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PINN POINTS ON WOMEN'S HEALTH

 

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PODCAST ON TUESDAY, APRIL 24, 2007

 

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               P-R-O-C-E-E-D-I-N-G-S

            ANNOUNCER:  From the National Institutes of Health in Bethesda, Maryland, America's premier medical research agency, this is Pinn Points on Women's Health with Dr. Vivian Pinn, director of the Office of Research on Women's Health.  Now here's Dr. Pinn.

            DR. PINN:  Welcome to our episode of Pinpoint on Women's Health.  Each month on this podcast, we'll take a look at the latest developments in the area of women's health and the medical research that affects our lives.

            For this podcast, I'm happy to welcome two guests who will tell us about breast cancer, a topic that is always of interest to women and to men and about which there has been much in the news recently.

            Joining us today are Dr. Worder McCaskill-Stevens, medical oncologist and program director in the Division of Cancer Prevention of the National Cancer Institute here, at the NIH, and also joining us is Dr. Marisa Corday, a staff clinician in the Clinical Genetics Branch, Division of Cancer, Epidemiology and Genetic, at the National Cancer Institute, also here at the NIH.

            But first, some hot flashes from the world of women's health research, coming up in 60 seconds, when we continue with Pinpoint on Women's Health.

            [Announcements]

            DR. PINN:  First flash, and something of importance, is to recognize that National Women's Health Week is going to be coming very soon.  Every year, the week following Mother's Day has been designated as National Women's Health Week.  It is a week to celebrate and to think about women's health and to think about ourselves.

            This year, National Women's Health Week will begin on Mother's Day, May 13, 2007, and the theme for this year's National Women's Health Week is Care for the Care-Giver, Woman as the Portal to Family Health.

            We focus on women and we focus on how women take care of members of their family.  Now we really want to focus on women taking care of ourselves as we take care of everyone else and that's going to be the theme for us here at the National Institutes of Health.  At your own location, in your own community, hopefully, you will be doing something to celebrate good health and wellness for women.

            I want to mention to you a recent Senate hearing that was chaired by Senator Gordon Smith of Oregon.  At this hearing which was focusing on hormone therapy in post-menopausal women, most of the testimony focused on issues related to the use of so-called bioidentical hormones, what that really means, and the fact that most of what is being utilized for women to take, that are called bioidentical hormones, are really not standardized and not regulated.

            This we think is a very interesting development, looking at both regulatory issues as well as scientific issues, as well as looking at interest of issue for women's health.  What do hormones in the menopausal years mean in terms of prevention or protection of women's lives, or are they really preventive mechanisms and can they really preserve health and youth?  We will be having a discussion on that at our next podcast, so stay tuned for that when we return with our next podcast in this series.

            There's been a lot of attention to obesity and especially obesity as it relates to women.  In the United States, women are more likely to be severely obese than similarly-aged men.  A recent paper published in the Journal of Women's Health by Dr. Joanne Manson from the Peter Bent Brigham Hospital in Boston, and her colleagues, goes into some detail about looking at the divergent figures that have been published about how many women actually suffer excess deaths or what is the magnitude of an increase in deaths due to obesity for women.

            They come to some really interesting conclusions but their bottom line is that we must recognize that certainly, obesity is a major contributor to not only mortality for women but also morbidity, meaning that obesity contributes to the burden of disease caused by obesity-related conditions such as diabetes, high blood pressure, cardiovascular disease, osteoarthritis and cancer.

            Their bottom line is, and I think this is important for all of us to recognize, that obesity is something we need to avoid, obesity is something we need to address, and that the research community is going to have to continue to help us learn more about obesity, how to prevent it and how to prevent is effects.

            We'll have more updates in the next podcast because there are so many things that are coming out in the literature and in the newspaper, and in the media, related to women's health.

            And coming up next our visit with our guests for a discussion about breast cancer.  We'll be right back with Pinpoint on Women's Health.

