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As the new year begins and election season accelerates, we will be hearing phrases like that more and more.  In the context of a political commercial, it is often pretty clear what is being approved and the basis for the approval.

But what about new drugs?  How does the FDA decide whether or not to approve a new cancer drug, and what exactly is being approved?  In the era of targeted therapies, which are incredibly expensive to develop, and therefore incredibly expensive for patients and their insurance companies, these are crucial questions.

I think the case of bevacizumab (Avastin) is a perfect example.  Avastin was the first of a new class of drugs that treats cancer not by directly killing tumor cells, but instead by attacking the blood vessels that feed a growing tumor, essentially attempting to starve the tumor of oxygen and nutrients.  Avastin was approved by the FDA for the treatment of renal cell carcinoma (kidney cancer) based on its ability to prolong the life of patients with this disease.   Avastin was given a provisional FDA approval to treat metastatic breast cancer, based on its ability to delay progression of the tumor.  It was big news last month, however, when further studies failed to show an improvement in “overall survival” (meaning how long the patient lives from the time she begins treatment) in women with metastatic breast cancer, and the FDA withdrew its approval.

Avastin is in the news again today.  In today’s issue of the New England Journal of Medicine there are two reports (links here and here) showing that Avastin prolongs Progression-free Survival (PFS; the time from beginning treatment until the tumor gets worse) but not Overall Survival (OS) in women with newly diagnosed ovarian cancer.  Based on these results, Genentech, the manufacturer of Avastin, declared that they will not seek approval from the FDA to treat women with ovarian cancer using Avastin, because they know approval will not be granted without an effect on OS.

Overall survival, an extension of life expectancy, is clearly the ideal for a cancer drug.  I certainly treat all of my patients with drugs that I expect will allow them to live longer (hopefully to cure, but even in patients who are not likely to be cured, I would like them to live longer).  But is that the only goal of cancer treatment?  Perhaps there is a benefit to an increase in PFS.  If I told you that your child was going to die in 10 months no matter what I did, but that there is a treatment that will keep his tumor from growing for 7 of those months, and that during those 7 months he would develop no new tumor-related symptoms, would you want him treated with it?  Probably that would depend on the side effects the drug causes, right?  If the drug was very toxic, you might decide that treatment isn’t worth it, but if all that happened to your child was high blood pressure that was easily controlled by medication, you might say yes.

The primary result the FDA wants to see before approving a new cancer drug is an improvement in OS.  Although FDA guidelines do allow for approval based on an improvement in PFS, the degree of improvement required for PFS-based approval is much more strict than what is required for OS-based approval.  I believe that there may be cases where even a modest change in PFS would be a more appropriate standard.  Demonstrating a change in OS requires large studies enrolling many patients.  For rare diseases, studies like this may not be feasible.  In that circumstance, FDA approval based on a change in OS may be an unattainable standard, and PFS may be a reasonable alternative.

Some may ask whether lowering the standard will change the entire drug approval process, because PFS is an easier standard to reach.  Concerns could be raised that no pharmaceutical company will ever try to reach the OS standard (which is more expensive and more time-consuming) if PFS is sufficient to be granted FDA approval, and thus we will never know which, if any, drugs prolong patient survival. 

These are valid concerns, but I believe they can be addressed.  Perhaps a two-tiered approval process, with a lower tier for drugs that affect PFS and a higher tier for drugs that affect OS, with financial incentives for reaching the OS standard, would be a solution.  I’m sure there are others.  But the status quo gives the impression that if a drug doesn’t change total survival time, it has no benefit.  And I’m quite sure that’s not true.

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Tears are a fact of life in my business.  Parents cry when I tell them their child has cancer.  Children cry when they undergo painful procedures.  We all cry when a child dies.

But sometimes the tears are tears of joy.

Jade came to my clinic for another opinion.  She has a benign tumor, but it’s in a bad place.  As I have shared before, sometimes it isn’t better to have a “benign” tumor.  In order to remove Jade’s tumor, she would need disfiguring surgery.  She and her father were told there was no choice.

Thankfully, they were told wrong.

Even though Jade’s tumor is benign, it can be treated with chemotherapy.  It’s a small tumor, and it’s not causing her any symptoms right now.  Even if we can’t make it go away, if we can keep it from growing, she will be fine.

