Diagnostic accuracy and cost‐effectiveness of different strategies to triage women with adnexal masses: a prospective study

Piovano, Elisa; Cavallero, Camilla; Fuso, Luca; Viora, E.; Ferrero, Annamaria; Gregori, Gabriella; Grillo, Caterina; Macchi, Chiara; Mengozzi, Giulio; Mitidieri, Marco; Pagano, Eva; Zola, Paolo

doi:10.1002/uog.17320

Cited by 31 publications

(34 citation statements)

References 28 publications

(40 reference statements)

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“…We were able to find only one paper dealing with the costeffectiveness of HE4 use in the initial triage of women with pelvic masses [74]. While the addition of CA125 to transvaginal US proved useful enough to triage those patients (but only in post-menopausal group), the study did not support the cost-effectiveness of HE4 use in replacing CA125 in the initial triage of adnexal masses (Table 2).…”

Section: He4 Cost-effectivenessmentioning

confidence: 92%

Making new biomarkers a reality: the case of serum human epididymis protein 4

Ferraro

Panteghini

2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background Measurement of human epididymis protein 4 (HE4) in serum has recently been proposed for clinical use in the framework of ovarian cancer (OvCa). We sought to retrace the translational phase and the clinical implementation steps boosting HE4’s clinical value and discuss the effects of its introduction on the diagnostic and management pathways. Methods Meta-analyses of running evidence have preliminarily suggested that HE4 may overcome carbohydrate antigen 125 (CA125) in identifying OvCa, showing however several gaps that need to be considered, i.e. definition of biomarker diagnostic performance in the early detection of OvCa, added diagnostic value, biological and lifestyle factors of variation, and optimal interpretative criteria. Investigation of the influencing factors has shown that renal impairment represents a major limitation for HE4’s diagnostic power. On the other hand, the demonstration of the substantial equivalence of results obtained by commercially available assays allows recommending harmonized thresholds for diagnostic purpose, even if the study of HE4’s biological variation has clarified that the longitudinal interpretation of the biomarker changes according to the reference change value could be more appropriate. Summary We used HE4 as an example for describing the long and bumpy road for making a new biomarker a reality, and the issues that should be checked and the information that should be provided in moving a novel biomarker from its discovery to an effective clinical adoption.

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Section: He4 Cost-effectivenessmentioning

confidence: 92%

Making new biomarkers a reality: the case of serum human epididymis protein 4

Ferraro

Panteghini

2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Ovarian cancer (OC) has the highest mortality rate and most unfavourable prognosis among the gynaecological malignancies; the average 5-year survival rate is < 50% (1,2). Currently, transvaginal ultrasound is the most commonly used, noninvasive, affordable imaging technique for pre-operative evaluations of adnexal masses with minimal risk and discomfort to the patient (3)(4)(5). And subjective assessments of ultrasound findings by specialists in gynaecological ultrasonography are one of the best means of evaluating adnexal masses in clinical practice (5)(6)(7)(8)(9)(10).…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Diagnostic Performances of Ultrasound-Based Models for Predicting Malignancy in Patients With Adnexal Masses

Qian

Jiang

et al. 2021

Front. Oncol.

