Landolfo, C. (Chiara)

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    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
    (2023) Jokubkiene, L. (Ligita); Epstein, E. (Elizabeth); Deo, N. (Nandita); Landolfo, C. (Chiara); Timmerman, S. (Stefan); Sladkevicius, P. (Povilas); Alcazar, J.L. (Juan Luis); Fruscio, R. (Robert); Kaijser, J. (Jeroen); Guerriero, S. (Stefano); Andreotti, R. (Rochelle); Scambia, G. (Giovanni); Calster, B. (Ben) van; Domali, E. (Ekaterine); Ceusters, J. (Jolien); Testa, A.C. (Antonia Carla); Franchi, D. (Dorella); Buonomo, F. (Francesca); Timmerman, D. (Dirk); Kudla, M.J. (Marek J.); Bourne, T. (Tom); Leone, F.P.G. (Francesco Paolo Giuseppe); Holsbeke, C. (Caroline) van; Chiappa, V. (Valentina); Coccia, M.E. (Maria Elisabetta); Froyman, W. (Wouter); Valentin, L. (Lil)
    IMPORTANCE Correct 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. OBJECTIVE To investigate the diagnostic performance of the O-RADS lexicon and the IOTA 2-step strategy. DESIGN, SETTING, AND PARTICIPANTS Retrospective 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. EXPOSURES Stratification 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 MEASURES Observed 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. RESULTS Median 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 RELEVANCE The 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%.
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    Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively: multicentre cohort study
    (2020) Jokubkiene, L. (Ligita); Epstein, E. (Elizabeth); Deo, N. (Nandita); Landolfo, C. (Chiara); Sladkevicius, P. (Povilas); Alcazar, J.L. (Juan Luis); Fruscio, R. (Robert); Guerriero, S. (Stefano); Calster, B. (Ben) van; Domali, E. (Ekaterine); Ceusters, J. (Jolien); Testa, A.C. (Antonia Carla); Franchi, D. (Dorella); Buonomo, F. (Francesca); Kudla, M.J. (Marek J.); Wynants, L. (Laure); Leone, F.P.G. (Francesco Paolo Giuseppe); Holsbeke, C. (Caroline) van; Chiappa, V. (Valentina); Coccia, M.E. (Maria Elisabetta); Froyman, W. (Wouter); Valentin, L. (Lil)
    Objective To evaluate the performance of diagnostic prediction models for ovarian malignancy in all patients with an ovarian mass managed surgically or conservatively. Design Multicentre cohort study. Setting 36 oncology referral centres (tertiary centres with a specific gynaecological oncology unit) or other types of centre. Participants Consecutive adult patients presenting with an adnexal mass between January 2012 and March 2015 and managed by surgery or follow-up. Main outcome measures Overall and centre specific discrimination, calibration, and clinical utility of six prediction models for ovarian malignancy (risk of malignancy index (RMI), logistic regression model 2 (LR2), simple rules, simple rules risk model (SRRisk), assessment of different neoplasias in the adnexa (ADNEX) with or without CA125). ADNEX allows the risk of malignancy to be subdivided into risks of a borderline, stage I primary, stage II-IV primary, or secondary metastatic malignancy. The outcome was based on histology if patients underwent surgery, or on results of clinical and ultrasound follow-up at 12 (±2) months. Multiple imputation was used when outcome based on follow-up was uncertain. Results The primary analysis included 17 centres that met strict quality criteria for surgical and follow-up data (5717 of all 8519 patients). 812 patients (14%) had a mass that was already in follow-up at study recruitment, therefore 4905 patients were included in the statistical analysis. The outcome was benign in 3441 (70%) patients and malignant in 978 (20%). Uncertain outcomes (486, 10%) were most often explained by limited follow-up information. The overall area under the receiver operating characteristic curve was highest for ADNEX with CA125 (0.94, 95% confidence interval 0.92 to 0.96), ADNEX without CA125 (0.94, 0.91 to 0.95) and SRRisk (0.94, 0.91 to 0.95), and lowest for RMI (0.89, 0.85 to 0.92). Calibration varied among centres for all models, however the ADNEX models and SRRisk were the best calibrated. Calibration of the estimated risks for the tumour subtypes was good for ADNEX irrespective of whether or not CA125 was included as a predictor. Overall clinical utility (net benefit) was highest for the ADNEX models and SRRisk, and lowest for RMI. For patients who received at least one follow-up scan (n=1958), overall area under the receiver operating characteristic curve ranged from 0.76 (95% confidence interval 0.66 to 0.84) for RMI to 0.89 (0.81 to 0.94) for ADNEX with CA125. Conclusions Our study found the ADNEX models and SRRisk are the best models to distinguish between benign and malignant masses in all patients presenting with an adnexal mass, including those managed conservatively.
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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
    (2023) Jokubkiene, L. (Ligita); Vergote, I. (I.); Epstein, E. (Elizabeth); Fischerova, D. (Daniela); Deo, N. (Nandita); Landolfo, C. (Chiara); Sladkevicius, P. (Povilas); Alcazar, J.L. (Juan Luis); Testa, A.C. (Antonia C.); Fruscio, R. (Robert); Kaijser, J. (Jeroen); Guerriero, S. (Stefano); Scambia, G. (Giovanni); Calster, B. (Ben) van; Domali, E. (Ekaterine); Ceusters, J. (Jolien); Franchi, D. (Dorella); Buonomo, F. (Francesca); Timmerman, D. (Dirk); Czekierdowski, A. (Artur); Coosemans, A. (An); Kudla, M.J. (Marek J.); Wynants, L. (Laure); Bourne, T. (Tom); Leone, F.P.G. (Francesco Paolo Giuseppe); Van-Holsbeke, C. (Caroline); Coccia, M.E. (Maria Elisabetta); Chiappa, V. (Valentina); Froyman, W. (Wouter); Savelli, L. (L.); Valentin, L. (Lil)
    ObjectivePrevious 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. MethodsThis 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. ResultsA 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). ConclusionA 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. (c) 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.