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New and Improved Breast Biopsies

A new tool is taking the guess work out of breast biopsies.

It may not happen a lot, but even once is too much. A women being treated with chemo, radiation, even a mastectomy and she doesn’t even have cancer.  Now, there is a new test to make sure the results are your own.
This doctor is preventing a horrible mistake. By swabbing his patient’s cheek- he avoids even one woman from hearing this:
“About 1000, maybe 1500, women are told ‘Hey Mrs. Jones you have breast cancer,’ and she does not,” Andrew Kenler, MD, Breast Surgeon, Bridgeport Hospital, Bridgeport, Conn., told Ivanhoe.
Dr. Kenler says so many steps go into testing breast biopsies that human errors can occur, and do. This simple DNA test ends the mix ups and, more importantly, the consequences.
“She can have unnecessary surgery, lumpectomy, mastectomy, [and] unnecessary chemotherapy,” Dr. Kenler said.
He advises all his patients to take the know error test. It costs $300 and every positive breast biopsy is sent to the test’s lab in Indianapolis to match with the DNA on file. A match means his patient is getting her correct results.
For Jacquelyn Conlon, it wasn’t what she wanted to hear two years ago.
“I had stage 2A breast cancer,” Conlon told Ivanhoe.
She got the truth because as thousands of women are told they “do” have it but actually don’t, another woman is being told she “doesn’t” have it and she does.
“It gives you the confidence that your diagnosis is truly indeed your diagnosis,” Conlon explained.
She got her answer, completed her treatment, and lives cancer-free today.
In some cases the test is covered by insurance, in instances where it is not, many women have chosen to pay $300 out of pocket and purchasing the know error test themselves.

BACKGROUND: Imaging techniques, like a MRI or a mammogram, along with physical exams of the breast can lead doctors to suspect that a person has breast cancer.  However, the only way to know for sure is to take a sample of tissue from the suspicious area, called a biopsy.  Usually, if the doctor notices anything suspicious he or she will order a biopsy. The tissue sample is examined by a pathologist to see if cancer cells are present or not.  (Source: http://www.breastcancer.org/symptoms/testing/types/biopsy)
HOW IT IS DONE:  There are several ways to do a breast biopsy, including:
* Fine-needle aspiration biopsy:  the doctor inserts a thin needle into a lump and removes a sample of cells or fluid.
* Core needle biopsy:  the doctor inserts a needle with a special tip and removes a sample of breast tissue about the size of a grain of rice.
* Open (surgical) biopsy:  the doctor will make a small cut in the skin and breast tissue to remove part or all of a lump.  This may be done as a first step to check a lump or if a needle biopsy does not provide enough information.
* Vacuum-assisted core biopsy:  this is performed with a probe that uses a gentle vacuum to remove the breast tissue sample.  The small cut does not require stitches and leaves a very small scar.  (Source:  www.webmd.com)
DR. KENLER: “There’s about 1.2 million what we call core biopsies, needle biopsies of the breast annually in the United States. I do about 400 a year where a woman presents either with a mass sometimes that they feel but most commonly, most often, a mass that’s seen by ultrasound and/or by a mammogram. They come into your office and you see it and, under image guidance, you place a needle within the mass or the calcifications. The specimen is then placed in a formalin jar and sent to your pathologist. Sometimes radiologist perform these biopsies, so they have to send out these specimens and there are about eighteen steps from the time that the surgeon performs the core biopsy until a report is generated that tells the patient if they do or you do not have cancer. There are approximately 300,000 breast cancers diagnosed annually in the United States. One in 100 times you tell a patient you have cancer and you don’t. That’s the mistake rate. Now for every false positive, unfortunately there’s a sister lesion, a sister error, that the woman you told who doesn’t have cancer actually does. There are 6000 cases annually where either you do have cancer and you don’t or you don’t have cancer and you do. Obviously the former, where you tell a patient you do have cancer and she doesn’t, is more egregious and potentially leads to unnecessary chemotherapy, hormonal therapy, surgery, even mastectomies as we’re probably going to talk about. Two thirds of the time you catch them, but a third of the time you don’t. So annually about 1000, maybe 1500, women are told that they have breast cancer but do not. They then go on to receive unnecessary surgery, radiation, or possibly chemo.” (Source: Dr. Kenler)
FOR MORE INFORMATION, PLEASE CONTACT:

Dr. Andrew Kenler
Assistant Clinical Professor of Surgery
Yale School of Medicine
Breast Cancer Surgeon affiliated with Bridgeport Hospital/Norma F Phriem Breast Care Center andrewkenlermd@ynhh.org


