Correlation of ductal lavage cytology with ductoscopy-directed duct excision histology in women at high risk for developing breast cancer: a prospective, single-institution trial.

OBJECTIVES: The study was designed to determine which histological lesions produce cellular atypia in lavage specimens and whether ductoscopy adds useful information for the evaluation of high-risk patients with atypical lavage cytology. METHODS: We prospectively recruited women ≥35 years at high risk for developing breast cancer. All underwent ductal lavage. Women found to have atypia underwent ductoscopy-directed duct excision (group 1). Women without atypia were observed (group 2). Data included patient demographics, risk assessment, cytologic and histologic findings, and outcomes. Descriptive statistics were utilized for data summary and were compared using Fisher's exact test. RESULTS: We enrolled 102 women; 93 (91%) were Caucasian. Their median age was 49 (range 34-73) years with a median follow-up of 80 (range 5-90) months. Overall, 27 (26%) had atypical lavage cytology (group 1), and 75 (74%) had benign cytology (group 2). Subsequent duct excision in group 1 revealed benign histology in 11 (44%), papillomas in 9 (36%), atypical hyperplasia (AH) in 4 (16%), and ductal carcinoma in situ (DCIS) in 1 (4%). At follow-up, three patients developed breast cancer, including one group 1 patient and two group 2 patients. There were no differences between groups 1 and 2 according to patient demographics, Gail scores, or risk for subsequent breast cancer (P > 0.05). CONCLUSIONS: Although 20% of high-risk women with ductal lavage atypia have AH or malignancy on subsequent excision, the majority do not. Atypia identified by ductal lavage is not associated with a higher risk of developing subsequent breast cancer, even in this high-risk population.

Ethical and regulatory issues related to pregnancy registries and their outcomes.

Pregnancy registries should be devised so that the interests of science, society, and the individual are all considered. For example, there may be ethical issues that relate to how women are chosen to participate in the registry and how informed consent is obtained. In most cases, consent is required for both the mother and the infant. Some institutional review boards will require that consent be obtained by someone other than the woman's physician. Once data are obtained, there may be an issue as to when results should be released. Options are to release data when there is the first indication of a concerning finding, thereby potentially preventing exposure in the largest number of women, versus waiting until the finding is absolutely confirmed. In a related issue, there are questions of when and how regulatory agencies should change labeling based on findings.