I spent much of yesterday waffling about the clinical trial thing. Initially, I'd leaned towards doing it. But on discussion, one good friend (a doctor, but not an oncologist) was concerned that my starting chemo has already been delayed due to the whole switching practices / hospitals thing -- it's now about six weeks since initial diagnosis, and entering the clinical trial would add another two weeks. Her initial inclination would have been to just start chemo immediately, esp. given that the standard protocol has such a high survival rate. And Kevin was concerned that given that many (most?) clinical trials don't actually succeed, I'd be putting myself through a lot of extra painful / tiring procedures for likely no added benefit. So by the end of the day, I was hesitating, and I admit, not looking forward to yet another biopsy this week.
But then I spent half an hour on the phone with a friend who is very knowledgeable in this area. And here are some of the points he brought up, which really helped me think through the issue, so I'm going to lay them out here, in case it's helpful to anyone else considering enrolling in a clinical trial:
- This one looks like a very good, well-designed trial. (Info that follows from clinical trials.gov.) It's in 21 sites (a multi-center national study), rather than just one or two locations. It seems to be run entirely by UCSF, with multiple different drug companies sponsoring the trial as a consortium (rather than one company running its own pet drug through its own pet trial). These factors indicate that it's likely to be a scientifically rigorous trial, and the adaptive design seems smart to me, the sort of thing that means if a drug isn't working for me, they'll know that quickly, and we can decide whether it makes sense to change my treatment in a very responsive manner.
- Being on a clinical trial at all has a good chance of improving my treatment, even if I weren't getting an active agent. He called this the high placebo response -- because there's a much higher level of monitoring in a clinical trial (all those extra MRI's and biopsies at frequent intervals), the patients end up getting more attention from their doctors, and even the ones on a placebo end up with better outcomes than those on the exact same standard regimen but NOT on a clinical trial. In an ideal world, every cancer patient undergoing treatment would at least be offered frequent biopsies and MRIs, to better track the progression of the chemo, etc. treatment -- but those are expensive, and insurance won't cover them if they don't think it's necessary. If you're in a trial, the trial picks up the costs (because the drug companies are hoping that the results will lead to them selling more drugs down the road).
- As a small side note, there are also some extra 'perks' that may come with being on a trial -- for example, the trial may cover your transportation costs to and from the hospital, because if you're having to go there a dozen extra times, and it's a $50 cab ride each way, that extra $1200 might otherwise make it impossible for you to participate in the trial, and they really want to facilitate your participation -- it's well worth an extra thousand dollars here or there, when they're hoping to make millions (billions?) with an exciting new cancer drug.
Those are some general points in favor of enrolling in a clinical trial. There are, of course, other factors to consider. A few questions to ask, if you're ever in this situation:
a) is it possible that the 'novel agent' (the new drug they're testing) will interfere with the rest of my treatment drugs? (It shouldn't, if it's a well-designed and ethical trial; they should have tested to make sure that it won't decrease efficacy of the other drugs you're taking; any treatment effects should be either additive or synergistic.)
(Sidebar: The ethical part is what's really protecting you here. A doctor friend was telling me about one study where they were treating children with a serious disease, and the drug was so effective that they just unblinded the whole study and gave all the kids the new drug, even though it meant they'd 'wasted' a lot of money. This is the lesson learned with the brutally horrid Tuskegee syphillis experiments, which if you're not familiar with, you should really learn about -- totally critical to the development of medical treatment in America. http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment)
b) what additional side effects will the novel agent bring to table? (If the study is blind and involves multiple novel agents, and you won't know which one you're on until afterwards, then you can ask for the side effects for all of them, so you at least know what the possibilities are.)
My impression (and I do want to confirm this tomorrow, if possible, before signing on), is that the side effects from these drugs are likely to be similar to the ones I'd have from the other drugs. It may intensify them -- more nausea, etc. But it may also decrease them (if the novel agent is working well, for example, they may be able to decrease the dose of one of the other standard drugs). The side effects are a bit of a gamble, but in the grand scheme of things, probably not that important to me; I'm young and relatively fit, and in my doctor's words, I "should tolerate any side effects well." (Feel free to remind me I said this in three months, when I'm complaining mightily about said side effects.) I'll also note that this is only the first step consent form, allowing them to take the initial biopsy to determine if I'm actually eligible. If I am, they'll then randomize me into one of the novel agent groups, and then, to quote the forms, "the risk from the treatment Ive been randomized to will be discussed in detail in the treatment consent form. If I agree to that treatment, then I sign the form and continue in the treatment phase." So there's another formal chance to back out if the side effects sound too bad then. And, of course, I can actually drop out of the study at any time and just go on with regular treatment.
One interesting possibility -- one of the drugs being tested in the trial is apparently a newer, fancier, version of Herceptin (one of the drugs I'll be on regardless), Trastuzumab emtansine, aka TDM-1, that works notably better than the standard treatment. It's much more expensive ($94,000 for a full course of treatment, as opposed to $70,000, according to Wikipedia), so my insurance wouldn't cover it normally; they'd need a reason to pay for the new version over the standard drug (for example, if I were already-proven resistant to the standard version). So getting that drug would clearly be a positive result. No guarantees it's the one I'm assigned, but there's a good chance, so that alone is a strong argument for my signing up for this trial.
That's what I've got so far; still waiting to talk to a few more people today. It helps to lay it all out! I got C's in my college science classes, so I need a lot of hand-holding to understand even a little of how this all works. And how lucky am I that I have medically knowledgeable friends, willing to take the time to walk me through this? INTENSELY lucky.