Transcript of the forum:
Senator Feinstein: I want to call this forum together and I really want to welcome everybody. As I said earlier, sort of sotto voce, it's great to see so many people here and interested in the subject matter.
Today, our forum is entitled "Preventing and Treating Breast Cancer: Seeking the Right Treatment at the Right Time." It sounds simple, but I've learned through my family that it is quite complicated. So we very much look forward to hearing our speakers, and I have been just delighted to be able to work with Senator Hutchison throughout her career on many different subjects, but this is really a good one for us in her final year in the Senate.
I have become very interested in cancer because as I grew up it grew and it appeared to me to be all around me. My husband's father died when he was ten of breast cancer, his mother died when she was in her seventies of breast cancer, my stepdaughter has breast cancer. She doesn't apparently have the gene, but nonetheless, she has breast cancer. So all around me, friends, we've gone through this. So it remains an issue of great concern to me and when I came to the Senate I determined, well if I can do anything to be of help, I want to do it.
Breast cancer, as you all know, is the most frequently diagnosed cancer in women. It's the second leading cause of cancer death in women after lung cancer. We now know there is not one kind of breast cancer as I thought in my young day, but five different subtypes with distinct biological features. What has changed is the recognition that these distinct biological features respond differently to different treatments. Therefore, the unique characteristics of each woman's breast and even a man's breast dictate which treatment course will be most effective.
Disease characteristics include the stage, the size, the grade of the tumor, whether or not lymph nodes are involved, whether or not the tumor is hormone positive or negative, and whether the tumor is positive or negative for the protein HER2, the human hepadermal growth factor. In 1975 the only accepted surgical option for breast cancer was to have a mastectomy. My best friend had a double mastectomy around that time. She's still alive and doing well. Today, the preferred surgical option is a lumpectomy followed by radiation therapy. Then, depending on the type of breast cancer, a myriad of treatment options exist, including hormone therapy, drug therapy, and combination chemotherapy.
In 1975, there were no genetic links to an increased risk of breast cancer. Today, several genes that make a woman more susceptible to breast cancer have been identified. As research continues, scientists will use additional information to identify changes in genes that may predict recurrence of breast cancer. They will also be able to predict metastases, the spread of cancer to the rest of the body, and what treatments result in the best outcomes. The Cancer Genome Atlas at the National Institutes of Health is mapping out the genetic changes of twenty cancers, including breast cancer. Along with treatment, we have learned more about prevention and the effects of diet and exercise on cancer risk and reoccurrence.
While there is no doubt tremendous achievements have been made in cancer research and care, the costs continue to rise. Critical advances in treatment mean that now more than ever women can survive breast cancer. However, with the many treatment options available, I believe there is a risk of confusion in newly diagnosed women and their families about which treatments are appropriate for a particular kind of breast cancer. And this has gone on in my family - should she have a lumpectomy, a mastectomy, radiation, drug treatment, this drug is bad for her, she can't tolerate that drug, chemotherapy, a combination of treatments.
So it's my hope today that our forum today will shed some light on which treatments may be indicated for a particular kind of breast cancer, particularly in light of genetic tests and advances that have resulted in much more personalized treatment plans.
So now, with great delight, it's my pleasure to turn to my distinguished co-chairman, the great Senator from the state of Texas, Kay Bailey Hutchison. And then I will introduce the witnesses, and Kay will introduce one.
Senator Hutchison: It is wonderful to co-chair with you Senator Feinstein. We have been chairmen and ranking member respectively of the Military Construction Sub-Committee of Appropriations and have always had a great working relationship. I wanted to also commend Senator Feinstein not only for her ongoing effort to do the most that we can in all cancers (obviously this specific one is personal to her) but for the breast cancer awareness stamp that was Diane's idea. We were able to get that stamp approved and renewed. We have, through that stamp, voluntarily, people buying it and paying just a few pennies more - we have put millions into breast cancer research.
Senator Feinstein: Actually, it's well over sixty million now. It's coming from the stamp for breast cancer.
Senator Hutchison: Sixty million, I knew that you would know. I was hoping that was your cue. Sixty million, and that was her idea, and I was proud to be her cosponsor on that bill because all of this research that we are doing is giving us the treatments that Diane mentioned. The variations in treatments, what can be best for one person is different for another because we now know that there are different kinds of breast cancer. The molecular makeup of the cancer itself is one of the great breakthroughs that the research that we have put federal money in.
We have the volunteer sector, we have the cancer organizations, like Susan G. Komen, that have put millions in and all of this has led us to better treatment. I will say the cancer organizations have done so much for early detection. Just making people aware that they need to be aware, looking for it early, has saved countless thousands of lives.
So, I am very pleased now, that we are going to have this panel that will talk about these findings and what it's doing for us. But I just want to say, as I'm in my final stages of my Senate career, that I have been a champion of all research, scientific as well as medical. It has been one of the focuses of my Senate career. Now, we want to take the next step. We want to not only detect and treat well, and prolong life, but let's eradicate it. Let's do what Salk did with Polio and not have it anymore, mostly anymore. We have a little bit of an uptick now, but as long as we can get a vaccine that will prevent or know what the cause is so we can prevent it, that would be even better, and only research will do that.
So thank you so much for calling this hearing and let's hear from the witnesses.
Senator Feinstein: Thank you so much. I'm going to ask the witnesses to try to confine their statements to five minutes; unfortunately we have a farm bill on the floor and 75 amendments to hear so this is important, and I hope the witnesses know this is not a scientific meeting. So I hope that you will talk in simple language that people like me can understand.
So let me welcome our distinguished witnesses. Dr. Barbra Wold joined the National Cancer Institute to found the Center for Cancer Genomics in September of 2011. She's leading this new center for one year while she's on leave from her position as the Brand Professor of Molecular Biology at the California Institute of Technology, better known as CalTech.
She recently completed a decade as the director of the CalTech Beckman Institute, which is dedicated to cutting edge technology development in biology and chemistry. She began working on genome structure and regulation for her PHD thesis at CalTech. She did postdoctoral work on gene function at Colombia College of Physicians and Surgeons in New York, and returned to the Cal Tech faculty in 1981 where she chartered the architecture of gene networks. This included developing modern DNA sequencing methods to match the genome. Barbara, if you would begin, and I will interrupt you at the five minute point, if that's alright.
Dr. Barbara Wold: The mission of the Center for Cancer Genomics at NCI is to develop and apply cutting edge genome science to prevent breast cancer and to better treat cancer patients. I think it's important that the patient is right in the mission for a cutting edge research enterprise such as this.
Cancer is many diseases, yet all of them have a common origin. The DNA of tumor cells is mutated or modified in the genes that govern cell division, survival, migration, and a number of other cellular functions. These DNA changes do their dirt, they do their harm by altering the amount, the structure, the function of RNA protein molecules, the active products of our genes.
There have been spectacular improvements in DNA sequencing methods over the past decade, and these now allow us to determine exactly how an individual tumor's DNA has been mutated. The path of discovery, this path, has important implications for better prevention, for better diagnosis, and ultimately for the prevention of cancer.