After discussing her options, I asked Jade and her father if they had any questions.  Her father started crying, and then Jade did, too.  They were so relieved to have non-surgical options!

How nice to make someone cry tears of joy for a change.

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The patient and her parents were hardly focused on what we were saying.  Not surprising, since she was still recovering from the news that the pain in her leg was not from a sports injury, but from osteosarcoma.

Kameron was a high school athlete, and now, instead of anticipating a college scholarship to play hockey, she was anticipating a year’s worth of chemotherapy and a major leg surgery.  She and her parents were in the office, listening (but probably not hearing) to the side effects she should expect from her upcoming chemotherapy.  At the end of the conference we discussed some of the “rare but serious” side effects, like fertility loss and heart failure.

Fertility loss is something that catches people’s attention.  To some extent, so does heart failure.  But for adolescent patients, somehow infertility feels more “real.”  So we talked about her possible future fertility problems much more than we talked about her heart.

Throughout her therapy, we monitored heart function with regular testing.  All of the tests were reassuring.  But one day, soon after her treatment was done, Kameron developed chest pain.  When treatment for reflux and then for infections didn’t make things better, she came to the emergency room, and that is when we discovered she was in heart failure.

These side effects, the “rare but serious” ones, are some of the hardest for us to deal with.  Kameron’s cancer prognosis is excellent.  I am optimistic she will become a survivor.  Unfortunately, she paid a huge cost to survive her cancer.  When she leaves the hospital, she will be on heart medicine for the foreseeable future.  She may even end up needing a heart transplant.  This is not a problem that is just going to go away, and for the rest of her life, Kameron will not only be a cancer survivor, but also a heart patient.

This is what drives us to work hard in the lab for treatments that won’t come at such a high price to our patients. 

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I think that is the hardest question I have ever been asked. The emotional weight that goes along with asking how many days are left in a child’s life is staggering. I have been asked this question many times during my career, and I still don’t know how to answer it.

Some doctors answer this question based on disease-specific statistics. For example, since most patients diagnosed with a brainstem glioma die within a year of diagnosis, some will tell the family of a patient who receives this diagnosis that the child has less than a year to live.

Some doctors answer this question based on personal experience. It is personal experience that has led me to dread this question the most. I would like to share two of these experiences to illustrate why.

It was a Monday night. I was home having dinner with my family when I was paged by the resident covering our inpatient unit. My patient had just completed an MRI, ordered to help us determine why he had lapsed into a coma. The MRI had just been read, and the radiologist had called the resident with the result: not only had my patient’s tumor grown substantially, but it was causing an “uncal herniation” (this is when a part of the brain is compressed, often by blood or a tumor, cutting off the blood supply to vital structures and often rapidly leading to death). Since the family had already decided not to pursue further treatment of their child’s cancer, the progression was not a surprise, but I went back the hospital immediately to talk to them about the herniation, since that was a sign that their child could die as soon as that very night. The previous week, when asked how long they had left, I had estimated several weeks, so this change would come as quite a shock.

When I got to the child’s room, we spoke at length about his prognosis. His parents asked me how long they would have with him. I answered honestly that I thought he would die within days, and that he could possibly die within hours. The next morning, when he was still alive, we started to arrange a discharge with hospice care. It was Friday when he was finally able to go home.

That was 52 days ago, as I type this. Since discharge, my patient has regained consciousness, resumed eating, and is considering an exercise program to regain some strength. He is on his second hospice company. My estimates of his lifespan were both way off base.

Two weeks after my Monday night conversation, another patient of mine was admitted to the hospital for end of life care. After a couple of days in the hospital, his mother asked me how long he had left. I told her that I had no idea, and shared with her the story of the patient with the herniation, who I thought would die within days and who was still alive almost 3 weeks later (at that point). I told this mother that, based on my experience, the best I could do was to guess how long she had with her son. She really wanted an answer, though, so I guessed for her. I told her that her son’s lifespan could be measured in weeks. Probably not days, certainly not months or years, but weeks. He died three weeks later.

I suppose sometimes I do guess correctly.

