Clinical value of O-RADS combined with serum CA125 and HE4 for the diagnosis of ovarian tumours

Abstract

Background Ovarian tumors (OTs) are common gynecological tumors in women. It is very important to correctly distinguish benign and malignant OTs. Purpose To assess the diagnostic performance of the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) and evaluate the clinical value of O-RADS combined with serum carbohydrate antigen 125 (CA125) and human epididymis protein 4 (HE4) in differentiating benign from malignant OTs. Material and Methods A retrospective analysis was performed on 431 cases including pathology and clinical data. The receiver operating characteristic (ROC) curve was drawn, and sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated. Results In premenopausal women, O-RADS and O-RADS combined with serum CA125 and HE4 showed sensitivity at 92.2% and 94.8%, specificity at 91.8% and 93.4%, and accuracy at 91.9% and 93.8%, respectively. In postmenopausal women, the sensitivity of O-RADS, O-RADS combined with serum CA125 and HE4 was 94.8% and 95.8%, specificity was 83.9% and 93.6%, and accuracy was 90.5% and 95.6%, respectively. The sensitivity, specificity, and accuracy of O-RADS combined with CA125 and HE4 in premenopausal and postmenopausal women were higher than that of O-RADS ( P<0.05). Conclusion O-RADS has high diagnostic performance in OTs. When O-RADS is combined with CA125 and HE4 in the diagnosis of OTs, the sensitivity and specificity are improved, which is helpful to improve the diagnostic efficiency of OTs and has high clinical application value.

External Validation of the Ovarian-Adnexal Reporting and Data System (O-RADS) Lexicon and the International Ovarian Tumor Analysis 2-Step Strategy to Stratify Ovarian Tumors Into O-RADS Risk Groups

“…Use of the O-RADS lexicon to stratify patients into O-RADS risk groups has been validated retrospectively in 13 other studies [11][12][13][14][15][16][17][18][19][20][21][22]24 and prospectively in 1 study 23 (search strategy and study details shown in the eAppendix and eTable 8 in the Supplement). The prospective study was small (50 patients) and included only tumors in O-RADS 3 to 5.…”

“…images with or without supplementary review of ultrasonographic reports. In 9 retrospective studies, the reference standard was histology, [12][13][14][15][17][18][19][20]22 in 3 it was histology or results of follow-up, 11,16,24 and in 1 it was the agreed diagnosis of 2 radiologists according to the ultrasonographic images. 21 The reported observed malignancy rates per O-RADS group and the sensitivities and specificities when O-RADS 4 to 5 was used (≥10% malignancy risk) to indicate malignancy are variable.…”

“…21 The reported observed malignancy rates per O-RADS group and the sensitivities and specificities when O-RADS 4 to 5 was used (≥10% malignancy risk) to indicate malignancy are variable. The point estimates of observed prevalence of malignancy in O-RADS 2 ranges from 0% to 5%, with 4 centers reporting it to be greater than 1% 12,15,18,22 ; that in O-RADS 3 ranges from 0% to 19%, with 4 centers reporting it to be greater than 10% 15,18,22,23 ; that in O-RADS 4 ranges from 21% to 79%, with 4 centers reporting it to be greater than 50% 12,15,18,23 ; and that in O-RADS 5 ranges from 66% to 95%. The divergent results are likely to be explained by differences in study population characteristics (eg, types of tumors included sample size, study design, interpretation of the O-RADS lexicon) and by a varying proportion of images that were not fully representative of the tumor.…”

“…In most of these studies, histology was the reference standard. [11][12][13][14][15][16][17][18][19][20][21][22][23][24] According to the original O-RADS publication, masses with risk of malignancy less than 1% could be managed with follow-up. 7 Therefore, validation studies should be performed for all patients with an adnexal mass, irrespective of whether they are treated conservatively or with surgery.…”

Diagnostic added-value of CA125 on O-RADS and Simple Rules in discrimination benign and malignant adnexal masses

“…Hack [33] proved that adding the information of acoustic shadowing as a benign nding can improve the diagnostic performance of O-RADS. Two recent studies have also focused on combing O-RADS and CA125 [34,35] . They used a combination of statistical methods, whereas this research offered a simpler as well as more practical method to combine CA125 and the O-RADS 4 category, and all got gratifying results.…”