This morning, I'd like to tell you a few key lessons that we've learned by systematically applying modern genomics to breast cancer, and I also want to point out how parallel research on other types of cancer is yielding valuable insights into breast cancer and vice versa. Breast cancer, as the Senator pointed out, is one of the most common cancers, with 230 cases and 40,000 deaths in the U.S. each year. Research over the past three decades has taught us that breast cancer, like the other adult human cancers, is caused by multiple mutations in the DNA of a cell that ultimately becomes a tumor. So this is a long process over many decades.
Most of the pertinent DNA mutations occur by chance and they accumulate over a period of many years. In some patients, as we know, one of the mutations is inherited from a parent, as is the case for breast and ovarian tumors with inherited bracket one or bracket two mutations.
We're presently learning an enormous amount about which gene mutations can cause breast cancer as part of the cancer genome atlas, also called TCGA. TCGA is the flagship program in adult cancer genomics and it was developed to run in a close partnership between NCICCG and the National Human Genome Institute called NHGRI.
TCGA is going to be complete in 2014. Cancer genomics won't be complete in 2014, but the TCGA program will. It's creating a reference genome and related data for more than 10,000 tumors. These 10,000 tumors include twenty major adult tumor types and ten rarer ones. Each TCGA tumor is characterized by multiple genomic methods in a systematic and rigorous way and the resulting reference data are made available to all cancer researchers. This is important, this is a reference that people can go to, researchers around the country and around the world.
Another program in CCG is called TARGET, which stands for Therapeutically Applicable Research to Generate Effective Treatment, and it leads a similar effort to TCGA and the childhood cancers with a special emphasis on cancers that respond poorly to the current therapies. So one of the general lessons that has been learned from work on many cancers is that combinations of mutations in a small number of genes are needed to produce a tumor. We also know that all breast cancers are not identical at the DNA level. Very far from it. So every tumor actually has its own genomic personality and each one falls into a subset, as was mentioned earlier, with some commonalities and with some distinctions with each other by group or subgroup.
Within those subgroups, there are even distinctions that we're now picking out at the DNA level. So for example, we've known for a long time that excess HER2 protein, caused by extra copies of the HER2 gene, is associated with a particularly aggressive group of breast tumors, and knowing this about her two led to the development of Herceptin, about which Dr. McCormick will say more, which is a drug that provides an effective targeted treatment for many HER2 positive tumors.
As is the case for other targetable so called "driver" causal genes, further research is now identifying new and additional drugs targeted at HER2 positive tumors, and what that will do is expand the suite of options available to physicians. You can almost think of it as a spice rack with multiple spices applicable to a given problem, and the more that the doctor can pull out in the way of a variety of treatment, the more hope one has with dealing with resistance with drug treatments and so forth.
At the genomics level, the TCGA confirmed ten previously known breast cancer genes, which is what such a study should be able to do, confirm prior things, but it also identified ten new and novel ones. So these studies are showing us that ten specific "drivers" that are found in one type can also be active in other unrelated tissues. I think that's an important conclusion. So, for this reason, it means that studying tumors of one type often enriches what we know about another tumor type and in unpredictable ways.
We don't know what we're going to discover until we learn about these tumors and learn about large numbers of them because they differ from each other and are so personal. We expect that these relationships are going to change and refine diagnostic categories and suggest different and effective uses of existing drugs as well as propel the development of new ones. Learning the specific identity of a "driver" gene set for an individual tumor is ultimately powerful in the clinic because it can help the physician to assess whether a given drug will be effective in a particular patient. So we already do this for estrogen sensitivity and HER2 status in breast cancer and with EGFR status in lung cancer, for example. The list of these distinctions that we can make is growing very fast, making it exciting times.
Genomic knowledge can also be used to decide against a particular treatment if the appropriate target mutations are not in play. I think this is incredibly important because in this way you don't waste the patient's valuable energy and time, that precious therapeutic window which can be short for cancer patients on a treatment that doesn't fit the tumor. Indeed, some of the most exciting clinical research that is going on around the country at NCI centers and elsewhere uses extensive genome sequence information to guide an individual patient's treatment.
Learning the DNA signature for each patient is ultimately going to be an important and routine part of diagnosis and treatment. So thank you very much for the opportunity to testify today. I would like to thank all the patients who participated in TCGA and TARGET and other studies like it for donating their information and their biospecimens in order to propel the research forward. This is an information intensive enterprise and we need information for more and more patients going forward. I'll be happy to answer any questions.
Senator Feinstein: Thank you very much, Barbara, and now sitting on Barbara's left is Zora Brown. Zora is a thirty-one year survivor of bilateral breast cancer. She's an ovarian cancer survivor and is now fighting her third round with the disease. She is also a senior advisor of external affairs at Integris Health. She was founder and chairperson of the Cancer Awareness Program Services (CAPS) which educates women, particularly minority women, about cancer and the Breast Cancer Resource Committee which focuses on reducing the mortality rates of breast cancer on African American women. She's an outspoken advocate for minority and women health issues and has received countless honors and awards for her advocacy and community service. She has previously served as a member of the special commission on breast cancer and the national action plan on breast cancer. And she is the lead author of a book in its third edition One Hundred Questions and Answers about Breast Cancer.
Zora, we are delighted you could be with us and please go ahead; we look forward to your testimony.
Zora Brown: Thank you, Senator Feinstein and Senator Hutchison, for resurrecting this much needed forum. I also want to thank you, since I moved to Oklahoma, for that farm bill as well.
And for me, cancer was a journey that began before I was born. Both my great grandmother and grandmother were diagnosed with breast cancer at a time where little was known of this disease. There was little reason for hope. Mammography had not yet been invented. Genetic factors were unknown. Radical mastectomy was virtually the only treatment option and survival statistics were grim. No one knew what caused breast cancer so it was something to discuss in whispers. So much has changed and improved since then and even during my own lifetime.
We know today for example why cancer struck five generations of the women in my family, a genetic mutation of the BRCA 1 gene which predisposes us to breast and ovarian cancer. We also know that as African Americans, the women of the brown family and others like us are at risk for more aggressive cancesr that strike earlier and have higher mortality rates. Understanding my family and racial history has taught me to be alert and proactive about my health.
Although this knowledge did not render me immune from breast cancer, it did facilitate its early detection, first in 1981 when I was just 32 years old and then again in 1997, which helped me survive and take back my life. As a member of a high-risk family, my mothers and sisters, and now our nieces and daughters, have come to understand that we have been given not a genetic curse but a benefit. The benefit of knowledge and the inspiration to use that knowledge to address the challenges of cancer and to view other survivors with hope. Now in the midst of my third round with this disease, stage 3 ovarian cancer detected in 2005, I know all too well what a serious adversary I face. But I also know how to be an advocate for myself, to arm myself with information and to surround myself with support and the best that science has to offer so that cancer does not have to be the victor. And as a result I continue to thrive, day after day. Early on I seized the opportunity to take part in a clinical trial that led to the identification of the BRCA 1 gene.
