Abstract P2-02-03: Assessment of an immune response panel of serum protein biomarkers for the non-invasive detection of breast cancer

Abstract

Background: Breast cancer screening guidelines (ACS) recommend annual mammography for asymptomatic women ages 45 to 54 and once every two years for women age 55 and older. Women with suspicious screening mammograms are recommended for a diagnostic mammogram and may also undergo MRI or ultrasound. Ultimately, unresolved suspicious findings frequently result in the recommendation of a breast biopsy. Approximately 10% of suspicious diagnostic mammograms are recommended for breast biopsies and a large majority of these biopsies yield benign results. We conducted a screen for serum protein biomarkers and identified a novel panel for the non-invasive detection of breast cancer with the goal of developing a diagnostic test that can reduce the number of patients with benign pathology undergoing invasive biopsies. Methods: Serum samples were collected at 4 US sites from women with suspicious diagnostic mammogram findings (primarily BI-RADS category 4 and breast composition b/c) undergoing biopsy for evaluation of a potential malignancy. Serum samples from 136 patients (87 benign pathology and 49 malignant pathology) were evaluated on the olink® Proteomics Immune Response Panel (92 analytes). Statistical screening methodologies, such as individual t-tests with control for false discovery, were used to identify markers with the potential to distinguish benign from malignant pathology. The candidate markers were further studied and combined using generalized linear modeling to develop potential diagnostic models. Results: A 19-marker model resulted in an AUC of 0.94 with a sensitivity of 90% and a specificity of 80%. A 12-marker model resulted in an AUC of 0.93, yielding a sensitivity of 90% with a specificity of 77%. Conclusions: This study reveals a novel panel of serum protein biomarkers that may allow for the non-invasive and sensitive detection of breast cancer in patients presenting with suspicious findings on mammography, thus reducing the need for invasive biopsies. Citation Format: McQuary PR, Copeland KAF, Sheibani NM, Friedman LA, Korn RL, Fiorica JV, Lourenco AP, Struthers SE, Hesterberg LK. Assessment of an immune response panel of serum protein biomarkers for the non-invasive detection of breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P2-02-03.