Moderator: Welcome to Viewpoint with our guest, Dr. Eric Winer. Dr. Winer, thank you for joining us, and let's begin.
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Toledo, Ohio: Less than 5 percent of adults participate in cancer research trials. Why aren't more adults participating? I've heard people say they never knew about clinical trials, that their doctor never mentioned clinical trials.
Dr. Eric Winer: It is true that fewer than 5 percent of adults with cancer participate in trials. The reasons are complex. Some patients are not aware of clinical trials, and some patients see doctors who are not aware of clinical trials. None of us believe that this number will ever be 100 percent, or even 50 percent, since clinical trials may not be right for some patients and others may choose not to participate. BUT, there is no question that many more than 5 percent of adults could be participating and that many more would be participating if they were aware of the trials. And there is no question that the more people participate, the faster we get answers, and the more rapidly we approach a time when cancer is less and less of a problem.
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Denver, Colo.: If my doctor doesn't tell me about clinical trials as a treatment option what should I do? How do I find a trial to participate in?
Dr. Eric Winer: The first thing to do is to ask your doctor about clinical trials that may be available for you. Sometimes this may help remind a doctor, and in other circumstances it lets your doctor know that you are interested. If your doctor does not know about clinical trials for your type of cancer, there are many resources available to you including the Coalition Web site which is cancertrialshelp.org and can also be found through the link on this page.
One added advantage of looking into clinical trials for any patients is that this process can often help educate a patient and inform him/her about what treatments are considered standard and what new therapies are being tested.
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San Diego, Calif.: What actually happens to a patient on a clinical trial? The treatment is experimental so isn't it safer for patients not to experiment with their care?
Dr. Eric Winer: Clinical trials come in many different types. The most common type of clinical trial is what is called a Phase III clinical trial. Such a trial usually compares the best available standard therapy with a treatment that cancer doctors/researchers think might be better. In a trial of this type, patients either receive the standard treatment (which they would often receive if they were not on the trial) or something, once again, that many experts think could possibly be better.
In Phase II trials, a new treatment regimen is being tested within a specific patients population. For example, a new breast cancer drug, that is not presently on the market. Phase II trials are often the easiest for patients to understand since they usually involve only one type of treatment.
In Phase I trials, which are the least common, a brand new drug or treatment or regimen is often being tested for the first time, or one of the first times. You may know that Phase I trials are often trying to see what doses are safe to give to patients. While many of the drugs tested in Phase I trials do not have an extensive track record, the hope is that the treatment will help the patient who is participating.
It is important to point out that patients who participate in clinical trials are often monitored more closely than they would be otherwise. This monitoring is in place to safeguard the patient.
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Upstate N.Y.: Are there currently any trials going on for treating chemotherapy-resistant ovarian cancer?
Dr. Eric Winer: There are many trials going on for resistant ovarian cancer at many different cancer centers around the country. You can go to one of the links on this Web page to see some of the trials that are presently enrolling patients. It is often hard to know whether you would be eligible for a trial without talking directly to the research team that is involved.
I want to point out there are trials available somewhere for almost all types of cancer.
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Kelowna, British Columbia, Canada: Recently the MA17 clinical trial (Letrozole) was stopped early. Critics of its termination fear many unfortunate consequences of this decision, such as they don't know long-term effects of Letrozole, another clinical trial B33 was also cancelled, and the study had insufficient power, etc. Can you please comment?
Dr. Eric Winer: The MA17 study was a trial that was conducted in women with breast cancer who had taken five years of Tamoxifen. Women on the trial were randomized to receive either Letrozole (a pill) or a placebo pill. The reason that this trial included a placebo is that there is no standard treatment after a woman has received five years of Tamoxifen. No woman was being denied a treatment that was known to be effective when the study was enrolling patients.
When studies are started, there are monitoring rules that are put in place, and there are rules as to when the study results will be analyzed. In this case, the study was monitored by a Data Safety Monitoring Board which found that there was a significant in recurrence rates between the women taking Letrozole and those taking the placebo. The Data Safety Monitoring Board required that the study be stopped to protect patient safety and to inform the public of this important result.
It is true that there are many unanswered questions about Letrozole and other drugs like Letrozole. And it is also true that the MA17 results led to the cancellation of B33.
