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Breast Cancer Potential Use of Biomarkers to Augment Clinical Decisions for the Early Detection of Breast Cancer Alan B Hollingsworth, MD 1 and David E Reese, PhD 2 1. Medical Director, Mercy Women’s Center, Mercy Hospital–OKC, Oklahoma City, OK, US; 2. Chief Scientific Officer and Chief Executive Officer, Provista Diagnostics, Inc., New York, NY, US Abstract Breast cancer remains a significant worldwide health problem, despite the fact that early detection is associated with excellent survival rates. Currently, a substantial proportion of breast cancers are not detected using routine screening. Therefore, there is a need to identify a technology that can improve the precision and accuracy of early breast cancer detection. Biomarkers are attractive in that they can potentially detect early cancers with high sensitivity, while distinguishing between benign disease and invasive cancers. Many commonly used serum biomarkers have limited use in screening assays for breast cancer as single agents due to the heterogeneous nature of breast cancer. However, the use of protein panels that detect multiple serum biomarkers offer the potential for enhanced sensitivity and specificity in a clinical setting. Recently, a serum biomarker test comprising five serum biomarkers for breast cancer was clinically validated and showed high sensitivity and specificity. Additional panels have been developed that combine serum protein biomarkers (SPB) and tumor-associated autoantibodies (TAb) to further enhance the clinical utility of the assay. Serum biomarkers are currently not the standard of care and are not recommended in any detection guidelines. However, tumor biomarkers are used in the breast cancer setting to determine the course of care. The purpose of this article is to review recent advances in SPB, TAb, and biomarkers used in breast cancer detection to provide a perspective on how these technologies may offer benefit when combined with current imaging modalities. Keywords Breast cancer, biomarkers, screening, protein panel, early diagnosis Disclosure: Alan B Hollingsworth, MD, is a consultant for Provista Diagnostics, Inc. David E Reese, PhD, is an employee of Provista Diagnostics, Inc. Acknowledgments: Editorial assistance was provided by Katrina Mountfort, PhD, at Touch Medical Media, London, UK, and was funded by Provista Diagnostics, Inc. Received: September 30, 2014 Accepted: November 12, 2014 Citation: Oncology & Hematology Review, 2014;10(2):103–9 Correspondence: Alan B Hollingsworth, MD, Mercy Women’s Center, 4300 McAuley Blvd, Oklahoma City, OK 73120, US (E: David E Reese, PhD, Provista Diagnostics, Inc., 160 Varick Street, 11th FL, New York, NY 10013, US (E: Support: The publication of this article was supported by Provista Diagnostics, Inc. The views and opinions expressed are those of the authors and do not necessarily reflect those of Provista Diagnostics, Inc. Breast cancer is the most common malignant disease in women: according to US statistics, one in eight women will be diagnosed with breast cancer in her lifetime. 1 It was estimated that approximately 232,340 new cases of invasive breast cancer and 39,620 deaths were expected among US women in 2013. 2 Early detection and diagnosis of breast cancer are essential for successful treatment; women diagnosed with stage II and III breast cancer have a high risk for recurrence and a higher chance of developing metastatic disease, which remains incurable. 3 Early diagnosis of breast cancer is associated with significantly lower morbidity; tumor detection at stages 0 and 1 is associated with approximately 98 % 5-year survival. 4 to locate the tumor for further treatment/assessment. Biomarkers can also be used in the diagnostic workup of suspicious lesions as part of the clinical decision-making process, and may provide biochemical evidence to inform decisions regarding the need for biopsy, much like positron emission tomography and computerized tomography (PET-CT) that measures the metabolic rate of a mass in conjunction with its anatomical presentation. The third potential use is to monitor for breast cancer disease recurrence. This article will outline the limitations of current breast cancer diagnostic methods and examine the role of biomarkers in current screening paradigms. The study of biomarkers in the monitoring of tumor progression began with the discovery of carcinoembryonic antigen (CEA) in 1965. 5 Biomarkers are Limitations of Current Breast Cancer Screening Techniques and the Potential Role of Biomarkers potentially useful in screening programs, but the application of biomarker testing requires the incorporation of radiologic screening methods in order Current screening in the US for breast cancer relies heavily on mammography, which is an oversold and expensive regimen that detects only 70  % of © To u ch MEd ica l MEdia 201 4 103