BBDRisk Dx™ Test and Physicians Medical Managements For Treating Pre-Cancerous Breast Growths

This information about BBDRisk Dx™ Test and physicians medical managements will help you manage treatment options for women who have been diagnosed with either atypical or non-atypical hyperplastias.

Hyperplastic Abnormalities and Increased Risk

It is well established that women who are diagnosed with atypical hyperplasias have a five-fold increased risk of developing breast cancer, and those diagnosed with non-atypical hyperplasias have a two-fold increased risk of developing the disease (References 1-17).

Decisional Dilemma in Administering Preventive Therapies

Although chemoprevention therapy with Tamoxifen (Tam), Raloxifene, and/or an aromatase inhibitor (AI), or and surgical therapy with removal of both breasts is/are available for the prevention of breast cancer in women at increased risk, patients as well as their providers, are faced with a decisional dilemma as to whether and how to proceed with preventive therapy. The dilemma is because the diagnoses conferring increased risk based on histology are not precise enough to predict who will go on to develop cancer. The uncertainty surrounding risk places an enormous emotional burden on both patients and their physicians. Current preventive treatments are administered without molecular risk stratification.

As a result, patients who are at low risk are unnecessarily subjected to the potential side effects of the above drugs (such as pulmonary embolism, deep vein thrombosis, stroke, cataracts and vasomotor instability (Tam and Raloxifene), endometrial cancer (Tam), or musculo-skeletal pain and bone loss (AIs)) or to the surgical risk and financial burden of possibly unnecessary mastectomies. On the other hand, patients who are at elevated risk but choose not to undergo cancer preventive therapy because of uncertainty as to their real risk are not receiving the benefit of life saving prophylactic treatments.

Risk Score by BBDRisk Dx™ Test and Medical Management of atypias and other hyperplasias

The tumor biology based BBDRisk Dx™ genomic test will assess multiple markers in the abnormal tissue and generates a ‘Cancer Risk Score’ in the range of 0-10. The test categorizes the patient as ‘Low Risk’, ‘Intermediate Risk’ or ‘Elevated (High) Risk’ (Figure) by comparing the risk score of a patient with the plurality of scores in Silbiotech’s data base. The test Results Report will also provide the ‘Cancer Free Rate or Cancer Rate’ among subjects who have a similar ‘Risk Score’ from the test validation study. (Click the Sample BBDRisk Dx™ Test Report link to open and use the Brower’s File Save As to save it)

BBDRisk Dx™ Guides in Informed Medical Management Decisions

Informed medical management decisions can be guided by the ‘Cancer Risk Score’ and ‘Risk Level’ of a patient. BBDRisk Dx™, provides molecular evidence to stratify and select those individuals at elevated risk, thereby personalizing treatment and minimizing unnecessary side effects. Thus the BBDRisk Dx™ test (Figure) provides a standardized modality to assess the risk of an individual with a hyperplastic biopsy demonstrating that she is at increased risk of developing breast cancer. By providing the personalized molecular risk information, patients can be informed of the benefit of prophylactic treatment and are more likely to comply with the treatment recommendation by their healthcare provider.

 

 

 

For example, standard screening for women with atypical as well as non-atypical tumors whose BBDRisk Dx™ results indicate a “Low Risk” of developing cancer. If BBDRisk Dx™ results indicate that a patient has an Intermediate or Elevated Risk of developing breast cancer, the following medical management options that are currently approved for women with atypias may help reduce risk by 1) detecting it at an earlier more treatable stage, 2) delaying the onset of cancer, or 3) preventing the development of cancer over the long term:

  • Increased surveillance
  • Risk-reducing medications and/or
  • Prophylactic surgery

Disclaimer: Any discussion of medical management options provided here are for general informational purposes only and should not be interpreted as recommendations by Silbiotech, Inc. While BBDRisk Dx™ test results provide useful information, medical management decisions should be made based on consultation between each patient and his or her healthcare professional. The patient and his or her doctor are solely responsible for making any medical management decisions.

References

1. Siegel, R., Miller, K.D and Jemal, A. (2017), Cancer statistics, 2017. CA: A Cancer Journal for Clinicians, 67: 7–30.
2. Tavassoli, F. A and Norris, H.J (1990), A comparison of the results of long term follow up for atypical intraductal hyperplasia and intraductal hyperplasia of the breast. Cancer, 65, 518-29.
3. Foote FW, Stewart FW. Comparative studies of cancerous versus noncancerous breasts. Annals of Surgery.1945; 121:197-222.
4. Ryan JA, Cody CV. Intraductal epithelial proliferation in the human breast- a comparative study. Cancer J/ Surge.1962; 5:2-8.
5. Wellings SR, Jenson HM, Marcum RG (1975) An Atlas of subgross pathology of the human breast with special reference to possible precancerous lesions. J. Natl.Cancer Inst. 55, 231-273.
6. Black MM, Barclay TH, Cutler SV, et al. Association of atypical characteristics of benign breast lesions with subsequent risk of breast cancer. Cancer. 1972;29:338-43.
7. Dupont WD, Page, DL. Risk factors for breast cancer in women with proliferative breast cancer. N. Engl. J. Med. 1985;312:146-51.
8. London SJ, Conolly JL, Schnitt SJ, et al. A prospective study of benign breast disease and the risk of breast cancer. JAMA. 1992;267:941-4.
9. Dupont WD, Parl FF, Hartman WH Breast cancer risk associated with proliferative breast disease and Atypical hyperplasia. Cancer, 1993;71:1258-65.
10. Page DL, Dupont WD. Association indicators (histologic and cytologic) of increased breast cancer risk. Breast Cancer Research and Treatment. 1993;28:157-166.
11. Karpus CM, Leis HP, Oppenheim A, et al Relationship of fibrocystic disease to carcinoma of the breast. Ann. Surg. 1995;162:1-8.
12. Allerd DC, Mohsin, SK, Fuqua, SAW. Histological and biological evolution of human premalignant breast disease. Endocrine Related Cancer 2001;8:47-61.
13. Krishnamurthy S, Sneige N. Molecular and biological markers of pre-malignant lesions of human breast. Adv. Antomical Pathology 2002;9:185-197.
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16. S. B. Coopey, E. Mazolla, J.M. Buckley, John Sharko et al The role of chemoprevention in modifying the risk of breast cancer in women with atypical breast lesions. Breast Cancer Res. And Treatment, 2012: 10549-012, 2318-
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