ATLANTASusan M. Love, MD, predicts that significant new
information about breast cancer will emerge as doctors begin using a
new duct cell screening technique. Dr. Love discussed her work on
ductal lavage at the Era of Hope: U.S. Department of Defense Breast
Cancer Research Program Meeting in Atlanta, and updated results of a
study of the technique were presented at the Second Annual Lynn Sage
Breast Cancer Symposium in Chicago.
Ductal lavage gives clinicians a way to detect cancerous
abnormalities in high-risk women through repeated testing without
surgery, she said. It can detect precancerous cells showing atypia as
well as malignant cells in fluid washed out of a womans milk
duct and withdrawn with a catheter.
In an interview with ONI, Dr. Love expressed the hope that use
of the technique would lead to a rethinking of breast carcinoma as a
ductal disease rather than a breast disease. All breast carcinomas
start in the milk ducts, she said, so the procedure can detect
cancers that are not yet seen on mammography.
Dr. Love compared breast lavage to Pap smear screening, since both
tests allow the early determination of premalignant and malignant
cells from their source of origin.
I think this is going to revolutionize breast
cancer, she said, forecasting that widespread adoption of the
technique will lead to the discovery of new cancer markers in milk
ducts, information about carcinogens that promote breast cancer, and
ultimately the delivery of new treatments through the ducts.
Dr. Love, adjunct professor of surgery, University of California at
Los Angeles, is a founder and board member of Pro·Duct Health,
Inc., Menlo Park, California, which has started to market the
Pro·Duct Breast Aspirator and Catheter for breast lavage. The
devices received FDA approval last summer.
The company provides training to physicians interested in
incorporating ductal lavage into their practice. Dr. Love described
the procedure as relatively simple; she said that surgeons would
probably be the first to perform it, but that nurse practitioners
might start doing it within the next 2 years.
Some pathologists received training in interpreting ductal lavage
samples during a clinical trial of the technique at 19 sites in the
United States and Europe. Pathologists need training, Dr. Love said,
because they are called on to analyze exfoliated breast cells, which
are different from cells collected by other procedures.
Ductal Lavage vs NAF
The multicenter trial tested the lavage device on more than 507
high-risk women, aged 26 through 81. These women scored at least 1.7
on the Gail index, had previous breast cancer, or were carriers of a
BRCA1/BRCA2 gene mutation. All had normal mammography and physical
In this study, nipple aspiration was performed on all eligible
breasts; then ductal lavage was attempted in all fluid-yielding
ducts. The nipple aspirate fluid (NAF) and ductal lavage samples were
read by two independent cytopathol-ogists. At the Lynn Sage Breast
Cancer Symposium, results were presented on 323 evaluable women and
Ductal lavage yielded sufficient cellular material for diagnosis in
212 of 307 breasts (69%) when NAF showed insufficient cellular
material for diagnosis, while the reverse was true in only 12 of 107
Mild or marked atypia was found in 76 of 383 cases (20%) using ductal
lavage vs 19 of 383 NAF cases (5%) (P < .001). Marked
atypia was detected in 18 ductal lavage cases (5%) but only 7 NAF
In 64 of 76 (84%) cases of atypia found using ductal lavage, the
corresponding NAF samples were insufficient for diagnosis or were
benign. The reverse was true in 7 of 19 (37%) NAF cases.
Two of the women with markedly atypical cells found by ductal lavage
underwent ductal resection for biopsy. Pathology confirmed a 1.8 cm
high-grade ductal carcinoma in situ (DCIS) in one patient and a 6 cm
intermediate-grade DCIS in the other. Both women had normal
mammograms before and after the procedure.
Two other cases of marked atypia with negative mammograms,
ultrasound, MRI, and limited biopsy via ductoscope were confirmed at
pathology as papillomas. Further workup of the remaining cases of
marked atypia found by ductal lavage is pending.
The final data from the trial will be presented at the San Antonio
Breast Cancer Symposium in December.
Safe With Minimal Discomfort
procedure is relatively safe only two presumed infections
were recorded in the trialand most women found it less painful
than a mammogram, according to Dr. Love, who said she has had the
procedure done several times herself.
If women are squeamish beforehand about having something put into
their nipple, they usually have no problems with future tests, she
said. A topical anesthesia is applied before the procedure, and there
is typically no discomfort afterward. A Pro·Duct fact sheet
reported, Anecdotally, some patients experience mild discomfort
or breast fullness, which is similar to the sensation
experienced during lactation.
Nipple aspiration is performed first to identify which milk ducts to
lavage. Then the practitioner inserts a double-lumen catheter into a
milk duct opening in the nipple area (see Figure). No incisions or
skin punctures are required. Each of the lumens is less than 0.5 mm
in diameter and is inserted less than 1 cm into the duct. A saline
solution is injected into one lumen, causing fluid containing cells
from the duct lining to be aspirated through the other lumen.
Milk Ducts Mapped
Dr. Love and her colleagues not only had to create the technology to
make the test possible, but they also had to establish the ductal
anatomy by creating a map of the ductal system. Nobody had ever
bothered, she said.
They developed an anatomic diagram using studies of nipples of
lactating women, archival x-ray images called duc-tograms, and breast
tissue from mastectomies. They found that, on average, five to nine
unconnected milk ducts extend from the nipple area back to the chest
wall of each breast. These project in a pattern of two concentric
circles without regard to quadrants or radial wedges.
Contrary to prevailing views, the breast is actually a
collection of ductal systems, not one organ, Dr. Love said.
With the system so new, she does not have a recommendation for how
often the procedure should be performed. Were arbitrarily
thinking once a year or maybe even every 6 months, she
commented. We dont know how long the duct takes to
repopulate after washing it out. Its logical that if there is a
pathology, it will repopulate faster, but we dont know.
Breast duct lavage will be especially useful, she predicts, for
high-risk women facing tough decisionsfor example, a woman
considering tamoxifen (Nolva-dex) for prevention or a woman who has
the breast cancer gene mutation and is considering mastectomy.
I see it almost like a cholesterol or bone density test,
Dr. Love said. If youre high-risk and you find atypical
cells on ductal lavage, it gives you more information to make decisions.
No information on the cost of the procedure was available from
Pro·Duct. A spokesperson said the technique does not have a
unique CPT code yet for reimbursement by health insurers. The company
has set up a reimbursement hotline to advise billing departments on
the data and forms needed for claims.