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Benign descriptors and ADNEX in two-step strategy to estimate risk of malignancy in ovarian tumors : retrospective validation on IOTA 5 multicenter cohort

Landolfo, C. ; Bourne, T. ; Froyman, W. ; Van Calster, B. ; Ceusters, J. ; Testa, A. C. ; Wynants, L. ; Sladkevicius, P. LU orcid ; Van Holsbeke, C. and Domali, E. , et al. (2023) In Ultrasound in Obstetrics and Gynecology 61(2). p.231-242
Abstract

Objective: Previous work suggested that the ultrasound-based benign Simple Descriptors can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. We aim to validate a modified version of the Benign Simple Descriptors (BD), and we introduce a two-step strategy to estimate the risk of malignancy: if the BDs do not apply, the ADNEX model is used to estimate the risk of malignancy. Methods: This is a retrospective analysis using the data from the 2-year interim analysis of the IOTA5 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... (More)

Objective: Previous work suggested that the ultrasound-based benign Simple Descriptors can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. We aim to validate a modified version of the Benign Simple Descriptors (BD), and we introduce a two-step strategy to estimate the risk of malignancy: if the BDs do not apply, the ADNEX model is used to estimate the risk of malignancy. Methods: This is a retrospective analysis using the data from the 2-year interim analysis of the IOTA5 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 one year of follow-up. Multiple imputation was used when outcome based on follow-up was uncertain according to predefined criteria. Results: 8519 patients were recruited at 36 centers between 2012 and 2015. We included all masses that were not already in follow-up at recruitment from 17 centers with good quality surgical and follow-up data, leaving 4905 patients for statistical analysis. 3441 (70%) tumors were benign, 978 (20%) malignant, and 486 (10%) uncertain. The BDs were applicable in 1798/4905 (37%) tumors, and 1786 (99.3%) of these were benign. The two-step strategy based on ADNEX without CA125 had an area under the receiver operating characteristic curve (AUC) of 0.94 (95% CI, 0.91-0.95). 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 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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
ADNEX model, benign simple descriptors, IOTA, ovarian neoplasms, ultrasonography, validation study
in
Ultrasound in Obstetrics and Gynecology
volume
61
issue
2
pages
231 - 242
publisher
John Wiley & Sons Inc.
external identifiers
  • pmid:36178788
  • scopus:85143240688
ISSN
0960-7692
DOI
10.1002/uog.26080
language
English
LU publication?
yes
id
f415a911-6929-42c5-9de0-8b71b3f05792
date added to LUP
2023-01-30 14:13:37
date last changed
2024-04-14 05:25:11
@article{f415a911-6929-42c5-9de0-8b71b3f05792,
  abstract     = {{<p>Objective: Previous work suggested that the ultrasound-based benign Simple Descriptors can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. We aim to validate a modified version of the Benign Simple Descriptors (BD), and we introduce a two-step strategy to estimate the risk of malignancy: if the BDs do not apply, the ADNEX model is used to estimate the risk of malignancy. Methods: This is a retrospective analysis using the data from the 2-year interim analysis of the IOTA5 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 one year of follow-up. Multiple imputation was used when outcome based on follow-up was uncertain according to predefined criteria. Results: 8519 patients were recruited at 36 centers between 2012 and 2015. We included all masses that were not already in follow-up at recruitment from 17 centers with good quality surgical and follow-up data, leaving 4905 patients for statistical analysis. 3441 (70%) tumors were benign, 978 (20%) malignant, and 486 (10%) uncertain. The BDs were applicable in 1798/4905 (37%) tumors, and 1786 (99.3%) of these were benign. The two-step strategy based on ADNEX without CA125 had an area under the receiver operating characteristic curve (AUC) of 0.94 (95% CI, 0.91-0.95). 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 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. <br/></p>}},
  author       = {{Landolfo, C. and Bourne, T. and Froyman, W. and Van Calster, B. and Ceusters, J. and Testa, A. C. and Wynants, L. and Sladkevicius, P. and Van Holsbeke, C. and Domali, E. and Fruscio, R. and Epstein, E. and Franchi, D. and Kudla, M. J. and Chiappa, V. and Alcazar, J. L. and Leone, F. P.G. and Buonomo, F. and Coccia, M. E. and Guerriero, S. and Deo, N. and Jokubkiene, L. and Savelli, L. and Fischerova, D. and Czekierdowski, A. and Kaijser, J. and Coosemans, A. and Scambia, G. and Vergote, I. and Timmerman, D. and Valentin, L.}},
  issn         = {{0960-7692}},
  keywords     = {{ADNEX model; benign simple descriptors; IOTA; ovarian neoplasms; ultrasonography; validation study}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{231--242}},
  publisher    = {{John Wiley & Sons Inc.}},
  series       = {{Ultrasound in Obstetrics and Gynecology}},
  title        = {{Benign descriptors and ADNEX in two-step strategy to estimate risk of malignancy in ovarian tumors : retrospective validation on IOTA 5 multicenter cohort}},
  url          = {{http://dx.doi.org/10.1002/uog.26080}},
  doi          = {{10.1002/uog.26080}},
  volume       = {{61}},
  year         = {{2023}},
}