Breast Density It's the Law

Transcription

1 Last year Iowa became the 30th state in the last 12 years to require that density information be added to the written mammogram report to the patient. This report is sent directly from the interpreting radiologist to the patient, bypassing the primary care provider, and has been mandated by federal and state law since Patients started receiving letters with density information January 1st. All 148 Iowa facilities must be onboard by March 1 st. Robert R. Shreck, M.D. April, 2018 rshreck@cancercenterofiowa.com Breast Density It's the Law

2 What is breast density? First of all, it has nothing to do with the way the breast looks or feels to the patient or the doctor. So it cannot be diagnosed on physical exam. It refers to the amount of fibro-glandular tissue (which is what turns malignant) in relation to the amount of fat. It is a gradient. A woman s position on the density gradient is discovered when she has her first mammogram. Increased density is lifelong. It does tend to decline after menopause, but very slowly over many years. Medical science has no way of decreasing the density of a breast.

3 Fatty 10% Scattered 40% Heterogeneous 40% Extreme 10% For practical management purposes the American College of Radiology (ACR) has defined four levels of density fatty, scattered, heterogeneous, and extreme-- distributed in the following proportions 10%, 40%, 40%, 10%.

4 Increasing density carries two disadvantages to the patient: 1. It increases the risk of getting breast cancer Women in the top half of density are more than twice as likely to be diagnosed with breast cancer than those in the bottom half. Women in the extreme category are 4-6 times more likely to get breast cancer than those in the fatty category. Extreme density the top 10%--is second only to an inherited BRCA gene as an independent risk factor for breast cancer it even outweighs a positive family history. 2. It masks cancer on mammography, making early diagnosis less likely. One need not be a radiologist to see why this is true......

5 Fatty 10% Scattered 40% Heterogeneous 40% Extreme 10% Cancer appears on a mammogram as clusters of small white flecks, or a coalescent white nodule. Unfortunately, so does normal fibro-glandular tissue, raising the classic snowflake in a blizzard, tree in a forest, or grain of sand on a beach issue.

6 What does the Iowa Density Law require? The written report of the mammogram must now include, in language appropriate for the population served -- For all women, all reports must now include: Her density category fatty, scattered, heterogeneous, extreme Information, or links to information, regarding breast density For women in the top half of density (heterogeneous or extreme), the report must now include the following facts: Increased density increases the risk of getting breast cancer Increased density impairs early diagnosis by mammography

7 Density is not all gloom and doom, relatively speaking Patients in the lower half of the density gradient (fatty and scattered) are less likely to develop cancer than the average woman; Moreover, any breast cancer they develop will very likely be detected early in its course on a mammogram, leading to a very high likelihood of cure and hopefully without the most aggressive therapy. A thought: given the lower risk of cancer, and the sensitivity of mammography in early diagnosis, these women could be the candidates for mammograms on an extended cycle; i.e., every two years instead of annually.

8 How many women in Iowa are affected by this new law? Population of Iowa is right at-- 3,000,000 Half of them are women-- 1,500,000 Median age in Iowa is 41, mammographic age 750,000 Just over two-thirds of them get mammograms-- 500,000 40% have heterogeneously dense breasts-- 200,000 10% have extremely dense breasts-- 50,000 So, over one mammographic cycle (1-2) years, over a quarter of a million Iowa women will now receive information on density increased risk and diminished sensitivity that is new to them. Once this backlog is worked through, over 1-2 years, the numbers will fall off dramatically, consisting only of those that age into mammography-- about 8,000 each year.

9 What will be the impact on office practice? Given the number of primary care providers in Iowa (internists, family physicians, OB/GYNs, ARNPs and PAs), and assuming a mammographic cycle of one year women with increased density are evenly distributed amongst PCPs all women with increased density will come in with questions..... each PCP will see, on average, one patient/week with a high-density letter. Of course, the above assumptions are not entirely correct OB/GYNS may see many more than their "share" many women will not have an interest in, or understanding of, density info cycles longer than one year will delay the influx of patients with letters after the backlog is exercised, then incidence will drop to just a few/year/pcp Those that do present with high-density letters will have questions, including:

10 With increased density should I continue to get a mammogram? Absolutely!! A regular mammogram schedule should be continued until advanced age. Women in all density categories who maintain a regular mammogram schedule will live longer (and better) than those who do not. And even though the most disadvantaged group patients with extreme density will often discover their own breast mass between "normal" mammograms (40%), many will still be tipped off by the study (60%). What type of mammogram should I get? All mammograms should be tomo-mammograms, or "3-D" studies. Still an insurance gap, but it is rapidly disappearing (Medicare!!) For women with dense breasts it is worth the extra $25-45 out-of-pocket expense at a private office, and/or worth the extra drive to a facility that has 3-D mammography equipment Equipment and insurance disparities are rapidly disappearing (demand)

11 What else can I do to get the best deal despite high density? Body awareness; breast awareness; body awareness, breast awareness You cannot say it enough times. Changes in the breast o a lump or thickening in the breast or armpit o a bloody nipple discharge o skin dimpling on the breast o a change in shape or texture --should all be promptly reported and further investigated. A recent normal mammogram is of no reassurance whatsoever if any of these changes are noted. A thought: given the increased risk of cancer, this is a population of patients that should maintain an annual mammography schedule

12 Anything else I can do to "gild the lilly"? Yes, but it is the hardest thing of all to do, for both patients and their concerned PCPs, but increased density should provide additional motivation for-- Life-style changes Obesity 70% of American adults are "overweight or obese" 37% of American adults are "obese" Inactivity Alcohol, in excess of one drink/day especially white wine

13 What other tests can be done on dense breasts? This is mainly a concern for extreme density, or heterogeneously dense breasts with additional risk factors, especially a personal or family history of breast cancer. This takes us into what your radiologist call s "supplemental imaging. We are here because extreme density alone carries a 20% lifetime risk of breast cancer.

