The majority of people diagnosed with cancer are over 65, but most major cancer studies exclude them, leaving a wide gap in knowledge about how best to treat older patients.
The knowledge gap about older cancer patients was highlighted recently by researchers from Barcelona who studied the role that age played in the prognosis of 224 cancer patients.
According to the National Cancer Institute, 60 percent of newly diagnosed cancers are found in people over the age of 65. Overall, people in this age group are 10 times more likely to get cancer, and 15 times more likely to die from the disease, than are people under the age of 65.
But even though most cancer patients are older, age is typically not the deciding factor in whether someone survives the illness, the Spanish researchers showed. In their study, cancer survival was most affected by how much the cancer had spread at the time of diagnosis. Other issues, like the patient’s overall quality of life, also influenced survival. The research was published this month in The International Journal of Clinical Practice.
“We found that there were a number of factors that influence survival rates — including physical quality of life and how far the cancer had spread — but age was not one of them” said lead researcher Dr. Eva Domingo from Hospital Vall d’Hebron, in a press release. “Despite this fact, and the challenges that clinicians face from an aging population, there has been little research into how to treat older cancer patients, who often have complex medical needs because of other health issues.”
Dr. Domingo notes that older people are “systematically excluded” from many clinical trials. Among cancer patients who participate in clinical trials, only about one in four is over 65, she said.
As a result, doctors know very little about how drug therapies affect older patients. In addition, many doctors lean toward less aggressive treatment for older patients, based on the fact that they have shorter life expectancies or other health problems. But the Barcelona researchers found that whether a person has a high quality of life and functions well are more predictive of cancer survival than issues associated with normal aging.
“Older people tend to have more complex health needs, such as other illnesses, and that is one of the reasons that has frequently been put forward for not treating their cancers aggressively,” Dr. Domingo noted. But those factors were “much less significant” than factors like quality of life for predicting survival, she said.
“We would like to see fewer decisions taken on the basis of age and more research that explores the complex needs of older people, so that they can be treated more effectively and enjoy a better quality of life,” Dr. Domingo said.
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From 1 to 25 of 42 Comments
If it is true that a quarter of clinical trials patients are over 65, that does not sound to me like “systemic exclusion.” I’m sure such exclusion happens most often when the treatment is particularly rigorous or toxic. Older folks do less well with those types of treatments.
When a new treatment is going for FDA approval, you want to have as few complications in the trial as possible. Older folks tend to have more of these complications (making the risk of injury much higher), and screening these more complicated older folks out is extremely time consuming.
When the treatment is FDA approved, that is typically when subgroups of patients, including older patients, can be the subjects of their own clinical trials.
— jackFROM TPP — I don’t understand your logic. If 60% of cancer patients were children or women, it would make no sense to do most of the research on a new treatment in adults or men. Since 60% of cancer patients are above 65, we need to know how cancer treatments are going to be tolerated by that age group. What you’re saying is that it’s okay to study a less relevant group because the study will be easier and less complicated. But what about what goes on in the real world? And as you know, after the treatment is approved, nobody goes back and studies older patients.
Unfortunately, it IS about getting the drug approved by the FDA and it is true that on the whole, older patients do not make as ideal research subjects from that perspective. Older patients tend to have more concurrent medical problems, be taking more concomitant medications and are more likely to experience adverse events (which must be included in the data for the FDA submission). They also tend to face more problems with transportation to the research site (many oncology trials are VERY intensive and compliance and follow-up are necessities). Also, it breaks down to that many oncology research protocols want to long-term follow ups (5-10 years); a younger patient already has better odds of being followed for that time. Although I agree that older patients are a subset with their own needs and nuances who should not be neglected, we should be careful to not view research as ‘exclusionary’ in the same way we would say, an employer who refuses to hire someone who’s over 65. The reality is, older people do benefit too from the results gleaned from a research population that is statistically more reliable.
— Erin“In their study, cancer survival was most affected by how much the cancer had spread at the time of diagnosis. Other issues, like the patient’s overall quality of life, also influenced survival.”
This wasn’t the main point of the study, but it is a very important point nonetheless. It is significant that early detection improves survival, as does a healthy lifestyle. This seems a simple prescription for lowering mortality from cancer.
And yet there is far more invested in research on novel cancer treatments than on the role that a healthy lifestyle plays in survival.
— CJ#1 Response to TPP. Don’t confuse gender (disease manifestions in women and men can be very different) or pediatrics (children are not small adults) with age. These are separate issues when it comes to clinical research
For the *cancers being studied* is it still true that they are diagnosed in elders 60% of the time??
