Healthcare Professionals - Ob/Gyn or Primary Care Provider

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• As a primary care clinician, you are often regarded as the “front line” of breast health monitoring
• The American College of Obstetricians and Gynecologists (ACOG) has adopted the goals of assisting in educating primary care clinicians in the diagnosis and treatment of benign breast disease.
• Limited tools have been available to assist in breast cancer risk assessment until now. With the HALO Breast Pap Test, routine Nipple Aspirate Fluid (NAF) analysis provides you and your patients a new opportunity to assess risk.

Where does HALO fit in your practice?

The noninvasive HALO Breast Pap Test, allows you to easily implement NAF screening into your practice to provide women with an objective assessment of breast cancer risk as part of a comprehensive breast health exam.

HALO uses a combination of warmth, massage and suction to elicit nipple aspirate fluid NAF from the milk ducts where almost all breast cancers originate. The fluid is then sent to your lab for cytologic evaluation to determine if the patient is at high risk for developing breast cancer. If your patient produces fluid with atypia or abnormal cells, she is 4 to 5 times more likely to develop breast cancer compared to someone who does not produce fluid. If your patient has atypia, this doesn’t mean that breast cancer is inevitable, but it does mean that her breast health must be monitored more closely. Most likely she’ll be referred to a breast specialist for a complete risk assessment and possibly further imaging studies. HALO identifies women who are at highest risk for developing breast cancer allowing for risk reduction, strategies, and closer breast health surveillance. If breast cancer develops, it is more likely to be identified in the earliest, most treatable stages where outcomes are considerably better. It is important to remember that the HALO Breast Pap Test is not a diagnostic for breast cancer and it does not replace routine mammograms or breast exams.

Breast Cancer Development

It is believed that nearly all breast cancer originates in the epithelial cells that line the interior of the milk ducts in the breasts. Like cervical cancer, breast canceris believed to progress through identifiable stages of development.

Breast cancer typically grows slowly, taking, on average, 8 years before it can be detected by mammography, or up to 10 years before the lesion is palpable. The inability of current breast cancer screening methods to detect cellular changes at an early stage of development, much like the Pap test does for cervical cancer, is one reason for the lack of significant reduction in the death rate of breast cancer.

Clinical Utility of Risk Assessment for Benign Breast Disease

With the understanding that almost all breast cancers begin in the milk ducts, Nipple Aspirate Fluid (NAF) examination allows the identification of benign breast disease and the attendant increase in relative risk, years before an abnormality becomes a palpable lesion or visible by imaging.

The study of NAF to identify high risk women is not new. In 1958, Dr. George Papanicolaou et al described obtaining fluid from the breast milk ducts by suction to analyze cell samples. Just like his procedure for detecting normal versus abnormal cells in the cervix (the "Pap test"), this technique demonstrated the ability to find abnormal cells in NAF from within the breast duct. Dr. Papanicolaou concluded that "cytology of breast secretions was valuable in differential diagnosis of mammary diseases and carcinoma" and that "a cytological diagnosis of malignancy was highly reliable."

Multiple clinical studies involving over 30,000 patients, followed for up to 25 years, all reach the same conclusion: benign breast disease, specifically atypia, confers a significantly higher risk of breast cancer. On average, these clinical studies demonstrate the presence of atypia to mean a woman has a greater than 4X relative risk of developing breast cancer than women who do not produce fluid.

The findings of Wrensch, Petrakis et al and the clinical significance of atypical hyperplasia have been validated through independent studies of samples collected from NAF, fine needle aspiration biopsy, or surgical excision.

An official statement from the American Society of Breast Surgeons reads in part "A variety of techniques exist to obtain cells for examination, including open surgical biopsy, fine needle aspiration (FNA), nipple aspirate fluid (NAF), and ductal lavage. In current studies of surgical biopsy, FNA and NAF report a 5-fold increase in the relative risk of developing breast cancer when cellular atypia is found. Having atypia coupled with a first degree family history of breast cancer confers an 11-fold increase in relative risk of developing breast cancer."

Helpful Links:

• Screening for Benign Breast Disease
• Abstracts Summary

Key Articles:

• West J.G., Hollingsworth A.Screening for breast cancer risk in the obstetric/gynecological setting: a breast surgeon's perspective Exp Rev. Obstet. Gynecol. 2008, 3(1), 59-63
• Wrensch MR, Petrakis NL, King EB, et al. Breast cancer risk in women with abnormal cytology in nipple aspirates of breast fluid. American Journal of Epidemiology 1992;135(2):130-141
• Tice JA, Miike R, Adduci K, et al. Nipple Aspirate Fluid Cytology and the Gail Model for Breast Cancer Risk Assessment in a Screening Population. Cancer Epidemiol Biomarkers Prev 2005;14(2):324-328.
• Hartmann LC, Sellers TA, Frost MA, et al. Benign Breast Disease and the Risk of Breast Cancer, New England Journal of Medicine 2005; Volume 353:229-237 Number 3
• Hollingsworth A, Singletary S, Morrow M, et al. Current comprehensive assessment and management of women at increased risk for breast cancer, The American Journal of Surgery 187 (2004) 349-362
• Proctor K, Rowe L, Bentz J. Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study, BMC Women's Health 2005, 5:10
• Lee WY. Cytology of abnormal nipple discharge: a cyto-histological correlation, Cytopathology 2003, 14, 19-26

 

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