Tolerability of breast duct lavage in women from BRCA mutation-positive families participating in an intensive breast cancer screening trial.

A48

Background: Intensive breast screening is routinely recommended for women at increased genetic risk of breast cancer, aimed at early breast cancer detection. Breast duct lavage (BDL) has been proposed as a less invasive, well tolerated tool for obtaining breast epithelial cells for cytological evaluation, and breast duct cells and fluid as research reagents to identify biomarkers of breast cancer risk. We report breast ductal lavage tolerability data from participants in a breast cancer screening trial which targets mutation-positive and -negative women from families with known BRCA1/2 mutations. Methods: 150 mutation-positive and 21 mutation-negative family members underwent mammography, breast MRI and breast duct lavage at the first of four annual breast cancer screening visits. Questionnaires evaluating perceptions of pain were obtained prior to and after the BDL, which was compared with pain experienced during other medical procedures . Results : 94% of women expected to experience some discomfort with BDL; 23 % anticipated extreme discomfort. The average expected discomfort rating for BDL was 47 (0-100). This rating was significantly higher (p < 0.01) than the anticipated discomfort of a mammogram (38), MRI (36) and nipple aspiration (42). After completing BDL, 34%, 39% and 28% of women reported none/mild, moderate and extreme discomfort, respectively. The average experienced discomfort rating for BDL was 48 (0-100). This rating was significantly higher (p < 0.01) than discomfort actually experienced during mammography (34), MRI (25) and nipple aspiration (27). 78% of the women described BDL discomfort as "sharp," and 52% described the discomfort as "burning." Although BDL was expected to be and actually experienced as the most painful protocol-related procedure, participants generally reported that BDL discomfort was the same or less than they had expected it to be, and rated it as equally or less painful relative to other medical procedures. Finally, women with a history of breast cancer rated BDL as more tolerable than women without a breast cancer history (p < 0.05). Conclusions : BDL was both anticipated to be and actually experienced as causing more discomfort than other procedures used in the breast cancer screening, but most women rated the discomfort of BDL the same or less than discomfort associated with other common medical procedures. Women with a history of breast cancer may find BDL more tolerable than those without such a history. Our data do not confirm earlier reports suggesting that BDL represents a minimally invasive procedure that is well tolerated and no more painful than mammographic screening. If BDL is to become part of the standard care of high-risk women, significant value added will need to be demonstrated to justify the additional, procedure-related morbidity.