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This post is dedicated to a close friend of mine, a budding scientist with an aversion to yoga.

The benefits of yoga for cancer patients were plastered throughout the popular press recently, in anticipation of a presentation by Dr. Karen Mustian from the University of Rochester Medical Center at this year’s meeting of the American Society for Clinical Oncology in Chicago. This study enrolled 410 cancer survivors (96% female, 75% had breast cancer) suffering from moderate or worse sleep disturbance. The participants were randomized to standard monitoring versus a 4 week yoga intervention. Participants in the yoga program had improvements in sleep quality, fatigue, and various measures of Quality of Life compared with the control arm (no intervention). The benefit was significant enough to be covered by mainstream media outlets like CNN as well as web-based media like Breastcancer.org. ASCO president Douglas Blayney, MD, stated that the results are “readily applicable” for a huge patient population.

But wait. As we scientists often ask, do the results support the conclusions?

I think the answer is a resounding “Maybe.”

There is mounting evidence that cancer survivors benefit from participating in yoga programs. Although this study is the largest thus far reported, it is certainly not the first to show a benefit to yoga. Back in 2003 a study presented at the ASCO meeting showed that participation in a yoga intervention improved the Quality of Life of women newly diagnosed with breast cancer.

But is it yoga, per se, that helps? So far none of the studies have compared participation in yoga with any other exercise program. This study, for example, published in 2001, demonstrated that a home-based walking exercise program improved fatigue and other Quality of Life measures in women being treated for breast cancer. The studies cited on this page of the American Cancer Society’s website demonstrate a benefit to using a treadmill or an outpatient wellness program involving aerobic exercise, strength training, flexibility and relaxation. So maybe it’s exercise in general, and not specifically yoga, that helps cancer survivors live better.

Are the results of the yoga study “readily applicable” to a huge patient population, as suggested by Dr. Blayney? Again, I think the answer is “Maybe.” It depends on how you define “a huge patient population.” Dr. Mustian’s study is certainly applicable to the very large number of women diagnosed with breast cancer every year, but her study involved essentially only women with breast cancer. Given the variety of ways various cancers are treated, it may be premature to conclude that because yoga helped these women, that it would make a difference for young adults being treated with intensive chemotherapy for leukemia.

So what can we conclude? I think it is safe to conclude that some degree of exercise is beneficial for cancer patients, probably regardless of where they are in the course of their therapy. But before we can state that yoga is the best form of exercise, the right study has to be performed: patients need to be randomized to various forms of exercise, and research participants need to include men as well. Perhaps for a relatively inflexible man like me, the frustration of not being able to do “downward dog” will make yoga a poor choice, while the feeling of accomplishment associated with being able to last 5 more minutes on the treadmill will make that form of exercise a much better choice. Only a well-designed experiment can tell us for sure.

 
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Ten years ago this month, President Clinton, along with Drs. Craig Venter and Francis Collins, announced the completion of the Human Genome Project – the complete DNA sequence of the human genome. As is typical of such announcements, there was much pomp and circumstance, as the President declared it a “day for the ages.”

Why the excitement? It was fully expected by participants in the struggle to sequence our genome that achieving this goal would rapidly lead to a new understanding of the genetics of common disease, and would yield new genomic treatments that would revolutionize the practice of medicine. In fact, Dr. Collins predicted that the genetic diagnosis of disease would be accomplished within 10 years, and treatments would begin to appear 5 years later.

This, sadly, has not happened.

So does that mean the Human Genome Project was a bust? Hardly. While medicine has not been revolutionized, basic biology has been. The complete sequence of the human genome has shed tremendous new light on a variety of ways that genes are regulated, especially by RNA, which would never have been understood without sequence information.

So why has the sequence of the human genome not revolutionized medicine? As discussed in an article from The New York Times, there are several reasons. One reason cited by The Times is that many of the sequence variations associated with common diseases are not found within genes. This raises the possibility that these sequence variations are a statistical fluke, not really associated with the disease at all… or by anything other than chance. More disconcerting, if your goal is to develop a new treatment, is that common diseases may be caused by a large number of very rare sequence variations, so that individuals with a particular disease may have very little in common with each other, and nothing amenable to a drug.

