Ductal Lavage Finds Early Breast Cancer.

SAN ANTONIO -- Breast ductal lavage detected premalignant or frankly cancerous cells in one-quarter of high-risk but mammographically negative women in a multicenter trial, Dr. William C. Dooley reported at a breast cancer symposium sponsored by the San Antonio Cancer Institute.

The trial results establish ductal lavage using the Pro Duct Health microcatheter as a simple, well-tolerated, safe, and minimally invasive office procedure for cytologic assessment of the milk ducts, where 95% of breast cancers arise, said Dr. Dooley, who was at Johns Hopkins University, Baltimore, when he served as principal investigator in the trial.

"We clearly have a technique that allows pathologic assessment of proliferative changes, which impact surveillance, diagnosis, and treatment of the highrisk breast in those at highest risk," said Dr. Dooley, who is now the G. Rainey Williams Professor of Breast Surgical Oncology and director of the Breast Health Institute at the University of Oklahoma, Oklahoma City.

Dr. Dooley reported on 383 women in whom ductal lavage was performed at 19 centers. All participants were deemed at high risk for breast cancer either because of a history of prior breast cancer, BRCA-positive status, or a Gail Index score of 1.7 or greater. All of the women had a negative mammogram and negative physical exam within the prior 12 months.

Ductal lavage produced atypical breast milk duct epithelial cells in 17% of subjects and suspicious or malignant cells in another 7%. The specimens were read blindly using standard cytologic criteria for fine-needle aspiration.

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. All had normal preoperative repeat mammograms. One patient who also had a normal preoperative MRI turned out to have a multifocal 6-cm ductal carcinoma in situ. Five women had multiple papillomatosis with severe atypia, and two had fibrocystic disease.

The average yield was 40,000 or more epithelial cells per duct lavaged. In contrast, conventional nipple aspiration rarely yields more than 100 cells, which is why it has never become broadly accepted as a reliable screening method, the surgeon said.