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Benign descriptors and ADNEX in two-step strategy to estimate risk of malignancy in ovarian tumors: retrospective validation in IOTA5 multicenter cohort
C. Landolfo, T. Bourne, W. Froyman, B. Van Calster, J. Ceusters, AC. Testa, L. Wynants, P. Sladkevicius, C. Van Holsbeke, E. Domali, R. Fruscio, E. Epstein, D. Franchi, MJ. Kudla, V. Chiappa, JL. Alcazar, FPG. Leone, F. Buonomo, ME. Coccia, S....
Language English Country England, Great Britain
Document type Multicenter Study, Journal Article
PubMed
36178788
DOI
10.1002/uog.26080
Knihovny.cz E-resources
- MeSH
- CA-125 Antigen MeSH
- Diagnosis, Differential MeSH
- Humans MeSH
- Ovarian Neoplasms * pathology MeSH
- Adnexal Diseases * pathology MeSH
- Retrospective Studies MeSH
- Sensitivity and Specificity MeSH
- Ultrasonography methods MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
OBJECTIVE: Previous work has suggested that the ultrasound-based benign simple descriptors (BDs) can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. This study aimed to validate a modified version of the BDs and to validate a two-step strategy to estimate the risk of malignancy, in which the modified BDs are followed by the Assessment of Different NEoplasias in the adneXa (ADNEX) model if modified BDs do not apply. METHODS: This was a retrospective analysis using data from the 2-year interim analysis of the International Ovarian Tumor Analysis (IOTA) Phase-5 study, in which consecutive patients with at least one adnexal mass were recruited irrespective of subsequent management (conservative or surgery). The main outcome was classification of tumors as benign or malignant, based on histology or on clinical and ultrasound information during 1 year of follow-up. Multiple imputation was used when outcome based on follow-up was uncertain according to predefined criteria. RESULTS: A total of 8519 patients were recruited at 36 centers between 2012 and 2015. We excluded patients who were already in follow-up at recruitment and all patients from 19 centers that did not fulfil our criteria for good-quality surgical and follow-up data, leaving 4905 patients across 17 centers for statistical analysis. Overall, 3441 (70%) tumors were benign, 978 (20%) malignant and 486 (10%) uncertain. The modified BDs were applicable in 1798/4905 (37%) tumors, of which 1786 (99.3%) were benign. The two-step strategy based on ADNEX without CA125 had an area under the receiver-operating-characteristics curve (AUC) of 0.94 (95% CI, 0.92-0.96). The risk of malignancy was slightly underestimated, but calibration varied between centers. A sensitivity analysis in which we expanded the definition of uncertain outcome resulted in 1419 (29%) tumors with uncertain outcome and an AUC of the two-step strategy without CA125 of 0.93 (95% CI, 0.91-0.95). CONCLUSION: A large proportion of adnexal masses can be classified as benign by the modified BDs. For the remaining masses, the ADNEX model can be used to estimate the risk of malignancy. This two-step strategy is convenient for clinical use. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
1st Department of Gynecological Oncology and Gynecology Medical University of Lublin Lublin Poland
Clinic of Obstetrics and Gynecology University of Milano Bicocca San Gerardo Hospital Monza Italy
Department of Biomedical Data Sciences Leiden University Medical Centre Leiden The Netherlands
Department of Clinical Science and Education Karolinska Institutet Stockholm Sweden
Department of Clinical Sciences Malmö Lund University Lund Sweden
Department of Development and Regeneration KU Leuven Leuven Belgium
Department of Gynecologic Oncology National Cancer Institute of Milan Milan Italy
Department of Obstetrics and Gynecology Ikazia Hospital Rotterdam The Netherlands
Department of Obstetrics and Gynecology Skåne University Hospital Malmö Sweden
Department of Obstetrics and Gynecology Södersjukhuset Stockholm Sweden
Department of Obstetrics and Gynecology University Hospitals Leuven Leuven Belgium
Department of Obstetrics and Gynecology University of Florence Florence Italy
Department of Obstetrics and Gynecology Whipps Cross Hospital London UK
Department of Obstetrics and Gynecology Ziekenhuis Oost Limburg Genk Belgium
Institute for Maternal and Child Health IRCCS 'Burlo Garofolo' Trieste Italy
Preventive Gynecology Unit Division of Gynecology European Institute of Oncology IRCCS Milan Italy
Queen Charlotte's and Chelsea Hospital Imperial College Healthcare NHS Trust London UK
References provided by Crossref.org
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- $a OBJECTIVE: Previous work has suggested that the ultrasound-based benign simple descriptors (BDs) can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. This study aimed to validate a modified version of the BDs and to validate a two-step strategy to estimate the risk of malignancy, in which the modified BDs are followed by the Assessment of Different NEoplasias in the adneXa (ADNEX) model if modified BDs do not apply. METHODS: This was a retrospective analysis using data from the 2-year interim analysis of the International Ovarian Tumor Analysis (IOTA) Phase-5 study, in which consecutive patients with at least one adnexal mass were recruited irrespective of subsequent management (conservative or surgery). The main outcome was classification of tumors as benign or malignant, based on histology or on clinical and ultrasound information during 1 year of follow-up. Multiple imputation was used when outcome based on follow-up was uncertain according to predefined criteria. RESULTS: A total of 8519 patients were recruited at 36 centers between 2012 and 2015. We excluded patients who were already in follow-up at recruitment and all patients from 19 centers that did not fulfil our criteria for good-quality surgical and follow-up data, leaving 4905 patients across 17 centers for statistical analysis. Overall, 3441 (70%) tumors were benign, 978 (20%) malignant and 486 (10%) uncertain. The modified BDs were applicable in 1798/4905 (37%) tumors, of which 1786 (99.3%) were benign. The two-step strategy based on ADNEX without CA125 had an area under the receiver-operating-characteristics curve (AUC) of 0.94 (95% CI, 0.92-0.96). The risk of malignancy was slightly underestimated, but calibration varied between centers. A sensitivity analysis in which we expanded the definition of uncertain outcome resulted in 1419 (29%) tumors with uncertain outcome and an AUC of the two-step strategy without CA125 of 0.93 (95% CI, 0.91-0.95). CONCLUSION: A large proportion of adnexal masses can be classified as benign by the modified BDs. For the remaining masses, the ADNEX model can be used to estimate the risk of malignancy. This two-step strategy is convenient for clinical use. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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