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Study: Analyzing Screening for Breast Cancer by Analyzing Cells from Breast Ducts Has Limitations (dateline February 8, 2004)

Ductal lavage is a new procedure that involves analyzing cells washed out from the breast ducts to determine whether they have cancerous qualities before they develop into breast cancer. Though initial studies have shown ductal lavage to be promising in identifying women at high risk of breast cancer, a new study of women with breast cancer raises concerns about the procedure. In the study, over half of the women who had been diagnosed with breast cancer had "normal" results with the ductal lavage procedure, meaning that ductal lavage failed to detected any abnormalities in these women. While the researchers believe ductal lavage is still important for learning about the development of cancer, they warn that ductal lavage has limitations as a screening procedure and should not be performed in place of regular mammography.

Physicians estimate that over 95% of breast cancers begin in the cells lining the breast ducts. Ductal lavage is a new procedure (lavage translates as "wash" or "rinse" in French) that involves analyzing cells washed out from the breast ducts to determine whether they have pre-cancerous qualities and are likely to develop into cancer in the near future. If pre-cancerous cells exist, women may wish to consider preventive measures to help protect against breast cancer. Since ductal lavage can be repeated, the idea behind the procedure is that physicians can track changes in a woman’s cells over time. Currently, ductal lavage is available at a handful of locations across the United States.

Ductal lavage is normally used as a screening procedure in women who have not been diagnosed with breast cancer. To study the effectiveness of ductal lavage, Edi Brogi, MD, PhD of the Memorial Sloan Kettering Cancer Center in New York and colleagues studied 26 women who had already been diagnosed with breast cancer and were preparing to under mastectomy (removal of the cancer breast). An additional four women underwent mastectomy because they were at very high risk of developing breast cancer. Ductal lavage was performed on each of these women prior to mastectomy.

The idea of testing fluid from the nipple was first suggested in the 1950s by Dr. Papanicolaou, the physician who developed the Pap smear to test for cervical cancer. To perform ductal lavage, a physician uses a breast pump to apply mild suction to the nipple to draw out tiny amounts of nipple fluid from the milk ducts up to the nipple surface. Typically, fluid is only be extracted from one to two breast ducts (each breast contains six to eight ducts).

An analysis of the ductal lavage performed on the women in the study showed that four out of 29 breast cell samples (14%) were abnormal, 10 samples (34%) were mildly abnormal, and 15 samples (52%) were normal. This was a concern since all of the women in the study either had breast cancer or pre-cancerous cells, which means that the results of the ductal lavage should have yielded abnormal results in these cases.

Another problem that alarmed the researchers was the inconsistency among physicians to classify mildly abnormal ductal lavage results. With three pathologists analyzing each ductal lavage cell sample, none were able to agree on labeling samples as mildly abnormal. Some pathologists labeled these minor abnormalities instead, which would mean that in a clinical setting, these women might not receive adequate follow up.

Based on these results, Dr. Brogi and his colleagues conclude that ductal lavage is not a sensitive test, particularly with invasive breast cancer. (In the study, 20 of the women had invasive breast cancer). Therefore, ductal lavage remains an experimental procedure, and women who are screened with ductal lavage should not use it as a substitute for more established screening methods, such as mammography and physician-performed clinical breast exams.

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