Abstract
With improvements in breast cancer imaging, there has been a corresponding increase in false-positives and avoidable biopsies. There is a need to better differentiate when a breast biopsy is warranted and determine appropriate follow-up. This study describes the design and clinical performance of a combinatorial proteomic biomarker assay (CPBA), Videssa Breast, in women over age 50 years. A BI-RADS 3, 4, or 5 assessment was required for clinical trial enrollment. Serum was collected prior to breast biopsy and subjects were followed for 6-12 months and clinically relevant outcomes were recorded. Samples were split into training (70%) and validation (30%) cohorts with an approximate 1:4 case:control ratio in both arms. A CPBA that combines biomarker data with patient clinical data was developed using a training cohort (469 women, cancer incidence: 18.5%), resulting in 94% sensitivity and 97% negative predictive value (NPV). Independent validation of the final algorithm in 194 subjects (breast cancer incidence: 19.6%) demonstrated a sensitivity of 95% and a NPV of 97%. When combined with previously published data for women under age 50, Videssa Breast achieves a comprehensive 93% sensitivity and 98% NPV in a population of women ages 25-75. Had Videssa Breast results been incorporated into the clinical workflow, approximately 45% of biopsies might have been avoided. Videssa Breast combines serum biomarkers with clinical patient characteristics to provide clinicians with additional information for patients with indeterminate breast imaging results, potentially reducing false-positive breast biopsies.
Highlights
Breast cancer is the second leading cause of cancer-related deaths in U.S women; with 246,600 cases diagnosed and 40,450 deaths in 2016 [1]; if diagnosed early in a localized state, 5-year survival rates are > 98% [2]
Breast imaging results are scored by radiologists using the ACR BI-RADS classification [3]; there exists a significant amount of inter-reader variability [4,5,6]
The American Cancer Society recently recommended that age-at-first-mammogram be changed to 45 for women of average risk and the U.S Preventative Services Task Force recommends screening mammography every two years starting at age 50 [17, 18]
Summary
Breast cancer is the second leading cause of cancer-related deaths in U.S women; with 246,600 cases diagnosed and 40,450 deaths in 2016 [1]; if diagnosed early in a localized state, 5-year survival rates are > 98% [2]. The gold standard in breast cancer diagnosis remains breast imaging followed by biopsy when warranted. Breast tissue structures, for example, dense fibrous tissue or scar tissue from prior biopsy [7,8,9,10], false-positives remain a significant problem in the diagnosis of breast cancer [11, 12]. The American Cancer Society recently recommended that age-at-first-mammogram be changed to 45 (from 40) for women of average risk and the U.S Preventative Services Task Force recommends screening mammography every two years starting at age 50 [17, 18]. Breast cancer detection could be greatly aided by the addition of a secondary, objective assessment
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