Amanda Wilde (Host): Guidelines for breast cancer screenings have recently been changed by the FDA. We're talking about the potential impact of those recommendations with Dr. Aurela Clark, breast radiologist with the Comprehensive Breast Care Center at UK Markey Cancer Center.

Welcome to UK HealthCast, a podcast presented by UK HealthCare. I'm Amanda Wilde. Welcome, Dr. Clark. So glad to have you here.

Dr. Aurela Clark: So glad to be here. Thank you.

Host: Well, first, just before we get into the guidelines, I do want to find out what brought you here, maybe not right here to the podcast, but why you became a radiologist and what led you to UK HealthCare's Comprehensive Breast Care Center?

Dr. Aurela Clark: Well, the story goes back to my years of growing up in Albania. I had this amazing role model, my cousin, Bonna, who was this compassionate, beautiful, and incredibly driven woman. And she became our family's very first doctor, which was a really big deal. I spent most of my summers shadowing her in medical clinics. She eventually became a surgeon, and I'll never forget the time she let me observe in the operating room. She even took me along with her when she was doing her house calls to check on her post-surgical patients. So, she had this incredible sense of dedication and kindness, and she was so connected to her patients and took her work so seriously. So, watching her became pretty clear to me early on that I wanted to follow in her footsteps and become a doctor too. She even helped me study English when I was taking the English test. And eventually, I attended medical school at the University of Kentucky.

So during medical school, I stumbled upon Radiology somewhat by an accident. I was trying to understand some PET CT scan results and then it just clicked for me. As I learned more, I started seeing the vital importance of imaging in patient care. And specifically. As I was dealing with my mom's cancer diagnosis, pancreatic cancer diagnosis. She didn't get to see me finish medical school, but my experiences with her played a big part in my eventual decision to go into Radiology.

And then, in what felt like a bittersweet full circle, my beloved cousin, Bonna, who had been my role model for the longest time, was diagnosed with advanced breast cancer at the age of 43. Her journey battling the disease inspired me to specialize in breast imaging and to do everything I can for early detection. So, she passed away after battling the disease for four years at the age of 47, and her legacy drives me every day.

So, I call Kentucky my second home. In fact, I've spent 25 years of my life here. And after completing my fellowship in breast imaging at the Medical University of South Carolina, I returned to work as a dedicated breast imager at the Comprehensive Markey Cancer Center. So in my daily work, I make early detection my priority. Bonna is very forward in encouraging women to stay on top of their health. So, this is how I landed in Radiology and specifically in Breast Radiology.

Host: And radiology is the point of early detection, and we can only emphasize that early detection is commensurate with greater chances of successfully treating breast cancer.

Dr. Aurela Clark: That's absolutely correct. Early detection makes the world of difference in this specific field of Radiology where there is a 95% chance of survival if the cancer is caught early. So, it is my mission to spread awareness about this.

Host: And that is the vital importance of imaging. This month, the FDA issued new guidelines requiring that women receive information about their breast density following a mammogram. So, what are we talking about when we discuss breast density?

Dr. Aurela Clark: So, when we talk about breast density, we have to understand a little bit about the anatomy of the breast. The breast is composed of milk glands and milk ducts in a bed of fibrous tissue. And this we call the fibroglandular component of the breast. The breast is also composed of fatty tissue. So, when we talk about density, we're talking about the relationship of the fibroglandular tissue compared to the fatty tissue. So if one patient has more fibroglandular tissue than they have fatty tissue, they're called dense. However, if there is a smaller amount of fibroglandular tissue and more fatty tissue, that patient's breast density is called not dense.

And this can only be determined, I want to stress this, after a mammogram. It cannot be determined by feel during the self-exam or during a clinician's physical exam. So, again, density is only a mammographic finding. For the FDA purposes here, there are two major categories of breast density. FDA cares about notifying people about dense breast and non-dense breast. However, we in Breast Imaging subcategorize these two categories into four categories. So, each category has two subcategories. The dense breast is divided into or subcategorized into extremely dense and heterogeneously dense. And then, the non-dense breast is further subdivided into scattered fibroglandular tissue and fatty breast tissue.

And the reason why this is so important for women to know what their breast density is, it is because research has shown that cancers can be missed in dense breasts due to the masking effect of the dense breast, which appears white on the mammogram, similarly to the appearance of cancer. So, you have it white on white, with complete loss of contrast, it makes it extremely hard to detect cancer. And the way I think about it is like writing with a white marker on a white board. So, you can't really appreciate the contrast.

