I want to know whether I'm taking deforolimus or the placebo, and the way I'm going to find out (*) is by monitoring my blood work and symptoms closely. But through some weird sort of medical certainty principle (Schrödoctor's?), obsessively monitoring one's body for symptoms... ensures that you'll experience symptoms. In the kind of sterling move that probably would have been smart before I started this trial, I searched for deforolimus side effects and found this article from a patient advocacy organization recounting a presentation by Camille Bedosian, Ariad's chief medical officer. This was a year or so ago, but the non-legally-vetted talk is more illuminating than Ariad's official publications.
Some excerpts:
Why would someone who has had a favorable response to chemo want to take deforolimus?
People who have gotten remission are unlikely to stay on chemo, but they may want to take deforolimus in hopes of staving off a recurrence. Also, it is common for people on chemo to take a break from time to time to let their body recover a bit. Those who have had shrinkage or stability may want to take deforolimus while on a break from chemo. Others may have reached their limit of a certain kind of chemo or be waiting to figure out what to do next.
...
Even so, why test the drug against a placebo?
"How are we going to know if it works?" Dr. Bedrosian said. Dr. Sant Chawla of Los Angeles added, "Someone has to prove this to the nonbelievers. Otherwise, we’ll be talking about this for 10 years."
If people get new tumors or their existing tumors grow, they have to leave the trial. Those who were on the placebo can't get the drug, Dr. Bedrosian said, because that would affect the trial results. People who complete the trial will be told whether they got the drug or the placebo. If they got the placebo, they will not be allowed to get the drug.
If people get side effects, won't they know they are getting the drug, not the placebo? For example, she said, about 70 percent of the people who took deforolimus before have gotten mouth sores.
But some of these sores were minor – similar to what people get in the general population, she said. People who have had chemo recently may have a hard time distinguishing chemo side effects from the side effects of deforolimus.
Bedosian also mentioned that they felt like deforolimus worked best against faster-growing sarcomas and that about one-third of heavily pre-treated patients in phase II trials had a positive response to the drug. I summarized some information about the study design and side effects here.
According to my doctor, the mouth sores (a 70 percent side effect, according to Bedosian) can often be resolved by temporarily altering the dosing scheme; they won't necessarily last the entire course of treatment.
And so here I find myself, searching for mouth sores, and wondering if the stomach ache I had last night is related to my flu shot, the pepperoni pizza I ate, the chemotherapy, or the anxiety of living with still more uncertainty.
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* Ariad is willing to "break the code" if necessary once you leave the study and tell you whether you received the drug or the placebo. I would like to know sooner, however.
2 comments:
I'm curious...but, did they tell you how long it would take to see results? either in scans, or otherwise? thank you. be well.
As someone who has somatic symptoms sufficient in force to send me to the hospital--via ambulance, i can tell you this is all tricky territory.What i don't get--um...because i'm ignorant as all get out, is can the placebo actually bring benefit? Ok, perhaps it's wishful thinking here, but if you know what the desired outcome of treatment is (shrinking tumors, full remission, whatever the specifics are), and your mind believes 100% that you are on the drug rather than the placebo, can it bring something like the desired results? If that were true, then in either case--placebo or trial drug, could both bring results if the brain was working in that powerful, uncontrollable somatic way. I suppose the danger of thinking anywhere near these lines is it seems to put responsibility for success on the patient--which is clearly not where it belongs. I don't know though. I still feel like opening the door of optimisim and letting in a crack of it's light might not save the day, but could, nevertheless, produce something positive. Again, forgive my ignorance general and specific. Also, my brother's friend, who was far older than yourself was part of a trial--i could get more details, but I do know this: it gave him many more good years than anyone would have anticipated. My friend, i keep fingers crossed and my heart full of prayer for you. --mld
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