1st guidelines issued on ductal lavage as risk assessor

The procedure may be appropriate for women at high risk for breast cancer, but critics charge that more evidence is needed.

By Victoria Stagg Elliott, amednews staff. Feb. 11, 2002.

Hoping to provide additional information to women at high risk for breast cancer, a panel of experts issued the first clinical practice guidelines for the use of ductal lavage as a risk stratification tool. The guidelines were published last month in the journal Cancer.

The process of ductal lavage uses a catheter and a saline solution to collect ductal cells from within the breast. This procedure is considered an improvement over nipple aspiration, which only collected cells from the surface and is no longer used.

Risk assessment
Links

About 95% of breast cancers originate in the ducts, and abnormal cells found there are believed to be associated with a significant increased risk of breast cancer.

"On the basis of ductal lavage results, physicians have additional information to determine which women are at highest risk and to help guide them in making breast cancer management decisions," said Joyce O'Shaughnessy, MD, director of breast cancer prevention at Baylor University Medical Center in Dallas. She was the paper's lead author and a member of the panel.

Another member of the expert panel that issued the clinical guidelines was an employee of Pro-Duct Health Inc., the Menlo Park, Calif., company that manufactures the ductal lavage equipment.

The specifics

The guidelines recommend that the procedure be repeated if the results are inconclusive. Treatment with tamoxifen should be considered if atypical cells are found and intensive breast imaging should be conducted if malignant cells are found.

"Current mathematical models of risk don't really take into account anything about the woman in particular," said Scott H. Kurtzman, MD, associate professor of surgery at the University of Connecticut Health Center in Farmington. He uses ductal lavage in his practice, but was not a part of the panel.

95% of breast cancers originate in the ducts.

"This allows us to look at what's actually going on in the individual woman's breast. If a woman is considered high risk because of a family history or other factors but she doesn't have any atypical cells, one could argue that she's not really at high risk."

Critics of the paper, however, said that there was not enough evidence connecting the presence of atypical cells to the development of breast cancer.

Although the cells increase the risk, not all lead to cancer. And if malignant cells are found in ductal lavage, it's very difficult to discern their origination point.

"It's not clear what advantage this technique has," said Carol Slomski, MD, associate professor of surgery with Michigan State University in East Lansing.

"My fear is that if a woman has malignant cells on this test, and you can't feel anything or see anything on a mammogram or an ultrasound, that she's going to want the breast removed. That's a pretty drastic step to take based on this procedure, which hasn't been around all that long."

Anxiety a concern

Some experts were also concerned about raising the anxiety of women, and the possibility that some women who did not really need tamoxifen would end up on the drug, which does have significant side effects.

Advocates of ductal lavage, however, maintain that women who know they are at high risk for the disease are already anxious and that this procedure does not add to that anxiety.

"This is being done in women who are already known to be at high risk, and you're trying to stratify within this group," said Ben Anderson, MD, clinical medical director of the University of Washington breast care and cancer research program in Seattle and one of the paper's authors. "The fear factor is probably already present."

The procedure also is not a substitute for mammography. Nor is it appropriate for low-risk women.

"It's too labor intensive," said Dr. Kurtzman. "And if you start looking for things in women who are asymptomatic, you're going to end up doing a lot of unnecessary biopsies."

Experts suggest that in the future the same catheter used in ductal lavage could also be eventually used to deliver chemotherapy, possibly reducing the need for breast cancer surgery.

ADDITIONAL INFORMATION:

Risk assessment

Recommendations for the use of ductal lavage in women at high risk of breast cancer:

If the amount of cells collected is not enough to draw conclusions, repeat procedure as soon as possible.
If benign cells are found, repeat procedure in one to three years.
If atypical cells are found, consider tamoxifen or another drug regimen that reduces the risk of breast cancer; repeat procedure in six to 12 months to confirm results; consider additional imaging or a biopsy.
If malignant cells are found, repeat to confirm; consider additional imaging or surgical exploration; strongly consider drug regimen to reduce risk.

Source: Cancer, Jan. 15