            [Announcements]

            DR. PINN:  Welcome back to Pinpoint on Women's Health and our discussion on breast cancer, and I'm delighted to have two of the experts from the National Cancer Institute here with us, and I'd like to start by asking Dr. Corday to comment on the fact that we've seen a lot of news about breast cancer recently.

            We know that breast cancer is one of the major areas of concern that women have about their health, one of the major fears that women have about causes of their death, or potential causes of their death.

            Tell us, Dr. Corday, where are we now in terms of the incidence of breast cancer.  Is it rising?  Is it decreasing?  Can we offer more help?  And then we'll come back and talk about why there is reason for hope for women today.

            DR. CORDAY:  Well, thank you, Dr. Pinn.  It's a pleasure to be here.  Let me start by saying that breast cancer is the most common malignancy in the U.S. in women and it's the second most common cause of cancer death in women.

            However, there is some goods news on the horizon and that is from a recently published report, we know that the incidence of breast cancer in this country actually decreased in the year 2003.

            The decline in breast cancer incidents reported, in 2003, tracked time-wise with a decline in the use of menopausal hormone therapy, which fell by about 38 percent toward the end of 2002.

            There was a leveling off of the rate of menopausal hormone replacement therapy used in 2004, which coincides with a leveling off of decrease in breast cancer incidents.

            DR. PINN:  So let's just focus on that.  So our good news for women is one, there appear to be fewer new breast cancers being detected or arising.

            Do we think that's a true figure?

            DR. CORDAY:  So data suggests that it is a true figure.  Data from CERE, and also data that has now been published from the American Cancer Society, both saw this decrease.

            DR. PINN:  And we think that this decrease can be attributed somewhat, or to some degree, because of a decline in the use of hormone therapy in post-menopausal women?

            DR. CORDAY:  Yes.  The decline was seen in women age 50 or older, and was seen primarily in estrogen receptor positive tumors, which are the tumors that are thought to be driven by hormones in the body.

            So looking at the data together, this does suggest that menopausal hormone therapy may have played a role.

            DR. PINN:  Well, that's really exciting news, to think that we may be seeing a leveling off in the incidence of breast cancer and that perhaps we may have identified one of the causes or one of the contributors to the development of breast cancer which is so common in women in this country.

            Well, with that good news, then what kind of news do we have, good or bad, or what are some of the recent developments from research related to how to treat breast cancer?

            Dr. Macaskill-Stevens?

            DR. MACASKILL-STEVENS:  Thank you, Dr. Pinn, for having me. 

            One of the concerns that women who have a diagnosis of breast cancer have is that they're concerned about developing breast cancer in the other breast, in other words, the contralateral breasts.  Women who have a diagnosis of breast cancer are at significant risk of developing breast cancer in the other breast.  And to date, women would undergo surveillance, they would see their oncologist and have screening as per their age.

            We know some risk factors that predict the risk of recurrence but we don't know all of those risk factors.  So we now have a study that was published in the New England Journal of Medicine, looking at the MRI and its ability to complement mammography.

            What--this study looked at women who had a diagnosis of breast cancer, who had a normal mammogram and who had a normal clinical exam, and these data, from 969 women, showed that 3.1 percent of those women had cancers diagnosed in the other breast.

            Of the 969 women who were included in the MRI study, there were 30 cancers, 18 of those cancers were invasive and 12 were non- invasive cancers.

            I think the significance of this study is that women now can have some impact upon treatment.  Previously, if a woman had a diagnosis of breast cancer and her tumor was hormonally-dependent, that woman would receive hormonal therapy, and we now have data from over 20 years of follow-up now, that suggests that women who take hormone therapy, whose tumors are endocrine responsive, get a reduction in their risk of contralateral breast cancer by 50 percent.

            But these data are significant in that we now have findings at the time of the diagnosis.  So some of the worry that a woman would have about developing breast cancer in the future are now certainly alleviated by these data.

            DR. PINN:  Let me just ask you to clarify one thing.  We've been talking about hormonal therapy in post-menopausal women and you're referring to hormonal therapy and breast cancer.  Could you clarify those issues.