And what's also important to stress is that while mammogram may not be as efficient in dense breasts, it is absolutely necessary because certain forms of cancer such as ductal carcinoma in situ or even early invasive breast cancer can present as microcalcifications, which are little white dense dots that we can only see on the mammogram. So, sometimes we're not able to see those on other forms of imaging and they can only be detected on mammogram. That's why the importance of mammogram.

Host: So, there is no substitute for mammograms in detecting certain qualities and again to try to get in on early detection.

Dr. Aurela Clark: That's absolutely correct.

Host: Dr. Clark, how common are dense breasts?

Dr. Aurela Clark: So, dense breasts are very common, and they're also normal. If you are sitting in a room of patients or women who recently had their mammograms, about 60 out of 100 of those women will have non-dense breasts, and 40 out of 100 of those women will have dense breasts. So, 60 of those 100 women who have non-dense breasts will fare better in terms of cancer reduction than the 40% of the women who run the risk of having their cancer go undetected on mammogram.

So, as you can see here, mammograms do not benefit every patient equally. The denser the breast, the lower likelihood of mammogram to detect early cancer, which is our major purpose for screening mammography. But the good news is that mammogram is highly sensitive for detecting cancer in non-dense breasts. On the other hand, the sensitivity will drop significantly by 30-40% in those 40% of women with dense breasts.

The other thing I wanted to stress is that the 40% of individuals who have dense breasts and are at higher risk of developing breast cancer just by virtue of having dense breasts, as dense breast tissue alone is an independent risk factor for breast cancer. They unfortunately happen to be the younger women. So, those are the women that are typically between 40 to 50. So, this creates this unfortunate situation where people with dense breasts are more likely to develop breast cancer and are more likely for cancer to go undetected on screening mammogram. So if you have dense breasts and your mammogram is reported as a negative mammogram, this means that no cancer was seen on the mammogram, but it does not mean that cancer is not present. And I want to make that clear. And that's what the new guidelines are doing. They're making this statement sort of more transparent for all women.

The other point that's important to make is that mammography does not serve all patients equally. In some racial groups, including African Americans and Asian women who also have dense breasts, mammography can provide a disadvantage. But it's true that, again, the younger age group of women and the racial groups are more likely to have cancers undetected on screening mammograms.

So, with the new guidelines, if patients have dense breasts, they're advised to talk to their doctor about adding the supplemental screening options, which may include full breast ultrasound, breast MRI or contrast-enhanced mammography, but these options are in addition to screening mammogram, but they're not a substitute for it. The patient will see this recommendation in their lay letter that we send to them, so they will know their breast density, whether they're dense or not dense, and they will also be advised in that same letter to speak to their doctor about breast cancer risk, about what dense breast implications mean for them, and about their individual risk for breast cancer. So, this letter goes to both patients with dense breasts and non-dense breasts. So, it kind of levels the field. Everybody gets this knowledge. It's become transparent.

Host: Well, knowledge is power, but I can imagine receiving a letter like that if you have dense breasts would be very concerning. What kind of questions do women have after being told they have dense breasts? And how do you and your team respond to those questions?

Dr. Aurela Clark: Although Kentucky law has required that women be notified of their dense breasts since 2017, so for Kentucky this law is not entirely new. This law kind of levels the field throughout the U.S. But prior to this law coming into effect, about 38 states and the District of Columbia had this law already in place, and Kentucky already had this law. So, we have been notifying our patients of their breast density since 2017. But despite that, many patients do not fully understand what it means to have dense breasts, or even if it's normal. So, we go above and beyond when we see them in the diagnostic rooms to have a conversation with them. And they often understand that while mammogram is essential, it may not be as effective as they had initially thought. And they do appreciate the knowledge and they're generally open to discussion about screening options, especially if they have additional risk factors and those can include family history of breast cancer, prior biopsies, including even benign biopsies or even genetic predisposition.

The other thing that's still a challenge that, hopefully, we'll see some sort of resolution and I'll talk about later, is insurance coverage. Insurance coverage is another concern. So, dense breast tissue does increase a woman's lifetime risk for breast cancer. However, it does not increase it enough to where a woman is considered high risk just by its own. So if you have dense breast and you have no other risk factors, you might go from having average risk, which in America is about one in eight women, so about 12.5%, into the intermediate risk category, which would be about 15% to 20%. So, it bumps you perhaps one category to intermediate risk, but it does not bump you enough to the high level or high risk category to where insurance would pay for supplemental screening. So, again, that is a concern, but if you encourage the women to have a discussion with their doctor and weigh in other risk factors such as family history, prior biopsies, genetic predisposition and whatnot, they might just bump over that 20% and have the insurance coverage.