Dr. Andrew Kenler, Assistant Clinical Professor of Surgery, Yale School of Medicine, and Breast Cancer Surgeon affiliated with Bridgeport Hospital/Norma F Phriem Breast Care Center, talks about diagnosing breast cancer earlier.
How often is there a mix up when a woman go gets a test for breast cancer?
Dr. Kenler: There’s about 1.2 million what we call core biopsies, needle biopsies of the breast annually in the United States. I do about 400 a year where a woman presents either with a mass sometimes that they feel but most commonly, most often, a mass that’s seen by ultrasound and/or by a mammogram. They come into your office and you see it and, under image guidance, you place a needle within the mass or the calcifications. The specimen is then placed in a formalin jar and sent to your pathologist. Sometimes radiologist perform these biopsies, so they have to send out these specimens and there are about eighteen steps from the time that the surgeon performs the core biopsy until a report is generated that tells the patient if they do or you do not have cancer. There are approximately 300,000 breast cancers diagnosed annually in the United States. One in 100 times you tell a patient you have cancer and you don’t. That’s the mistake rate. Now for every false positive, unfortunately there’s a sister lesion, a sister error, that the woman you told who doesn’t have cancer actually does. There are 6000 cases annually where either you do have cancer and you don’t or you don’t have cancer and you do. Obviously the former, where you tell a patient you do have cancer and she doesn’t, is more egregious and potentially leads to unnecessary chemotherapy, hormonal therapy, surgery, even mastectomies as we’re probably going to talk about. Two thirds of the time you catch them, but a third of the time you don’t. So annually about 1000, maybe 1500, women are told that they have breast cancer but do not. They then go on to receive unnecessary surgery, radiation, or possibly chemo.
What happens in that case, could she go even further and have surgery and the chemo?
Dr. Kenler: Yes and yes. She can have unnecessary surgery, lumpectomy, mastectomy, unnecessary chemotherapy so there’s obviously a huge cost. I mean emotionally, physically, disfigurement, time from work that’s lost, and cost of treatment.
Is cancer a time sensitive disease?
Dr. Kenler: It is. I mean you do have some time. The standard of care is about four weeks from diagnosis to surgery, that’s what we strive for. The process in our office, when the core biopsy is performed and the tissue sent to Yale pathology, we also swab the inner cheek which is the DNA fingerprint of the patient. Once the specimen is matched, if that woman has cancer, my comment is always, “I’m waiting on the Know Error test, it takes a couple extra days because it has to go to the Know Error Lab in Indianapolis. They know that it’s 95% but nothing is done, no discussion in my office never mind surgery until we know that her tissue sample matches her own DNA swab. So, it’s a very important part, it’s really called the DNA time out.
Are you saying from this know error there is actually no error to those results?
Dr. Kenler: Right. That’s a good pun, but you’re right the test is basically 100% accurate where at the time of core biopsy we simply swab the patient’s inner cheek. The buccal swab, using forensic chain of command custody principles, is sealed and bar-coded. The swab is basically the patients DNA fingerprint and is sent to the Know Error Lab in Indianapolis where it’s archived and held. The tissue is then sent to your pathologist and, God forbid, if you’re one of those women who it’s positive for cancer or precancer, a piece of that tissue is then sent to Indianapolis and they are matched. The DNA from the buccal swab has to match the DNA analysis which The Know Error Lab runs from a piece of the specimen, it’s as simple as that. If they match you have a Know Error match and you know that woman truly does have cancer or precancer. If there is a mismatch, something’s wrong and there was an error: a labeling error, contamination, or both. Then you have to work back and figure out who did have cancer that day or who didn’t. But regardless of that, this test is a few hundred dollars and we call it the DNA timeout to prevent unnecessary surgery. I stop and make sure there’s a match.  That’s something I’ve been doing now for almost 3 years and, quite frankly, I wouldn’t operate on a woman with breast cancer without the Know Error testing.
Now you said you won’t perform surgery without the test and use the test what’s been the response of your patients? When you’re talking to them and you’re telling them 100%, what’s going on?
Dr. Kenler: It’s a great question because when I first started doing this, it was like
“Hey, DNA, it’s almost kind of like forensic CSI type stuff.” Everyone can relate to that because it’s on the popular news and television.  Right off the bat people said absolutely. When I meet a patient I leave the room while my nurse gets set up for these core needle biopsies. They go through the whole kind of, “What’s going to happen?”  The first step is the swab of the cheek. And I’ve been doing this for about three years we have not had one patient who said they don’t want it done. To further highlight that, if I see a patient who’s already had the core biopsy performed at another facility and they come to me, I retroactively test the tissue. All of my patients are going to be Know Error tested, I make no exceptions.






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