This is good news, not bad news. B33 had to be cancelled because we learned that there was an effective treatment available, and we could no longer randomize women to a placebo after five years of Tamoxifen.
You have to remember that not all trials will answer all questions. In this setting, there are multiple other studies that are going on that will help us sort out what role drugs like Letrozole can have in women with breast cancer. What we can say, as a result of this study, is that we now know that a woman who has completed five years of Tamoxifen will have a lower chance of having a recurrence of breast cancer if she decides to take Letrozole. Personally, I think this is an excellent example of the progress that we are making in cancer research.
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Denver, Colo.: What was Lance Armstrong like?
Dr. Eric Winer: That is an easy one. I had the pleasure of riding next to Lance as we crossed the Mississippi from Missouri into Illinois. Pleasant, very regular guy. Great athlete, and he has done a tremendous amount for cancer trials and to raise awareness of survivorship issues.
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Washington, D.C.: For years, women of child-bearing age were excluded from clinical trials research. Now, they are included more frequently, but the research results are not always reported by sex differences. How can we make sure that happens, so that every patient population has the most complete information available about how a drug or treatment might affect them?
Dr. Eric Winer: Women of child-bearing age are rarely excluded from clinical trials. Women who are pregnant, for obvious reasons related to the safety of the unborn child, are usually excluded. I agree it is important, whenever possible, for results to include a detailed description of exactly what type of individual (man or woman, young or old) participated.
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Burlington, Vt.: Is there a role for cancer patients to generate new ideas for clinical trials in cancer care? Often it is the patient that spurs a new way of thinking or new approach. Other than raising funds to support research, are there ways we can help to advocate or educate other patients to enroll in clincal trials?
Dr. Eric Winer: First, let me say that virutally all of the questions that I ask in research come from the work I do as a clinician. My patients, and all of our patients, are our best teachers.
They tell us both directly and indirectly where we need to do more work.
Second, there has been a real push over the past decade to include advocates in the research process. In many cancer centers and in most of the cooperative groups, advocates play a key role in helping to set the research agenda.
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Washington, D.C.: You explained that Phase III trials test researchers' hypothesis that the trial regimen is better than standard treatment. But there is no data showing that the new regimen will be better (that's the point of the trial), and there is a risk it will not be better or might even be worse than the standard treatment. Has anyone quantified that risk on a global basis? In other words, what percentage of Phase III trials for breast cancer show the trial regimen to be better, equivalent, or worse than the standard regimen? (My hunch is that a significant portion, if not a majority, of trial regimens turn out to be no better than or worse than the standard treatment, so enrolling in such a trial carries significant risk.)
Dr. Eric Winer: Generally, the experimental (non-standard) arm of a Phase III trial is the result of promising findings from Phase II trials. You are right, there is no guarantee that the experimental arm will be better, but it is almost always a treatment approach that many knowledgeable people (doctors, scientists, often advocates) think may be better. Of course, if we knew for sure it were going to be better, then it would be unethical to conduct the trial.
Because there is an experiemental arm, there may be a little more risk associated with it -- this is something that is discussed extensively in consent forms. This is also the reason that trials are monitored so very closely.
As a doctor, what worries me the most is when patients receive non-standard treatments that are not administered as part of a trial. In this case, there is not the necessary monitoring in place.
I do not know of systematic review of all Phase III trials, but it is extremely rare for an experimental arm to be worse from the standpoint of effectiveness. Again, trials are monitored closely and if there is any suggestion of inferiority, the study can be stopped early.
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New York, N.Y.: How do you feel about children participating in clinical trials?
Dr. Eric Winer: 85 percent of eligible children with cancer participate in clinical trials. There have been huge advances in the field of pediatric oncology. OF COURSE, there are very complicated informed consent issues which our colleagues in pediatrics have to deal with.
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Chester Springs, Pa.: Do minority patients enroll in clinical trials at the same rate as white patients? If not, what can be done or is being done about this?
Dr. Eric Winer: There is much attention that is paid to participation in trials by members of minority groups. In many studies, the participation rate is very similar to white individuals.
There is no question, however, that in the U.S. we have problems related to access to care that are far more acute for many minority patients than for many white patients.
Outstanding and timely cancer care need to be made available to people of races, ethnic groups, ages, etc. If we succeed in doing this, then we will eliminate, I think, any disparities in terms of trial participation.