Anyway, most trials don’t exclude all those over 65. They exclude subjects with certain concurrent illnesses, which are much more likely to be present when one is over 65. A lot of these conditions are found during the screening process. One has to screen many more elderly than younger folks to get enough subjects that don’t have these illnesses. Typically, there will be some elderly that are healthy enough for the trial, and some data may be then be available.
The cut-off of age 65 is arbitrary. It is more important to be relatively healthy for a trial, or clinical treatment after a drug is approved. The reality is that there are no silver bullets out there, and that those of any age that have concurrent illnesses are less likely to do well.
Unfortunately, those who are already chornically ill and then get aggressive cancer are not going to do well.
In practice, the doctor must then decide about a particular treatment, not based solely on age, but on co-morbidities and even subjective issues like “frailty.”
— jackThe least researched group of cancers are actually not those of older adults, but those of children–because they get an entirely different group of tumors. Older adults get the same cancers as those under 60, even if their responses to treatment may differ…but we know comparatively little about the biology of pediatric cancer.
— NY docFrankly it annoys me no end to read the excuses for the low percentage of over 65 people in cancer treatment studies. It brings back memories of the excuses cooked up by researches for excluding women in various studies - the difference in hormones, smaller body size, etc, and for excluding children etc. The medical establishment seems to have a hard time with the concept that IF most of those who get cancer are over 65, then it makes sense to include those over 65 in studies of cancer treatment. Yes some have other chronic illnesses - I bet many of those under 65 also have chronic illnesses as well- such as heart disease and diabetes. Age 65 is not some magic age when these diseases pop up along with medicare cards and membership in AARP.
— Annoyed seniorAppalling - but what is new - and Jack - you are a piece of work.
My 85 year-old mother-in-law is currently recuperating from a successful major cancer surgery.
She lives in a small Florida town, and thank goodness her local gynecologist referred her to a major cancer center (2 hours away), where she saw a gynecologic oncology surgeon who had many previous successes in women over age 65.
She was ready to give up after the first round of chemo knocked her for a loop, but he encouraged her to try again with doses divided over 3 weeks, rather than given all at once.
The side effects were tolerable. The tumor shrank, as he suspected it would. The surgery was “smooth sailing”–far easier than she had ever imagined– and the prognosis is good.
Had she listened to her local oncologist, as she was inclined to do, she would have stopped treatment and gone straight into hospice.
Lesson learnned: See an expert, do your research, and bring knowledgeable caring advocates with you–who ask lots of questions.
If you’re in good physical health, besides the cancer–age is just a number.
We’re so thankful!
http://www.happyhealthylonglife.com
— The Healthy LibrarianThank you for writing about this…the exclusion of older Americans from clinical and drug trials is such an important public health issue right now, and will be more so in the future. A few years ago, I did some research about people over 65 living with HIV and AIDS and heard a similar story from physicians working with that population. Until we figure out ways to test the effects of treatments on older Americans, we aren’t going to be able to treat older Americans very well.
One more thing the baby boomers have to look forward to!
— momI can understand the need for a control group that can effectively support a drug’s success (or failure) in treating a certain type of cancer.
Once that approval is obtained, however, Doctors and patients over 65 need to know how effective that drug is in their age group, or with other conditions.
It would seem that there is a benefit in gaining this initial information during clinical trials. While there can be a core trial group limited to strict patient’s criteria I don’t see why there cannot be random groups outside of the core group.
One “satellite group” might include those with diabetes, or congestive heart failure. The efficacy of the drug being tested would be focused on the core group while the satellite groups would be used to provide additional data for use after a drug’s approval.
— KenAgree with Jack (#4)
Oncology trials do exclude subjects with certain concurrent illnesses, which are much more likely in the elderly. This is to make sure the research subjects are comparable.
In addition, the trials often look at survival as an endpoint (which makes sense, don’t you think?) So if your subjects are all 80 year-olds, their life expectancy is about 7.6 years at that age (see the SSA table below). If you do a Kaplan-Meier analysis, then it would be more difficult to see a separation of curves, meaning a demonstratable diffrerence between treatment and control groups. You are setting yourself up for failing to reach statistical significance and that’s not good for anybody… not only the company, but also the younger patients who are more likely to benefit from the treatment.
http://www.ssa.gov/OACT/STATS/table4c6.html
— NYCRealistThe study of 224 people who ultimately were diagnosed with cancer, over seven distinct types with about 25% women and all at average of age 66 but running from ages 54-78. Not a lot of folks in the cells needed to prove much. But since they all were under study the diagnosis of their cancers were made as soon as possibly could be done, yet there is a death rate of 61.2% if only 38.8% survived just one year. We could assume that those diagnosed with cancer all got the accepted regime of medical care otherwise the study would have mentioned those who died as dying due to a lack of care.
