At the Crossroads Once Again

Today I had a visit with Dr. Kipps and the news I had been expecting for about 2 months finally happened.  It looks like I am beginning a new round of treatment, maybe as soon as this week.  End of short report.

This has not come as a complete surprise.  My numbers have been going the wrong way for over 3 months, a month after I stopped the clinical trial.  Today, Dr. Kipps took a long time in reviewing all my data before he came in to see me. When he walked in, I told him that this was not a good sign, and I immediately figured out what he was going to say.  Once again, he is concerned that I will spiral out of control too quickly, and then my options become limited. 

 As some of you remember, there was some glimmer of hope that I could wind up getting the drug (Ibrutinib) that was on the other arm of the trial.  This appears NOT to be an option.  The drug company is pushing so hard to get this approved for the general population (see BIG $$$$$), that small matters, like taking care of those people who proved the value of their drug by participating in a clinical trial, are pushed aside.  I do understand rules and regulations making sure that drugs are safe for people, but I don’t think the fault lies entirely with the FDA.  I think the drug company should step up and take some moral responsibility for their role in this.  I could devote an entire blog to this topic, but I will save my venom for killing those nasty cancer cells.

 Based on the fact that I have had Autoimmune Hemolytic Anemia, and the fact that my prognostic and genetic markers make me a difficult patient (no comments) to treat, Dr. Kipps is fairly certain that no treatment using chemotherapy will ever be in the cards for me again.  The protocol that I will be starting is using two drugs, Revlimid, a pill, and Rituxan, an IV infused drug.  The pills are given 21 of 28 days on a monthly cycle, and the Rituxan, is given once a month.  The length of treatment should be about 7 months, with a possibility of an extension depending on how I am doing.  Revlimid is an immune-modulating drug, and Rituxan is a monoclonal antibody.  Neither of which is chemotherapy.

Right now we are working on approval from the drug company and from the Insurance company to determine my eligibility and the out of pocket costs to me. 

 There are several other drugs that are close to beginning clinical trials, which have shown very positive results. So if this doesn’t work, there are still things in the wings that may fit the bill for me.

 None of this news took away from a joyous event for the Evans Family 2 weeks ago.  Our son Jeff, married his longtime girlfriend Kristen, in a beautiful ceremony.  Family and friends gathered together to celebrate this memorable event.  Since my diagnosis I have experienced 3 weddings and the birth of two grandchildren.  I thank God every day for the life he has extended to me and the fact that I am healthy enough to enjoy all the blessings that he has bestowed on our family.

 For those of you that care, Crossroads was the name of a song that was written by the famous blues guitarist Robert Johnson.  It was made popular when the Cream (Clapton, Baker, Bruce)recorded the song, and later became the name of a boxed set of Eric Clapton songs from all of his groups, The Yardbirds, John Mayall's Blues Breakers, Cream, Blind Faith, Delaney & Bonnie & Friends and Derek and the Dominos, as well as his solo career.  For some odd reason when I chose my blog title, that song came to mind.  Don't ask me why...It was the 60's.

 

Terry

Another Reason for Celebration and Equipoise

Two weeks ago had my one month follow-up blood test and I also received my monthly IVIG infusion.  All my numbers remain the same, as I would have expected.  Now I get to wait another month and have a bone marrow biopsy to really see what is going on.  For the last 6 months I have been receiving Ofatumumab, which is supposed to manage the CLL, at least in the short term.  Next month it will have been 2 months since I received an infusion, so we will see what happens then.

The most exciting news in the Evans Family is the birth of our second grandchild on April 15^th.  Naomi Jean Evans came into this world very quickly.  We received a call around 5am saying Matt and Randi were going to the hospital and at 8:15 she was born.  Donna flew up that day and I followed the next day.  We stayed in Seattle at Matt & Randi’s  for a week and it was a real treat to be able to spend time with them, and the new family member, Naomi.

There was an interesting post 2 weeks ago by a prominent CLL expert named Dr. Susan O’Brien.  In this post she argues that there is no sensible reason for not allowing the 180 of us who were on the Clinical Trial and received Ofatumumab to now receive the trial drug, Ibrutinib.  The interesting thing is that ALL of the major CLL experts in the U.S. agree with her.  The problem here is the FDA.  They follow guidelines that are completely out of touch with reality.  It is well documented that Ofatumumab will give CLL patients a partial short lived remission.  So when I start to relapse, wouldn’t it make sense to move me over to the Ibrutinib which has had a 95% success rate in controlling CLL.  Although the trial officially closed in April, the documented results may not be available for over a year.  So, I suppose that you hope and pray that you can wait that long and have the drug approved for general distribution.  Seems like a crazy system to me.

http://www.ascopost.com/issues/may-1,-2013/ibrutinib-cll-trial-where-is-the-equipoise.aspx

So which category did you fall into?  Already knew what equipoise meant, didn't know, but looked it up, or didn't care?  I'm not doing your work for you.  Figure it out.

 

 I had an ‘end of trial’ CT Scan in March and results show that my lymph nodes have basically stayed the same (after initially shrinking at the beginning of the trial).  I am scheduled for another bone marrow biopsy in June to see how the drug impacted the marrow.  Then, in July, I will see Dr. Kipps and figure out what my next steps might be.  I’m still feeling well and enjoying life.

 

Terry

D(ONE) Once Again!

After 6 months of treatment I finished my Clinical Trial on Tuesday.  All of my numbers continue to look good and now we get to wait.  I will have monthly blood tests and another CT Scan at 9 months to check for disease progression.  End of short Report.

