BREAST CANCER RISK ASSESSMENT AND PRIMARY PREVENTION FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 1

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1 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 1 Hello, my name is Rachel Jankowitz, I m an assistant professor of medicine in the Division of Hematology Oncology at the University of Pittsburgh Medical Center and today I m going to be talking to you about breast cancer risk assessment and primary prevention in high risk patients. I have no relevant financial relationship to disclose at this time. The goals of this talk are to be able to estimate the risk of breast cancer associated with certain high risk pathologies such as atypical ductal hyperplasia, atypical lobular hyperplasia, borderline BCIS and LCIS as well as BRCA mutation carriers. In addition, the goal is to identify the amount of risk reduction that is conferred to high risk patients with preventive therapy for breast cancer and to understand the benefit to risk ratio of preventive therapy and its duration in patients with an elevated risk of breast cancer. So breast cancer risk factors are well established, women are much more likely than men, age is a continuous variable for risk with 2 out of 3 breast cancers occurring over the age of 55. And there are certain genetics inherited predispositions for breast cancer such as BRCA mutations and other inherited syndromes listed here that also markedly increase the risk of breast cancer, family history, one first degree relative confers a two-fold increased risk, two first degree relatives increases risk by five-fold as well as a personal history of breast cancer confers a 3 to 4 fold increased risk of a second breast cancer event. Breast density has become more apparent as a distinct risk factor for breast cancer as well as benign breast diseases including certain proliferative lesions like atypia or LCIS, a history of previous chest irradiation, and the women s lifetime estrogen exposure, which is manifested in such things as the total lifetime menstrual period time as well as when she started

2 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 2 childbearing, not having a child before the age of 30 is an increased risk factor, and OCP and hormone replacement therapy use, particularly with the use of combined hormone replacement therapy, not breastfeeding and alcohol is a clear risk for breast cancer that increases according to the amount consumed. Obesity and lack of physician activity are also other risks. So who are those patients we consider at highest risk of breast cancer? Those are the patients who either have an inherited predisposition such as a BRCA 1 or 2 mutation or those patients who are first degree relatives of known mutation carriers who are themselves untested. And also the highest risk patients are those who we consider to have higher than a 20 to 25% lifetime risk based on a risk assessment tool that takes into account age of their affected family members, such as Claus or BRCAPRO. This risk estimation is not to be done by Gail Score for this purpose, that model does not take into account the age of affected family members. In addition patients who had radiation to their chest wall particularly at young ages are at markedly increased risk of breast cancer as are certain other patients with inherited syndromes such as Li-Fraumeni, Cowden s Syndrome and others. So when we look at the entire picture of breast cancer the majority of breast cancer is considered sporadic, illustrated in red in this pie graph and very little breast cancer is what we consider strongly inherited. You can see that the yellow is related to yet undiscovered genes and the BRCA mutation carriers are illustrated in orange and green. And then we have a piece of the pie graph that is considered familial. But again the majority of breast cancer is sporadic and not strongly inherited.

3 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 3 So when we look at risk in BRCA mutation carriers who are amongst the highest risk patients we see, the risk varies by whether they are BRCA 1 or BRCA 2. In general BRCA 1 patients have higher risks than BRCA 2 patients, and this publication illustrated that risk according to their current age and by decade of years obtained. You can see that a BRCA 1 patient who is currently 20 years of age has a 44% risk of getting breast cancer by the time she is 60. In comparison the BRCA 2 carrier s risk in a similar situation is 35%. This illustration is often helpful for patients to see their risk according to decade because when you quote them their lifetime risk, which is anywhere from 50 to 80% that number is often overwhelming and it s more meaningful for them sometimes to see the data illustrated in this way. So what about those patients who do not have a mutation or who are not defined to have greater than 20% lifetime risk based on a model that takes into account age of affected family members? Well those patients fall more into a moderate risk category and articulating risk to those patients is often even more challenging. They often are the people who have a personal history of breast cancer themselves or other high risk pathologies such as DCIS, LCIS, atypia or atypical lobular hyperplasia, and also those patients with extremely dense breast tissue. The Gail Model gives us one tool to clarify risk for these patients. It s an online risk prediction model that you can go to and input the woman s age, the time of her first menstrual period, how old she was with the birth of her first child and how many first degree relatives she has affected by breast cancer. It also takes into account whether the person has had a breast biopsy, how many biopsies she has had and whether at least one of those biopsies revealed atypia. It also incorporates

