Up Up and Away

I don’t know why this lyric by the Fifth Dimension (A 60’s group for all you youngsters) came to mind in writing this update, but it seems appropriate given what is now happening.  Tuesday I met with Dr. Kipps and I have tentatively been approved to start a new clinical trial on October 30^th.  I am feeling well with the exception of having shingles.  End of short report.
Well, our trip to Hawaii was very nice with the exception of getting shingles while I was there.  About 4 days into the trip I noticed a pain in my lower left shin, and then the next day it moved up to mid leg, then to my knee.  At that time I knew something was brewing, so I started my antivirals (which I always carry with me).  Two days later the rash broke out on my left lower back.  It is still there, and is bothersome, but yesterday I got a prescription for some medicine to block the nerve pain.  I don’t know what would have happened if I hadn’t started the antivirals that early, but Dr. Kipps said my outbreak would have probably been much worse.  A word of advice.  If you are able to get the SHINGLES VACCINE, get it.  You DO NOT want to get shingles.  If you have ever had chicken pox the herpes zoster virus is in your body.  When this is reactivated (no one knows why this happens) you get shingles.  It usually happens to adults over 50 and that is the age you should get the shingles vaccine.  30% of the adult population over 50 will get shingles, so the risk is there for just about everyone.  Some people can’t get the vaccine because it is a LIVE virus which is contraindicated for immune compromised patients, so check with your doctor before just going to prompt care and getting the shot.  By the way, I am NOT a doctor and cannot give medical advice, so this just my own explanation of what happened to me.

Now on to the fun stuff.  Yesterday we met with Dr. Kipps and he once again said I am coming out of remission.  My blood numbers are moving in the wrong direction, he can start to feel the spleen, and my lymph nodes are increasing in size.  So the question is, what do we do?  We could wait, but with my history, it doesn’t seem like a good idea.  There is no real benefit of waiting except I wouldn’t have to have my life revolve around weekly appointments.   The consensus between Dr. Kipps and me is that it is better to start the treatment now while I am feeling well and have no other issues.  I think I will respond better and have fewer side effects if we start now.

The Clinical Trial we selected is a two arm trial, which means you will get either drug A or drug B.  Drug A, which is called PCI-32765, Ibrutinib, or the new approved name of Resonate.  Drug B is called Ofatumumab or Azerra.  This is a humanized monoclonal antibody that works on the CD-20 marker of the cell.  It is also called the son of Rituxan which was the first CD-20 monoclonal antibody, but was mouse based.  I know some of you are asleep, but too bad.  Dr. Kipps thinks that I will have a positive response with either drug, and I am not burning any bridges for future treatments by taking either one of these drugs.  It is also a plus that neither of these drugs are true Chemotherapy, so the side effects (which there will still be some with either drug) are much less than with conventional chemo drugs.

The arm I really want is drug A, or Resonate.  This drug is a pill you take every day.  There are 3 outcomes possible.  You get worse, stay the same, or get better.  In the over 400 patients on this drug, only 3 have gotten worse, and the majority have gotten better.  This is REALLY good news for the CLL community.  We now may have a drug that you just take every day and it keeps you in remission.  It is the talk of the town and the company’s stock has gone from 7 to 65 in 9 months.  The company name is Pharmacyclics or PCYC for anyone that cares.  Johnson & Johnson thought so much of the company that they loaned them $800 million to continue their development of the drug.  Even though there are still side effects, they seem to be manageable, and as they say it beats the alternative.

So what happens if I get drug B?  I could just stop the trial, or I could hope I get a positive response from drug B.  Dr. Kipps thinks I will, so that is good news.  The first part of the trial is only 6 months, and I have been told that if I complete the 6 months that I would be first in line to get drug A sometime in the future.  So this makes you stay in the trial no matter which arm you are assigned.

There is a lot to be done before the 30^th.  They still have to go over my records to determine if I ‘qualify’.  I also have to have a boatload of tests to establish the baseline of BEFORE the treatment.  So next Wednesday I will have a bone marrow biopsy, my monthly infusion of IVIG, a CT scan, and EKG and an Echocardiogram.  All of this in one day.  I told them I would rather do it this way than have to make multiple trips to La Jolla.  So it is really my choice and I am glad they could accommodate me.

The good thing is that I am feeling well, and we just got back from 2 weeks in Hawaii.  We spent a week on the Big Island of Hawaii and a week on Maui.  The nice thing about Hawaii is that it always the same, pretty much paradise.  We are taking a couple of short trips before I begin treatment because that is going to tie me down for about 2 months.

Terry