27.01.2022 | Clinical trial
Diagnostic performance improvement with combined use of proteomics biomarker assay and breast ultrasound
verfasst von:
Su Min Ha, Hong-Kyu Kim, Yumi Kim, Dong-Young Noh, Wonshik Han, Jung Min Chang
Erschienen in:
Breast Cancer Research and Treatment
|
Ausgabe 3/2022
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Abstract
Purpose
To investigate the combined use of blood-based 3-protein signature and breast ultrasound (US) for validating US-detected lesions.
Methods
From July 2011 to April 2020, women who underwent whole-breast US within at least 6 months from sampling period were retrospectively included. Blood-based 3-protein signature (Mastocheck®) value and US findings were evaluated. Following outcome measures were compared between US alone and the combination of Mastocheck® value with US: sensitivity, specificity, positive predictive value (PPV), negative predictive value, area under the receiver operating characteristic curve (AUC), and biopsy rate.
Results
Among the 237 women included, 59 (24.9%) were healthy individuals and 178 (75.1%) cancer patients. Mean size of cancers was 1.2 ± 0.8 cm. Median value of Mastocheck® was significantly different between nonmalignant (− 0.24, interquartile range [IQR] − 0.48, − 0.03) and malignant lesions (0.55, IQR − 0.03, 1.42) (P < .001). Utilizing Mastocheck® value with US increased the AUC from 0.67 (95% confidence interval [CI] 0.61, 0.73) to 0.81 (95% CI 0.75, 0.88; P < .001), and specificity from 35.6 (95% CI 23.4, 47.8) to 64.4% (95% CI 52.2, 76.6; P < .001) without loss in sensitivity. PPV was increased from 82.2 (95% CI 77.1, 87.3) to 89.3% (95% CI 85.0, 93.6; P < .001), and biopsy rate was significantly decreased from 79.3 (188/237) to 72.1% (171/237) (P < .001). Consistent improvements in specificity, PPV, and AUC were observed in asymptomatic women, in women with dense breast, and in those with normal/benign mammographic findings.
Conclusion
Mastocheck® is an effective tool that can be used with US to improve diagnostic specificity and reduce false-positive findings and unnecessary biopsies.