Efficacy of Mastocheck for Screening of Early Breast Cancer: Comparison with Screening Mammography

Abstract

This study was designed to verify the effectiveness of Mastocheck, a new diagnostic tool developed with proteomics techniques using plasma proteins. In addition, checked the current state of mammography used for breast cancer screening. Methods: A total of 305 cases were analyzed (normal 122, breast cancer 183) and used for validation after Mastocheck development. First, screening mammograms of normal patients and pre-diagnosis mammography of cancer patients were reviewed retrospectively. The results were compared with Mastocheck, a newly developed blood test. Imaging tests were blinded and analyzed by dividing the readings of breast specialists and non-breast specialists among radiologists. We confirmed how much better the results would be if only the mammography was used and if both tests were used together. Results: The sensitivity, specificity, and accuracy of mammography alone, reviewed by non-breast specialists among radiologists, were 63.0%, 85.7%, and 71.3%, respectively. In dense breasts, the values were 59.2%, 84.8% and 69.0%, which were too low to be considered interpretable. The sensitivity, specificity and accuracy of the test was 93.9%, 83.8%, and 90.2% when using mammography and Mastocheck together. From these results, an improvement in sensitivity of about 30% and an improvement in accuracy of about 15% or more in concomitant use than mammography alone can be seen. Conclusion: Mastocheck can be widely used for screening breast cancer, especially in dense breasts, patients with low accuracy in mammography, and patients with mammography side effects. In addition, it has the advantage of increasing the diagnosis rate when used with mammography, the current screening method of choice.

Identification and validation of plasma biomarkers for diagnosis of breast cancer in South Asian women

“…In recent times, the use of multiple markers for BC detection is gaining interest because, the combination of functionally important genes and proteins involved in breast tumorigenesis, have exhibited better diagnostic accuracy than single candidate markers 30 . A 3-protein diagnostic model named Mastocheck was able to predict BC with a sensitivity, specificity of 71.58%, 85.25% and AUC 0.8323 39 , 40 . A tumour suppressor methylation panel ( APC, BIN1, BMP6, BRCA1, CST6, ESR-b, GSTP1, P16, P21 and TIMP3 ) showed 91.7% sensitivity in distinguishing BC patients from normal individuals 41 .…”

Diagnostic performance improvement with combined use of proteomics biomarker assay and breast ultrasound

“…A previous study reported 0.0668 as an optimal cut-off value of Mastocheck® for breast cancer diagnosis, with a sensitivity and speci city of 67.0% and 82.0%, respectively. Further validation studies showed sensitivity and speci city of 71.6% and 85.3%, respectively, with the cut-off value mentioned above (31,32). Based on this, a positive result was de ned as a Mastocheck® value of ≥ 0.0668 and a negative result of < 0.0668 [32].…”

“…Further validation studies showed sensitivity and speci city of 71.6% and 85.3%, respectively, with the cut-off value mentioned above (31,32). Based on this, a positive result was de ned as a Mastocheck® value of ≥ 0.0668 and a negative result of < 0.0668 [32].…”

“…H-1807-057-957) and underwent bilateral whole-breast US within at least 6 months from the sampling period. The subgroup of this study population has been reported in previous studies [31][32][33]. Patients were excluded for the following reasons: undergone breast surgery within the previous 12 months, personal history of breast cancer, and no follow-up for at least 12 months to con rm the stability of the lesion.…”

“…According to a recent publication, a blood-based 3-protein signature derived from multiple reaction monitoring (MRM)-based proteomic assay showed sensitivity, speci city, and accuracy of 71.6 %, 85.3%, and 77.0%, respectively, with an area under the receiver operating characteristic curve (AUC) of 0.83, which is speci c for breast cancers and no other types of malignancies including thyroid, pancreatic, lung, and colon cancers [31]. In addition, the results of a blood-based 3-protein signature alone were superior compared to that of only mammography, as interpreted by non-dedicated general radiologists; furthermore, the diagnostic performance was improved by using a combination of mammography and a blood-based 3-protein signature [32]. Although this method showed a potential to be used as a test for breast cancer screening, as well as a complementary tool for preexisting diagnostic imaging modalities, to the best of our knowledge, there have been no studies comparing the value of a proteomics biomarker and breast US for the evaluation of breast masses or of its additional diagnostic value when used in combination with breast US.…”