MANAGEMENT OF OVARIAN CANCER RISK IN WOMEN WITH BRCA 1/2 MUTATIONS, KRISTEN K. ZORN, MD 1

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1 MUTATIONS, KRISTEN K. ZORN, MD 1 I m going to be discussing with you today the management of ovarian cancer risk in women with BRCA 1 and 2 mutations. I have no relevant financial relationships to disclose and our objectives today are going to be describe the risk for ovarian, fallopian tube and peritoneal cancer in women with BRCA mutations, to review the current recommendations for genetic counselling and testing in women with these cancers and to discuss the current options that are available for prevention and early diagnosis of the cancers. In general we have to keep in mind that ovarian cancer is a rare cancer, about 1 in 70 American women gets ovarian cancer in her lifetime, this compares to 1 in 8 American women who get breast cancer in their lifetime, so almost a whole power of 10 difference there in how common they are. And if you think better in percentages than you do in fractions, this means that there is a baseline risk of ovarian cancer in American women of approximately 1.5% versus a 12.5% lifetime risk for breast cancer in American women. So we start to pay attention in families that have cases of ovarian cancer. If you have one first degree relative, again a first degree relative is a mother, a sister or a daughter with ovarian cancer that doubles your risk of developing ovarian cancer, which sounds awful if you say it that way, but when we go back to the absolute numbers that we realize that that means approximately a 1 in 35 lifetime risk or an approximate 3% lifetime risk. So even having that one first degree relative with cancer it s still a relatively low lifetime risk for ovarian cancer and again if we try to put that in perspective with some other cancers I think we would all agree that pancreatic cancer is also a rare cancer and it s

2 MUTATIONS, KRISTEN K. ZORN, MD 2 really the same approximate lifetime risk as ovarian cancer is, whereas colon cancer and prostate cancer are both much more common cancers. So in families that are known to carry BRCA 1 and 2 mutations we know that this has a significant impact on that relatively low lifetime risk of ovarian cancer that the general population has. And when I say ovarian cancer with BRCA mutations I m actually including fallopian tube cancer and peritoneal cancer risk with that. These cancers look the same, are diagnosed similarly and are managed similarly so we tend to group them together and call them under the name of ovarian cancer but we do need to specifically remember that fallopian tube and peritoneal cancer are both risks that go along with BRCA 1 and 2 mutations. And if try to quantify those risks with BRCA 1 mutations the literature has a range of risks but the upper limit of risk is approximately 35 to 46% in the woman s lifetime, I generally round that off to about a 40% lifetime risk across most of the literature. For BRCA 2 mutation carriers the lifetime risk for ovarian, fallopian tube and peritoneal cancer is somewhat lower but it s still markedly above the baseline population risk, and is in the 13 to 23% range. As you ll remember from the previous lectures this is a pattern of autosomal dominant inheritance. I think it s important to reiterate that when we are talking about breast and ovarian cancer because it is so easy to forget the paternal lineage and we need to remember that as in this diagram the father is the one who carries the mutation, he has a 50/50 chance of passing it to his children so he can have

3 MUTATIONS, KRISTEN K. ZORN, MD 3 an affected son as well as an affected daughter. But we just have to remember that BRCA mutations can come from the paternal lineage as well as the maternal lineage. And we also have to keep in mind certain caveats when we are thinking about family histories. About 20 to 30% of women who have breast cancer have at least one relative who also had breast cancer, but only 5 to 10% of all hereditary of all breast cancer is hereditary in nature, so breast cancer is a common cancer where many families will have sporadic cases when it s not an inherited situation. We also have to remember that there are other syndromes that can involve either breast or gynecologic cancer, so the most common that we are going to encounter in our daily practices is HNPCC or Lynch Syndrome which can involve colon cancer, endometrial cancer and ovarian cancer, Li-Fraumeni Syndrome which can involve breast cancer and sarcomas and Cowden Syndrome which can involve breast cancer and hamartomas. I would stress the importance of genetic counselors in helping to detect these other cancer syndromes. We in our practice here always involve genetic counselors before we consider genetic testing, it s always done through the Genetic Counseling Service because they simply are the experts in managing these issues. Other caveats that we have to keep in mind about family history are that the same mutation can behave differently in different families and in different members of the same family. We call that variable expressivity and incomplete penetrance, so we can never exactly predict what the phenotype in a particular person is going to be of their gene mutation. We also have a lot of families that don t know much about their history. In the gynecologic world this is a particular issue of the cancer down there phenomenon where they know that grandmother had something low in her pelvis but

