Validation of the Performance of International Ovarian Tumor Analysis (IOTA) Methods in the Diagnosis of Early Stage Ovarian Cancer in a Non-Screening Population

Abstract

Background: The aim of this study was to assess and compare the performance of different ultrasound-based International Ovarian Tumor Analysis (IOTA) strategies and subjective assessment for the diagnosis of early stage ovarian malignancy. Methods: This is a secondary analysis of a prospective multicenter cross-sectional diagnostic accuracy study that included 1653 patients recruited at 18 centers from 2009 to 2012. All patients underwent standardized transvaginal ultrasonography by experienced ultrasound investigators. We assessed test performance of the IOTA Simple Rules (SRs), Simple Rules Risk (SRR), the Assessment of Different NEoplasias in the adneXa (ADNEX) model and subjective assessment to discriminate between stage I-II ovarian cancer and benign disease. Reference standard was histology after surgery. Results: 230 (13.9%) patients proved to have stage I–II primary invasive ovarian malignancy, and 1423 (86.1%) had benign disease. Sensitivity and specificity with respect to malignancy (95% confidence intervals) of the original SRs (classifying all inconclusive cases as malignant) were 94.3% (90.6% to 96.7%) and 73.4% (71.0% to 75.6%). Subjective assessment had a sensitivity and specificity of 90.0% (85.4% to 93.2%) and 86.7% (84.9% to 88.4%), respectively. The areas under the receiver operator characteristic curves of SRR and ADNEX were 0.917 (0.902 to 0.933) and 0.905 (0.920 to 0.934), respectively. At a 1% risk cut-off, sensitivity and specificity for SRR were 100% (98.4% to 100%) and 38.0% (35.5% to 40.6%), and for ADNEX were 100% (98.4% to 100%) and 19.4% (17.4% to 21.5%). At a 30% risk cut-off, sensitivity and specificity for SRR were 88.3% (83.5% to 91.8%) and 81.1% (79% to 83%), and for ADNEX were 84.5% (80.5% to 89.6%) and 84.5% (82.6% to 86.3%). Conclusion: This study shows that all three IOTA strategies have good ability to discriminate between stage I-II ovarian malignancy and benign disease.

O-RADS US Risk Stratification and Management System: A Consensus Guideline from the ACR Ovarian-Adnexal Reporting and Data System Committee

“…Results from the logistic regression formula can be obtained by using a calculator freely available online (https:// www.iotagroup.org/adnexmodel/ or https://www.evidencio.com/ models/show/946), in applications for smartphones, or integrated in the US systems. The ADNEX model has undergone O-RADS 1, the physiologic category that is relevant only in premenopausal patients, includes the follicle and corpus luteum as defined in Figure 1 (also see Figs 6,7). To prevent misunderstanding by patients, it is recommended that the US report describe these as a follicle and corpus luteum rather than a cyst.…”

“…O-RADS 0 is an incomplete evaluation due to technical factors such as bowel gas, large size of the lesion, location of the adnexa, or inability to tolerate endovaginal imaging (Figs 2,3) literature (4,6,7,11,42,46). Also included are unilocular cysts with wall irregularity, multilocular cysts less than 10 cm without solid component(s) with a color score less than 4 (Fig 1), and avascular solid or solid-appearing lesions with a smooth external contour of any size.…”

“…Published studies, as well as expert consensus, support the use of pattern recognition by an experienced US examiner as the most accurate US method of discriminating between benign and malignant adnexal lesions (6)(7)(8)(9)(10). However, the level of expertise of practitioners who perform and interpret sonograms varies widely (5).…”

Serum HE4 and diagnosis of ovarian cancer in postmenopausal women with adnexal masses

“…8,9 A number of factors are likely to contribute to this difference: the latter conducted in secondary care symptomatic patients with larger adnexal masses (median diameter of 10.6 cm in stage I and 8.5 cm in stage IIeIV 7 vs 4.4 cm in our study), more advanced disease, 7 additional features including Doppler, and TVS performed by IOTA-trained sonographers. 34 Of note, the majority of our scans (96%) were performed by senior NHS ultrasonographers. Similar variables were captured as those in the NHS, making our findings generalizable to this setting.…”

Practical Recommendations for the Management of Benign Adnexal Masses

“…For the 30% risk cutoff, the sensitivity was of 89.0%, the specificity was of 84.7%, the LR was þ 5.8 and -0.13, the PPV was of 75.4%, and the NPV was of 93.9%. 13 The use of SRs was subsequently validated considering their performance in the diagnosis of early ovarian malignancies, even when compared with the other models pro-posed by the IOTA. At this point, we highlight the high NPV (98.9%) of the SRs in scenarios of low risk of malignancy.…”