Is this result entirely a surprise? To any serious student of human genetics, the answer has to be, “Not really.”

The First Genetic Disease

After reading any article in the popular press about genomic medicine, one would get the impression that the genetics of human disease is a new field, and that before the human genome was sequenced, there was nothing known about how gene mutations cause disease. This, however, is not true. In a paper published in Science in 1949, Linus Pauling and his colleagues demonstrated that sickle cell anemia is caused by a mutant form of hemoglobin, the protein that carries oxygen in red blood cells. In 1956, Vernon Ingram and his colleagues proved that this mutation was at the 6th amino acid of the protein. This change was soon shown to be the result of a single DNA base pair change.

For more than 50 years now, physicians and scientists have understood Sickle Cell Disease in molecular detail. Nevertheless, we are still unable to explain how this molecular defect causes any of the symptoms of the disease, and we are unable to do anything about it. To this day, despite how long we have understood the molecular biology of the disease, treatment remains supportive (meaning prophylactic antibiotics, pain medicine, and transfusions) or aimed at changing the way the hemoglobin genes are controlled (using a medicine called hydroxyurea). There is no treatment available that is directly related to the genetic cause of the disease, the mutation at amino acid 6.

I think this should be a warning to those who think that the path from the molecular understanding of a disease to a treatment will be straightforward. The era of genomic medicine may be upon us, but it is probably going to be a very slow change, not an overnight revolution.

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The ethics of modern medicine has always fascinated me, and Pediatric Oncology has provided me with more than my fair share of ethical issues to contemplate. I want to share today’s, and see what people think about this particular, emotionally charged, situation.

I received an email today from a colleague in another state. He trained under me, and I guess he thinks I did a good job, since he emails me for advice from time to time. He met a new patient today – a 23 year old woman with a new diagnosis of osteosarcoma. Unfortunately, she is 20 weeks pregnant.

One of the mainstays of osteosarcoma treatment is high dose methotrexate. Methotrexate is a very effective drug for terminating pregnancies, and this is where the ethical dilemma begins. The patient has a choice to continue her pregnancy or not. Except that the state in which she lives does not allow medical assistance funds to be used to terminate a pregnancy, and she has Medicaid as her sole source of health insurance. She cannot afford to pay for an abortion herself. If she chooses to continue the pregnancy, either out of necessity or out of desire to do so, giving her methotrexate will be fatal to the baby inside of her.

If the patient chooses to remain pregnant, my friend has some very difficult decisions to make: should he wait to treat her until the baby is born? This would give the tumor as much as 4 months to spread before treatment, a huge risk to the patient. Should he begin therapy early, maybe once the third trimester begins, and just not use methotrexate? This would allow the baby to develop to full term prior to delivery, and only delay beginning chemotherapy a few weeks, but would provide less than optimal care to his patient. Could an obstetrician ethically deliver the baby early, say at 30 weeks, a time when the child’s development is likely to be normal (but, of course, may not be) despite being premature? This would allow him to use methotrexate almost 3 months earlier than if the baby is delivered at full term.

I told him what I think I would do, but I’m glad that for me this is just an ethical puzzle, instead of a real situation where I have to make real decisions.

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The patient is a young boy with leukemia. We have been treating him for over a year, and his leukemia just won’t go into remission. For the past 3 months he has been in the hospital, first to receive chemotherapy and then to manage the side effects we caused. His bone marrow is nearly empty, but almost 80% of what few cells are present are leukemia cells. His only potential curative therapy is a bone marrow transplant.

Therein lies the problem. Not only does he have refractory leukemia, but his lungs are significantly injured from his previous chemotherapy, functioning at just about 55% of their predicted ability. For my patient, this is a major problem, because sick lungs make a bone marrow transplant very risky. Also, he doesn’t have a matched donor, so we would have to do a highly experimental type of transplant called a “reduced intensity haploidentical transplant.” This means we would give less than the usual amount of chemotherapy (to try to decrease the toxicity), and would use a donor that is only half matched.

I presented this case to the adult BMT group last week. Not one of them thought going through with the transplant was a good idea. They are convinced the patient will do badly, that he will end up dying in the ICU on a ventilator, and would never be cured with this approach anyway. Better to send him home on hospice care.

