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A bay area doctor is the first in Florida to offer it. It's designed to help high-risk women assess that risk and intervene.
By WES ALLISON
© St. Petersburg Times, published May 20, 2001
Many of Dr. Harvey A. Levin's patients are deeply worried about breast cancer. So when a sales rep contacted him about a new test, he researched it, learned it and last month became the first doctor in Florida to offer it.
The test checks for abnormal or precancerous cells in the milk ducts of the breast, in an effort to help a woman better determine her risk of developing breast cancer. It is designed for women already at high risk of developing the disease.
The usefulness of the test, called ductal lavage, is being debated among cancer researchers, but several other Florida physicians are considering offering it. And with the backing of one of the nation's most popular experts on breast cancer, women can expect to hear much more about it in upcoming months.
"It's helpful, just like a physical examination, just like a mammogram," said Levin, a gynecologist with offices in Palm Harbor and New Port Richey. "It just gives us another tool that one can use to assess what's happening, and really help to predict whether this woman is going to get breast cancer."
Researchers are eager to learn more about the test, which was approved by the U.S. Food and Drug Administration last year. But some breast cancer specialists question its value because there is no guarantee -- or even likelihood -- that abnormal cells discovered by the test will become cancer.
"So you get some atypical results. What do you do, where do you go, what do you tell the poor patient?" asked Dr. Elisabeth Dupont, a breast surgeon in the comprehensive breast center at the H. Lee Moffitt Cancer Center and Research Institute who is considering trying the procedure.
Cancer does not occur suddenly. It may begin years earlier with an abnormal proliferation of cells, some of them mutated, called atypical hyperplasia. According to the American Cancer Society, finding atypical cells in the milk ducts means a woman is four to five times more likely to develop breast cancer.
That may sound like a lot, but the typical woman's chance of getting breast cancer before age 40 is just 1 in 217. A 40-year-old's chances of developing it by age 50 is 1 in 67.
However, scientists aren't sure what percentage of women with atypical hyperplasia will develop breast cancer. One study suggests 15 percent.
"Anybody who uses this test right now needs to sit down with the patient and say, "We don't know what this means. I don't know what I should be recommending. It may not really help you,' " Dupont said.
The patented equipment and technique are being marketed by Pro-Duct Health Inc., a California company. About 75 physicians across the country offer it, though the company plans to train more soon.
About 192,000 American women will get breast cancer this year. More than 95 percent of those cases will start in the milk ducts. The test costs about $400 to $800 per breast, depending on how many ducts are lavaged, and insurance so far has covered it about half the time.
The test is poised to begin popping up in women's magazines and TV shows. It's backed by Dr. Susan Love, who founded the company and whose Dr. Susan Love's Breast Book was anointed the "bible" of breast health by the New York Times. She is advertising ductal lavage on her Web site, and the test will be the focus of the Susan Love Breast Foundation's conference later this month.
Pro-Duct officials have interviewed with Redbook for a story slated to run in October, which is Breast Cancer Awareness Month, and the company expects a major medical journal to publish a favorable study on the test this summer or early fall.
Findings of a Johns Hopkins School of Medicine study involving about 500 high-risk women have been presented at two recent conferences, including one for the American College of Obstetricians and Gynecologists.
In that study, which was funded by the company, the test found mild to marked levels of atypical cells in 24 percent of the women. It also found cancerous cells in two women. In the emotionally charged realm of breast cancer, company officials and independent experts agree it's important for women to know what this test truly is, and what it is not.
It is not a routine screening tool, like the mammogram, and it is not intended for everyone. Nor is it designed to diagnose cancer.
It is designed to help women who may be at high-risk -- such as those who already have had breast cancer, or whose mother or sister had it -- to better determine their risk.
"The best way to prevent a disease is to identify which population is most likely to get it," said Dr. David T. Hung, president and chief executive officer of Pro-Duct Health. "What ductal lavage does is it gives you more information to stratify risk and determine who really is at high risk."
Conceptually, the test is simple: Saline solution, injected through the nipple, is used to wash fluid and cells from milk ducts. Those cells are analyzed.
In most cases, the tests will show nothing. For the small percentage in which abnormal cells are found, options include waiting and watching, or removing the duct where the abnormal cells were found.
Some women may opt for tamoxifen, a drug shown to reduce the risk of breast cancer among some women in that high-risk group.
Dr. Debbie Saslow, director of the breast and cervical cancer program at the American Cancer Society, said those already are the options for women at higher risk of breast cancer, and it's not quite clear what the test adds.
"If the test is negative, I still need to keep getting my mammograms. If the test is positive, it doesn't mean I'm going to get breast cancer, therefore it doesn't mean I need to go out and get prophylactic mastectomy," Saslow said.
"There's a fine line there. It doesn't say you're going to to get cancer, it's just now we know a little bit more what your risk is. That doesn't give you a reliable sense of security, or doom."
Levin has lavaged eight women in the past month and is still awaiting the results. While he understands questions about the procedure, he said his patients want to know everything science can tell them.
"Most women today are really in tune with their bodies," he said. "It would be emotionally upsetting, of course, (to find abnormal cells) but most women would welcome the information."