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AimThis study aimed to compare different ultrasound-based International Ovarian Tumor Analysis (IOTA) prediction models, namely, the Simple Rules (SRs) the Assessment of Different NEoplasias in the adneXa (ADNEX) models, and the Risk of Malignancy Index (RMI), for the pre-operative diagnosis of adnexal mass.MethodsThis single-centre diagnostic accuracy study involved 486 patients. All ultrasound examinations were analyzed and the prediction models were applied. Pathology was the clinical reference standard. The diagnostic performances of prediction models were measured by evaluating receiver-operating characteristic curves, sensitivities, specificities, positive and negative predictive values, positive and negative likelihood ratios, and diagnostic odds ratios.ResultsTo discriminate benign and malignant tumors, areas under the ROC curves (AUCs) for ADNEX models were 0.94 (95% CI: 0.92–0.96) with CA125 and 0.94 (95% CI: 0.91–0.96) without CA125, which were significantly higher than the AUCs for RMI I-III: 0.87 (95% CI: 0.83–0.90), 0.83 (95% CI: 0.80–0.86), and 0.82 (95% CI: 0.78–0.86), (all P < 0.0001). At a cut-off of 10%, the ADNEX model with CA125 had the highest sensitivity (0.93; 95% CI: 0.87–0.97) compared with the other models. The SRs model achieved a sensitivity of 0.93 (95% CI: 0.86–0.97) and a specificity of 0.86 (95% CI: 0.82–0.89) when inconclusive diagnoses (11.7%) were classified as malignant.ConclusionADNEX and SRs models were excellent at characterising adnexal masses which were superior to the RMI in Chinese patients.

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“…Despite our findings, as well as those of other studies that characterize CA125 to be considerably less sensitive and specific than multimodal risk algorithms such as MIA2G or even ultrasound [10] for determining the likelihood of malignancy, the use of CA125 alone to assess women with adnexal findings remains a popular choice in the assessment of women presenting with an adnexal mass. A recent study from Italy by Piovano and colleagues [11] found that adding CA125 and ROMA to triage algorithms for postmenopausal women with adnexal masses improved screening accuracy compared with ultrasound alone; the addition of ROMA was considerably more expensive and provided for minimal additional screening benefit compared with CA125 alone. While economic considerations do play some role in the continued use of CA125 alone for the presurgical assessment of women with adnexal masses, the availability of FDA-cleared multimodal assays and the lack of FDA clearance for the use of CA125 in these clinical situations continue to call into question the ongoing use of a single analyte assay for which there is considerable evidence to support it being an inferior triage process for women presenting with adnexal masses compared with multimodal algorithms [12].…”

Section: Discussionmentioning

confidence: 99%

Clinical Performance Comparison of Two In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs) for Presurgical Assessment for Ovarian Cancer Risk

Shulman

Francis²,

Bullock³

et al. 2019

Adv Ther

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IntroductionAdnexal or pelvic mass is a finding that commonly raises suspicion for malignancy, especially for ovarian cancer. Proper identification prior to surgery would permit appropriate referral to a specialty center in cases likely to be ovarian cancer, as optimal outcomes in such cases are obtained when surgical staging and treatment are provided at the time of initial surgery.MethodsWe compared the screening capabilities of two in vitro diagnostic multivariate index assays (IVDMIAs), a new IVDMIA (second-generation multivariate index assay: MIA2G) and a currently used triage algorithm (Risk of Ovarian Malignancy Assay: ROMA).ResultsAmong 245 subjects (24.7%) determined to have a malignancy, ROMA misclassified 51 malignancies (including 10 high-grade ovarian malignancies), whereas MIA2G misclassified 22 (including 5 high-grade ovarian malignancies). Early stage cancers were more frequently misclassified by ROMA (20 vs. 8 cases). The rate of “test-negative” malignancies was significantly higher for ROMA, while the rate of “test-positive” benign cases was significantly higher for MIA2G.ConclusionTriage algorithms play an important role in improving clinical outcomes for women presenting with an adnexal mass regardless of the eventual diagnosis. In this study, MIA2G was shown to correctly predict more cases of ovarian cancer than the ROMA algorithm.FundingAspira Labs/Vermillion Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-01010-8) contains supplementary material, which is available to authorized users.

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Diagnostic accuracy and cost‐effectiveness of different strategies to triage women with adnexal masses: a prospective study

Cited by 31 publications

References 28 publications

Making new biomarkers a reality: the case of serum human epididymis protein 4

Making new biomarkers a reality: the case of serum human epididymis protein 4

Comparison of the Diagnostic Performances of Ultrasound-Based Models for Predicting Malignancy in Patients With Adnexal Masses

Clinical Performance Comparison of Two In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs) for Presurgical Assessment for Ovarian Cancer Risk

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