Purpose: To evaluate the utility of preoperative diagnostic models for ovarian cancer based on ultrasound and/or biomarkers for referring patients to specialized oncology care. The investigated models were RMI, ROMA, and 3 models from the International Ovarian Tumor Analysis (IOTA) group [LR2, ADNEX, and the Simple Rules risk score (SRRisk)].Experimental Design: A secondary analysis of prospectively collected data from 2 cross-sectional cohort studies was performed to externally validate diagnostic models. A total of 2,763 patients (2,403 in dataset 1 and 360 in dataset 2) from 18 centers (11 oncology centers and 7 nononcology hospitals) in 6 countries participated. Excised tissue was histologically classified as benign or malignant. The clinical utility of the preoperative diagnostic models was assessed with net benefit (NB) at a range of risk thresholds (5%-50% risk of malignancy) to refer patients to specialized oncology care. We visualized results with decision curves and generated bootstrap confidence intervals.Results: The prevalence of malignancy was 41% in dataset 1 and 40% in dataset 2. For thresholds up to 10% to 15%, RMI and ROMA had a lower NB than referring all patients. SRRisks and ADNEX demonstrated the highest NB. At a threshold of 20%, the NBs of ADNEX, SRrisks, and RMI were 0.348, 0.350, and 0.270, respectively. Results by menopausal status and type of center (oncology vs. nononcology) were similar.Conclusions: All tested IOTA methods, especially ADNEX and SRRisks, are clinically more useful than RMI and ROMA to select patients with adnexal masses for specialized oncology care. Clin Cancer Res; 23(17); 5082-90. ©2017 AACR.

Clinic of Obstetrics and Gynecology University of Milan Bicocca San Gerardo Hospital Monza Italy

Department of Development and Regeneration KU Leuven Leuven Belgium

Department of Gynecologic Oncology Catholic University of the Sacred Heart Rome Italy

Department of Obstetrics and Gynecology Azienda Ospedaliero Universitaria Policlinico Duilio Casula Monserrato Cagliari Italy

Department of Obstetrics and Gynecology DSC L Sacco Milan Italy

Department of Obstetrics and Gynecology Skåne University Hospital Malmö Lund University Malmö Sweden

Department of Obstetrics and Gynecology Södersjukhuset Karolinska Institutet Stockholm Sweden

Department of Obstetrics and Gynecology University Hospitals Leuven Leuven Belgium

Department of Obstetrics and Gynecology University of Udine Udine Italy

Department of Obstetrics and Gynecology Ziekenhuis Oost Limburg Genk Belgium

Gynecologic Oncology Center Department of Obstetrics and Gynecology 1st Faculty of Medicine Charles University General University Hospital Prague Prague Czech Republic

Gynecology and Reproductive Medicine Unit S Orsola Malpighi Hospital University of Bologna Bologna Italy

Nuffield Department of Primary Care Health Sciences University of Oxford Oxford United Kingdom

Preventive Gynecology Unit Division of Gynecology European Institute of Oncology Milan Italy

Queen Charlotte's and Chelsea Hospital Imperial College London United Kingdom

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