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Goldsboro, N.C.: What can we do to raise the bar so to speak so that the first question that patients ask when they have a cancer is "what clinical trial is available for me?" Lance has done a great job but how do we get more people involved like Katie Couric or Oprah?
Dr. Eric Winer: One of the major reasons I rode in the Tour of Hope was to raise awareness of the importance of clinical trials. Many, many people don't even know what a clinical trial is.
The fact is that we will never take the exciting laboratory discoveries of today and translate them into standard treatments for tomorrow without this totally CRITICAL clinical trial step. People need to be aware.
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Edmonton, Alberta: Here in Canada our governemnt (HPB) has made all research involving human subjects more difficult. Is this the direction it is going in the USA? I know the EU is also going in this direction. What can we as researchers do to inform the public and get their support? We cannot make progress without research.
Dr. Eric Winer: Clinical research and clinical trials have become more complex in the U.S. in the last decade. To large extent, I believe that these changes have been good. We are more aware than ever before of protecting patients rights and privacy. However, the problem is complicated, and we clearly need to make it as easy as possible for large groups of individuals to participate in trials.
If a trial completes its enrollment in two years instead of four years, we potentially have an answer to an important question two years sooner.
As you well know, almost all standard cancer treatments today have come about as a result of clinical trials.
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Alexandria, Va.: Breast cancer has certainly captured the attention of the public and of women due to its grave personal nature and its connection to its victims' gender identity. However, lung cancer kills more women annually than breast and colorectal cancer combined. What can we do to get women to think more broadly about their cancer risks and do you think the media plays favorites with specific types of cancer, providing them more coverage than their incidence (compared to others) warrants?
Dr. Eric Winer: I could not agree with you more. Despite the fact that I am a breast cancer doctor, I fully recognize that many other cancers do not get an adequate amount of attention.
Lung cancer kills more women than breast cancer ... one of the issues is that the women who die of lung cancer are not here to advocate for themselves.
Does this mean we should have fewer breast cancer trials and less money for breast cancer research? Absolutely not.
But it does mean that we need to provide addditional support to those areas that have not been adequately addressed.
Cancer is a complicated set of diseases. We are not going to cure all types of cancer overnight. But we have real hope of making tremendous strides in the next decade.
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Fairfax, Va.: My wife jsut died of ovarian cancer last week. My experience in dealing with the medical community suggests that there is already enough money out there funding cancer research. The problem is solving the cancer problem is not one of funds, it is one of coordination. In all honesty, the research and tretament is haphazard. There is a general lack of coordination and sharing of information. The egos of the doctors and the researchers are getting in the way. Please comment.
Dr. Eric Winer : I cannot speak to your experience. I do know of situtations where cancer care could be better coordinated.
I do not agree that there is adequate funding. More funding is required, though we have to use that funding in a responsible manner. I can tell you that from my standpoint, more than ever before, there are close collaborations across cancer centers, cooperative groups, the National Cancer Institute, and with the pharmaceutical industry. It is going to take teams of individuals to solve these problems, but the goal is quite clear. We want to see fewer and fewer women and men dying of cancer. And this is a goal that will be achieved in the years ahead.
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Reston, Va.: A family member was recently diagnosed with a Neuroendocrine carcinoma which has spread from the intestines to the liver and abdominal wall. While we're early in the fight, I've been beginning to search for trials that focus on this rare form of cancer. Any suggestions where to focus my search?
Dr. Eric Winer : It can feel particularly frustrating when you or a family member has a rare type of cancer. Best bet is to ask your doctor and to explore some of the Web sites (links on this page) that we have talked about.
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Dr. Eric Winer : I want to thank everyone for taking part in this online discussion.
It is going to take teams of people -- patients, family members, doctors, nurses, researchers and others to solve the cancer problem. More progress is being made than ever before -- but still not fast enough for any of us. We just have to keep working together. Eric Winer
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Moderator: Our thanks to Dr. Eric Winer, the Coalition of National Cancer Cooperative Groups, Inc., and all who participated.
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Dr. Eric Winer, one of the country's foremost breast cancer specialists, recently rode a bicycle 3,200 miles in eight days from Los Angeles to Washington, D.C., as a member of the Tour of Hope to raise awareness of the importance of cancer research. Dr. Winer was online to discuss the ride and why participating in clinical trials is such an important treatment option for cancer patients to consider.
