic (ROC) curve analysis. Decision curve analysis (DCA) was performed to evaluate the clinical net benefit of the models across a range of threshold probabilities. Patients were stratified into premenopausal (n = 228) and postmenopausal (n = 139) subgroups for comparative analysis.ResultsMalignant tumors (n = 163) were associated with significantly older age, larger lesion diameter, higher O-RADS categories, and elevated levels of CA125, HE4, and ROMA compared to benign tumors (n = 204) (all p < 0.001). O-RADS classification showed a strong correlation with malignancy (χ²=278.335, p < 0.001). Multivariable logistic regression identified O-RADS score and HE4 as independent predictors of ovarian malignancy. In stratified analysis, age was not a significant discriminator in postmenopausal women (p = 0.743), unlike in premenopausal women. ROC analysis revealed that in premenopausal women, O-RADS had superior diagnostic accuracy (AUC = 0.971) compared to CA125 (AUC = 0.798), HE4 (AUC = 0.838), and ROMA (AUC = 0.843). Conversely, in postmenopausal women, HE4 demonstrated the highest accuracy among serum biomarkers (AUC = 0.971), comparable to O-RADS (AUC = 0.939). Critically, the combination of O-RADS and HE4 yielded the most balanced and robust diagnostic performance overall (AUC = 0.959, Sensitivity = 94.95%, Specificity = 92.50%, PPV = 96.91%).Decision curve analysis confirmed clinical utility across threshold probabilities.ConclusionO-RADS dominates in premenopausal women, while HE4 performs comparably to O-RADS in postmenopausal women, highlighting the need for menopausal status-specific diagnostic strategies. Integrating O-RADS with HE4 further enhances preoperative diagnostic certainty.