Most recently I participated in a trial for patients with the BRCA gene, which is now not only allowing me to benefit from cutting edge treatment, but to contribute to research which will advance the science around cancer and benefit women like myself. At one point during my treatment, I had 2 to 3 hour infusion every day for five days. The following week I was infused for two days. I am currently taking daily oral chemotherapy. The oral chemotherapy treatment has lifted an enormous burden of the anxiety of lost hours at work among other things, and I feel much more productive. However the cost and equity of oral versus infused chemotherapy creates sticker shock for many patients. Let me conclude that the threat of cuts in research funding, not just in cancer, but in all medical research is alarming, and we can't allow the advances that may lead to a cure for this and other diseases to propel.
Without the money required to pay for research and development, I might not be sitting before you today. The difference between death and survival may well be the ability to expand our knowledge of this disease through research, and I suggest that the threat of cuts in medical research funding is a huge problem. We need your help in finding a solution. And while we may not have yet discovered a cure for cancer, our crusade against this disease is far from lost. As a result of research, we have witnessed unprecedented advancements in cancer prevention and treatment. Because of research and clinical trials, we now know that cancer is a clinical illness that can strike anyone. Thousands of individuals who in the past would have concealed their illness are seeking risk reduction measures and treatment. Our army of researchers has isolated the BRCA 1 and 2 genes. This discovery holds enormous promise for the early identification of breast cancer in high risk patients.
We have expanded treatment options for breast cancer. Women are no longer exposed to the agony of undergoing a biopsy and depending on the findings, discover that one or both breasts must be removed. Patients can now choose lumpectomy with radiation as opposed to mastectomy. Bilateral prophylactic mastectomy is yet another option for consideration and for particularly high risk women. And depending on the case, many women have the option of forgoing surgical treatment altogether in favor of drug therapy. The research from which these developments spring goes on with increased intensity even as we gather here. In the United States we endure the distinction as being people who, if we see a problem, we find a solution. Resilience defines us. For me this has been a long journey, fortunately a long and slow journey, and I would like to continue on it for a while. So thank you for all you do to help us get cures much faster. Thank you.
Senator Feinstein: Oh thank you Zora, we're all on that journey with her, right? So, thank you very much. Yes.
And now someone from my home-stomping ground, Dr. Frank McCormick. He is the President of the American Association of Cancer Research and the director of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. He holds the E. Dickson Highs Distinguished Professorship in Oncology and the David A. Wood distinguished professorship of tumor biology and cancer research at the University California at San Francisco. He is the associate dean at the UCSF School of Medicine and distinguished professor of microbiology and immunology. That keeps you busy. Also, biochemistry and physics, if that isn't enough.
He pioneered cancer research at the molecular basis for cancer. Previously he founded the biotech company Onyx Pharmaceuticals and developed the cancer treatment Nexovar. He's received numerous awards and accolades in the field of cancer, chairs on multiple task forces and committees, and is an elected member of the Institute of Medicine of the National Academies. Welcome Frank, we look forward to your comments.
Dr. Frank McCormick: Thank you for your kind introduction. I am Frank McCormick director of the Helen Diller Family Comprehensive Cancer Center and President of the American Association of Cancer Research. As President of the world's largest and oldest cancer research organization, I am very honored to be here today to talk about the progress we have made of saving lives from cancer and the unprecedented scientific opportunities that lie before us in cancer research. This really is a unique time in history when for the first time we really understand cancer at the molecular level. And although it is extremely complicated and presents many challenges, it also presents many major opportunities for breakthroughs. Funds provided by Congress through the last many decades for the NIH and the NCI have made this extraordinary progress possible, and as influential leaders in Congress you are to be commended for your continued support of the NIH and NCI.
Senator Feinstein: Thank you.
Dr. Frank McCormick: As a scientist whose own lab and cancer center relies heavily on the NCI for its continuous support, I am personally extremely grateful. At the most basic level, cancer is a biological process gone awry. It is much more complex than we could have possibly even imagined when the National Cancer Act was signed 40 years ago. In 1971 it was presumed that cancer was a single disease and perhaps there would be a single cure. This turns out to be not the case; cancer is at least 200 diseases. Cancer is caused by thousands of mutations in a very complicated manner, as we have already heard from Dr. Wold. Each of these different kinds of tumors requires different types of treatment. For example, we have learned that there are at least 7 different types of breast cancer, and with further research we are likely to discover that there are even more. Because we know now breast cancers are not all the same, we understand why not all breast cancer can be treated the same.
To capitalize on this knowledge, we must leave behind the era of one size fits all cancer treatment, and move swiftly into the realm of targeted treatments and personalized or precision medicine. This means that we treat patients based on the specific characteristics of the individual patient on his or her tumor. This is one of the most promising new approaches in modern cancer treatment. This is really what modern cancer treatment is all about: identifying exactly the molecular basis of an individual's tumor, and targeting a specific therapy that will be most effective against that individual patient. To best illustrate for you the progress we have made across all cancers, I'll tell you the story of Trastuzumab, known by the name of Herceptin, a drug which has changed the lives of women with breast cancer since it was approved by the FDA in 1998.
We have already heard something about herceptin today, but I would like to express further how it exemplifies the advances we have made in the field. It is a drug that has changed the lives of millions of women but I would like to discuss further how Herceptin has shown the advances made in this field. It is one of the first examples of targeted therapy and precision medicine. The roots of Herceptin's success can be traced to our fundamental understanding of BRCA genes and self-serving networks that led to the study and characterization of receptor called HER2.
This research done in academic centers supported mostly by the NCI are all over the country. HER2 has been shown to be present in high levels in human breast cancer tumors. We learned that about 20 percent of breast cancers have a fraction of HER2 and these cases tend to be more aggressive and therefore more deadly. Further studies suggest that interfering with HER2 activity or antibody could stop tumor growth, again based on studies done in academic centers. More advances in the independently developed field of the antibodies, mostly in the private sector, have led to the creation of Herceptin. And this medicine, which was novel at the time, caused dramatic positive results with women with stemic HER2 breast cancer. Following its initial approval, Herceptin was approved in 2006 for use after surgery in early stage HER2 positive breast cancer. In these cases it was shown to reduce the risk and occurrence of up to 24 percent. The impact of herceptin has continued to grow with the discovery that it may help patients with cancers of the esophagus, uterus, GI tract, bladder and b-cell acute lymphoblastic leukemia, in which we see the HER2 gene overexpressed. For example, two years ago Herceptin was approved by the FDA for use with patient of HER2 positive advanced gastric cancer. But the story does not stop with herceptin.
A continued pursuit for women with HER2 positive breast cancer has led to a new therapy, Pertuzumab, which was just recently approved by the FDA. There is a whole range of derivatives and second generation versions of these therapies which are currently being developed in the clinical pipeline. So as you can see, by continually probing the biology of cancer, researchers can make new discoveries and then apply that knowledge to improve clinical outcomes to patient benefit.