            DR. MACASKILL-STEVENS:  Yes.  When I refer to hormonally-dependent breast cancer, I mean breast cancer that has receptors on those cancer tumors that respond to anti-hormonal therapy.  So I'm talking about hormonal agents that have been around since the mid '70s, that are used for the treatment of breast cancer, not for treating of symptoms of menopause and other factors.

            DR. PINN:  Thank you.  I just think, because we talk so much about hormones, we should clarify that for our listeners, a very, very important point, and actually, the importance of being able to detect the malignancies in the opposite breast by MRI is...?

            DR. MACASKILL-STEVENS:  That women who have a negative MRI at the time of diagnosis can have a relative amount of assurance that she will not develop a contralateral breast cancer in the near future.  That does not mean that she is not at risk later, but certainly, in the immediate future she does not, she can have less worry about developing that cancer.

            DR. PINN:  And that's very important because so many women who have breast cancer worry about whether or not they will develop a lesion in their other breast.  That means that we are making progress based through research and our documentation, through our data, about how to better detect as well as to manage breast cancer.

            Well, what about on the treatment front?  Are we having any new advances related to treatment of breast cancer?

            Dr. Corday?

            DR. CORDAY:  Yes, Dr. Pinn, there have been some recent advances in the therapy of breast cancer.  The audience may have heard of a new drug called Lipatinef which was recently FDA-approved for the treatment of HER2 positive breast cancer.

            About 20 to 30 percent of breast cancers express a protein on their surface called HER2, and we now have two medications, Lipatinef, this new drug, and a previously-approved drug, Treschusmap, for the treatment of this particular subclass of breast cancer.

            A recent study found that Lipatinef, when used in combination with a chemotherapy agent, Zaloda, increased the time to progression in women with metastatic breast cancer, so breast cancer that has spread to other organs, as compared to using the chemotherapy agent alone.

            DR. PINN:  Well, it seems that we've got good news in that there appears to be a decline and a leveling off of the incidents of breast cancer, we're developing new treatments to help us better be able to treat breast cancer.  We're also getting better ways to be able to help with the prognosis for women who develop breast cancer and better ways to detect breast cancer in the opposite breast.

            But that brings me to another topic that has been in the news recently.

            We had a consensus conference here at NIH some time ago to look at when should mammography start, when should women get their first baseline mammogram, and then at what age should women begin to get their regular mammograms.

            And so some time now we've been looking at the question of, and it's been debated, about women age 40 or under age 50 getting mammograms.

            Recently, there have been some reports in the news related to women and when they should start getting mammograms.

            Could I ask either of you if you'd like to comment on this issue, because it is one of great confusion to women who want to know when should I get my first mammogram, when is it important for me to get my mammogram, and on the other hand, they hear the word in the media about what is cost-effective.  Women are concerned about what is important for protecting their lives.

            So without putting you on the spot, could you comment on this, and I think our bottom line should be, how should women consider this new information that's in the media and how can they make informed decisions.

            DR. MACASKILL-STEVENS:  Well, I think I would just like to comment that the--they did that, where recently, guidelines were recently discussed in the media and were published by the American Cancer Society, specifically address women who are at high risk of developing cancer.  So I think it targets at the population.  I think that the criteria that were listed for women to get MRI screening, I think is very helpful, I think it certainly opens the dialogue for the research, certainly on larger populations, and helping women to understand, to better define the risk population.

            DR. PENN:  Thank you, Dr. Macaskill-Stevens.  But then let's look to the other issue, which is related to breast cancer screening for women in their 40's, which also came from a statement from the American College of Physicians, recommending that perhaps we should have a change in policy.

            Dr. Corday?

            DR. CORDAY:  There was some recent information published in the Annals of Internal Medicine, looking at screening mammography in women age 40 to 49 years of age.  The benefits of screening mammography in women age 50 to 69, in terms of decreasing mortality, have been clear.

