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Breast Cancer

Ductal Lavage: A New Look Inside the Breast  
  Submitted By: Patricia Clark, MSN, APRN, BC, AOCN

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Patricia M. Clark, MSN, APRN, BC, AOCN

Nurse Practitioner, Breast Care Center

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI



Ductal Lavage: A New Look Inside the
Breast



Women at high risk for developing breast cancer now have another tool
to use to help assess their personal risk of developing this disease. Ductal
lavage is a minimally invasive procedure that can be performed in the doctor’s
office. It consists of inserting a small catheter into ductal openings
that produce fluid and washing out ductal cells. The cells are sent to
a cytopathologist and examined using the same techniques used for Pap smears.
Results from ductal lavage can be used to help decide which screening tests
should be performed and how often for women at high risk and may help women
and their doctors decide on other breast cancer risk reduction strategies.



Why Do Ductal Lavage?


Research has shown that most breast cancers start in the lining of the
breast ducts. Current thought is that these cells start as normal cells
that line the milk ducts and through a series of changes, become atypical
(or abnormal) cells. Some of these abnormal cells may further change to
become cancer cells. When cancer cells remain in the breast duct or lobule
they are called in situ or non-invasive. When they break through the lining
of the duct or lobule, they become invasive cancer.


Women with atypical cells found in fluid coming from the nipple
(nipple aspirate fluid or NAF) have been found to be at increased risk
for developing breast cancer. If abnormal cells are detected earlier rather
than later, chemoprevention drugs such as tamoxifen may be given to help
prevent the changes that lead these cells to become cancer cells. If cancer
cells are detected earlier, a woman may have more options for surgical
and other treatments.



Who Should Have Ductal Lavage?


Women at High Risk for Developing Breast Cancer

Currently, ductal lavage is offered to women who are at high risk
for developing breast cancer. For women without a personal history of breast
cancer, risk is measured by one of several statistical models. The model
most often used in studies of ductal lavage is the Gail Model. This model
looks at personal and family factors that influence breast cancer risk.
Personal factors considered are:

· Age that menstrual periods start (menarche)

· Age at time of first live birth

· Presence of a gene mutation in either the BRCA1 or BRCA2
gene


· Number of breast biopsies

· Presence of atypical ductal hyperplasia in a biopsy

Family factors that are considered include the number of first-degree
relatives that have been diagnosed with breast cancer. First-degree relatives
include mother, sisters and daughters.


All of this information is used to calculate the relative risk of
a women developing breast cancer in the next 5 years. Women who have a
relative risk equal to or greater than 1.7% in 5 years are considered to
be at high risk for developing breast cancer. This risk is equal to that
of a normal 60 year old, Caucasian woman living in North America.



Women with Non-invasive Breast Disease


Women who have a history of in situ (non-invasive) breast disease are
also at risk for developing invasive breast cancer. Women with lobular
carcinoma in situ (LCIS) have a cellular marker indicating increased risk
for developing invasive ductal cancers in both breasts. Ductal lavage may
be performed in both breasts to further define their risk. Women with ductal
carcinoma in situ (DCIS) have a non-invasive cancer that is often treated
with surgery with or without radiation therapy. Radiation therapy is used
when a lumpectomy is performed. For women receiving radiation therapy,
ductal lavage is usually performed in the untreated breast. Women having
surgery alone may have ductal lavage performed in both breasts depending
upon the extent of surgery performed. Ductal lavage is used in addition
to clinical breast exams and mammography to further examine cellular activity
in the breast. Women in both these groups may be offered tamoxifen as prevention
for developing invasive breast cancer. However, some women may decide not
to take tamoxifen due to side effects that mimic menopause or due to health
problems that might be made worse by tamoxifen. For women considering chemoprevention,
ductal lavage results that come back with atypical cells may encourage
them to begin tamoxifen or other chemoprevention and seek treatment for
any side effects that occur. For women who are unable to take tamoxifen,
ductal lavage may serve as another screening tool to detect breast abnormalities
at an earlier stage.



Women with a History of Breast Cancer


Women with a history of breast cancer are at high risk for developing
an invasive breast cancer in their unaffected breast. Estimates of this
risk range from 0.5% to 1.0% per year of follow-up depending upon the age
at diagnosis of breast cancer. Ductal lavage may be a helpful tool, along
with clinical breast exam and mammography, in finding a second breast cancer
at an early stage.



How is the Procedure Performed?