I'll close by stating that if we are to fulfill these results with the astounding medical promise of cancer and biomedical research, it is going to require steadfast commitment from everyone, especially from the President and members of Congress, for sustained growth in the budgets for NIH and NCI. The 1.6 million Americans who receive cancer diagnoses this year, including more than 230,000 women with breast cancer, count on us to continue the fight. Thank you, I'll be very happy to take any questions.
Senator Feinstein: Thank you very much. Thank you.
Dr. Leslie Bernstein is Professor and Director of the Division of Cancer Etiology within the Department of Population Sciences (big title!) at the Beckman Research Institute and the City of Hope Comprehensive Cancer Center. She also serves as the Dean for Faculty Affairs at the City of Hope. An internationally recognized epidemiologist, she has focused her research primarily on breast cancer, seeking to identify modifiable lifestyle factors that will reduce and extend survival. She was the first to show a link between exercise activity and lower breast cancer risk.
Dr. Bernstein has published more than 500 research papers and 50 book chapters during her career. She leads the California Teachers' Study. That's a prospective cohort of over 134,000 female public school professionals formed to study breast and other cancers and actively involved in research collaborations examining the genetic and environmental risks for breast cancer. She is the recipient of many awards, including the Kale Five Award from the National Cancer Institute. I want to welcome you here today and we look forward to your comments.
Dr. Leslie Bernstein: Thank you so much, Senator Feinstein and Senator Hutchison. It's really a pleasure to be here. I want to thank everyone who has brought this meeting together. City of Hope appreciates your continued leadership to support federal funding for cancer research and treatment.
City of Hope was founded in 1913 and is a pioneer in the fields of bone marrow transplantation and genetics. I'm hoping it will be a pioneer in cancer prevention now that I am there and working there. I have been there for now five years. It's a leading research institution, treatment institution, educational center for cancer, diabetes and other life-threatening diseases. And we are located, for those of you who do not know where we are, in Northeast Los Angeles in Duarte, California and we are a comprehensive cancer center.
I started my career when I was in my 40s. I got a PhD at that time and began to work in breast cancer. And my goal was really to find novel factors that would reduce women's risk of breast cancer and to do this by understanding some of the biological mechanisms that influence risks and then, most importantly, by finding practical ways, things we could tell women to do, to reduce their risk of breast cancer.
During that time, I met wonderful women like Zora, working with the National Breast Cancer Coalition, so it also altered what I was doing, not just to find causes of breast cancer, but how to extend women's lives who have breast cancer, to begin to work in survivorship before survivorship was really on the table as an important thing to do.
I began my research by trying to understand the hormonal basis for breast cancer; this was in the early 1980s. And you base things on your own experience. I'd been a competitive swimmer who trained 8 hours a day as a high school student and experienced menstrual cycle disturbances. We already knew at that time that when a woman had her first menstrual cycle or when she had her last one at menopause were important breast cancer risk factors. We also knew a little bit about women who were likely to develop breast cancer, like when they had their first babies. This was important. But we didn't have practical solutions because we couldn't recommend when you stop menstruating or when you should have your first child.
So I began to study physical activity. It was my own experience. We knew that physical activity impacted menstrual cycles of young teenage girls. We knew that it actually regulated hormones that women were exposed to, that come from the ovary, and so I began to study it and spend most of my career in the 80s and 90s trying to understand this, and was lucky enough to be one of the first people to link exercise to breast cancer risk and to show that in fact women who were physically active had a much lower breast cancer risk. We did studies of young women, women who were in their 40s or younger when they were diagnosed with breast cancer. We studied post-menopausal women. We studied Asian-American women. We studied African-American women, and each of our studies showed a marked impact of physical activity on breast cancer risk. So, that's one of these modifiable risk factors.
There are others, and in the mid-1990s a group of colleagues, epidemiologists - we all work in collaboration because trying to do prevention research requires a team - we formed the California Teachers' Study, so it's a resource for California, and I am lucky enough to be the principal investigator for this large study. And we've continued to look for novel risk factors in the California Teachers' Study, factors like whether passive smoke exposure impacts breast cancer risk, and we've been able to confirm our understanding of other factors like alcohol intake and breast feeding, learned about how menopausal hormones influences some of the sub-types we've been talking about, the different sub-types of breast cancer, and we were able to show using the California Teacher's Study how the rates changed depending on what type of cancer you had; the hormones affected only certain types of breast cancer.
There are some interesting areas I hope we'll be pursuing, many of us in the future. Aspirin is one of them because it reduces inflammation, but it also inhibits aromatase, and armomatase inhibitors are drugs used to treat women with breast cancer. So women don't want to exercise if they haven't been doing it. We need to find more practical ways so they're not marching along taking tamoxifen as a prevention, or taking raloxifene as a prevent drug. I'm hoping that before I finish my career that we might learn that aspirin as an anti-inflammatory and as an aromatase inhibitor might work. So, in the meantime we'll be working to try to understand what influences breast cancer and what practical messages we can give to women. One of the things we've found is, in fact, that these practical messages also work for breast cancer patients who are post-treatment.
I appreciate the Senate Cancer Coalition's time to showcase the progress that we've made, and I'm very thankful that you're even considering prevention as most meetings only consider treatment. So thank you for letting me highlight this.
Senator Feinstein: Thank you, and now I'd like to ask my co-chair to recognize the final distinguished witness.
Senator Hutchison: Thank you. Dr. Ana Maria Gonzales Angelou attended medical school in Colombia and moved to the United States to continue her training in New Orleans, and then at the University of Texas MD Anderson Cancer Center, to specialize in breast cancer. She was a Susan G. Komen breast cancer fellow. She is on the faculty there in the departments of breast medical oncology and systems biology, working exclusively with breast cancer patients and in breast cancer research. She's the chair of the Endocrine Resistance Working Group and a member of the Correlative Sciences Working Group for the Translational Breast Cancer Research Consortium. She serves as a member of the steering committee for the U.S.-Middle East partnership for breast cancer awareness and research and the Partnership for Breast Cancer Awareness and Research of the Americas. And she is the Texan on the panel.
Dr. Ana Maria Gonzalez-Anguilo: Senator Feinstein and Senator Hutchison, thank you for giving me the opportunity to appear before you today. And thank you for the kind introduction. So I'm here to summarize, in brief, how we treat breast cancer in 5 minutes. That's my challenge. Just briefly, the management of breast cancer has significantly evolved over time. With the incorporation of new treatments and better understanding of the disease itself, things have significantly improved. As Zora said, we started with single option which was radical mastectomy, and now the introduction of radiation therapy, chemotherapy, target therapy, things have significantly evolved. So today, we make treatment decisions for patients with breast cancer based on the disease's state, its sub-type (like we described), and the risk those patients have.
So we divide the stages into one, two, three and four. These stages one through three are what we call early breast cancer, and we can cure that disease. Unfortunately, stage four today is not curable disease. However, due to the advances that we have, patients live for long periods of time with very good quality of life. And in practical terms -- although we have genomic technologies that have explained to us how biological [sic] who have different sub-types -- five or six sub-types of breast cancer, in practical purpose in clinic, we divide breast cancer in three sub-types. One sub-type expresses the hormone receptor, so the estrogen and progesterone receptor, one sub-type that expresses the HER2 receptor, and one sub-type that doesn't express any of the three receptors that we call triple-negative, and is probably today one of the most abrasive types of breast cancer [sic].