 I have now officially finished my 5^th treatment since 2007.  I have to say that this last treatment was the mildest of all the treatments that I have received.  I basically have had no side effects, and the only issue is to go down to La Jolla and spend 5 hours in the infusion chair.  All of my numbers looks good and my physical exam is very positive.  The one thing that we do know is that the treatment that I received (Ofatumumab), knocks the disease down, but does not knock it out.  So the big question is how long will this remission last?  No one really knows as everyone responds differently, but the hope is that it will be a while before I need treatment again.

 What I am really waiting for is the availability of the Clinical Trial drug Ibrutinib.  This is the drug that was on the other side of the trial that I was on.  As I have mentioned before, the hope is that if I do need treatment again, that Ibrutinib will be available to me because I was on the trial.  No one knows when this drug will be officially approved by the FDA, but they are thinking sometime in 2014.  The results from Ibrutinib have been nothing short of amazing.  About 97% of the people who received the drug have responded.  This is unheard of in the cancer treatment drug world.  Besides the response, this drug is a pill, not an infusion.  It also is not chemotherapy, but it is called a Bruton Kinase Inhibitor.  If you would like a technical description, here it is:

 

Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel — regulating apoptosis, adhesion, and cell migration and homing. Through these multiple actions, BTK helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a microenvironment necessary for survival.

 I thought that was pretty humorous.  If anyone would like a more detailed description, you can email me.  Even if I don’t get Ibrutinib, there are a number of trials of non-chemo based drugs that are really promising.  The talk among all the CLL experts is that they expect that in 3-4 years there will be no chemotherapy used in the treatment of CLL.  This is really exciting news.

 There is always excitement in the Evans family.  We are now anxiously waiting for the birth of our Second grandchild (a baby girl).  The official due date for Matt & Randi’s baby is April 18^th, and we are just waiting for the call so we can fly up there.

 Some people may be wondering what the title of my blog posts actually means.  You have to have read this far to find out.  You will notice that the ONE is in parenthesis.  This is because the word DONE has a double meaning.  I received my last treatment on Tuesday, and on Wednesday I went out and played golf.  On the 3^rd hole at El Dorado I got a hole in ONE.  Hence the double meaning.  So you can tell that this treatment affected my golf game in a positive way.

 All for now.  I hope to be boring for a long time.

Terry 

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

4 Down 8 to go!

I just wanted to send out a quick update after my first month on the Trial.  I have had 4 weekly infusions and so far all the results are positive.  I have 4 more weekly infusions and then 4 months of monthly infusions.  So if all goes according to plan, I will be done in April. 

So far the only real issues have been the length of the infusions.  They take between 5-7 hours so it winds up being a very long day.  I have not had any infusion reactions, which are pretty common with this drug.  I have also not had any post infusion reactions with the exception of being a little tired for a day or so.  I did wind up getting a cold after week 2 and I am just now getting back to normal.  I don’t know whether it was lengthened because I was in treatment, because I have a compromised immune system, or because it was just a really bad cold.  I did start preventative antibiotics just to protect myself from a more serious infection.

I did have a 4 week check by the doctor and he commented that all my blood numbers are moving in the right direction, and my nodes and spleen have shrunk.  He did mention that the most dramatic results will be in the first 8 weeks, and after that we will probably not see much movement.

All in all it has been a boring first month, so let’s hope the remainder of the treatment goes as smoothly.

Terry

It has begun

On Tuesday I started the new Clinical Trial.  As you may remember the trial consists of two different arms with one being a pill (the one I thought I wanted) and one being an infusion.  By random draw I got the infusion.  The first infusion is now over, and I only have 11 more to go.  End of short report.

Before I could begin the trial I had to have a number of tests, sign paperwork, and be 'approved'.  All of this was done in the last two weeks.  Last Friday I got the word that I was accepted and which arm of the trial I would be in.

Tuesday turned out to be a LONG day.  Over 15 hours door to door.  I first had lab work, then a doctor’s appointment, more lab work, the pre-meds, then the infusion.  The total infusion time is about 7 hours.  At first I was a little disappointed that I got the infusion instead of the pill, but after talking to Dr. Kipps, I think that I will have a good response to this drug.  It is called Ofatumumab, or Azerra.  It is a monoclonal antibody like Rituxan is, but it is a second generation of the drug.  It is approved for use in CLL so it has been around for a while and even though there are side effects associated with it, they can be managed.  Tuesday I got what they call a TEST dose.  It was only about 1/6 of what I will get in subsequent doses.  They want to make sure that you don’t have a reaction to the drug and that is why they give such a small dose and give it over a long period of time.  My dose next Tuesday will be 6 times as much and given over a shorter period of time. 

I will get a weekly dose of this for the next 7 weeks and then I will get a monthly dose for the following 4 months.  So the total time will be 6 months.  We are not quite sure what happens after that.  There is some talk that the pill drug might be made available to those patients that need it.  Obviously if all my counts, scans and physical exams show I am back to normal there would be no need for the drug.  But if at some time in the future I would relapse, I may be first in line to get the pill drug, called Ibrutinib.  The main goal here is to buy me some more time and not burn any bridges for future treatments.  I think the Ofatumumab will accomplish this.

I have had very little side effects from the test dose and the nurses all expected that because of my past experiences with Rituxan I wouldn’t have very many with the Ofatumumab either.  The measure of how well I am doing can’t be really verified until another CT scan and a bone marrow biopsy.  But I think they will know in a few weeks if I am responding.

Thanks for all the well wishes and prayers, they are uplifting. 

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