4 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 4 race. The problem with the Gail Model again is that it does not incorporate age of first degree relatives, so it gives you the same risk whether your mother was 65 with her first breast cancer or whether she was 40. So no one risk prediction model is perfect for articulating risk for these moderate risk patients. We know in these patients that certain pathologic diagnoses significantly increase the risk of breast cancer such as ADH, ALH, LCIS and borderline DCIS or severe atypical ductal hyperplasia, however it is not clear from the literature how much they increase risk due to very conflicting papers on this topic. Recently however at the recent San Antonio Breast Cancer Symposium in 2011 a group from Mass General presented a study that aimed to clarify the risk of breast cancer by each one of these diagnoses and then evaluate the effectiveness of preventive therapy in these patients. What they found was that there was no significant difference amongst these four high risk pathology in terms of their 10 year risk of breast cancer, they all increased the risk of breast cancer by a similar amount. Initially at the 5 year analysis it appeared that perhaps ADH was slightly lower risk than the other three high risk pathologies, but at the 10 year analysis that difference was no longer statistically significant. So in general for these four high risk pathologies the 10 year risk of breast cancer ranged from 17 to 26% and there was no statistically significant difference amongst them. These results were somewhat surprising to us because classically we have always considered borderline DCIS and LCIS to be higher risk than the atypias. They next went on to look at the role of preventive therapy in these patients and they saw that in each high risk pathology subtype the drop in breast cancer risk occurred regardless of the type of the lesion. Preventive therapy for all of the

5 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 5 atypia types significantly reduced the breast cancer risk at both 5 and 10 years by 50 and 66% respectively. The next area that is under active investigation as an increased risk factor for breast cancer is breast density. We know that variations in breast density are associated with up to a 4 or 5-fold difference in risk of breast cancer in the literature, unlike many other breast cancer risk factors breast density is modifiable which is an important point. In a nested case control study of the International Breast Cancer Intervention Study, often referred to as IBS-1, this was a randomized prevention trial of Tamoxifen versus placebo, in univariate analysis aside from history of atypia or LCIS mammographic breast density was the single most important baseline factor for predicting breast cancer risk. The mean breast density at entry was 51% in case subjects versus 44% in control subjects, a difference that was statistically significant. Moreover in the Tamoxifen arm almost half of the women had over a 10% reduction in breast cancer risk and I m sorry, in breast density and they had a 63% reduction in breast cancer risk. The Tamoxifen users who did have that 10% reduction in breast density had no who did not have that 10% reduction in breast density had no risk reduction. So in conclusion, the 12 to 18 month change in breast density seemed to be an excellent predictor of response to Tamoxifen in this study, and there was a suggestion that women who had little or no reduction in their breast density on Tamoxifen may not be deriving the benefit from Tamoxifen and possibly should consider alternative risk reducing strategies. However these findings do need confirmation in a separate study but they are interesting and compelling.

