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

Author:

Timmerman Stefan12,Valentin Lil34,Ceusters Jolien5,Testa Antonia C.6,Landolfo Chiara7,Sladkevicius Povilas34,Van Holsbeke Caroline8,Domali Ekaterini9,Fruscio Robert10,Epstein Elisabeth11,Franchi Dorella12,Kudla Marek J.13,Chiappa Valentina14,Alcazar Juan L.15,Leone Francesco P. G.16,Buonomo Francesca17,Coccia Maria Elisabetta18,Guerriero Stefano19,Deo Nandita20,Jokubkiene Ligita34,Kaijser Jeroen21,Scambia Giovanni6,Andreotti Rochelle2223,Timmerman Dirk12,Bourne Tom17,Van Calster Ben124,Froyman Wouter12

Affiliation:

1. Department of Development and Regeneration, KU Leuven, Leuven, Belgium

2. Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven, Belgium

3. Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, Sweden

4. Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden

5. Laboratory of Tumor Immunology and Immunotherapy, Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium

6. Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCSS, Rome, Italy

7. Queen Charlotte’s and Chelsea Hospital, Imperial College, London, United Kingdom

8. Department of Obstetrics and Gynecology, Ziekenhuis Oost-Limburg, Genk, Belgium

9. First Department of Obstetrics and Gynecology, Alexandra Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece

10. Clinic of Obstetrics and Gynecology, University of Milan–Bicocca, San Gerardo Hospital, Monza, Italy

11. Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden

12. Preventive Gynecology Unit, Division of Gynecology, European Institute of Oncology IRCCS, Milan, Italy

13. Department of Perinatology and Oncological Gynecology, Faculty of Medical Sciences, Medical University of Silesia, Katowice, Poland

14. Department of Gynecologic Oncology, National Cancer Institute of Milan, Milan, Italy

15. Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, School of Medicine, Pamplona, Spain

16. Department of Obstetrics and Gynecology, Biomedical and Clinical Sciences Institute L. Sacco, University of Milan, Milan, Italy

17. Institute for Maternal and Child Health–IRCCS “Burlo Garofolo,” Trieste, Italy

18. Department of Biomedical, Experimental and Clinical Sciences, University of Florence, Florence, Italy

19. Department of Obstetrics and Gynecology, University of Cagliari, Policlinico Universitario Duilio Casula, Monserrato, Cagliari, Italy

20. Department of Obstetrics and Gynaecology, Whipps Cross Hospital, London, United Kingdom

21. Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, the Netherlands

22. Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee

23. Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee

24. Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, the Netherlands

Abstract

ImportanceCorrect diagnosis of ovarian cancer results in better prognosis. Adnexal lesions can be stratified into the Ovarian-Adnexal Reporting and Data System (O-RADS) risk of malignancy categories with either the O-RADS lexicon, proposed by the American College of Radiology, or the International Ovarian Tumor Analysis (IOTA) 2-step strategy.ObjectiveTo investigate the diagnostic performance of the O-RADS lexicon and the IOTA 2-step strategy.Design, Setting, and ParticipantsRetrospective external diagnostic validation study based on interim data of IOTA5, a prospective international multicenter cohort study, in 36 oncology referral centers or other types of centers. A total of 8519 consecutive adult patients presenting with an adnexal mass between January 1, 2012, and March 1, 2015, and treated either with surgery or conservatively were included in this diagnostic study. Twenty-five patients were excluded for withdrawal of consent, 2777 were excluded from 19 centers that did not meet predefined data quality criteria, and 812 were excluded because they were already in follow-up at recruitment. The analysis included 4905 patients with a newly detected adnexal mass in 17 centers that met predefined data quality criteria. Data were analyzed from January 31 to March 1, 2022.ExposuresStratification into O-RADS categories (malignancy risk <1%, 1% to <10%, 10% to <50%, and ≥50%). For the IOTA 2-step strategy, the stratification is based on the individual risk of malignancy calculated with the IOTA 2-step strategy.Main Outcomes and MeasuresObserved prevalence of malignancy in each O-RADS risk category, as well as sensitivity and specificity. The reference standard was the status of the tumor at inclusion, determined by histology or clinical and ultrasonographic follow-up for 1 year. Multiple imputation was used for uncertain outcomes owing to inconclusive follow-up information.ResultsMedian age of the 4905 patients was 48 years (IQR, 36-62 years). Data on race and ethnicity were not collected. A total of 3441 tumors (70%) were benign, 978 (20%) were malignant, and 486 (10%) had uncertain classification. Using the O-RADS lexicon resulted in 1.1% (24 of 2196) observed prevalence of malignancy in O-RADS 2, 4% (34 of 857) in O-RADS 3, 27% (246 of 904) in O-RADS 4, and 78% (732 of 939) in O-RADS 5; the corresponding results for the IOTA 2-step strategy were 0.9% (18 of 1984), 4% (58 of 1304), 30% (206 of 690), and 82% (756 of 927). At the 10% risk threshold (O-RADS 4-5), the O-RADS lexicon had 92% sensitivity (95% CI, 87%-96%) and 80% specificity (95% CI, 74%-85%), and the IOTA 2-step strategy had 91% sensitivity (95% CI, 84%-95%) and 85% specificity (95% CI, 80%-88%).Conclusions and RelevanceThe findings of this external diagnostic validation study suggest that both the O-RADS lexicon and the IOTA 2-step strategy can be used to stratify patients into risk groups. However, the observed malignancy rate in O-RADS 2 was not clearly below 1%.

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

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