So basically today, when we talk about risks after treatment completion we talk about the risks that the cancer has with coming back. And based on that risk we choose the treatment for our patients with breast cancer. So we estimate the treatment based off the different characteristics of the tumor, how big the tumor is, the number of lymph nodes that are removed at the time of surgery and that have cancer when they remove the lymph nodes from the axilla. We also look at these receptors that we talk about, the grade of the tumor, which is how ugly the cancer looks under the microscope. We assess that and we estimate if a patient needs or doesn't need chemotherapy, for example.
So in general, with breast cancer treatment we can split it in two parts. One part is called the local control, and that is what prevents the cancer coming back into the area of the breast or the areas that are close to the breast. And that's made of two parts, radiation therapy and surgery. And the other part is what we call systemic control, and systemic control is what prevents cancer coming back in other areas of the body. When cancer metastasizes it tends to go to the lungs, the liver, the brain, the bones. And that is made out of endocrine therapy or anti-hormone therapy, chemotherapy, and target therapies, such as Trastuzumab or Hereceptin.
When we talk about local control we have different options for patients. We have either mastectomy or lumpectomy, and today, less is more. So our treatment of choice today, as Senators say, is lumpectomy. And before we used to remove all the lymph nodes in the armpit, and now we do a procedure thats called sentinel lymph node biopsy which is to try to identify the first lymph node in which cancer has gone. And if that lymph node is clean, we stop right there and we avoid removal of the lymph nodes and the risk for the patient to develop lymphedema or the swelling arms that they're afraid of. There are some cases in which we have to do mastectomies, for example when patients have more than one cancer in the breast in different quadrants, so that is an indication to the mastectomy.
The other part of local control is made out of radiation therapy, and there are specific indications for radiation therapy. For example, every patient that gets lumpectomy requires radiation therapy. Every patient that has large tumors requires radiation therapy. And every patient that has a large number of lymph nodes, three or more that are compromised, requires radiation therapy.
The systemic control, which is the last part, is divided according to those three sub-types of breast cancer. So patients that have hormone receptor positive breast cancer should be treated with anti-hormone therapies. If they're pre-menopausal, we use a drug that is called tamoxifen. If they are post-menopausal, we use the aromatase inhibitors. Until about two or three years ago, every patient that had a tumor that was greater than one centimeter, even if their lymph nodes were negative, was treated with chemotherapy. But thanks to a genomic testing that we have today, we can actually define which of those patients actually benefit or don't benefit, and we can avoid chemo therapy in more than half of those patients. We're doing the same type of clinical trial today in patients with positive lymph nodes, and we're trying to learn who are the patients in enough risk that require chemotherapy, and who are the patients that don't have benefit, or they will not benefit from chemotherapy.
Patients with HER2-positive breast cancer have to be treated with Trastuzumab. Tastuzumab reduces the risk of recurrence and death of these patients significantly, and it went from being the most aggressive type of breast cancer to actually one of the breast cancers that today we can cure. Our big problem today is triple negative breast cancer because we don't understand clearly the biology of that disease. And when we study this disease in the lab we've seen that there is not only one disease but about six different sub-types of triple-negative breast cancer. So today, the only current treatment for triple-negative disease is chemotherapy. It is sensitive to chemotherapy. We can cure about a third of those patients with chemo. However we have two-thirds of those patients that succumb to the disease, and this is where our research should be focusing. Thank you for the opportunity.
Senator Feinstein: Thank you very, very much. I think we've had a very distinguished panel. I just mentioned to Sen. Hutchison, I'd like to do something a little different today. I'm going to ask one question, she will ask one question, then I'm going to ask our audience if you have a question that you might like to address to any of our witnesses. It must be on the topic, however, or my bicep will come after you. So let me ask my question, and let me ask this of Zora Brown.
Zora, we had one of these hearings, it was many years ago, and I wanted a cancer survivor, and so a young African American woman testified. She was from New York, and what she spoke to was getting the diagnosis, not knowing where to go, what to do, being alone, having no one to consult with. She was imprinted on my mind, I think this was ten years ago, and therefore we began to think in terms of a patient quarterback, an oncologist. Should health care provide for coverage of an oncologist that goes with a woman every step of the way and gives her advice on what to do? How, now, how is your experience different from what it was thirty years ago? When you first got the diagnosis, what options did you have, you know? What loneliness did you feel? What happened after that? If you could sort of trace that aspect for us, I think it might be very useful.
Zora Brown: Thank you. I started out by saying that this was a family journey, so my activity was a little bit different because I did have a family. And that's why I started the cancer awareness program services, to be able to intervene for other women. What we have now, the improvement that we have now, is we have patient navigators almost within every single facility that treats breast cancer and other cancer patients. That has helped to navigate the waters, if you will. And one of my friends calls it navigating the minefields because there are so many questions, and I think when a woman is diagnosed with breast cancer her mind just goes blank. You know, she doesn't have the faculty to be able to maneuver all the things that she needs to know. That led me to write 100 questions and answers about breast cancer.
Also, giving women the tools that they need early on, I mean when you're first diagnosed, I think every woman should be prescribed a support group. I really do. I think that whether you engage in it initially, eventually every woman seems to get in a support group. Sharing those commonalities has been one of the benefits that I see since before I was diagnosed. I had my family to rely on, and of course, they gave me all the support I needed. But at the same time when you leave home and you're out by yourself, you sometimes want to be able to grab on to someone else who has successfully gone through this process with you. And that's where I see us now. We've now come to the point where we have people who can talk to you, take you by the hand, take your through that maze and tell you what to do. We have come a real long way.
Senator Feinstein: Senator Hutchison?
Senator Hutchison: Yes. My mother had uterine cancer and went to MD Anderson. She had a wonderful doctor and did very well, and this was when I was a teenager. And some thirty years later, when she was having a normal checkup, the doctor looked in her ear, a general practitioner looked in her ear and said, you know, I see something growing there and you need to go to an oncologist. Well, she had brain cancer that was the same as the uterine cancer, and this was thirty years later. What you said, Dr. McCormick, and what some of you have alluded to is that we have always treated the cancer where it is for our purposes of funding: so breast cancer, ovarian cancer, prostate cancer, and that's how we fund. But now, and this is all coming from my own experience, but also things that you have said, really it is a type of cancer which can occur in many different places.
So, my question is, should we be refiguring the way we fund cancer now as United States Senators on the strain of cancer? Can it be defined by types and is that a better approach than the placement? Dr. McCormick? Or really anyone?
