Important industry news regarding breast cancer risk assessment, NAF, and the NeoMatrix HALO™ Breast Pap Test.

*Nipple Aspirate Fluid (NAF) Identification of Patients at Increased Risk of Breast Cancer.
Michael G. Ross, MD, MPH FACOG Harbor UCLA Medical Center, Los Angeles, CA.
Joel Bentz, MD University of Utah School of Medicine, Salt Lake City, UT

Abstract
OBJECTIVE : The correlation between atypical cytologic findings in NAF and breast cancer risk has been well described. We sought to determine the utility of the automated HALO (Neomatrix) NAF device to identify patients at increased risk of breast malignancy.

METHODS : NAF was obtained from 190 women using an office-based HALO™ Breast Pap Test. Women with no history of breast cancer were selected from the general practice population. NAF specimens were analyzed by a single cytopathology lab. Patients with NAF atypia were referred for further screening and diagnostic studies.

RESULTS : Among the 190 NAFs, 5 (2.6%) patients demonstrated atypical ductal epithelial cells, using standardized definitions of NAF cytology. Of these five patients (ages 24, 38, 45, 52, 65), only one (age 65) had a Gail score > 1.7. All patients were referred for further imaging studies (mammography, ultrasound, MRI), with three patients receiving subsequent biopsy. One biopsy indicated LCIS with proliferative ductal changes. Two biopsies were benign, though one patient was diagnosed with DCIS in the contralateral breast 6 months subsequent. The two patients with normal imaging studies were recommended increased surveillance.

CONCLUSION : Because the presence of NAF atypia modifies an individual’s risk profile, the use of simple, noninvasive NAF assessment may enhance breast cancer screening practices. Findings of NAF atypia, coupled with enhanced imaging surveillance may aid in earlier diagnosis of breast malignancy.

*Automated noninvasive Nipple Aspirate Fluid (NAF) Collection for Breast Cancer Risk Assessment.
Michael Glenn Ross, MD, MPH, FACOG Harbor UCLA Medical Center Los Angeles, CA

Abstract
OBJECTIVE: The use of ductal cytology obtained from NAF has been described for prediction of carcinoma. Notably, 85-90% of all breast cancers are intraductal in origin. Prior investigations of NAF utilized cumbersome, inconsistent, manual collection methods. We investigated a new device for the non-invasive collection of NAF in the office setting.

METHODS: The HALO™ Breast Pap Test was utilized. The automated system incorporates heat, compression, and vacuum in a 5 minute cycle. Initial HALO investigation at Harbor-UCLA Medical Center utilized a unilateral collection system. Subsequent evaluations utilize a bilateral collection system. Currently a multi-center study is underway.

RESULTS: Fifty patients were enrolled in each of two early investigations. NAF was collected from 40% of patients. To date, 97 women have been enrolled in the multi-center study with average age 39 years. All women had normal clinical breast exams immediately prior to NAF collection. Forty-two (43%) produced NAF samples that were evaluated by cytopathologists. Using standardized definitions of NAF cytology, 4/42 demonstrated benign hyperplastic ductal epithelial cells, 1/42 demonstrated atypical hyperplastic ductal epithelial cells, and 12/42 had normal ductal epithelial cells noted. There were no significant adverse reactions reported. Patients rated the procedure comfortable, with 82% stating they would undergo HALO™ Breast Pap Test again, and 88% stating they would recommend it to others.

CONCLUSIONS: The HALO system reliably and consistently obtains NAF fluid. This automated system is easy to use, well tolerated by patients and may ultimately be a cost-effective adjunctive screen for breast cancer risk assessment.

*Breast Cancer Risk Prediction: Gail Model and Nipple Aspirate Fluid (NAF).
Michael Glenn Ross, MD, MPH FACOG Harbor UCLA Medical Center, Los Angeles, CA

Abstract
OBJECTIVE: Breast cancer remains the leading cause of cancer mortality of women ages 40 to 45. Despite attempts at prevention, prediction and treatment, breast cancer incidence has risen during the past two decades. The Gail risk model predicts an individual’s risk of breast cancer, although there is limited experience in recommending treatment plans based upon the Gail model. NAF has been demonstrated to be a significant risk factor for breast cancer, with non-producers being at the lowest risk, producers at increased risk, and NAF producers with atypical cells at the highest risk. We sought to explore the concordance of Gail model and NAF status for breast cancer risk prediction.

METHODS: A total of 97 women underwent Gail risk assessment and NAF collection, using the HALO system (NeoMatrix, Irvine, CA). NAF producer status and risk was correlated with Gail assessments = 1.67, the threshold for Chemoprevention therapy by Chi square analysis.

RESULTS: Of the 97 women, 56 were = 35 years of age. Among these women, 26 (46%) produced NAF. Among patients < 35 (n=41), 16 (39%) produced fluid. Among patients = 35, four had Gail = 1.67. The Gail score did not predict NAF producer status.

CONCLUSIONS: Gail score and NAF producer status independently predict risks for breast cancer. We propose that the addition of NAF status to breast CA risk assessment will improve predictive ability.