Personalized Cancer Care and Liquid Biopsy for Breast Cancer Monitoring

It is the fear that strikes all women. Approximately one in eight American females will develop invasive breast cancer over the course of her lifetime.¹ According to breastcancer.org, an estimated 247,000 new cases of invasive breast cancer will be diagnosed in 2016. Sixty-one thousand cases of non-invasive (in-situ) breast cancer are also expected to be diagnosed this year. Although men share their wives’, sisters’, and daughters’ concerns about the disease, they are not exempt from the illness. Roughly 2,600 new cases of invasive breast cancer are projected to be diagnosed in men in 2016.

Why This Is Important
Breast cancer is the cause of 23 percent of all cancer diagnoses in women.² More than 61 percent of patients at diagnosis will have Stage 1 breast cancer, also known as localized disease, which is routinely treated with radiation, surgery, and pharmaceuticals.

Cancer stage signifies the degree of cancer (Chart 1) and defines patient treatment options. The earlier cancer is detected, the greater the survival rate. The five-year survival rate for Stage 1 female breast cancer is 98.8 percent. Once cancer has spread to a different part of the body, the stage is diagnosed as regional or distant.³ Stage 1 disease has five-year survival rates comparable to more advanced cancers, making early detection and treatment a critical factor in outcomes.⁴ 

Although survival rates have been encouraging, clinicians nevertheless need the proper tools to classify risk for Stage 1 breast cancer patients. The risk of disease progression and potential for metastasis is highest in the two-year window after Stage 1 diagnosis. However, an estimated 50 percent of recurring breast cancer is detected more than five years after surgery.⁵ A new minimally invasive diagnostic tool—liquid biopsy for circulating nucleic acids—can help improve early breast cancer detection, disease progression, and recurrence. Liquid biopsy analyzes blood samples to look for specific DNA that cancer tumors cast into the bloodstream (CTC). The clinical data are exciting: In a study of more than 15,000 patients with 50 different tumor types, it was determined that liquid biopsy can accurately detect mutations in cancer DNA.⁶

Multiple studies correlate with the findings presented at the 2016 American Society of Clinical Oncology Annual Meeting in Chicago, Ill. In one study, CTCs at diagnosis were evaluated to determine if they were related to disease-free survival and overall survival.⁷ Blood was collected from patients and prognosis was assigned to two categories—favorable (CTC=0) or unfavorable (≥1 CTC). While not a perfect diagnostic tool, the outcomes for the Franken liquid biopsy study are seen in Chart 2.

Another assessment examined ctDNA (circulating tumor DNA)  to determine its efficacy in identifying the risk of breast cancer survivor relapse.⁸  Study investigators evaluated the ctDNA of 55 breast cancer patients, and found the marker in 80 percent of those whose cancer had returned. Early detection is critical to outcomes, and relapse predictions based on ctDNA occurred at an average of eight months before detection by imaging.

What Tools Will Your Company Use to Improve Early Detection?
The use of liquid biopsy in patients with breast cancer is an exciting new tool to enable early changes in treatment strategy. Can your medtech company commercialize this new tool for the disease state your company addresses? 

References

1. http://www.breastcancer.org/symptoms/understand_bc/statistics?gclid=CNCX_vzUvs0CFYwfhgod9fUJWQ
2. Abraham, J., J.L. Gulley, and C.J. Allegra, Bethesda handbook of clinical oncology. Fourth edition. ed. 2014, Philadelphia: Wolters Kluwer/ Lippincott Williams & Wilkins Health. xiv, 742 pages.
3. http://www.cancer.org, Accessed June 23, 2016.
4. SEER Stat Fact Sheets: Female Breast Cancer. 2006-2012; Available from: http://seer.cancer.gov/statfacts/html/breast.html.
5. Ibid
6. Mack, P.; Schilsky, R.; Brody, J.; Pal, S.; June 4, 2016, presentation, American Society of Clinical Oncology annual meeting, Chicago, Ill., and https://www.nlm.nih.gov/medlineplus/news/fullstory_159208.html
7. Franken, B., et al., Circulating tumor cells, disease recurrence and survival in newly diagnosed breast cancer. Breast Cancer Res, 2012. 14(5): p. R133.
8. Garcia-Murillas, I., et al., Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med, 2015. 7(302): p. 302ra133.

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Maria Shepherd has more than 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. After her industry career, including her role as vice president of Marketing for Oridion Medical where she boosted the company valuation prior to its acquisition by Covidien/Medtronic, director of Marketing for Philips Medical and senior management roles at Boston Scientific Corp., she founded Medi-Vantage. Medi-Vantage provides marketing and business strategy and innovation research for the medical device industry. The firm quantitatively and qualitatively sizes and segments opportunities, evaluates new technologies, provides marketing services and assesses prospective acquisitions. Shepherd has taught marketing and product development courses, and is a member of the Aligo Medtech Investment Committee (www.msbiv.com). She can be reached at 855-343-3100 ext. 102 or at mshepherd@medi-vantage.