4 MUTATIONS, KRISTEN K. ZORN, MD 4 they don t know if it was ovarian, cervical, uterine, fallopian tube, peritoneal, colon, bladder or some other cancer that was metastatic to one of those sites. And so the implications for genetic inheritance also obviously vary quite a bit depending on what was really happening. As has also been discussed today we now know that there are many families that have a small kindred or that have relatively few women in a kindred and so it s hard for those families to inform us about their breast and ovarian cancer risk. We call those small kindreds that they ve been defined in the literature as families with 2 or fewer first or second degree female relatives who have reached the age of 45 on both the paternal and maternal sides; so families that don t have a lot of women who have lived to an old enough age to see their breast cancer and ovarian cancer risk express itself can be problematic. We do have recommendations that were published in 2005 from the U.S. Preventative Services Taskforce regarding recommendations for genetic testing. Their testing guidelines are stratified based on the presence of Ashkenazi Jewish ancestry or not. Those who are not of Ashkenazi Jewish decent are seen in the left column here and it involves having significantly more family history of breast cancer which is abbreviated BC, ovarian cancer which is abbreviated OC and amongst different family members either first degree relatives or second degree relatives as you can see explained here. However if there is a history of Ashkenazi Jewish ancestry the column on the right hand side is obviously much shorter because that inherently increases the risk of carrying a germ line mutation

5 MUTATIONS, KRISTEN K. ZORN, MD 5 and so the requirements for family history are much less stringent. However I would argue that these guidelines have now been sort of usurped by the presence of new guidelines from the NCCN and these are available on the NCCN website and now recommend that anyone, any woman with a personal history of epithelial, ovarian, fallopian tube or primary peritoneal cancer is recommended to undergo genetic counseling and testing. So there is no longer from the NCCN standpoint a requirement for family history of breast or ovarian cancer. It s not dependent on being of Ashkenazi Jewish decent and it s not dependent on having specific tumor pathology. As many of you know, serous ovarian cancer, fallopian tube cancer and peritoneal cancer is the one that is most associated with BRCA mutations but it is not the only histology that can be associated with them. So none of those things, family history, ethnicity or a specific tumor histologic type are required to recommend that a woman undergo genetic counseling and testing. So I think it s incumbent upon us who work in this field to really help encourage this process of genetic counseling and testing. And strategies that can help with that is to make family history a routine part of our intake of our patients so that we are very aware of a patient s family history and that that is updated over time. As we all know, family histories change as family members get older and develop cancers so it needs to be something that we review on an annual basis so that now a family history that may not have seemed ominous in the past can be more worrisome and can trigger that thought process of referral for genetic testing. We also need to introduce the concept of the testing at an initial visit early in the process, maybe if a patient or her family member is newly diagnosed with cancer that s not something that they are

6 MUTATIONS, KRISTEN K. ZORN, MD 6 ready to pursue right away but we need to at least introduce the concept so that they know that it s part of what we consider our fundamental care of this problem and maybe can review it, return to it at a later date when it s a less stressful time for them. I think it s also important that women who have breast lesions that are undergoing evaluation actively think about their family history and whether that means that there is a need for genetic testing and counseling because we know from past experience that many women with BRCA mutations have already undergone previous biopsies due to abnormalities on their mammograms. So we need to be thinking about patients who may be still in a premalignant phase to try to find them as early as possible. And I think it s also very helpful to have family members present with the patient at the genetic counseling visit. This helps to get more accurate family histories sometimes and it also provides a support mechanism so that everybody is hearing what the counseling is and can help support family members as they are making individual decisions about whether to undergo testing or not. So when we think about screening for ovarian cancer now in somebody that we do feel like is at increased risk for ovarian cancer unfortunately the story in ovarian cancer is not as hopeful as it is in breast cancer. As you probably know, we do not recommend screening in the general population for ovarian cancer at this time, we have a number of various studies, the most recent and broadest study is updates from the Prostate, Lung Cancer and Ovarian Cancer Trial, the PLCO Trial that have shown no improvement in survival in women who undergo routine ultrasound and CA-125 screening when they are at the general population risk for ovarian cancer. Unfortunately we also can t show any survival benefit in women who are at increased risk for ovarian cancer based on known BRCA mutations or strong family history. We do have recommendations for CA-125 and pelvic ultrasound