6 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 6 So what are our options for women at increased risk of breast cancer? We can either screen them in a more enhanced way, we can consider prophylactic surgeries, we can consider pharmacologic preventive strategies and lifestyle changes. Prophylactic surgery for breast cancer is very effective, it generally is reserved for those patients who have a BRCA 1 or 2 mutation and there was an article in JAMA in 2010 that was a prospective cohort study of almost 2500 patients who had these two mutations, the median follow-up was over 3 years and in patients who underwent prophylactic bilateral mastectomies there were actually zero breast cancer events seen in those 3 ½ year time period. So there was essentially 100% risk reduction, albeit at a fairly short time of follow-up, but very, very effective strategy. In addition what was really interesting about this study was that bilateral salpingo oophorectomy also significantly reduced the risk of breast cancer in both BRCA 1 and 2 mutation carriers. The effect was a 37% risk reduction in BRCA 1 mutation carriers, and a 64% risk reduction in BRCA 2 mutation carriers. In all patients there was a significant reduction in all cause mortality by 63%. So in terms of BRCA 1 and 2 mutation carriers this is one of the most effective things we can do for them is to consider prophylactic surgeries, even if they are not ready to undergo prophylactic mastectomies there was a reduction in all cause mortality by the use of bilateral salpingo oophorectomy by 63%. I m next going to talk a little bit about preventive therapy. In the early adjuvant trials in breast cancer it was noted that Tamoxifen, which is a selective estrogen receptor modulator, decreased rates

7 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 7 of contralateral breast cancer. And that sort of heralded its potential as a preventive agent. In fact in the most recent EBCTCG meta analysis update on the use of adjuvant Tamoxifen which included over 20,000 women, Tamoxifen reduced contralateral breast cancer risk by 38% independent of age in a highly statistically significant way. So with that background four Tamoxifen prevention studies were initiated, the two largest of these were the NSABP Trial which was referred to as the Breast Cancer Prevention Trial, or the P1 Study and the IBS-1, which I ve already mentioned. Both of these trials demonstrated that in comparison to placebo Tamoxifen reduced the risk of breast cancer in high risk patients by 50%. So to just look at the P1 Study, the first of those two trials, again the reduction in breast cancer risk in comparison to placebo was almost 50%, highly statistically significant, it was seen in women of all age groups and at all levels of breast cancer risk. It also reduced the incidence of noninvasive breast cancer by 50% as well, and the rates of osteoporotic fractures were lower in the Tamoxifen group. The risks of Tamoxifen included endometrial cancer, thromboembolic events and cataracts. So based on that study by the NSABP the suggested candidates for Tamoxifen were those patients who had a favorable benefit to risk ratio and they articulated that as any patient with a history of DCIS, LCIS, atypical hyperplasia, high risk women who were between the age of 35 and 50 and that was considered a Gail Score over the level of 1.7% risk in the next 5 years, or high risk women over the age of 50 who had had a hysterectomy.

8 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 8 The next very large prevention trial was the STAR Trial or the P2 Study. It also showed it was a randomized clinical trial of high risk postmenopausal women only of Tamoxifen versus Raloxifene for 5 years. It initially appeared in the STAR Trial that Raloxifene was as effective as Tamoxifen in the prevention of primary invasive breast cancer, but it appeared that Raloxifene looked less effective than Tamoxifen in the prevention of noninvasive breast cancer. And compared to Tamoxifen however Raloxifene use resulted in fewer thromboembolic events, fewer endometrial cancers and fewer cataracts. We now have long term follow-up of the STAR Trial that shows us that Raloxifene is less efficacious than Tamoxifen. At 81 months of follow-up Raloxifene is generally 76% as effective at reduce as effective as Tamoxifen for reducing risk of invasive breast cancer, and 78% as effective for preinvasive breast cancer. This translates into a reduction in invasive breast cancers versus placebo of 38% for Raloxifene and 50% for Tamoxifen. In addition the relative safety profile of Raloxifene has improved over time, there is now a statistically significant lower rate of uterine cancer and an ongoing significant difference in the rate of thromboembolic events with Raloxifene in comparison to Tamoxifen. We have other data regarding long term use of SERMs for primary prevention in breast cancer, in fact there has been a 10 year overview of 7 placebo controlled trials of SERMs, 4 of those were Tamoxifen trials, 2 of those were Raloxifene trials and 1 was with Lasofoxifene, and they were all for breast cancer preventive therapy. In sum these trials included over 54,000 patients and across the trials there was a 38% reduction in invasive breast cancer risk, which was very statistically

