7/28/11

Update, Again

Not a lot happening at the moment, although there's plenty of busy-ness.  I'm getting tested to see if I qualify for a Phase 2 Drug Trial, which means blood tests and scans and lots of paperwork.

Phase 1 Trials generally test mostly for how toxic the drug is, with effectiveness being secondary.  They are generally very small trials.  Phase 2 Trials check for both toxicity and effectiveness, with a moderate number of study patients - in the case of the trial we are considering, this is about 160 metastatic breast cancer patients.  When drugs/treatments fail, it is usually in the Phase 2 Trials, primarily because the treatment proves to be either ineffective or too toxic for large numbers of patients to tolerate.  Phase 3 and 4 trials are usually longer, larger cohort studies, fine-tuning issues such as most effective dosage and dose frequency, toxicity management, long-term and rare side effects, etc.

With a new drug, early Phase 2 Trials are more or less a crap shoot.  You don't really know all the side effects (the prior trials were probably too small to indicate the less common - and usually more severe - side effects, and of course there is no data on long term effects).  You usually don't really know the effectiveness of the drug on your specific type of cancer.

There are benefits, but they often don't fall upon the patient (unless it turns out to be a spectacular success - Tamoxifen, for instance, was stopped in the middle of the Phase 3 trials because it was so effective that they wanted to make it available to all breast cancer patients with hormone-sensitive tumors).  The study pays for testing and drugs - which could be useful to patients with no health care insurance, but in my case the benefit is to my insurance company, rather than to me.  The pharmaceutical company benefits, because they get to test and hopefully eventually market a very profitable drug (chemo drugs bring in HUGE amounts of money to the industry).  Doctors get to learn about new drugs, and find out whether they are effective before they are even generally available.  But the patients...

Well, a miracle could happen, and the drug could be an amazingly effective treatment.  We haven't found one yet, but you never know.  But the odds aren't in your favor.  The likelihood is that the drug will either be completely ineffective, or it will be minimally effective, or - at best - it will have about a 30% (the 'gold standard' chemos have about a 30% 'success' rate) chance of either shrinking, stabilizing, or slowing down your tumors for a little while.  In most cases, a 'little while' is literally a matter of a few days to a few weeks.  If it's a few weeks, they call out the media and stop the presses and declare it The Next Big Thing.  And again, they are generally looking for 'progression free' weeks, rather than longer lifespan.

And in the meantime, the patient is the one taking all the really big risks.  Because it's the patient who goes in with no idea of what horrible things the drug might do to them, and nobody can tell them.  Which is why so many drugs don't get past Phase 2 - people die or have new cancers or heart attacks or blood clots, and maybe it's for a drug that helps some people, or maybe it's all for nothing.

But if nobody joins a Phase 2 Trial, then they will NEVER find the REAL cure.  Somebody has to do them.  The question is: in this case, should somebody be me?

I'm not sure yet.  I'm thinking about it.  In the meantime, I'm going in tomorrow to drink a lot of contrast dye and get injected with even more, so that I can be extremely thoroughly CT'd and bone scanned.  The CT scan is because they don't care about my bone mets - they aren't 'properly measurable'.  Though why they then want a bone scan, I can't imagine.  What they are insisting on is that I have soft tissue tumors that are big enough to measure through a period of shrinkage (in the best of all possible worlds).  Which may not be the case.  So first we find out if I'm eligible.

Then I decide.  The devil we sort of know (Gemzar), or the devil we don't?

4 comments:

Delighted Hands said...

Hmmm, hard to make a decision with so little info. Do well on the scan...

soren2go said...

Decisions, decisions.....never easy. Our son Stephen opted to not join a trial that was available to him. The potential quality of life issues were what helped him decide. It is all a very personal decision. I continue to keep you in my thoughts and prayers. May today bring blessings to you.
Leslie

Nancy K. said...

Which ever way things go, you're in my prayers. I think you're brave for even considering being a part of a stage 2 trial.

BIG hugs!

mrspao said...

I think you have a hard decision but whatever you do, it will be a good decision and right for you. Sending you big hugs xxxx