One key factor for survival was ” …functional status, dissemination, the physical component in the quality of life scale…”
Another relates to a thing doctors like to measure and one is the spread of the cancer. So even if there is early detection, it seems that cancer detection did not occur until the cancer has already spread. Two of these three indicators are related to healthy life style.
Life style and the ability to function. The life style and the ability to function. The ability and the ability to function.
When do we get it. Health is not won by the start of the pill.
— ed gThe primary goal of any pharmaceutical company is to bring a drug to market as quickly as possible with the least amount of cost. The pharmaceutical companies are for-profit organizations not charities. If they help some people along the way to lining their pockets, well that’s ok too.
— Rx JI am always amazed how people misinterpret findings. The “early detection” for example is a fallacy that everyone likes to believe but it is not in the data.
How far the cancer has spread equals timing of detection (early versus late) if and only if a cancer spreads progressively and evenly as time goes on, which is not correct. We actually know very little about how cancers spread, not just in elderly people, but in all cancers.
The biggest misconception people have about cancer is that it evolves in a smooth, predictable and nicely organized fashion. First local growth then local spread, then subsequently more distant metas. The data shows otherwise. Some cancers spread extensively before growing much at all, while others can grow to large sizes and not metastasize much.
Some cancers grow furiously while others remain stable for extended periods of time. Even fast growing cancers can suddenly stop for a while, and then start again later. Equating spread with time of detection is incorrect.
Unfortunately this faulty paradigm underlies all therapy and management and even though doctors know it is false -some will only acknowledge there are exceptions-, they have no better alternatives so they just go with the flow.
For patients of course, the idea of progressive spread is appealing because it offers hope if we can only get there “early enough” and remove the whole tumor.
Little do they know or appreciate that it is hogwash, and unfortunately, their doctor is the last person to tell them about it.
— FrankSo Dr. Domingo notes that the age does not affect the survival rate in cancer, but then complains that older people are “systematically excluded”. This seems completely illogical. If age is irrelevant to the outcome of cancer treatments, then it would seem unnecessary to consider age in recruting clinical trial patients.
FROM TPP — Age isn’t the most important factor in survival but treatment needs may be different in older people.
— aveAs others have said, if what you’re looking to do is test a new treatment on one illness, you are naturally going to try to isolate it by testing on those with few other problems. There’s nothing sinister about this, you want the test to use as few people as possible for a given statistical confidence.
If beyond this need you reject people based on age, that would be analogous to rejecting women, but it doesn’t seem like anyone has claimed there is data that they do this.
It sounds like what you’re really pointing out is that too little research is done on less well-defined targets, like how to treat people with multiple illnesses. Presumably good hospitals informally accumulate experience about this, but you can’t patent and sell a package of treatments so it’s not treated the same way as drug research. The same is true of preventative measures, and seems like a real problem in the current organisation of medicine. But how to improve it isn’t obvious.
— improbableto #1 and TPP. There are 2 different questions. The first question is whether the treatment works at all compared to standard therapy. For that question you need a study with as little comorbidity as possible,’pure’ study populations, implying amongst others younger patients. If this is confirmed, then one can go to question two: how does it hold up in the elderly patient or the patient with significant comorbidity.
— erik de koster, brusselsThis seems a bit like sensationalist journalism. The opinion of ONE person is presented here, and I am suspicious about whether or not the information is fully in context. I think that post #4 is excellent, and I’d like to see many of these questions answered myself.
To prove whether or not a drug is effective you need people without comorbidities to get the statistically significant results; otherwise, you don’t know if the drug killed them, the cancer killed them, or one of the 5 other serious illnesses they just happened to have killed them. It’s a scientific reality and though this story makes for good press, the fact is that the initial phase of a clinical trial has to do what it takes to separate confounding effects as much as possible.
— GailUnfortunately the logic of this article is flawed. The elderly are not excluded from oncology clinical trials. Instead the trials exclude patients with co-morbidities (other serious medical conditions) that could cause adverse events which would then be falsely attributed to the cancer drug.
Sub-population studies are often done after a drug is approved to investigate its particular performance on different sub-groups…to the extent there is reason to believe they are different (certain ethnic groups, for instance, respond differently to drugs than others). However your article states that the elderly fare no differently than other adults of the same health and cancer stage - indicating a sub-population study would not be necessary.
— LauraFROM TPP — But that’s the point — that the way we do clinical trials ends up excluding the type of person who is most likely to need the treatment, an elderly person with co morbidities.
This piece never specified the kind of “research” from which elderly patients are “excluded” — although there is one mention of clinical trials.