14 Keeping supplemental imaging in perspective Density discussions have tended to focus on supplemental imaging, which is understandable given new modern techniques. However, only a small fraction of women are candidates extreme for sure; or heterogeneous with addition risk factor(s): mainly a personal or family history of breast cancer, but obesity also qualifies The main benefit of providing density information comes from understanding and motivation to make life-style changes and maintain body/breast awareness and a mammogram schedule Supplemental is exactly that all women should continue a mammogram schedule even if supplemented Finally, there is immeasurable value in bringing women into the conversation on all aspects of breast health. We saw this in 1992 with the original requirement for a written report directly to the patient, and we will see it again

15 Automated Whole Breast Ultrasound (ABUS) Pro: ABUS will "see through" density and detect dominant lumps that are more likely to represent malignancy; it produces a refined definition of anatomy; non-invasive. Con: Has a high incidence of false-positives; Con: Time-consuming; expensive; Con: Relatively low incidence of additional cancer diagnoses

16 MRI of the breast, abbreviated" or otherwise Pro: MRI will "see through" density and detect small lesions, often many of them, which can be benign or malignant; it is widely available Con: Very expensive; requires IV contrast agent Con: Claustrophobia, metallic body parts and even mild kidney failure limit its use Con: high incidence of false positives

17 Molecular breast imaging (MBI) Pro: Uses a radioisotope with short half-life that localizes in metabolically-active tissue; test for physiology, not anatomy. Pro: Lowest incidence of false-positives of any test Pro: Very sensitive in detecting small, active tumors Pro: Least expensive of all supplementary imaging tests Pro: Mayo Clinic has actively promoted this technique Con: Limited availability; currently not available in Iowa Con: Involves a radioactive isotope and hence total-body radiation exposure, which limits frequent use A thought: If it is true that breast cancer is over-diagnosed and over treated at some level, MBI may be the ideal screening test as the small, low-grade, physiologically-inactive "cancers" will be invisible to this study.

18 What about insurance and supplemental imaging? Currently this is a major issue. Like the vast majority of states, the Iowa legislation did not include an insurance mandate. To get insurance payment requires the PCP (or a consulted specialist) to write a letter of "medical necessity, including: The woman s density category The increased risk associated with high density The masking of early diagnosis on routine mammography Any additional risk factors, e.g. personal/family history For those with extreme density this is usually successful, especially for those with even one other risk factor. Extreme density alone confers a 20+% lifetime risk of breast cancer, which is the usual trigger for supplemental breast imaging. Increasing demand will solve this insurance problem.

19 Keeping supplemental imaging in perspective Density discussions have tended to focus on supplemental imaging, which is understandable given new modern techniques. However, only a small fraction of women are candidates extreme for sure; or heterogeneous with addition risk factor(s): mainly a personal or family history of breast cancer, but obesity also qualifies The main benefit of providing density information comes from understanding and motivation to make life-style changes and maintain body/breast awareness and a mammogram schedule Supplemental is exactly that all women should continue a mammogram schedule even if supplemented Finally, there is immeasurable value in bringing women into the conversation on all aspects of breast health. We saw this in 1992 with the original requirement for a written report directly to the patient, and we will see it again

20 What else? Increased density can influence primary treatment decisions. Women diagnosed with large, advanced cancers because of masking on mammography are more likely to choose bilateral mastectomy, ridding themselves of all glandular tissue. The alternative is to continue through life with not only increased risk of getting another breast cancer, but also living with the knowledge that early detection of that potential malignancy is encumbered. To be involved in this decision the patient needs to know and understand the significance of increased density.

21 Resources The definitive Mayo Clinic review article on density, its significance and management. This is the website of the national organization that has spear-headed density legislation and information for more than a decade. It is evidence-based, up-to-date and serves as a resource for both patients and physicians. Has a 45-minute tutorial that offers CME credit to physicians after a quiz and payment of a small fee. The website of the grassroots Iowa "Army of Pink" that labored for five long years to bring about legislation in Iowa requiring density information be included in the written report to the patient. They were rewarded in the last legislative session with a 49-0 vote in the Senate and a 98-2 vote in the Iowa House. Further questions, or more difficult cases, can be addressed by your radiology department, any cancer medicine office or breast health center. This may be of particular value in addressing questions of supplemental imaging.

22 Fatty Scattered Heterogeneous Extreme Dear Radiologist: I would like to know my density information now and not wait for my next scheduled study. Please review my most recent films and provide this information to me and to my PCP. Thank you! Name: Birth date: Primary Care Provider (PCP):