7 MUTATIONS, KRISTEN K. ZORN, MD 7 every 6 to 12 months in the high risk population, but I characterize this as because it s simply the best that we can do right now, not again because it s ever been proven to improve survival. So we need to think about prevention methods for ovarian cancer then, we do actually have one of the most effective prevention strategies ever known but it has shown benefit for ovarian cancer in the form of birth control pills. This is often a poorly understood phenomenon but it s been documented over and over in the years, as you can see from the citations here. There s an approximate 50% risk reduction for ovarian cancer associated with 5 years of birth control pill use. This has been documented primarily in the general population. It s been shown that ever having used birth control pills is protective, it doesn t have to just be current use in order to see that benefit and we do have some literature that suggests that the benefit may extend to mutation carriers. We obviously don t have as much information about that population, and I don t know that this has been completely assessed as of yet, but it has some possible benefit in mutation carriers as well. The downside of course to birth control pills is the persistent controversy over whether they are associated with an increased risk of breast cancer. I think in the BRCA mutation population what we have to keep in mind is that they already have such a drastically increased lifetime risk for breast cancer that it s hard to imagine that the possible slight increased risk from birth control pill use is ultimately going to make a big difference for them, but it is a factor that many mutation carriers are concerned about. We also know that other gynecologic issues such as tubal ligation and hysterectomy can decrease the risk for ovarian and fallopian tube cancer, this has been documented

8 MUTATIONS, KRISTEN K. ZORN, MD 8 to be approximate 30 to 50% reduction in risk. We are not completely clear about the mechanism for this but it does seem to extend to the high risk population as well. But ultimately the most effective prevention strategy is to simply surgical remove the tubes and ovaries. This needs to be a bilateral salpingo-oophorectomy. It is critically important to remove the fallopian tubes as well as the ovaries. In the early years of risk reducing surgery, the importance of the fallopian tube was not understood and we unfortunately had relatively high rates of subsequent fallopian and peritoneal cancer diagnoses, but now that we are routinely removing the ovaries and the fallopian tubes it s up to a 95% risk reduction associated with the surgery. There is a small residual risk for peritoneal cancer because we simply can t remove the entire peritoneum to afford risk reduction there, but that risk is probably quite low and under 5%. The bilateral salpingo-oophorectomy can also be protective against breast cancer risk in the premenopausal population with an approximate 50% risk reduction for breast cancer. The main issue with bilateral salpingo-oophorectomy aside from it being an invasive surgery is that it is associated obviously with premature menopause, and that s critically important in this population of women, many of whom are looking at doing this surgery in their 30s and 40s, some 10 to 20 years before they would go through a natural menopause. So I think it s important as we are asking women to consider salpingo-oophorectomy after age 35 or once child bearing is complete to really think about the risk over time. We can break this risk down for both breast cancer and ovarian cancer and by mutation status based on BRCA 1 or BRCA 2 mutations, and look at that risk over time. and I think what s important to take away from this is that in the decade of the 20s the risk of ovarian

9 MUTATIONS, KRISTEN K. ZORN, MD 9 cancer is overall quite low. This does increase in the 30s, but it is still quite low overall and really only starts to drastically increase later in life. This can also be seen by the fact that the most common age of diagnosis in BRCA 1 mutation carriers of ovarian cancer is still in the 50s, but we do see cases in the 40s and late 30s, often enough that that has led to the guideline recommendation for 35 or beyond being the ideal time for risk reducing surgery. In BRCA 2 mutation carriers again remember that they have a lower overall risk for developing ovarian cancer and so these numbers are lower as well. Again the decade of the 20s is not critical to be thinking about a prophylactic oophorectomy because that s not simply when we are seeing the increased risk. Even the decade of the 30s is a relatively low decade, but as we get into the 40s and 50s we now start to see increases in risk above the baseline population and that s when we start to recommend that prophylactic surgery be performed. In BRCA 2 mutation carriers the average onset of ovarian cancer is actually still in the early 60s, not that different from the sporadic population but again we will still have families where individual people will develop their cancer much younger. So that s why we still have to recommend the idea of the guidelines being to get the tubes and ovaries out before we typically see the earliest onset of cancer to try to avoid that diagnosis. With ovarian cancer in, even in women who are going undergoing ultrasound and CA-125 screening the average stage of diagnosis is still Stage 3 where we have only a 20 to 30% chance of curing the cancer. So for most of us that s simply not an acceptable risk and it s why we have to fall back so consistently on asking women to consider risk reducing surgery.

