Objective: Since the promulgation of the International Ovarian Tumor Analysis (IOTA) Simple Rules (SR) and the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) , many studies have verified their diagnostic performance successively. But the low accuracy of masses of O-RADS 4 and SR inconclusive still perplex sonographers, thus this study aimed to settle this problem by combining Cancer Antigen 125 (CA125) with those masses, and to assess diagnostic added-value of CA125 on O-RADS and SR in discrimination benign and malignant adnexal masses.
Methods: Data of women with adnexal masses recruited from a tertiary center between January 2019 and September 2021 were included in this study. All patients underwent transvaginal or transabdominal ultrasound examination as well as had complete ultrasound images and clinical data. Firstly, the masses were classified retrospectively using O-RADS and SR by two less experienced sonographers according to the corresponding criteria. Then, the masses of O-RADS 4 and SR inconclusive were reclassified according to the level of CA125,that is, the combination of O-RADS and SR with CA125. And analyzed the differences in diagnostic efficacy of the above methods for menopause status. Finally, receiver operating characteristic (ROC) curves were plotted to evaluate the diagnostic performance of CA125,O-RADS, SR, CA125 combine with O-RADS, and CA125 combine with SR, and calculate the area under the curve (AUC), sensitivity, specificity.
Results: Of the 403 patients (143 premenopausal and 260 postmenopausal), 269 had benign lesions, and 134 had malignant tumors. The AUCs of CA125, O-RADS, SR, O-RADS combined with CA125, SR, SR combined with CA125,and CA125 in the whole study group were 0.842, 0.939, 0.963, 0.884, and 0.944, respectively. The findings showed that the AUCs of O-RADS and SR combined with CA125 were significantly higher than O-RADS and SR alone severally (p <0.05). The accuracy of O-RADS 4 and SR inconclusive masses were only 0.438 and 0.534, however, their accuracy has been improved to 0.829 and 0.814 when combined with CA125. Furthermore, the addition of CA125 into O-RADS and SR significantly increased the AUC to 0.930 (0.930 vs 0.712, p <0.001) and 0.931 (0.931 vs 0.774, p <0.001) separately in women with amenorrhea.
Conclusions: CA125 can markedly improve the accuracy of O-RADS 4 and SR inconclusive masses, thereby improving the overall diagnostic efficiency of the O-RADS and SR classification system, especially for menopause women.