Dr. Frank McCormick: Well, that is the debate that is going on all over the country. Because we see the same driver genes can be responsible for very many different types of cancer. So you might think that therapists will be more driven by the actual driver mutations than the type of tissue that the cancer is derived from, which would be a shift in the direction you're saying. And that is true for some of the examples we've already mentioned today. But there are other examples where that has not been the case. There have been, as you may know, dramatic improvements in the treatment of melanoma over the last few years by recognition of a driver gene called BRAF which causes 60% of melanoma. A drug has been developed that is very effective against BRAF mutant melanoma. But very surprisingly the same drug was not effective in BRAF driven colon cancer although most people expected it to be. So we have to recognize that these driver genes function differently in different contexts. I think we're not ready to abandon...
Senator Hutchison: ...very interesting
Dr. Frank McCormick: There is a case to be made for looking at how drugs that target a specific gene target different types of cancer. I think it's premature to abandon the definitions by disease at this point.
Senator Hutchison: I think Dr. Wold looked like she had an answer as well.
Dr. Barbara Wold: I would just like to endorse Dr. McCormick's answer. We see that every given tumor involves a couple of genes. The idea that the combinations are part of the context that he described makes one tumor that looks on the basis of one of its mutant genes like it should respond like the others, or not. This is going to be an evolution, I think, in our way of thinking, and perhaps the funding will follow.
Senator Hutchison: Thank you.
Senator Feinstein: Alright, now the great experiment. In 20 years I have never done that, don't disappoint me out there! Does anyone have a question? If you'd begin by just introducing yourself and ask your question and indicate who you might like to answer it. Yes. Can you stand up so we can please hear you?
Audience member: [Cannot be heard]
Senator Feinstein: Can anyone answer that? I don't think...Dr. Wold can answer that.
Dr. Barbara Wold: Well I think our hope of regaining it perhaps belongs more to you than to me...and so I will toss it to the Senators.
Senator Feinstein: As many of you know, we had a great mission earlier on to double the research and came very close to doing it. We came close, a few dollars. The question is what happens next year when we go over a cliff, where a lot of revenue stops. Payroll tax goes out. Bush tax cuts end. There are many problems coming up. So this has to be a relatively conservative time. So I think I can safely say that virtually every member of the Senate gives a high priority to medical research and really wants to see dollars for medical research and that's the closest I can come. Senator?
Senator Hutchison: I do agree. I think that a vast majority of the Senate values research and considers it as a priority and an investment. We reauthorized the American Competes Act and just last year and that was unanimous in the Senate, and that is a research base. So I do think that commitment is there. I can't tell you it is going to be $6 billion, but I can tell you that within the framework of fiscal responsibility which we must, we have no choice but to do, nevertheless the areas that will be prioritized will include research.
Senator Feinstein: Well I'm going to ask a question because I don't see a lot of hands out there. Dr. Gonzales I thought you made a very good statement, and you detailed the variety of treatments available for a woman. You describe both local controls and systematic controls. Can you just elaborate clearly and distinctly, because I am still puzzled by it? When would you recommend a mastectomy versus a lumpectomy?
Dr. Ana Maria Gonzalez-Angulo: Today we try to avoid mastectomies in most of our patients, so our initial recommendation for our patients is to have breast conservation which is actually made of lumpectomy
Senator Feinstein: Even on a recurrence?
Dr. Ana Maria Gonzalez-Angulo: So we started with lumpectomy in breasts. For a tumor, for example, on the outer part of the breast that has a second tumor on the lower inner part of the breast, the entire breast needs to be removed because there is a higher risk that there is a teeny-tiny tumor somewhere else in the breast we are not seeing and we can leave cancer in the breast. The other complication is inflammatory breast cancer. The other types of patient for whom we advise mastectomies are patients that have BRCA mutations have that gene that puts them at risk because of one breast cancer, and they continue to be at risk with a 2nd, 3rd, or 4th breast cancer if they have breast tissue behind. Those patients though have the option, if they want to preserve their breasts, and have very straight forward operation screening. If they develop a cancer it can be caught on time and treated appropriately. The recurrence is a little different. When we have a patient that had treatment for breast cancer conservation and back in that breast we cannot do breast conservation that had already radiation, and we cannot do radiation. So at that point we do a mastectomy. We wait for healing and for the patient to have reconstruction.
Senator Feinstein: Senator, you had another question?
Senator Hutchison: Yes, I want to say that I thought that-well, first of all, let me say, I thought that every single person on the panel offered something different, and I really liked that. I thought that Dr. Bernstein's sort of practical, what you can do in everyday life focus, was excellent. And you were looking at something so available as aspirin as a potential to look at that might be a deterrent. Are there other areas like that that are so readily available, where if it has an impact, like if aspirin did turn out to be successful, oh my gosh, what an easy, simple thing. Are there other things in your arsenal that you can share with us that are practical that we can do everyday for prevention?
Dr. Leslie Bernstein: Well, I wish it were an arsenal and that we had a multiplicity of things. One of the ones I failed to mention was obesity, which is really important both in developing breast cancer, but also in preventing recurrences later on because we know obesity is one of the most important factors predicting shorter survival for women with breast cancer. Arsenal, hm. You know, I think people look for simple solutions, that's why I'm trying to look at something as simple as aspirin. Metformin, a drug used to treat Type Two Diabetes, seems to have some great promise and other researchers are looking into that, but you know these are like Magic Bullets.
The problem is: how do you convince a population to go out and exercise, maintain their weight, not gain, limit their alcohol intake, breastfeed their children? These are the things we know right now. We're probably missing some things.
When I came in, as I said, we only knew about reproductive factors. And then we began to learn about hormone therapy. Although oral contraceptives don't appear to have a marked impact on breast cancer risk now that formulas have changed, we still study them because they keep changing the formulations. So I don't have more magic bullets yet, but there's a lot of work ongoing. People are interested in Vitamin D, whether that might have an effect.
So we're looking for those recommendations we can make. Whether people pick up on them, whether women practice them, that I'm not sure. And in terms of that question about, you know, should we study breast cancer or are the factors that we look at more pervasive? We do that as well in epidemiology and find many of the factors that we study for one type of cancer actually apply to another type of cancer. Most of our studies look at more than one cancer.
Senator Feinstein: Oh, everybody's come awake! All right! Could you please stand and give us your name?
Audience Member: Thank you, I'm [unclear] from the American Association for Cancer Research. I'd like to ask the panel to address the issue of personalized therapies. We're obviously in a new era of personalized cancer medicine and prescription medicine. What are the greatest challenges that we face in order to be able to bring new drugs, new treatments, to patients? Is it funding? Is it regulations? Is it science? What are the issues that we need to grapple with at this point?
Senator Feinstein: All right, that's a good question, and I'm going to ask our experts. I'm also going to ask them to add one thing to the treatment. Is a treatment different for a 35 year old woman than it would be for a 55 or 65 year old woman? Who would like to take that? Go ahead, Doctor.
Dr. Ana Maria Gonzalez-Angulo: Since I'm the one who treats the 45 to 55s? So, yes, I think that breast cancer is one of the few tumors that we can say that we do as much personalized therapy as we can. But we should be able to, we need to do better. So today we have the privilege of being able to, for example, have a general test that allowed us to see if patients will benefit from chemotherapy or not and avoid the side effects of the chemotherapy in a very large group of patients versus actually select the ones that need this specific chemotherapy. We also can give Trastuzumab to the patients that are HER2 positive diseases and cure that disease.
