A Boring Report

I haven't posted for a while so I thought I would post a short update on what is going on.  The good news is that this drug, which goes by 3 names, PCI-32765, Ibrutinib, and finally Imbruvica, seems to be doing what it is supposed to do.  My counts are all moving in the right direction and my side effects have been minimal.  I can't say that they are non-existent, but they do seem to be manageable, and also transient.  They seem to come and go, but mostly they come and then disappear. I have monthly visits until April and then I go to every 3 months. 

The drug is made by a company called Pharmacyclics, but because they needed funding, they partnered with Jannsen, (who is actually owned by Johnson & Johnson).  In November the FDA approved Imbruvica for Mantle Cell Lymphoma, but for some reason held back the approval for CLL.  The thinking was that they were waiting for some Clinical Trial data that would be finalized in February.  If everything goes according to plan, it should be officially approved in February for CLL.

As some of you remember, I am getting monthly infusions at Moore's Cancer Center of IV immunoglobulins, or IVIG.  I have been doing this every month since November of 2007.  Since I have a compromised immune system, this monthly infusion helps protect me against common infections.  I was recently told that in the near future Medicare will no longer pay for Medical Center infused IVIG.  It will have to be self administered at home.  The problem is that at home you can't infuse it as fast, so you have to have WEEKLY infusions that last 2 hours.  I wonder how long it will be before we have to perform open heart surgery on ourselves?

We continue to make plans (now that we can) and we will be traveling quite a bit in the next 4 months.

Boring is good!

8 Down & 4 To Go

I have finished my 8 weeks of Azerra (Ofatumumab) and now get 5 weeks off.  All in all the treatment was a non event for me; it just takes a long time to get.  It is usually an 11 hour day, which is probably why I am tired after the infusion.  I have no real side effects with the exception of some slight numbness in my fingers and lips and a slight cough , which I always had with Rituxan.  So I get to enjoy Christmas, the New Year, and a cruise to Mexico with the Barden side of the family in mid January.  Life is good.

After the ASH (American Society of Hematologists) 2 weeks ago, there is a lot of encouraging news of the drug front.  Ibrutinib, which is the drug in the other arm of my trial, has had a 96% progression free survival on patients 22 months out.  This is nothing short of amazing.  The drug is a pill, taken daily, and has very few side effects, all of which can be managed.  Here is a link to a talk by Dr. John Byrd from OSU talking about the Ibrutinib trials.  http://www.onclive.com/conference-coverage/ash-2012/Dr-Byrd-on-Ibrutinib-in-CLL

I am now on a monthly schedule and will get 4 more doses before I complete the trial comparison in April.  Even though my blood numbers are all in normal range, they are at the high end, and have not dropped to the low levels that I experienced in the other trial.  I did have a doctor exam on Tuesday and he said that everything looked good, but that he would have a better idea after my 5 weeks off. 

This is somewhat of a two edged sword.  If I completely respond, then I won’t need the Ibrutinib.  If I do respond, then I am not proving that drug A is better than drug B, which is the whole point of the study.  And if I don’t respond that well, and/or if I relapse quickly, then I will need treatment again, and hopefully they figure out a way to get me the drug A. 

Other than a few “over 65” medical issues, I have been feeling fine.  Everything is on track for a Family cruise in January, a trip to Seattle in February, a new grandbaby in April and a wedding in July.  All just part of the normal Evans family life.

Please keep my life long friend 'Tall Tom' in your prayers as he gets an experimental stem cell lung treatment at the end of December.

Wishing everyone a Merry Christmas, believing that there is a reason for the season, and a Healthy and Happy New Year.

Terry

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