Pap smear for the breast? 

Oct 25
2009

Current statistics on breast cancer have women on edge. The fact that one in four cancers diagnosed in American women is breast cancer, that death rates are higher than any other cancer besides lung cancer, and that one in eight women will develop breast cancer in her lifetime, have researchers seeking ways to get in front of the disease.

Finding women at risk for developing breast cancer, who may harbor atypical cells years before a lump forms is the idea behind collecting and analyzing nipple aspirate fluid, essentially a Pap test of the breast.

A device popping up in gynecology offices across the country, albeit rare and slow to catch on in Chicagoland, is emerging as another tool in the armamentarium doctors use to zero in on breast cancer earlier.

Similar to a breast pump, the HALO breast Pap test device, manufactured by NeoMatrix, provides suction to try and extract nipple fluid for cytological examination. The five-minute, noninvasive test performed as part of a woman's yearly wellness exam does not diagnose breast cancer, nor does it replace a mammogram. It can be done in women as young as 25 to try and find what doctors term "atypia," or abnormal cells, an indicator of a woman's future risk of developing the disease.

Proponents of the HALO test say the chance of locating atypia is so significant, it is certainly worth the test despite the fact that yielding no fluid or not finding cells does not provide any reassurance that cancer is not present. They say it should be done routinely in gynecology and family practice offices and possibly in conjunction with a mammogram to find women at risk who can then undergo more intensive testing and preventive measures.

Others say the test is premature given current science about evaluating nipple fluid. They contend the chance of abnormal cells dropping into the milk ducts or being collected at all is questionable. Some even call it a strictly money-making venture.

Dr. Anthony Gentile, vice chair of obstetrics and gynecology at The Community Hospital in Munster, is the only provider of the HALO test in Northwest Indiana and the Chicago suburbs. The next closest provider is in Champaign, Ill.

Gentile says it's really only a useful test if it yields a positive result, which he hasn't yet seen in his office after doing the test on some 200 patients. Still, many of his patients are willing to spend the $85 out-of-pocket for the potential of finding something that could be brewing undetected for years.

"The test may come back negative, it doesn't mean you don't have breast cancer," he says, "but if it comes back positive, then it's very significant because your chances of progressing to cancer are four to five hundred percent increased."

Oncologist Dr. Bharat Barai, chair of the cancer committee at The Methodist Hospitals and member of the medical licensing board for Indiana, says the chances of yielding an abnormal result is "next to nothing," unless the abnormal cells happen to be located right under the nipple.

Refuting reports that the majority of breast cancers originate in the milk ducts, Barai explains that precancerous cells are likely to be forming far away from the duct and this is where they will stay.

"If you look at how breast cancer grows and how breast cancer spreads and how the cells are being shed," Barai says, "that tells you right away that, wait a minute, this is all baloney."

Dr. Marylyn Rosencranz, a radiologist at The Indiana Breast Center, says it's an incomplete exam that provides women either with a false sense of security or creates anxiety. She says the test doesn't reveal where the atypia came from and it likely didn't get cells from entire milk duct system. Hence, there is not much to do with a diagnosis of atypia.

Breast Surgeon Dr. Dario Francescatti, assistant professor of surgery at Rush Presbyterian St. Luke's Medical Center in Chicago, disagrees.

First, he says breasts can certainly be massaged to yield fluid going deeper than the areola and in fact would be most effective if performed in conjunction with a mammogram after the breast has been compressed.

Further, he says there is indeed something to do with those patients that show atypia. Specifically, he would follow up with ductoscopy and likely recommend a medication like tamoxifan which he says has shown to reduce a recurrent or subsequent breast cancer by about 86 percent.

He says this test and follow-up on women with atypia who are given tamoxifan will allow the accumulation of data that other docs criticize is absent right now.

He agrees with Gentile about the significance of finding atypia.

"Atypia is something that has been in front of our nose for years and has not been followed up on in a proper fashion," Francescatti says.

"I think that if we incorporate this technique and we actively go after or investigate patients with atypia," Francescatti says, "we are going to find that a majority of those breast cancers that are going to have atypia associated with it in an early fashion, we are going to be able to treat atypia and I believe we will reduce the incidence of breast cancer tremendously in the future."