But we have to put into context all that information; it's not the same to treat a very young patient, let's say a 25, 28 year old patient that has triple negative breast cancer, 75 year old patient that has hormone receptor positive disease. One will receive a lot, 6 months, of chemotherapy; the other will receive probably breast conservation surgery and a pill every day with no chemotherapy and today we're actually questioning the need for radiation. So I think that we're getting better and better. I think that we need to do better in science.
Cancer is like, I like to quote Georgia Sledge, who is the former president of Osco, that says that one dumb tumor is smarter than ten smart oncologists. And it's true, there is a lot of heterogeneity of the disease, and it's hard to understand what the diseases are. And the disease actually finds a way around the treatments, so we need to do better sciences and we need to study better. In order for that, we need the funding. The regulation part that Dr. Foti allows is also true. It's very difficult to bring, being a translational researcher, it's very difficult to bring to this [sic] from the lab from the clinic, and Dr. McCormick can tell us because he created a drug that is used today to treat several types of cancer. There's a very useful drug, but to bring those discoveries from the lab to the clinic takes years and years of work, and years and years of paperwork.
Senator Feinstein: Well, thank you, that's helpful. Dr. McCormick, respond.
Dr. Frank McCormick: Okay, well developing a drug certainly is a very long and expensive and risky process, but the main problem really is the complexity of the disease itself. We must identify what the drivers are that the tumor depends on for survival. We mentioned HER2, a new breast cancer, turns out to be a great target. BRAF and melanoma, a great target. So we know that's a driver of the cancer, if we hit that driver with a drug, we expect to see a clinical response. But in many cancers, we don't know what the driver is. And ovarian cancer, there doesn't seem to be one single driver. Triple negative breast cancer, we don't know if there's a single major driver.
Senator Feinstein: What's triple negative breast cancer? Explain that.
Dr. Frank McCormick: Well, that's-it's a definition that we heard from Dr. Gonzalez. It's basically [Gastro] negative, HER2 negative. It's a clinical definition, sorry.
Senator Feinstein: Thank you.
Dr. Frank McCormick: It's one of the subsets of breast cancer which is the most difficult to treat, partly because we don't know what the driver is. We have no way of matching a drug to the driver if we don't know what the driver is. In pancreas cancer, we know what the driver is but we can't figure out a way of finding a drug to hit it. So there are many enormous gaps in our ability to actually deal with the knowledge that we already have, and that means more research to understand and to develop new, innovative methods for attacking what's called "undrugable" drivers and for discovering drivers and tumors which we can't really currently understand. Would you agree with that?
Dr. Barbara Wold: Once again, I endorse everything that he said. And my coda this time is that our tradition of testing and approving drugs in a particular setting for a particular kind of tumor is a tried and true one, and one we should not abandon. However, off-label use, so-called off-label use, is now driven by the science. When you see a driver in a type of tumor where a drug has not been tested, but it appears as if it's likely playing an important role, the doctor will probably be motivated, all other things being equal, to attempt to use that drug. But now you're in the realm of off-label use and that has real implications in the structure of our health care system.
Senator Feinstein: Thank you. Yes?
Audience Member: Hi, I'm Sherry Washington, and I actually am a patient [unclear], and I was recently awarded a grant [unclear]. I work with inner city women in Ward 8 and Anacostia here in Washington, D.C. My question is: what is the scientific community doing to recruit more African American women in their clinical trials? I don't see where they're coming into our neighborhood or whatever tools there are to increase that because they have that higher mortality rate, and they get a more aggressive form of breast cancer.
Senator Feinstein: Go ahead, Doctor.
Dr. Wold: We're coming to your neighborhood with a big public event in July and it's aimed specifically, from the point of view of TCGA, for bringing up the participation and numbers of patient samples who are from the underrepresented minority community, particularly in this case in breast and prostate but moving forward. And so there's a big unspecific push in that direction in order to enable hospitals that more frequently treat larger numbers of minority patients to actively participate.
Audience Member: So that's the Antioch and Silver Springs?
Dr. Barbara Wold: Yep.
Audience Member: Not in my neighborhood!
Dr. Barbara Wold: Well, I mean, metaphorically, sort of your neighborhood.
Senator Feinstein: Close enough. Yes, if you'd give your name?
Audience Member: I'm [unclear] from the National Breast Cancer Coalition and I wanted to address something that Senator Hutchison brought up in her opening remarks about a vaccine. I know it's something that we're very interested in and I know that there's a number of other groups interested. Dr. Bernstein, since you've been touching a lot on the prevention angles, if you could start by leading the panel about the plans for a vaccine for us.
Dr. Barbara Wold: Well, yes I have been part of the Artemis project from the National Breast Cancer Coalition which is looking at the possibility of developing a vaccine, not the kind of vaccine you think about when you think about the HPV vaccine or a small pox vaccine, but a genetically driven vaccine that would prevent breast cancer. We are working with immunologists and other biologically oriented scientists, people who come from fields we aren't used to, to try to work this all out. My role is to study design because that's my expertise. So I sit there and listen to what they are doing, but the goal is before 2020 to have something like this in place.
Senator Feinstein: That's great! Anybody else?
Zora Brown: May I go back to the question about increasing minority participation in clinical trials. I think we need to increase participation in clinical trials across the board. But I work with the National Medical Association, Project Impact, and that is one public service activity in which we have tried to get minorities to understand the benefit of participating in clinical trials.
When I moved to Oklahoma and wanted to participate in a clinical trial, every scientist or community told me, "Oh well you need to go to Loma Linda or perhaps you could go to Dana-Farber or MD Anderson." And I was like, "Look people, I live in Oklahoma, I can't afford to get on a plane and go off for 2 weeks to get this therapy."
So what I was able to do is collaborate with the pharmaceutical company so that I could receive the drug. I got infused 5 days a week, and I went to work every day. I know there are people that want to participate, but just those barriers of not being able to get to your job, that's a big barrier for many minority women, and also where the trials are located. We have to find a way to collaborate more with community cancer centers so we can get more people into clinical trials where they feel comfortable.
Senator Feinstein: Yes, absolutely! Anyone else? Yes?
Dr. Frank McCormick: I just want to make one more comment on the vaccine.
Senator Feinstein: Sure, go ahead.
Dr. Barbara Wold: Back to the vaccine kind of issue, I think it is extremely exciting to broaden that and think about the genomically driven. It happens to be immune therapies. So there are many of these strategies that revolve around the interface between the immune system. Particularly there may come a day soon, and I know there are some trials being organized that are literally around the subject of a custom vaccine for one person based on their tumor in order to attempt to help their immune system defeat it. It's in their early days, but I think its one of the most exciting genome interfaces in the research going forward.