I polled a number of pediatric colleagues by email. They all said the same thing – better to do hospice care than a transplant that will most likely make the patient sicker before he dies anyway.

Our group has discussed the case extensively. We all agree that the chance of cure for this child is less than 5%. There is a 95% chance he will die faster and in more pain if we go ahead with the transplant than if we send him home on hospice care. So is the more humane choice to not offer the family a transplant, knowing the odds are overwhelmingly against success, knowing that the transplant will most likely make an already tragic situation worse?

Who gets to decide if the 5% chance of a cure is worth the risk? Is this chance of success so small as to qualify as futile?

If I know the father the way I think I do, if I hold out ANY chance of cure, he’ll take it, no matter the cost. That means, if I offer the family the transplant, he will go for it. But is that fair of me? He doesn’t know what it’s like to watch a child die in the ICU. I don’t think I can fully explain to him how awful a death his son may have, especially compared with what it would be like for him to die peacefully at home. Given that, can he truly give informed consent?

On the other hand, if I don’t offer the transplant, I take away even that slim chance of survival. Can I ethically do that? Or is that a decision the parents get to make?

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The headline in the Washington Post caught my eye: “Fighting a smarter war on cancer,” [sorry, you must register to read the article] an opinion piece by Dr. John Marshall, a faculty member at the Lombardi Cancer Center in Georgetown. It is about the intersection between health care reform and cancer care – it seemed like just the thing to read while drinking my morning coffee. But halfway through the article I found myself feeling marginalized, and that got me thinking. Although Dr. Marshall makes some good points, I think he missed a golden opportunity to propose changes that could make a real difference in our lifetimes.

How did Dr. Marshall make me feel marginalized? He wrote the following about chemotherapy:

“The most common approach to treatment involves exposing large populations of patients to highly toxic poisons in the hopes that the treatment will kill the cancer cells and not the patient. This strategy has succeeded with several types of less-common cancers, curing some patients with leukemia, lymphoma, testicular cancer and most childhood cancers [emphasis is mine]. But it has not worked for more common forms of the disease, including breast, prostate, lung, colon, pancreas, stomach and ovarian cancers. These cancers represent an enormous public health problem, consuming the majority of our cancer-specific health-care costs and research dollars.”

I realize that childhood cancer is rare, and that to make an impact on the total health care system in our country will require real progress against such public health menaces as breast and lung cancer. However, I believe that rather than brushing aside the approach that transformed childhood cancer from a death sentence to a treatable disease, the medical oncology world needs to embrace it.

Most oncologists know this, but in a single generation, collaborative clinical research in pediatric oncology, exemplified now by the Children’s Oncology Group, has revolutionized the way childhood cancer is treated in this country. Once uniformly fatal, there are now some types of childhood cancer that are cured 95% of the time. This transformation did not come about by chance. It came about because of a culture change that is now a huge gulf between pediatric oncology and medical oncology: the role of the clinical trial.

Dr. Marshall hints at this in his article: “In cancer medicine, fewer than 5 percent of all patients in the United States enter clinical trials. That means more than 95 percent are treated with the ‘standard of care’ — a legal term denoting a minimum level of care for an ill or injured person.” In contrast, being entered on a clinical trial IS the standard of care in pediatric oncology. Partly this is born out of necessity – childhood cancer is rare enough that unless nearly every child with cancer is treated on a trial, not enough patients can be studied to yield reliable results, making progress impossible.

The cultural difference in the view of clinical trials between medical and pediatric oncology is readily apparent in my every day practice, particularly when I have to approach an insurance company about enrolling a patient of mine on a trial. In the “adult” world, a clinical trial is something offered when there is nothing “standard” to offer, just as Dr. Marshall implies. What this means is that insurance companies often feel justified in denying coverage for trials, since these are “experimental therapies” and “not standard.” In the “pediatric” world, everyone goes on a clinical trial. Coverage is routine, because the trial IS the standard.

Dr. Marshall makes an excellent point about where the future of cancer therapy lies. He believes, as do I, that the future is in “personalized medicine,” meaning treatments that are individualized for each patient, based on the molecular and cellular composition of their individual cancer. Unfortunately, therein lies the problem. In the world of “personalized medicine,” there will be no standard. What works for Patient A will not necessarily help Patient B. Destruction of the concept of “standard of care” in oncology will make coverage decisions by insurance companies far more complex. This will need to be accounted for as we move towards a reformed health insurance system.