The good news, however, is that the new Kentucky Law to take effect January 2nd, 2025, House Bill 115 was signed by Governor Andy Beshear in April this year. It will require elimination of cost-sharing, both deductible copay for patients who have insurance and for Medicaid patients so that they can have full coverage of the supplemental screening that's required when it's indicated. And it's very exciting because it will also cover the diagnostic exams. So, we're really looking forward to having this House Bill come into effect January 2025 and eliminate some of the cost sharing, which is still a hindrance for people despite having insurance coverage.

Host: Right, and you can reach more people that way. I think it's interesting too what you've pointed out that although you may find you only have dense breasts, that by visiting your doctor, you may also find that you have other risk factors that you didn't know about, which again gets us on top of this earlier rather than later. You mentioned too that Kentucky has had these guidelines already for several years. Why have these become guidelines nationally just now with the FDA? Was the impact of breast density not as well documented before or what changed?

Dr. Aurela Clark: Well, you know, for years, we in the radiology community have recognized the challenge of mammography, often misses breast cancer in dense-breasted women. But now, it's become clear through countless studies that the denser breast tissue, the harder it is to spot early breast cancer. So, unfortunately, convincing everyone involved, policymakers, healthcare providers, and stakeholders has been an uphill battle for Radiology.

But again, as cancer rates have risen, and more research has highlighted the limitations of mammography, research is stating that mammogram can only detect about 50% of cancers in dense breasts, and we're starting to see this shift. There's also increased advocacy efforts from many individual radiologists, as well as radiological societies, who have been passionate about this issue, and they have led to legislation, and great strides have been made, especially this year.

In chronological order, United States Preventative Services Task Force, USPSTF, changed its recommendation earlier this year for screening mammograms to start at age 40, where they previously had advocated for starting at age 50. Before that, they had 40, then they went to 50, then now they're back at 40. So, what led this change was a strong evidence that a significant amount of cancers, nearly a quarter of the cancers that were diagnosed in women in the 40s in these early cancers that are usually more aggressive were being missed by starting at age 50. So, this is huge, because data has shown for many years that starting at age 40 provides the most reduction in mortality for breast cancer.

However, the United States Preventative Task Force is only recommending biannual screenings. So, we're recommending for women to screen every other year, which is in opposition with American College of Radiology, NCCN guidelines, American College of Surgeons. We all are recommending screening to be performed every year, starting at age 40 for women with dense breasts, because that is the most solid research that has proven a reduction in mortality and the most lives saved in women. So, it is important and the data is very compelling, but the death rates will go up if we stop screening every year.

Now, their argument for not screening every year is the concern for women's anxiety if you're called back for more imaging. However, research has proved this is short-lived. Many studies have shown this anxiety is only transient. But most importantly, this decision is being made for women in an area where women are empowered and should have that decision for themselves. So, diagnosing women with breast cancer for nearly a decade and telling a woman that she has breast cancer that is advanced and has spread to the lymph nodes or other parts of the body, it's way more stressful than a call-back for additional workup or even for uncertain findings or even a breast biopsy.

And then, coming back to the most recent guidelines from FDA in 2024, now FDA is mandating that all women in the United States be told that their breast density. So, this law states that every woman should be notified. And previously, like I said before, only 38 states had some sort of notification law and they were not consistent throughout the entire United States. Some states notified the women of the dense breast. Some states provided guidance as to whether they should discuss or not, the implications of this for their providers. Some states did not even notify the women of the dense breast. So, there's a lot of variability throughout the U.S. So now, if you get a mammogram in any of the 50 states of the U.S. and U.S. territories, there should be unity and uniform information.

So, that's really important because it empowers women and informs women to take care of their breast health and even do their research more and discuss some of the benefits and some of the pitfalls with the additional imaging. Because unfortunately, while all this imaging that we have for additional supplemental screening is important in terms of detecting more cancers above screening mammography, however, there are recall rates that are going to happen. So, this is not perfect, This is a means of detecting more cancers, but at a small cost of having more callback rates, maybe having a few more biopsies. So, women also need to be aware of that as they discuss this, drawbacks of the additional imaging and in a way the risk and benefit and more informed to make their own decisions about that.

