Although we have been screening high-risk patients with MRI since our program began, guidelines for using MRI from the American Cancer Society were announced for the first time in 2007. Four groups of patients were identified as candidates for MRI screening. The first three groups are at an extraordinarily high risk, and few women are included (BRCA gene+ families, families with other genetic syndromes predisposing to breast cancer, history of chest wall radiation between ages 10 and 30). It is the fourth group that not only applies to most high-risk women, but is also the most controversial: “Women whose lifetime risk for breast cancer exceeds 20-25% as calculated by the various mathematical models that emphasize family history.”
Unfortunately, the most common mathematical model (Gail model – a.k.a. NCI model) used to determine risk is considered least desirable in the new guidelines. This is a peculiar stance since the Gail model is the most validated and most utilized of all the available mathematical models. However, the reasoning of the ACS is that the published studies on MRI screening did not use the Gail model, but instead, focused on strong family histories. Thus, the mathematical models used in the published studies are favored. Whether or not insurers will base their policies on specific mathematical models is unknown at this point in time. The Gail model can be accessed online and used by anyone. However, the other models (Claus, Tyrer-Cuzick, BRCAPRO) are preferred by the American Cancer Society, while at the same time are more complicated and generally require a formal risk assessment. At our facility, we are able to perform calculations with any or all of these models to see if you qualify for MRI screening. In addition, we assist patients in obtaining insurance coverage by writing letters to insurers explaining the ACS guidelines and how the lifetime risk determinations were made.
If you qualify, there are three other major points to be made about the new ACS guidelines. First, the screening interval is recommended to be every year, the same as mammography. Second, mammograms are to be performed along with the MRI (MRI does not dismiss the need for X-rays, the latter being better at detecting calcium). Third, the starting age for screening these high-risk women is 30, ten years prior to the usual starting age of 40.
As for women with lifetime risks of 15-20%, the ACS has stated “more research is needed.” Women with prior biopsies showing atypical hyperplasia or LCIS, or a past history of breast cancer, or dense mammograms are also in this “more research” group. Oddly enough, though, depending on your age, these risk factors are sometimes enough to bring calculated risks above 20% even with the “approved” mathematical models. So, we have to remember that the ACS has only provided guidelines, and the real issue is whether or not your insurer is going to cover the expense.
Because most women who consider themselves high-risk are in this 15-20% controversial zone, we believe it is important to consider the density of mammograms since this is the primary determinant as to whether or not the eventual cancer will be detected on routine screening. In fact, we developed an in-house protocol from Day One that included both risk level and mammographic density in providing patient guidance. In most cases, we advise MRI screening be done every two years in this group of patients, while reserving annual screening for the extremely high-risk patients.
Because the issues here are so complex, we submit claims for MRI screening in our high-risk patients, but if the claim is denied, we make arrangements for payments at a discounted rate.
For patients who are below 15% lifetime risk, the ACS has advised against MRI screening. This does not mean MRI doesn’t work in this group. Such a statement is made for economic and practical reasons. The breast MRI capacity in the U.S. is unable to handle even high-risk screening, much less screening the general population. Sadly, though, at least half of all breast cancers that eventually develop will come from this group, speaking for the need for alternative ways to select patients for MRI screening.
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In April 2006, Dr. Hollingsworth addressed the general assembly of the American Society of Breast Disease on “MRI Screening in High-Risk Patients” becoming the first non-radiologist to speak on the subject in a national forum. This has led to requests for other speaking engagements and publications on the subject. And, it is the proven superiority of MRI screening for breast cancer that is the justification of his research agenda to develop a screening blood test that would render obsolete the idea of using risk status as the criterion for MRI screening. |
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