Dr. Seema Khan, professor of surgery and Bluhm Family Professor of Cancer Research at Northwestern University's Robert H. Lurie Comprehensive Cancer Center, says diagnosing atypia in the first place is notoriously difficult and that using this test outside of a research setting is premature.

Khan acknowledges perhaps the device is ahead of the science.

She is leading a study funded by the National Cancer Institute to determine whether the hormone content of nipple fluid is an indicator of breast cancer risk. She thinks if such a biomarker is found, a test can be applied to all women rather than relying on the HALO test which will only yield fluid about half the time, making it an incomplete test.

"Atypia is something that has been in front of our nose for years and has not been followed up on in a proper fashion," Francescatti says.

"I think that if we incorporate this technique and we actively go after or investigate patients with atypia," Francescatti says, "we are going to find that a majority of those breast cancers that are going to have atypia associated with it in an early fashion, we are going to be able to treat atypia and I believe we will reduce the incidence of breast cancer tremendously in the future."

Dr. Seema Khan, professor of surgery and Bluhm Family Professor of Cancer Research at Northwestern University's Robert H. Lurie Comprehensive Cancer Center, says diagnosing atypia in the first place is notoriously difficult and that using this test outside of a research setting is premature.

Khan acknowledges perhaps the device is ahead of the science.

She is leading a study funded by the National Cancer Institute to determine whether the hormone content of nipple fluid is an indicator of breast cancer risk. She thinks if such a biomarker is found, a test can be applied to all women rather than relying on the HALO test which will only yield fluid about half the time, making it an incomplete test.
 

"Ongoing research may bring out a marker, a protein, some attribute of nipple fluid that sorts out reliably whether a woman is at increased risk or not," she says. "At the moment, I don't think we are there yet."

She thinks perhaps the nipple fluid test will lead researchers towards something to look for in the blood, urine or needle biopsy, which can someday be applied to all women and not just those who produce nipple fluid.

According to Radiation Oncologist Dr. Urmi Kalokhe, medical director of the oncology center at St. Margaret Mercy Healthcare Centers, "If the cancer grows in those ducts and if those cancer cells are shed into the tube and if you are able to extract them, then one would be able to make the diagnosis earlier before it makes even an impression on the mammogram, however as good as it is in theory, it's not so in practice," Kalokhe says. "Right now it has no definitive predictive value and its clinical role is still not determined."

In general, she says with better imaging on the horizon, researchers' attention is better focused toward that end.

Dr. Esther Lee, a radiologist with Porter Health System, completed a fellowship specifically in breast imaging at Northwestern Memorial Hospital in Chicago. She feels an MRI, which is reliable not for spotting potentially precancerous cells, but for seeing early cancer that is already there, is still preferable to a test that provides what she believes to be nonspecific findings.

"I'm not saying it's a bad test," she says. "I just think it's not very helpful."

To doctors who say mammogram, ultrasound and MRI are still a better weapon against cancer, Francescatti says it's an apples to oranges kind of comparison.

"What we are talking about with the HALO test is finding the predisposition for cancer when it is in a very early, early stage that is not image evident and that instituting a treatment to either prevent the development of the breast cancer or stop it completely is a totally different game."

He adds later, "There is a much better chance in looking with a ductoscope of finding it that finding it with an MRI or an ultrasound in the early stages of development and that is what we are talking about. We're talking about the early, early stages."

Francescatti scoffs at the idea this is nothing more than a money-making venture.

"Atypia is something that has been in front of our nose for years and has not been followed up on in a proper fashion," Francescatti says.

"I think that if we incorporate this technique and we actively go after or investigate patients with atypia," Francescatti says, "we are going to find that a majority of those breast cancers that are going to have atypia associated with it in an early fashion, we are going to be able to treat atypia and I believe we will reduce the incidence of breast cancer tremendously in the future."

Dr. Seema Khan, professor of surgery and Bluhm Family Professor of Cancer Research at Northwestern University's Robert H. Lurie Comprehensive Cancer Center, says diagnosing atypia in the first place is notoriously difficult and that using this test outside of a research setting is premature.

Khan acknowledges perhaps the device is ahead of the science.

She is leading a study funded by the National Cancer Institute to determine whether the hormone content of nipple fluid is an indicator of breast cancer risk. She thinks if such a biomarker is found, a test can be applied to all women rather than relying on the HALO test which will only yield fluid about half the time, making it an incomplete test.

