You are diagnosed with cancer. You remember some of what the doctor said, but not much. So, following the recommendations of the American Cancer Society, you do everything you can to get information online and elsewhere that may help you better understand your treatment and your disease.
That’s the right thing to do, isn’t it?
Maybe yes and maybe no, if you agree with the findings of a paper published today in the journal Cancer.
The article, which describes research on how patients with colon cancer sought information about their disease and how that information-seeking behavior influenced their treatment, looked at survey responses from 633 patients in Pennsylvania initially diagnosed with colon cancer in 2005.
The researchers measured a number of items including the patients’ general health, education, age, marital status, race/ethnicity and disease stage. They then determined which patients used the new targeted therapies Avastin and Erbitux for the treatment of their disease. They further broke down the survey group as to whether or not the treatment with these drugs was “on-label” (that is, the patients received these drugs when the disease had spread to other parts of their body) or was “off-label” (which means they received either of these drugs before there was evidence of disease spread beyond the primary cancer site).
They then determined whether or not the patients used information sources to find out more about their disease. Newspaper articles, internet, television and radio, telephone hotlines and books or pamphlets were among the types of sources examined.
What the authors found was that 14% of the colon cancer patients had heard about targeted therapies, and that 10% of the patients had actually received one of the two drugs in question. Of the 102 patients in the survey whose disease had spread at the time of diagnosis, 51% had received either Avastin or Erbitux (which was considered appropriate treatment) while 3% of the 527 patients diagnosed with localized disease received the drugs even though their disease had not spread (which was considered inappropriate treatment).
As noted by the authors, “approximately 25% of those who reported receiving the drugs were receiving it for non-FDA-approved indications.” To me, that means that one out of four patients who received these drugs shouldn’t have had that treatment.
The results of the study showed that “high levels of treatment information seeking were associated strongly with both hearing about…and receiving…targeted therapy for cancer.” Information seeking increased both on-label and off-label usage of these targeted therapies.
The authors go on to draw several conclusions about their study and its implications.
First, they suggest that patients who seek information influence doctors’ decisions as to what treatment to prescribe.
Then, they go on to say that this information seeking could persuade doctors to use a drug even when it is not appropriate, as was the case with off-label usage in this study.
“Adjuvant use of targeted therapy is an area of active research, but some experts fear that oncologists may inappropriately consider using adjuvant targeted therapy in selected patients…The diffusion of information may be a key factor in off-label use and that media exposure and direct to consumer advertising (DTCA) may alter the demand for new technologies…
“However, if patient information seeking leads to an increase in inappropriate access, then we may find overall reductions in the quality of care or, worse still, an increase in patient harm.”
The authors conclude their report by noting that their study shows that most cancer patients are trying to get information about their disease and that once they get that information they may receive both appropriate and inappropriate treatment.
That is a pretty important statement, because it suggests that all types of information seeking from different places may not be such a good thing.
But a couple of things need to be kept in mind before assuming that these findings are necessarily the final answer to this question.
Let me point out some information that may help put this study and my concerns into perspective.
Erbitux and Avastin are both drugs that have shown benefit in the treatment of advanced colorectal cancer. They were both approved for this indication by the FDA in February 2004. Neither drug has been reported so far to be of benefit in treating patients with localized disease in an adjuvant or preventive fashion to decrease the chances of recurrence. So, I agree that any use of the drug in this fashion outside of a clinical trial is not appropriate.
Both of these drugs are very expensive, and there are few patients who could afford them if they didn’t have adequate health insurance or significant money in the bank to pay for them or the co-pay.
The median age of the patients surveyed for this study was 70 (the age range was 26 to 99 years old), which means the majority of the patients were on Medicare.
Medicare patients still have to pay 20% of the allowed charge for these drugs, which could easily amount to thousands of dollars. Many Medicare patients don’t have co-insurance that would cover these out-of-pocket costs.
Having a college education was a factor that stands out for patients who heard about and received these drugs, which leads me to believe that the same patients who were seeking information were better educated, probably better off financially and probably had better insurance. Which of these factors actually influenced their ability to access these drugs is uncertain.
Finally, 3% of the patients in the study—or 19 people—got one of these drugs “off label.” That actually is not a particularly large number.
What if these patients had in fact been misclassified as to the stage of their disease? What if in fact their disease had progressed between their first diagnosis when it was localized and the time the survey was done a year or more later? And, we should note that there were clinical trials started in 2004—before these patients were diagnosed or surveyed—to study the value of adjuvant treatment of colorectal cancer with these drugs.
What if some of these “off-label” patients in fact had decided to participate in one of these trials? In that case, the use of these drugs would have been perfectly appropriate and in keeping with good clinical practice.
The risk here is that we create relationships and draw conclusions that may not reflect the actual cause for the observation.
It is my personal opinion that patients should be informed about their disease and their treatment options. It is also my opinion that it is the responsibility of the doctor treating a patient with cancer to provide appropriate treatment recommendations, and avoid succumbing to patient pressure to use a drug that is not appropriate.
Cancer drugs are serious business. Just ask any patient who has received them. They are not the same as an antibiotic that a doctor may give you for a cold, or an expensive antihistamine advertised on television when a cheaper over-the-counter version will work just as well.
Cancer drugs should not be used when the clinical research or FDA approval does not support their use. Using these targeted therapies in the adjuvant treatment of colon cancer outside a clinical trial is not good medicine.
Having said that, there is now an increasing focus on the off-label use of cancer medicines as reflected in several past and recent postings on this blog. There certainly are situations where the off-label use of cancer drugs is wrong, and has led to harm, such as the use of ESAs to treat the anemia of cancer that is not related to treatment for the disease.
But to draw the conclusion that information-seeking from organizations such as the American Cancer Society and other reputable organizations can lead to patients demanding their doctors treat them inappropriately is something that needs to be supported with very firm and clear evidence.
As you can probably tell from my comments, I am not convinced that this research supports that conclusion.
In the meantime, I am going to stick with my basic premise about information and cancer: Get the information you need so you are informed about your disease and its treatment. Get that information from reliable sources. Know that your doctor is recommending chemotherapy that meets appropriate guidelines for your cancer, whether or not that treatment is on-label or off-label.
Hopefully as we learn more about how patients and doctors get information and apply that information we will be able to get a clearer picture of all the considerations that go into making a treatment decision.
Until then, keep on seeking.