Ductal lavage is most often performed in the doctor’s office. After
application of a numbing cream, a small clear cap with a syringe attached
is placed over the nipple. This device (the nipple aspirator) is similar
to a small breast pump and is used to see if fluid will come out of the
nipple.



Figure 1: By pulling back on the syringe, negative
pressure in the breast allows ducts to expel fluid that they contain. Not
all women will produce fluid with this procedure. To encourage fluid production,
women are instructed in breast massage and heat packs may be used on the
breasts. If fluid is not produced, the lavage is not performed.



Figure 1




Figure 2.: If fluid is obtained with the nipple aspirator, then the
lavage procedure is started. The practitioner performing ductal lavage
may use one or two small dilators to help open the duct. Then the ductal
lavage catheter is inserted and a small amount of lidocaine, an anesthetic
may be injected through the catheter for comfort.



Figure 2.




Figure 3: Saline, a salt solution that is similar
to body fluids, is injected through the catheter into the duct and the
breast is massaged to bring ductal cells into the chamber of the catheter.
An empty syringe attached to the catheter is used to collect the cells
from the catheter chamber. Saline injection and massage are repeated until
a sufficient sample has been collected. The cells are then placed in a
preservative and sent to the cytopathologist where they are processed and
read much like a Pap smear. Results are usually available in about a week.



Figure 3.



How Often Should Ductal Lavage Be Performed?


The frequency of ductal lavage depends upon the results obtained from
the first procedure. If normal ductal cells are found or if after two attempts
at ductal lavage, there are not enough cells to make a diagnosis, ductal
lavage is repeated in 1 to 3 years. If atypical cells are found, the woman
and her doctor would want to discuss chemoprevention such as tamoxifen
or participation in a clinical trial of chemoprevention such as the STAR
trial if this was not already a part of clinical care. Ductal lavage would
be repeated in 6 to 12 months to monitor the atypical cells. If cancer
cells are found, additional studies such as mammography, breast MRI, ductoscopy
(looking in the duct with a very small, lighted tube) or ductal surgery
are options to be discussed.



Who Performs Ductal Lavage?


Quite often, surgeons will perform ductal lavage. Other practitioners
performing this procedure include: medical oncologists, cytopathologists,
radiologists, nurse practitioners and physician’s assistants.



Does Insurance Pay for Ductal Lavage?


Currently some insurance companies are paying for ductal lavage and
some are not. As with all new procedures, insurance companies and other
third party payors are interested in learning how the procedure is going
to be used, who will receive it and the impact of the procedure on clinical
care. As more scientific evidence for ductal lavage emerges, insurance
companies will be more likely to consider covering the cost of ductal lavage.
In the meantime, some centers that are performing clinical trials may have
funding to cover the cost of ductal lavage within the research setting.



How Do I Find Out More About Ductal Lavage?



Two websites have information about ductal lavage as
well as lists of practitioners that perform ductal lavage.


Dr. Susan Love’s Web Site for Women: http://www.susanlovemd.com

ProDuct Health (now Cytyc Corporation): http://www.producthealth.com

References
 


 


Additional Authors:  

Works Cited:  
  1. Allred DC. 2002 Evolution of premalignant lesions from normal epithelium to DCIS. Proc 19th Annual Miami Breast Cancer Conference.
2. Wrensch MR, Petrakis NL, Miike R, King EB, Chew K, Neuhaus J, Lee MM and Rhys M. 2001. Breast cancer risk in women with abnormal cytology in nipple aspirates of breast fluid.
3. Gail MH, Brinton LA, Byar DP, Corle DK, Green SB, Schairer C, Mulvihill JJ (1989). Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst, Dec 20;81(24):1879-86.
4. Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: Report of the national surgical adjuvant breast and bowel project P-1 study. J Natl Cancer Inst, Sept 16; 90(18): 1371-1388.
5. Iglehart JD. Prophylactic mastectomy. In Harris JR, Lippman ME, Morrow M and Osborne CK, eds. Diseases of the Breast. Philadelphia: Lippincott Williams & Wilkins, p255-264.
6. Dooley WC, Ljung BM, Veronesi U, Cazzaniga, et al. (2001) Ductal lavage for detection of cellular atypia in women at high risk for breast cancer. J Natl Cancer Inst, Nov 7; 93(21): 1624 – 1632.
7. O’Shaughnessy JA, Ljung BM, Dooley W, Chang J, et al. (2002). Ductal lavage and the clinical management of women at high risk for breast carcinoma. Cancer, Jan 15; 94(2): 292-298.
 
 


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