9 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 9 significant. The greatest risk reduction occurred in the first 5 years of follow-up but there was an additional 29% risk reduction for all invasive breast cancers that was seen in years 5 through 10 as well. When the analysis was restricted to ER positive cancers the incidence was decreased by 50%. In addition the risk of endometrial cancer was only increased in the Tamoxifen trials and was only seen in years 0 through 5, not in years 5 through 10. There was an increased risk of pulmonary embolus or deep venous or retinal vein thrombosis seen with all SERMs, but the absolute risk was quite minimal with an odds ratio of Conversely the risk of fracture was decreased with the use of SERM preventive therapy by 11%. However there is still a very low rate of prescribing SERMs for breast cancer preventive purposes due to cited reasons in the literature such as lack of time for counseling, concern over side effects and uncertainty about the risk benefit ratio. There is definitely a need for clarity regarding the risk benefit ratio of SERMs to patients and healthcare providers. There is evidence of ongoing and consistent reduction in breast cancer risk with SERMs that extends beyond the active treatment period, which is years 0 through 5 for at least 10 years of follow-up. This is coupled with a low potential for adverse events that does not extend beyond the active treatment phase. In fact in the breast cancer prevention trials and the IBS-1 Study in patients under the age of 50 there was no increased risk of endometrial cancer or pulmonary embolism on Tamoxifen versus placebo. It is basically an older woman s phenomenon these two risks. There was a higher risk of DVT in women under the age of 50, but again that absolute risk was small and it was only seen during the active treatment phase and that risk resolved after treatment.

10 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 10 In addition recently Dr. Friedman and colleagues published in JCO in 2011 an easy tool that the average practitioner can use to estimate the benefit risk of preventive therapy in postmenopausal women. This graph is one example of the graphs included in that publication, you can estimate for the individual patient according to their 5 year risk of invasive breast cancer on the left side and according to whether they have a uterus or do not have a uterus the benefit risk of Tamoxifen and Raloxifene in comparison to a placebo. The graph shows you that in the blue there is strong evidence that the benefits outweigh the risk and that is seen down here in the bright blue boxes, the yellow boxes show that there is moderate evidence of benefits outweighing the risk and the gray shows that the benefits do not outweigh the risk. You can see that in this particular slide there is a lot of gray because these women are postmenopausal and they still have a uterus, so the assessment is that likely Tamoxifen benefit is not going to outweigh the risk for the majority of these postmenopausal women. When you shift over to the Raloxifene side however the benefit risk ratio improves. And when you move to women without a uterus it greatly improves, even with Tamoxifen because remember Tamoxifen is more efficacious than Raloxifene. And in addition there are also two more graphs that I did not include here according to race of your patient that you can take into account as well. These are the graphs for Caucasian women that I m showing you right now. Moreover we now have a third prevention option with Aromatase Inhibitors based on the publication in the New England Journal of Medicine just this past year showing that Exemestane in comparison

11 FOR HIGH RISK PATIENTS, RACHEL CATHERINE JANKOWITZ, MD 11 to placebo decreased the risk of breast cancer by over 60% with very little difference in comparison to placebo in side effect profile. So this not yet an FDA approved preventive strategy but it certainly seems to be an effective and reasonable one if patients are interested in Aromatase Inhibitor therapy for a preventive therapy. Finally I do always stress in our high risk clinic lifestyle changes as a means to decrease risk of breast cancer. And the things that I stress are exercise, avoidance of postmenopausal weight gain and alcohol moderation as the three most powerful things they could do non-medically to lower their risk of breast cancer. So in conclusion we need to try to continue to decrease the incidence of breast cancer as the most common cancer affecting American women. We need to emphasize the favorable risk benefit ratio of current preventive strategies for appropriate patients and we need to continue to do research to identify novel agents with low toxicity profiles that we could use for primary prevention of breast cancer. Thank you.

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