And Now for Something Entirely Different!

Monty Python fans will immediately remember the title of this post, which was a line that they used in their shows when switching from one skit to another.   It appears that I am relapsing on the drug that I am on, and I am going to have to start another treatment protocol.  After an exhausting search I think I have found a treatment that fits the bill.  It is another Clinical Trial at UCSD and will start by the end of the month.  End of short report.  I will warn you ahead of time, the rest is pretty long.

It has been 54 months since I started the drug Imbruvica (Ibrutinib) as a part of the clinical trial that the FDA used to approve the drug for use in patients with Chronic Lymphocytic Leukemia (CLL).  I was happy to be a part of that trial, and even happier that I responded to the drug.  It now appears that the times, they are a changing.   Even though I feel fine, I had suspected something might be going on back in December and since then, my blood tests have shown a slight rise every month.  In January at my doctor's appointment, I asked him if he thought this was a trend upwards, and he said yes.  I also asked him if it was time to run what they call a deep gene sequencing test to see if I had developed any mutations that happens to some patients who are on Ibrutinib over time.  He again replied yes.  So he ran the tests in March and it was confirmed that I have a mutation in the C481S pathway.  (It is unfortunate that I understand this) This means that eventually this drug will stop working for me.  So it is not a question of IF, but WHEN. 

So the obvious question was what do we do now?  I actually feel fine right now but we want to head it off at the pass and start another treatment sooner than later.  My options are limited because of a couple of things.  I am what they call heavily pre-treated, which means I have had a lot of treatments.  I am also a Complex Karyotype, which means that I have some genetic abnormalities that don't respond to certain treatments.  So this has led me on the month and a half long search to find another protocol.  Since I will probably need a treatment that is fairly new, I started looking at Clinical Trials and found that there were a few options there. One of my options was a University of California at Irvine (UCI) trial and was for a drug similar to the one I am taking but is supposed to target the genetic mutation that I have developed.  The problem with this one, after consulting with their staff, is that it is REALLY new, and not many patients have been on the drug so far and they are still trying to figure out the dosage.  In fact they don't have a patient yet at UCI.  At this point in my journey I don't think I want to take the risk of this drug not working at all and then having the disease progress very rapidly.  There just isn't a lot of data yet on how patients are doing on this new drug.

So my next choices were at University of California at San Diego (UCSD) and they presented me with 3 options, all of which had pluses and minuses.  One was a trial and the other two were using combinations of already approved drugs.  After weighing all the options, I decided to go with the Clinical Trial.  On Friday, I agreed in principal to be a part of this trial.  They are now scheduling me for pre-screening, which should happen in the next week.  I would assume if all that goes as planned I would start the trial within the month.    Another plus for this trial is that because it was initiated at a University of California Medical Center, they may be able to transfer it to UCI, so I would go there for my subsequent testing and follow-up care.  Even though I was reluctant to go on the first trial at UCI because of the small number of patients, it turns out I may be Patient #1 on this trial.  It doesn't concern me as much because both of the drugs I will be taking have been tested together in the past and have been shown to be very effective.  The reason that this is a trial using two approved drugs but in one of them they are changing the normal dosage.  

The major downside to this trial is that I will have to pay for one of the two drugs.  Makes no sense, right?  It's a trial, right?  However, if I were to go out and get both of these drugs prescribed as a normal prescription, I would have to pay for BOTH of the drugs.  The problem here is something called CANCER ORAL DRUG PARITY.  Even though I have Medicare Part D, which is supposed to pay for my prescription drugs, this is a Tier 5 drug, which is the highest level they have for the newer costly drugs.  If the drug were given as an infused drug, it would be paid for by Medicare.  But because it is a PILL, it is covered by Medicare Part D, which has different rules.  It gets even crazier.  If I weren't on Medicare and just had regular insurance, the drug companies have programs to offset your co-pay and it would probably only cost me $50 per month.  But if you are on Medicare, it is ILLEGAL for drug companies to subsidize patient's drugs.  This is why one of the drugs will cost me about $12,000 out of pocket per year.  This absurdity is why 48 states have already passed laws making the coverage of Intravenous (IV) cancer drugs and pill-form cancer drugs the same.  Unfortunately that has NO weight because Medicare is a Federal Program.  There is a bill in the House of Representatives right now called H.R. 1409 Cancer Drug Parity Act , which would change this, and even though it has bi-partisan support, the pharmaceutical lobby is very strong and there are questions as to whether it will pass or not.   I am sure that most of you have been impacted by cancer, either thru personal experience, or a friend  or loved one.  It is mandatory everyone supports this bill.  I encourage you to call or send an email to your local representative in support of this legislation.

Yes, I'm disappointed that I am relapsing, but I am ready for the next round, and hopefully it will give me a couple of years and set me up for the next newest thing that is coming along.  The quest for the cure is maturing and the most promising of the treatments is something called CAR-T therapy.  It is very early in the development this treatment, and not very easy to explain in a paragraph.  Basically it is a treatment where they remove your T Cells, and infect them with a modified HIV virus that targets the leukemia.  They are grown for 2 weeks outside the body and re-infused.  It is not for the faint of heart.  Several patients have died, several have not responded at all, but several have been CURED.  My friend and fellow CLL warrior Dr. Brian Koffman has been in Seattle since March getting this treatment at the Fred Hutchinson Cancer Center.  As of Friday, he has been declared completely cured of leukemia.  He was extremely sick and hospitalized multiple times after the infusion, but he is on the road to complete recovery and is cancer free. Right now there aren't many places in the U.S. that do this type of treatment, but that landscape is changing, and as they refine the treatment the risks will decrease.  It is certainly something I would consider in the future.  Here is a link to Brian's CAR-T journey, with an explanation of what it exactly is.  Brian's CAR-T Blog  I would suggest you go to the beginning if you want an explanation of what it is about.

On a different (some people have said insane) note, we were fortunate to be able to go to Disneyland a couple of weeks ago celebrating our granddaughter Naomi's 5th birthday.  All NINE grandchildren went, 8 adults and 5 strollers.  Even though it was the hottest day of the year (94), we all surprisingly had a great time. We are truly blessed. 

Thanks for all of your prayers and words of encouragement.

Terry