Dr. Frank McCormick: I would like to echo that but also point out that some of the most exciting breakthroughs in the treatment of cancer have come from turbo-charging the immune system, just in the last few years. This has been an area that hasn't borne fruit in many, many decades, but suddenly it has hit primetime. So approval of provins, prostate cancer, but more dramatically, two new therapies that basically make the cancer cell more recognizable to the immune system have led to amazing durable responses in melanoma. Many patients seem to be alive and healthy five years after treatment, which in melanoma is an absolutely astonishing breakthrough. In lung cancer also, another immune-based therapy is showing really durable and amazing responses. So this field is really coming to life through research and innovation. It's really been translated into a real benefit.
Senator Feinstein: Is there a possibility that if you have the BRCA that there could be a vaccine that you could just take that would prevent the development of breast cancer?
Dr. Frank McCormick: Based on what we know today, I'd say that we couldn't think of a way to do it today. I think it's feasible that if we understood enough about the biology of those tumors with some more innovations, we might be able to devise a therapy for those kinds of tumors. We just can't do it based on what we know today. Do you think that's fair?
Audience Member: [Asks a question, but it cannot be heard]
Senator Feinstein: Belt it out so everyone can hear.
Audience Member: [Question still cannot be heard]
Dr. Leslie Bernstein: I think with the issue about whether Tamoxifen and Raloxifene are being recommended, I'd say not universally by internists and general practitioners who would be the ones to actually take the history and make the recommendation. But where they have universally recommended it, the uptake has been low.
One of the complications for Tamoxifen is if you have a uterus it increases your risk of anti-matriarchal cancer. We did research on this and found that it was really specific to women who are heavier or women who had been on estrogen therapy before their breast cancer. But in fact, women fear these side effects.
There is also the cost, and not everyone has a prescription plan. These drugs, they don't cost what aspirin costs. So I think if women are looking for some means of preventing breast cancer that's easy, and they want a pill, we know so much about aspirin, and we have decades and decades of research on it. We know what it will do. Most people have taken it. Most people can take it. I can't guarantee it does anything.
This is the research I want to do, so I am not recommending it. I am just saying by its biological properties, it should work, but it might not. Nothing is ever what we predict.
Senator Feinstein: Thank you. Yes?
Audience Member: [Cannot be heard]
Senator Feinstein: Dr. why don't you begin?
Dr. Ana Maria Gonzalez-Angulo: It depends on the subtype of breast cancer. If a post-menopausal patient or pre-menopausal patient has, for example, triple negative breast cancer, the standard treatment is chemotherapy, and we give the same chemo-therapy to the older patient compared to the younger patient, unless there is a contra indication for a specific medication, for example, if an elderly person has problems with their heart. So I have to avoid some of those drugs.
Patients that are younger tend to have more rapidly growing tumors that are more sensitive to chemotherapy or required chemotherapy. Patients that are post-menopausal tend to have more slow growing tumors and some times endocrine therapy or hormone therapy is enough. So we have to just kind of personalize or individualize the type of patients that we have and make decisions about, for the treatment of cancer considering their risk, their age and other things.
Senator Feinstein: Yes.
Audience Member: [Cannot be heard]
Zora Brown: Actually, I don't see them. I really don't. I think that we have a lot of patient advocates who are doing their best to get more minorities into clinical trials to educate them and what have you, but the funding isn't there. And so you have organizations that were run like mine for twenty years, and I was creating a path to the poor house pretty quickly because the funding just isn't there. And I think that's one of the ways we're going to get more minorities and more people into clinical trials is to recognize that the patient-to-patient advocacy and encouragement is going to make more people aware of what is needed, what is out there, and why it's important to be in clinical trials.
Senator Feinstein: Anybody, would you like to add?
Dr. Leslie Bernstein: Yeah, many of the cancer centers, comprehensive cancer centers, are making these efforts into communities and into the minority communities to try to educate more. It's a very difficult task and we need, I mean we actually need members of those communities to work with us. We have volunteers. It's easy when you're working with breast cancer survivors and advocates because they're wonderful and they'll do anything to educate other people, but we have to broaden these efforts. They are difficult but this is part of what we're supposed to be doing in terms of translating our research. It's getting it out to the communities as well as translating it to the fed side.
Senator Hutchison: I'd like to just jump in cause we all have heard about the delays of the FDA in approving drugs. Does the panel think that the clinical trials are an offset to the delays? That does make a difference if we needed to do any kind of reform of the FDA. Would you suggest that there be more clinical trials or that we instead move the timelines or urge the movement of timelines to be shorter?
Dr. Frank McCormick: Yeah, well, for one thing timelines will be long when patient survival is an endpoint. And as normal drugs improve, survival times of patients get pushed out. So every drug basically takes longer to assess in terms of its impact on survival. So time is an issue you can't really get around very easily.
Senator Hutchison: Will the approval of the...
Dr. Frank McCormick: Right, but approval is generally based on time to progression or survival, and that's a matter which is measured in, can be measured in months or years. So that process will take time. But I think one of the big issues that Barbara already said would now be having to deal with combinations of drugs to be effective. And this raises all kinds of complexity about how the FDA will approve those kinds of drugs.
So in my role as the President of AACR, we have a dialogue with the FDA. We are going to the FDA in a few weeks actually to help work with them, to help work through the problems and the challenges. We will try to address the complexities of clinical trials. They are very open and very receptive to new ways of doing things, and they want to make, they want to approve drugs that have a big impact. And they're facing the same complexities and challenges as we are in the scientific community. So my sense is the people at the FDA we talk to are extremely well-informed. They want be more informed. They're reaching out to us to help educate them to the complexities of the issue. They would claim to be under-funded and over-worked and I'm sure that's true. But they understand the complexities of the issues.
We in the scientific community are working with them to try and help navigate through it, but you know, it's a really tough issue. One example, you might say, is that measuring responses to drugs in the short term will predict whether the patients will survive in the long term. That's often not the case. Sometimes patients respond well to a drug but end up passing away on the same day, receiving no benefit to survival. So it's not a simple issue, and I think the FDA is struggling with this and again. We as a community are working with them to try and navigate through those terribly complex issues.
Senator Feinstein: Would you join with me? I have another appointment, but these people came a long distance to be here today. I think they were all quite wonderful. Would you give them a big round of applause please? And Kay, can you stay? So let me add my word of thanks. And let me say, this is such an emotional, difficult subject for so many of us. The fact that you were really clear... I've done these panels before, and for me this was the best. I learned the most, and what became very apparent, which really should be heartening for all of us where breast cancer stalks us one way or another, is so much is being done to find the answers and to help. So I hope everybody that leaves this room leaves it with that feeling. And that's all because of people, not Kay and myself, but the people that surround us are very special, and I just want to say thank you to each one of them for their role.
Senator Hutchison: I agree, and again I thought each of you gave a different perspective and added something so valuable. I think the fact that the room is completely full of people interested in what you all were bringing to the table and interested in our working together to find the funding sources and make sure that we're doing the right thing in the right places, it's very helpful to us. So thank you all.
Senator Feinstein: Thank you, and buy breast cancer stamps!