If this is a reference to drug trials, then half of the participants in any legitimate study would receive a placebo. In this case, excluding older patients would seem to be doing them a favor.
— RalphinjerseyI have reviewed many clinical trials at an NCI designated cancer center as part of the peer review process. i cannot remember a single trial with the exception of a bone marrow transplant study which had an upper limit of age eligibility (for the BMT trial it was 60 years). I also have never heard of the “International Journal of Clinical Practice”. I am not sure what data Dr Domingo is referring to when quoted that older patients are systematically excluded. I just read a report today in Journal of Clinical Oncology (vol26, page 5044; 2008) concerning adjuvant chemotherapy for lung cancer. The median age of patients enrolled in the study was 61 years in the treated group and 62 years in the observed group. Median means that one half of the patient were older.
— JCMDAs stated in previous posts it is not chronological age that is important but physiological age. The determination of physiologic age is often measured by what is called performance status. If a patient is unable to perform normal daily activities, then the cure may be worse than any disease.
I have always lumped into one category patients over 55 and assumed they were receiving equal attention. I apparently I am wrong. As a thirty-something with cancer, it is easy for me to envy the AARP crowd, whether you are over or under 65. Only 1% of 20 and 30-something are in clinical trials, and only now is the first ever long term clinical trial being designed specifically for our age group. In the cnacer world elders outnumber the young-ins for sure, but we have decades, not merely years more that we would like to extend out life. Let the age wars begin.
http://everythingchangesbook.blogspot.com/
— Kairol RosenthalI work in Oncology Research at an academic institution. We do not have age limits, unless you consider a study I have for newly diagnosed AML which is open ONLY for those age 65-75 (leukemia is tough to treat in this age group) or the lung cancer study ONLY for those older than 70. All studies have eligibility criteria and many older individuals do not meet the criteria. Remember, they have 65+ year old lungs, hearts, livers, kidneys. As with all of us, some are in better shape than others. Many elderly also decline participation or have family members who do not want them participating in studies (yeah, insert the guinea pig statement….) As other people have mentioned, there are the transportation issues and the fear that it will end up costing them more for the sometimes increased visits for monitoring or lab testing. Overall, I think cancer research has done a good job at trying to increase study enrollment in the older population. Now to work on minority recruitment which has been a real struggle for us.
— Mary RNI take issue with the presentation of the research here–it’s clearly presented in a way to attract attention (i.e. attention grabbing press release). It doesn’t seem like the author of this blog had done a any additional leg work beyond looking at the abstract & press release. The sensationalist angle (eg “Old folks don’t get the attention they deserve in cancer research! OMG!”) while attention grabbing, does not even come close to addressing the nuanced reality of cancer therapy and oncology research.
This blog entry actually does a disservice to the public because it gives a false impression that cancer research is (in some way) biased against older cancer patients. This blog entry on Well Blog is an example of lazy journalism and the common pitfall of missing the forest for the trees by looking at only one study.
— AL in PAThe cold reality is that most cancer treatment studies fail. As a result, there has been a push to try as many different ideas as possible in the hope that a few turn out to be viable treatment options. The way this has been accomplished is to first test the treatment in an ideal group of patients without other medical complications. As a result, most patients in a study are younger than what would otherwise be predicted. The advantage of this approach is that you can completed the study with fewer patients in a shorter length of time. This also means more studies can take place with the same amount of money and resources.
Once a treatment has been validated under ideal circumstances, it typically gets tested in all comers. However, only a few studies make it this far. As a result, the apparent bias against the elderly remains.
As a society, we could certainly choose to perform all cancer studies as “intention to treat”, which would include all people regardless of age or co-morbidity. However, this would require much larger, multicenter studies to reach statistical significance. Fewer studies could be performed overall. While the data from these studies would be more relevant to the general population, there would also be plenty of good ideas left on the drawing board since a much more limited number of ideas could be tested.
— RogerThe title of the article is misleading as it suggests that older patients are deliberately excluded from clinical trials because of their age. None of the recent clinical trials use age as the exclusionary criterion and this would now be considered unethical.
— amit gupta, MD, OncologistThe exclusionary criterion for cancer clinical trials mostly include; inadequate organ function (kidney, liver or heart disease), poor performance status and previous diagnosis of cancer. There is a scientific reason for using these exclusionary criterions as studies have shown that patients with poor performance status tolerate the cancer treatments poorly and adequate organ function is essential for metabolism of study drugs. It is the simple fact that as we get older there is higher incidence of co-morbid illnesses and organ dysfunction, which preclude enrollment in trials and leads to under representation of elderly patients. To suggest any other motive does a disservice to the scientific community.