            The benefits in the younger age group, those age 40 to 49, have been less clear.  Currently, most organizations do recommend screening mammography in women age 40 to 49, and this has not really changed.  The recent publication in the Annals of Internal Medicine presented a review of the data on screening mammography in women 40 to 49, and basically the outcome of this report was that they suggested a more individualized approach to deciding on screening mammography for these women.

            I think the suggestion is that physicians speak with women in this age group about the risk of false-positives from mammograms, and that women need to understand the implications of having a mammogram in this age group.  But, overall, I don't think that much has changed.

            DR. PENN:  Well, I think probably the closing paragraph of the editorial that was written by Dr. Joanne Elmore and Dr. John Cho of the University of Washington, related to these articles, probably summarizes best what we can say, and I'm going to just quote that, right here.

            They stated: No simple recommendation applies to all women in their 40's.  We must learn to become comfortable with using the art of medicine to translate the existing science.  We must listen carefully to our patients and communicate honestly, the benefits and limitations of our imperfect tests.

            And isn't that what women's health research, or, in fact, research is all about?  We need to get information so that women can make informed decisions.  Nowhere else was that more emphasized than when we were looking at hormone therapy for women in their menopausal years.  So here, we have the same issue coming up again, to provide data and information from research, and asking physicians and nurses, and other health care providers, to be willing to try to explain the inconsistencies in data and the changes in concepts and current policies and standards of practice, so that women can decide for themselves, how they wish to approach their health.

            In the meantime, yes, Dr. Corday?

            DR. CORDAY:  I think the bottom line here is that a patient and a physician should have a relationship in which they can have a discussion about their health, and therefore make the best decisions for an individual.

            DR. PENN:  Well, we don't have time to go into all the details but you both are involved in research and overseeing research, and it's been a very exciting area of research.  We've seen such an expansion of research related to breast cancer, in addition to all the other cancers.  But especially in the area of breast cancer by which women and their physicians, and their nurses, and their families have so much interest.

            So I want to, as we bring this to a close, ask each of you to comment on any new research, any new concepts that you would like to make sure that our audience knows about, or something that is pending, new research that may be starting, that we can look forward to hearing more about.

            So why don't we start with you, Dr. Corday, and then we'll let Dr. Macaskill-Stevens have the last word.

            DR. CORDAY:  One way in which the future of breast cancer research seems to be going is into exploring this concept of personalized medicine, and that is potentially identifying patients who are diagnosed with breast cancer, who would most benefit from the treatments that we currently have to offer them.  There are two tests that have been utilized in terms of trying to help predict whether a woman is at a higher risk of having her breast cancer recur, and therefore would be a patient who would potentially benefit the most from having adjuvant chemotherapy.

            There is a new clinical trial in the U.S. called Tailor RX, in which a new test looking at potentially predicting the risk of breast cancer recurrence is being used to stratify women into three groups, those at high risk or recurrence, those at low risk of recurrence, and those at intermediate risk of recurrence.

            In this trial, women who receive a score that puts them at an intermediate risk of recurrence are randomized, to receive chemotherapy or not receive chemotherapy.

            And hopefully this trial will give us more information on whether we can better predict whose cancers will come back and who benefit from treatment.

            DR. PENN:  Wonderful.  And Dr. Macaskill-Stevens.

            DR. MACASKILL-STEVENS:  We have learned quite a bit from microarray profiling of genes and we talked about targeting therapy for breast cancer patients, but there is one subtype of breast cancer that, at this time, it's very challenging.  However, I think it is a very exciting area for research, and this subtype of breast cancer is called triple negative.

            It means that it is not hormonally responsive.  It means that it does not express the HER2 protein that we have heard about.  So we call this triple negative breast cancer.  It is associated with a poor prognosis, it tends to occur in women who are younger, under the age of forty.  There's a higher incidence of this type of breast cancer among African American and Latino women.  If one looks at five year survival, overall, it has a five year survival of 77 percent as opposed to the 93 percent that we see overall in breast cancer.