Host: It does seem like it should be up to the patient.

Dr. Aurela Clark: I agree, completely agree. So, I think this is a big win for the breast imaging community and women in all.

Host: And so this uniform documentation around the country of breast density and getting that information out to women should bring up awareness and that should bring a decrease in advanced cancer findings because again, early detection. Will the new guidelines impact women during their actual mammogram? Does something change in that process?

Dr. Aurela Clark: As you're getting the mammogram, nothing changes, but after you get the lay letter, so after you've had the mammogram and you go home and within 30 days you get a lay letter telling you what your density is and what you should do about it, that's when they contact their provider and get to know more about their density and their implications and risk and whatnot.

Host: You know, we have talked about the importance of mammograms, even though they are definitely not foolproof. Why are mammograms important?

Dr. Aurela Clark: Well, the great news is that thousands of women are alive because a small cancer was caught early during screening mammography. So, if that doesn't sell mammograms, I don't know what else does. But mammography alone, from the current research, has reduced breast cancer mortality. It has reduced breast cancer deaths by 40% since 1990 when it first was implemented. And it is the first kind of detection we have, it is the gold standard for catching cancers early on when they're not felt, when it's most treatable, so patient can avoid those expensive and inexpensive treatments that reduce quality of life.

Screening mammogram, and currently with tomosynthesis, or as we otherwise call it, the 3D mammogram, is now the standard of care and up to 95% of the facilities in the United States use the 3D screening mammography. So, it is absolutely the standard of care, the gold standard for early cancer detection, with solid evidence, compelling evidence that death rates have been significantly reduced since its implementation.

I should also stress that 1% of breast cancers occur in men, and men with prior treated breast cancer, if it was treated conservatively, or if they have a BRCA mutation, they should also be offered mammography.

Host: And you mentioned the 3D mammography. The technology is continually improving so we can look forward to that. But bringing it back to you and your specific work, how does Markey help women in need of mammograms and then those who are diagnosed with breast cancer?

Dr. Aurela Clark: Markey has been one of the early centers in Kentucky who implemented 3D mammography. So, we've had 3D mammography since 2013. So, we're well established in that new technology. And of course, the supplemental method of screening that we're offering our patients currently is the supplemental breast MRI.

But currently, Markey Cancer Center is offering one extra day of screening in October, one Saturday of screening in October, that's occurring this upcoming Saturday, where we have about 65 patients scheduled for screening mammograms. We also have been working diligently to reduce the time from the cancer diagnosis to seeing the medical oncological team, which currently is about seven to 10 business days so that patient can get their treatments faster.

The other thing is that Markey Cancer Center is the center in Kentucky, for the Kentucky Women's Cancer Screening Program, which based on the Breast and Cervical Cancer Mortality Prevention Act of 1990, established by the CDC and funded by the CDC, is offering free cancer screenings for underserved women, including those with low income and minority groups.

Additionally, we're also partnering with the American Cancer Society, where they offer free places for patients to stay during their treatment, and I think Kentucky CancerLinks offers rides and gas cards to patients when they need it. And our social workers are really amazing in providing other resources to assist patients.

Host: So, Markey is really a leader in this area.

Dr. Aurela Clark: It's absolutely doing a wonderful job, and we have a very cohesive multidisciplinary team taking care of the cancer patients quickly.

Host: Yeah. Multidisciplinary is a great way to look at the whole person. And I'm really glad I asked in the beginning about your personal story because it was certainly inspirational and I can hear how you are carrying it forward and becoming a role model and leader yourself.

Dr. Aurela Clark: And that's absolutely my mission, my inspiration, my cousin who died of breast cancer at the age of 47, diagnosed at the age of 43. She did not have the privilege of having a screening mammogram. So when she was diagnosed, she was already stage IV. So, I cannot stress the importance of screening mammography and how early detection provides a true cure for breast cancer.

Host: Dr. Clark, thank you for this enlightening conversation and for the work that you do.

Dr. Aurela Clark: I appreciate you. Thank you.

Host: That was Dr. Aurela Clark, breast radiologist with the Comprehensive Breast Care Center at UK Markey Cancer Center. To find out more, please visit ukhealthcare.uky.edu. If you found this podcast helpful, please share it on your social channels and check out our entire podcast library for topics of interest to you. Thanks for listening to UK HealthCast, a podcast from UK HealthCare.