More importantly, demonstrating the value of “personalized medicine” will require more clinical trials. Only by enrolling patients in such trials, painstakingly dissecting the molecular changes in each patient’s tumor, and carefully proving that tailoring therapy based on these changes dramatically improves outcomes can real progress be made. Because these molecular changes will, by definition, vary widely from patient to patient, treating only 5% of adults with cancer on clinical trials will never get us to where we need to be. The medical oncology world needs to learn from the successes of pediatric oncology. Being treated on a clinical trial needs to be the standard, not something that is reserved for use when “standard of care” fails.

Instead of marginalizing pediatric oncology, hold our system up as the model. Only then will real progress be made in the war on cancer.

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In an unanticipated coincidence, these two groups, operating independently, reached similar conclusions about commonly utilized screening tests: mammograms and Pap smears. Both groups reviewed the data and concluded that routine use of these screening tests, as currently recommended, may not be warranted.

Much newsprint has been expended since then discussing the political implications of these new recommendations. As this is not a political blog, I will leave that discussion to others.

What I want to talk about is how guidelines (should) influence patient care.

I think a lot of the worry surrounding these guidelines stems from concerns that they will be interpreted by those who pay the bills in our system (meaning the Federal Government, through Medicare reimbursement regulations, and the private insurance industry) as “Actual Rules” rather than “Guidelines,” meaning that if you get a mammogram or a Pap smear but don’t meet the “Guidelines” your service won’t be covered. In the current environment, this may be true, but it shouldn’t be.

The key to my argument is the highlighted words above: “routine use” and “as currently recommended.”

The key to understanding why both groups reviewed the published data and reached similar conclusions is an understanding of the nature of screening tests as well as a bit on biostatistics. My work colleagues who read this will laugh at the idea that I am trying to teach anyone statistics, but that’s what I’m going to do.

To start, the accuracy and usefulness of any medical test can be described by the terms “sensitivity” and “specificity.” Sensitivity refers to how likely the test is to be positive if the condition is present. So a sensitive test will pick up every case. Specificity is the mirror image – if the test is positive, how likely is it that the condition is present. Screening tests are designed to be very sensitive, even if they are not very specific – that way, no cases are missed (very sensitive), but sometimes the test is positive even if the patient does not have the disease (not very specific).

The other statistical consideration is the concept of positive- and negative-predictive value. This means, how likely is a positive test to mean the disease is there, or how likely is a negative test to mean the disease is absent? Two concepts factor into the positive- and negative-predictive values of a test: the sensitivity and specificity AND how common the condition is in the population being tested.

These considerations underlie the new recommendations. Mammograms save lives. No one disputes that. Early detection of breast cancer saves lives. No one disputes that. But mammograms are not very specific, and the positive-predictive value of a positive mammogram is MUCH more if the woman is at risk of developing breast cancer than if the woman is at relatively low risk. Since a woman with a strong family history of breast or ovarian cancer is at higher risk of developing breast cancer in her 40’s than a woman with no such history. Thus, the positive-predictive value of a mammogram in a 40 year old woman is higher if the woman is at higher risk. This is why the Task Force no longer recommended ROUTINE mammograms for women under 50.

This is where the practice of medicine comes in. As the doctor treating a 40 year old woman, it is important to remember that a mammogram will be valuable if the woman is at risk, but far less valuable if the woman is NOT at high risk. So blindly refusing to order a mammogram simply because the patient is 40 makes no sense (and an insurance company refusing to pay for it based solely on age makes equally little sense). A 40 year old woman whose mother had breast cancer should have a mammogram and it should be covered. A 40 year old woman with no relatives who have ever had cancer may not need a mammogram. Determining whether a screening test is needed is a decision for the doctor and the patient to make together.

This isn’t rationing care, this is good medicine.

Related Posts:
As Breast Cancer Month Draws to a Close
Breast Cancer Risk & Alcohol
Is the Medical Community Complicit?

By FunMelaMasti.com

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