To view this page ensure that Adobe Flash Player version 11.1.0 or greater is installed.
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: firstname.lastname@example.org). David E Reese, PhD,
Provista Diagnostics, Inc., 160 Varick Street, 11th FL, New York, NY 10013, US (E: info@ProvistaDx.com).
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