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Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively: multicentre cohort study.

ABSTRACT: 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. TRIAL REGISTRATION:ClinicalTrials.gov NCT01698632.

SUBMITTER: Van Calster B

PROVIDER: S-EPMC7391073 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively: multicentre cohort study.

Van Calster Ben B Valentin Lil L Froyman Wouter W Landolfo Chiara C Ceusters Jolien J Testa Antonia C AC Wynants Laure L Sladkevicius Povilas P Van Holsbeke Caroline C Domali Ekaterini E Fruscio Robert R Epstein Elisabeth E Franchi Dorella D Kudla Marek J MJ Chiappa Valentina V Alcazar Juan L JL Leone Francesco P G FPG Buonomo Francesca F Coccia Maria Elisabetta ME Guerriero Stefano S Deo Nandita N Jokubkiene Ligita L Savelli Luca L Fischerová Daniela D Czekierdowski Artur A Kaijser Jeroen J Coosemans An A Scambia Giovanni G Scambia Giovanni G Vergote Ignace I Bourne Tom T Timmerman Dirk D

BMJ (Clinical research ed.) 20200730

<h4>Objective</h4>To evaluate the performance of diagnostic prediction models for ovarian malignancy in all patients with an ovarian mass managed surgically or conservatively.<h4>Design</h4>Multicentre cohort study.<h4>Setting</h4>36 oncology referral centres (tertiary centres with a specific gynaecological oncology unit) or other types of centre.<h4>Participants</h4>Consecutive adult patients presenting with an adnexal mass between January 2012 and March 2015 and managed by surgery or follow-up ...[more]

PMID: 32732303

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Project description:ObjectiveRathke cleft cysts (RCC) are benign lesions of the sellar region that require surgical treatment in case of visual deterioration or progression of the cyst. However, the natural course is often stable and asymptomatic. We aimed to investigate the characteristics of patients with cyst progression during follow-up (FU) and to compare the natural history of patients with RCC with patients who underwent surgery.MethodsPatients with an MR morphologic cystic sellar lesion classified as RCC between 04/2001 and 11/2020 were included. Functional outcomes, including ophthalmologic, endocrinologic, and MRI data, were retrospectively analyzed and compared between surgically treated patients, patients on a "watch and wait" strategy (WWS), and patients on a WWS who underwent secondary surgery due to cyst progression.ResultsOne hundred forty patients (median age 42.8 years) with RCC on MRI were identified. 52/140 (37.1%) underwent primary surgery. Of 88 patients (62.9%) with initial WWS, 21 (23.9%) underwent surgery for secondary cyst progression. Patients on the WWS had significantly smaller cyst volumes (p = 0.0001) and fewer visual disturbances (p = 0.0004), but a similar rate of hormone deficiencies (p = 0.99) compared with surgically treated patients preoperatively. Postoperatively patients suffered significantly more often from hormone deficiencies than WWS patients (p = 0.001). Patients who switched to the surgical group were significantly more likely to have preoperative T1 hyperintense signals on MRI (p = 0.0001) and visual disturbances (p = 0.001) than patients with continuous WWS. Postoperatively, these patients suffered more frequently from new hormonal deficiencies (p = 0.001). Endocrine and ophthalmologic outcomes in patients with primary and secondary surgery were comparable. Multivariate analysis showed that WWS patients were at a higher risk of requiring surgery for cyst progression when perimetric deficits (p = 0.006), hyperprolactinemia (p = 0.003), and corticotropic deficits (p = 0.005) were present.ConclusionSurgical treatment of RCC may cause new hormonal deficiencies, which are rare in the natural course. Therefore, the indication for surgery should be carefully evaluated. Hyperprolactinemia and corticotropic deficits were significant indicators for a secondary cyst progression in patients with RCC. However, a significant amount of almost 25% of initially conservatively managed cysts showed deterioration, necessary for surgical intervention.

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Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively: multicentre cohort study.

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Validation of models to diagnose ovarian cancer in patients managed surgically or conservatively: multicentre cohort study.

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