"Ongoing research may bring out a marker, a protein, some attribute of nipple fluid that sorts out reliably whether a woman is at increased risk or not," she says. "At the moment, I don't think we are there yet."

She thinks perhaps the nipple fluid test will lead researchers towards something to look for in the blood, urine or needle biopsy, which can someday be applied to all women and not just those who produce nipple fluid.

According to Radiation Oncologist Dr. Urmi Kalokhe, medical director of the oncology center at St. Margaret Mercy Healthcare Centers, "If the cancer grows in those ducts and if those cancer cells are shed into the tube and if you are able to extract them, then one would be able to make the diagnosis earlier before it makes even an impression on the mammogram, however as good as it is in theory, it's not so in practice," Kalokhe says. "Right now it has no definitive predictive value and its clinical role is still not determined."

In general, she says with better imaging on the horizon, researchers' attention is better focused toward that end.

Dr. Esther Lee, a radiologist with Porter Health System, completed a fellowship specifically in breast imaging at Northwestern Memorial Hospital in Chicago. She feels an MRI, which is reliable not for spotting potentially precancerous cells, but for seeing early cancer that is already there, is still preferable to a test that provides what she believes to be nonspecific findings.

"I'm not saying it's a bad test," she says. "I just think it's not very helpful."

To doctors who say mammogram, ultrasound and MRI are still a better weapon against cancer, Francescatti says it's an apples to oranges kind of comparison.

"What we are talking about with the HALO test is finding the predisposition for cancer when it is in a very early, early stage that is not image evident and that instituting a treatment to either prevent the development of the breast cancer or stop it completely is a totally different game."

He adds later, "There is a much better chance in looking with a ductoscope of finding it that finding it with an MRI or an ultrasound in the early stages of development and that is what we are talking about. We're talking about the early, early stages."

Francescatti scoffs at the idea this is nothing more than a money-making venture.
 

"Atypia is something that has been in front of our nose for years and has not been followed up on in a proper fashion," Francescatti says.

"I think that if we incorporate this technique and we actively go after or investigate patients with atypia," Francescatti says, "we are going to find that a majority of those breast cancers that are going to have atypia associated with it in an early fashion, we are going to be able to treat atypia and I believe we will reduce the incidence of breast cancer tremendously in the future."

Dr. Seema Khan, professor of surgery and Bluhm Family Professor of Cancer Research at Northwestern University's Robert H. Lurie Comprehensive Cancer Center, says diagnosing atypia in the first place is notoriously difficult and that using this test outside of a research setting is premature.

Khan acknowledges perhaps the device is ahead of the science.

She is leading a study funded by the National Cancer Institute to determine whether the hormone content of nipple fluid is an indicator of breast cancer risk. She thinks if such a biomarker is found, a test can be applied to all women rather than relying on the HALO test which will only yield fluid about half the time, making it an incomplete test.

"Ongoing research may bring out a marker, a protein, some attribute of nipple fluid that sorts out reliably whether a woman is at increased risk or not," she says. "At the moment, I don't think we are there yet."

She thinks perhaps the nipple fluid test will lead researchers towards something to look for in the blood, urine or needle biopsy, which can someday be applied to all women and not just those who produce nipple fluid.

According to Radiation Oncologist Dr. Urmi Kalokhe, medical director of the oncology center at St. Margaret Mercy Healthcare Centers, "If the cancer grows in those ducts and if those cancer cells are shed into the tube and if you are able to extract them, then one would be able to make the diagnosis earlier before it makes even an impression on the mammogram, however as good as it is in theory, it's not so in practice," Kalokhe says. "Right now it has no definitive predictive value and its clinical role is still not determined."

In general, she says with better imaging on the horizon, researchers' attention is better focused toward that end.

Dr. Esther Lee, a radiologist with Porter Health System, completed a fellowship specifically in breast imaging at Northwestern Memorial Hospital in Chicago. She feels an MRI, which is reliable not for spotting potentially precancerous cells, but for seeing early cancer that is already there, is still preferable to a test that provides what she believes to be nonspecific findings.

"I'm not saying it's a bad test," she says. "I just think it's not very helpful."

