Estimating the Risk of Malignancy in Adnexal Masses: Validation of the ADNEX Model in the Hands of Non-expert Ultrasonographers in a Gynecological Oncology Center in China
Abstract Background: The diagnosis of adnexal masses depends more on ultrasonography. This study aim to validate the diagnostic accuracy of the International Ovarian Tumor Analysis (IOTA) ADNEX model in the preoperative diagnosis of adnexal masses in the hands of non-expert ultrasonographers in a gynecological oncology center in China. Methods: This was a single oncology center, retrospective diagnostic accuracy study from 620 patients. All patients underwent surgery and the histopathological diagnosis was used as reference standard. The masses were divided into five types according to the ADNEX model: benign ovarian tumor, borderline ovarian tumor (BOT), Stage-I ovarian cancer (OC), Stages-II-IV OC and ovarian metastasis. Receiver-operating characteristics (ROC) curve analysis was used to evaluate the ability of the ADNEX model to classify tumors into different histological types with and without Cancer antigen 125 (CA 125) results. Results: Of the 620 women, 402 (64.8%) had a benign ovarian tumor and, 218 (35.2%) had a malignant ovarian tumor, including 86 (13.9%) with BOT, 75 (12.1%) with Stage-I OC, 53 (8.5%) with Stages-II-IV OC and 4 (0.6%) with ovarian metastasis. The AUC of the model to differentiate between benign and malignant adnexal masses was 0.97 (95% CI, 0.96–0.98). Performance was excellent for the discrimination between benign vs Stage II-IV OC, benign vs ovarian metastasis with AUCs of 0.99 (95% CI, 0.99-1.00) and 0.99 (95% CI, 0.98-1.00), respectively. Performance of the model was less effective at distinguishing between BOT and Stage I OC and between BOT and ovarian metastasis, with AUC of 0.54 (95% CI, 0.45–0.64) and 0.66 (95% CI, 0.56–0.77), respectively. When including CA125 in the model, performance in discriminating between Stages II–IV OC with stage I OC and ovarian metastasis were improved (AUC increased from 0.88 to 0.94, P = 0.01; 0.86 to 0.97, p = 0.01, respectively). Conclusions: The IOTA ADNEX model has excellent performance in differentiating benign and malignant adnexal masses in the hands of non-expert ultrasonographers with limited experienced in China. Between classification different subtypes of ovarian cancers, the model has difficulty to differentiate BOT from stage I OC, BOT from ovarian metastases.