The results of the pilot study suggest that "ductal lavage
may assist in risk stratification of this high-risk group, which in turn can enable clinicians and patients to make more accurate decisions regarding risk-reduction strategies," Dr.
Investigators found poor agreement between cytologic and histologic findings and a sensitivity of ductal lavage of only 13%-42%, depending on how a positive result was defined.
"If we can find a good molecular screen to improve its sensitivity, then ductal lavage may still be good for [detecting] small cancers ...
Interest in ductal lavage as a possible screening tool has been based on the premise that fluid-yielding ducts are the ducts most likely to contain disease and that when ducts are lavaged, cytologic findings will reflect the disease that's present, said Dr.
In the study, ductal lavage was performed in the operating room before mastectomy.
The findings suggest that in-office ductal lavage
and the aspiration procedure necessary to determine eligibility is feasible, and could serve as a useful adjunct to breast self-examination, physician examination, and mammography for identifying breast cancer in high-risk women, he said.
Dooley reported on 383 women in whom ductal lavage was performed at 19 centers.
Ductal lavage produced atypical breast milk duct epithelial cells in 17% of subjects and suspicious or malignant cells in another 7%.
Of 11 women to date who have undergone surgical biopsy following the finding of suspicious or malignant cells on ductal lavage, 4 proved to have ductal carcinoma in situ.
Joyce O'Shaughnessy, an investigator in the trial, stressed that while the study lacked the statistical power to show that ductal lavage is a useful screening tool, it does establish the technique as a helpful means of further stratifying an individual's risk beyond Gail score alone.
O'Shaughnessy said that "there is a huge amount of interest" in ductal lavage among breast cancer specialists around the country.
A company spokesperson told this newspaper that although the emphasis right now is on rolling out its Food and Drug Administration--approved ductal lavage system, company research also is actively pursuing potential therapeutic applications of the nipple duct microcatheter, including its use as a platform for local delivery of drugs or thermal ablation therapy