            Excitingly, the HER2 is only a member of an epithelial growth factor, a pathway of proteins.  We now know that possibly there are other chemotherapies that might target this particular pathway for this triple negative breast cancer.

            So this is an area that is challenging for oncologists.  Certainly, the 15 percent of women who have triple negative disease are in need of a targeted therapy.  I think this is a very exciting area of research that is ongoing with clinical trials as well as basic science.

            DR. PENN:  And just to back up a bit since we were just talking about some new recommendations, suggesting that perhaps mammography should not--mammography is not a value in women at age 40, or until they're close to age 50, and knowing that this triple negative type of breast cancer occurs mostly in women who are around age 40 or younger.

            Does that mean that that is something of concern for certain women in terms of having screening?  Or is mammography not the way this is most often detected?

            DR. MACASKILL-STEVENS:  this particular subtype is not necessarily specifically diagnosed by mammography.  Clearly, the data from the MRI study that was published did not show a distinction between menopausal status, post-menopausal or pre-menopausal, or density.  I think it is a question that needs to be answered, as to whether diagnosis amongst this particular subtype of breast cancer is more efficacious by MRI.  Certainly an area for future research.

            DR. PENN:  Well I'd like to thank both of you for being with us today to discuss breast cancer.  You've really given us some good information and let us know about the work you're doing and the area in which you are involved, and most of all, I think it offers hope and it offers excitement and it offers promise of more progress related to breast cancer.

            Coming up next, a few final thoughts for this month when Pinpoint on Women's Health continues.

            [Announcements]

            DR. PENN:  And now for a few final thoughts.  It should be encouraging to all of us, that while we don't know all the factors that lead to breast cancer, we don't know all the ways to prevent breast cancer, and we don't have all the answers for cures for breast cancer, research is clearly helping us to decrease the number of breast cancers that occur, helping us to learn better how to detect those breast cancers, when to detect them, what to do when we detect them, and how better to treat them, and hopefully to cure them, with a promise of more women who develop breast cancer being able to live and have a good quality of life with breast cancer and not fear breast cancer the way all of those in our families over the years have.

            We know that breast cancer does not mean a sentence of death for women, which has been the major concern we've heard, and the promise of research is going to help us overcome this condition.

            So we in the Office of Research on Women's Health will continue to do what we can to support and continue the efforts of the National Cancer Institute, other parts of the NIH, and other parts of the research endeavors across the country and around the world, to help us learn more about and to do more about breast cancer.

            And just as a final reminder, you heard a lot about clinical trials and clinical research, and I recall when this office was first established, there were many who said we would never get women to participate in clinical research, women would not be part of clinical trials.

            That's what's really led to the establishment of this office, to ensure that women are represented in clinical research.  Hopefully, through these podcasts, you're learning what your participation in clinical research can do to help us advance the science that can help each one of us and generations to come.

            So I want to remind you, if you're interested in clinical trials, there is the registry that is put together by the National Library of Medicine, here, at the NIH.  It is www.clinicaltrials.gov, g-o-v for government, that listed clinical trials, which ones are ongoing, which ones are still looking for volunteers to participate and hopefully you will join many others in becoming a participant in determining the knowledge and the science of the future.

            Thank you for joining us in this episode of Pinpoint on Women's Health.  In a moment the announcer will tell you where to send your comments and suggestions for future episodes.

            I'm Dr. Vivian Pinn, director of the Office of Research on Women's Health at the National Institutes of Health in Bethesda, Maryland.  Thank you for listening.

            ANNOUNCER:  You can e-mail your comments and suggestions concerning this podcast to Marshall Love at lovem@od.nih.gov. Pinpoint on Women's Health comes from the Office of research on Women's Health and is a production of the NIH radio news service, news media branch, Office of Communications and Public Liaison, at the Office of the Director, National Institutes of Health, Bethesda, Maryland, an agency of the U.S Department of Health and Human Services.

            (End of recording.)