To doctors who say mammogram, ultrasound and MRI are still a better weapon against cancer, Francescatti says it's an apples to oranges kind of comparison.

"What we are talking about with the HALO test is finding the predisposition for cancer when it is in a very early, early stage that is not image evident and that instituting a treatment to either prevent the development of the breast cancer or stop it completely is a totally different game."

He adds later, "There is a much better chance in looking with a ductoscope of finding it that finding it with an MRI or an ultrasound in the early stages of development and that is what we are talking about. We're talking about the early, early stages."

Francescatti scoffs at the idea this is nothing more than a money-making venture.

"If you really know the history and you've followed the history as it's unfolded and if you've studied the pathophysiology of the disease and you know the anatomy and you know the equipment and the clues that it's laid down, this is like a 'duh.'"
 

"Atypia is something that has been in front of our nose for years and has not been followed up on in a proper fashion," Francescatti says.

"I think that if we incorporate this technique and we actively go after or investigate patients with atypia," Francescatti says, "we are going to find that a majority of those breast cancers that are going to have atypia associated with it in an early fashion, we are going to be able to treat atypia and I believe we will reduce the incidence of breast cancer tremendously in the future."

Dr. Seema Khan, professor of surgery and Bluhm Family Professor of Cancer Research at Northwestern University's Robert H. Lurie Comprehensive Cancer Center, says diagnosing atypia in the first place is notoriously difficult and that using this test outside of a research setting is premature.

Khan acknowledges perhaps the device is ahead of the science.

She is leading a study funded by the National Cancer Institute to determine whether the hormone content of nipple fluid is an indicator of breast cancer risk. She thinks if such a biomarker is found, a test can be applied to all women rather than relying on the HALO test which will only yield fluid about half the time, making it an incomplete test.

"Ongoing research may bring out a marker, a protein, some attribute of nipple fluid that sorts out reliably whether a woman is at increased risk or not," she says. "At the moment, I don't think we are there yet."

She thinks perhaps the nipple fluid test will lead researchers towards something to look for in the blood, urine or needle biopsy, which can someday be applied to all women and not just those who produce nipple fluid.

According to Radiation Oncologist Dr. Urmi Kalokhe, medical director of the oncology center at St. Margaret Mercy Healthcare Centers, "If the cancer grows in those ducts and if those cancer cells are shed into the tube and if you are able to extract them, then one would be able to make the diagnosis earlier before it makes even an impression on the mammogram, however as good as it is in theory, it's not so in practice," Kalokhe says. "Right now it has no definitive predictive value and its clinical role is still not determined."

In general, she says with better imaging on the horizon, researchers' attention is better focused toward that end.

Dr. Esther Lee, a radiologist with Porter Health System, completed a fellowship specifically in breast imaging at Northwestern Memorial Hospital in Chicago. She feels an MRI, which is reliable not for spotting potentially precancerous cells, but for seeing early cancer that is already there, is still preferable to a test that provides what she believes to be nonspecific findings.

"I'm not saying it's a bad test," she says. "I just think it's not very helpful."

To doctors who say mammogram, ultrasound and MRI are still a better weapon against cancer, Francescatti says it's an apples to oranges kind of comparison.

"What we are talking about with the HALO test is finding the predisposition for cancer when it is in a very early, early stage that is not image evident and that instituting a treatment to either prevent the development of the breast cancer or stop it completely is a totally different game."

He adds later, "There is a much better chance in looking with a ductoscope of finding it that finding it with an MRI or an ultrasound in the early stages of development and that is what we are talking about. We're talking about the early, early stages."

Francescatti scoffs at the idea this is nothing more than a money-making venture.

"If you really know the history and you've followed the history as it's unfolded and if you've studied the pathophysiology of the disease and you know the anatomy and you know the equipment and the clues that it's laid down, this is like a 'duh.'"

The doctors who don't advocate the HALO test generally believe no harm is done by doing the test as an adjunctive measure as long as the woman understands that a negative result does not mean no breast cancer or even low risk of a future breast cancer. However, findings of atypia could be very significant when evaluated by a highly skilled expert in breast atypia.
 

When making decisions about new tests or procedures recommended by a doctor, Barai says it's important that women ask to see scientific research published in peer-reviewed medical journals.

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