10 MUTATIONS, KRISTEN K. ZORN, MD 10 So as we are doing that risk reducing surgery as we ve reviewed we are putting that patient into menopause, and this is one of the critical issues for many patients as to how, what are going to be my options for managing menopause. We know from abundant literature that the symptoms of menopause are primarily those of estrogen withdrawal and that estrogen is simply the most effective treatment for the patient who is significantly symptomatic of menopause. Many women who are in the prophylactic situation may well be candidates for hormone replacement therapy, but this has to be carefully considered. The primary issue with whether she s already had a diagnosis of breast cancer, and if she has had a breast cancer what was the hormone receptor status. I think this requires a careful conversation with the patient s medical oncologist as to based on the presence of absence of estrogen and progesterone receptors does that medical oncologist feel that the patient would be a candidate for hormone replacement. It s also important to consider whether the patient has had either a prior hysterectomy or is planning to undergo hysterectomy at the time of her risk reducing salpingo-oophorectomy. A hysterectomy is not required from a BRCA standpoint since there is not an increased risk for cervical and uterine cancer but many women either have undergone one previously or choose to undergo one. If the uterus is going to remain in place however the patient does need progestin as well as estrogen, this is because unopposed estrogen will cause hyperplasia and even malignancy in a subset of women undergoing hormone replacement. We also have made significant advances in hormone replacement therapy where the doses have been lowered, and the lowest possible does is typically what we recommend. I ask the women consider

11 MUTATIONS, KRISTEN K. ZORN, MD 11 hormone replacement and so they would have typically gone through a natural menopause which the average age in the United States is currently 51. So this is not lifelong hormone replacement therapy, this is simply trying to help replace the woman up to the point where she would have gone through a natural menopause. The goal of this of course is to help not just with the obvious side effects of menopause such as hot flashes, night sweats, sexual changes, but also to help with things like early onset osteoporosis and early onset cardiovascular disease. The last thing we want for these patients is to drastically reduce their risk of developing a cancer but then to increase their risk of other life threatening conditions such as cardiovascular disease. If hormones are not an option for a particular patient, nonhormonal medications can provide some benefit, they are not as effective as estrogen but they can help some patients. Many hospitals have specific clinics that help to address menopausal symptom management and I strongly recommend coordinating care with one of those. And in addition some non-medicinal interventions have actually shown benefits such as exercise, meditation, acupuncture and weight loss. So I do think menopause alone should not be the only factor in whether women are choosing to undergo prophylactic surgery because typically the symptoms can be managed. And the important issue of the timing of prophylactic surgery comes up because many of these women are being faced with decisions about prophylactic mastectomy and prophylactic salpingooophorectomy at the same time. So in a patient who knows that she wants to pursue both procedures I recommend that the prophylactic mastectomy goes first. The reason for this is that the patient is at a higher risk for breast cancer due to the presence of the BRCA mutation and the breast cancer tends

12 MUTATIONS, KRISTEN K. ZORN, MD 12 to happen at a younger age. In addition, undergoing prophylactic mastectomy doesn t interfere with childbearing so a patient could continue to complete her family after having a prophylactic mastectomy as long as breast feeding wasn t a particular concern for her. We then emphasize prophylactic salpingo-oophorectomy after age 35 or once childbearing is compete, whichever comes last. Many patients who are wanting to get both procedures done ask questions about whether they can be combined or not. In my experience this usually boils down to the whether they know that they are going to undergo a breast reconstruction. If they are having a simultaneous breast reconstruction, which is always the preference of the plastic surgeons because it typically gives the best cosmetic result, generally the pelvic surgery can t be combined just because of the length of the procedure in the OR that day, although there are exceptions that need to be discussed with the breast and the plastic surgeon, however that s usually only in the case that the patient is having laparoscopic bilateral salpingo-oophorectomy. If she is having a hysterectomy along with her salpingo-oophorectomy generally it won t be combined with the mastectomy or reconstruction due to concerns of the theoretical increased risk for infection. So these are critical questions that need to be addressed with the patient as she mapping out the course that she wants to take with her cancer prevention and management strategies.

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