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!

Senior Moment

After waiting 18 months to get Ibrutinib (now called Imbruvica), you would think that picking up my pills would be the foremost thing on my mind.  So last Friday I went down for my 1 month checkup and blood draw.  My blood numbers are going the way they expected them, and the doctor visit showed improvements in both my lymph nodes and spleen size.  So after getting the good report we decided we should get some lunch on the way home and we walked RIGHT PAST the pharmacy.  So at 3:30 that afternoon (after I was home) when it was time to take my pills I realized that we had FORGOTTEN to pick up my next month's supply.  I frantically then called back down to La Jolla and asked what I should do.  I knew I couldn't get back to the pharmacy by the time they closed, but when I called them they said not to worry about it since I would be back on Tuesday for my monthly IVIG infusion.  They told me that 3-5 days off of the drug is not critical because it is such a slow acting drug.  Whew! 

Enough of the sob story.  I am actually feeling pretty well.  No major side effects, just a lot of small irritating ones.  None of them are as bad as some of the side effects I have had in my past treatments, so that is a blessing.  The strange thing about this drug is that it causes your white blood count to rise.  That is really counter intuitive.  You would think that since CLL is mostly a disease where the white count goes up, that you would want your counts to go DOWN?  I started this treatment at 80,000 (remember normal is between 5-11,000), and after a month I was up to 160,000.    This means that the white cells that were 'hiding' in these places are being forced out into the bloodstream, hence a rise in white count. This makes some sense because my lymph nodes and spleen have shrunk down to almost nothing. This is pretty much normal for this drug.  Most of the people that I know that are on the drug said it takes about 2-3 months before the counts start to fall. 

My new drug was approved by the FDA for Mantel Cell Lymphoma this month, and is expected to be approved for CLL after the first of the year.  I have been told that this really won't affect me and my access to the drug because I am on one of their trials and they still want to track my progress.  So I guess I will keep getting the drug from them until they decide it is no longer appropriate.  This is especially good news because the price of the drug has been set at $91 / pill, which for me would be about $8,190 per month before insurance.

Last month I did make a trip to San Francisco to Genentech to give a 'patient's perspective' on their drug Rituxan.  This gets a bit confusing.  I am no longer taking Rituxan, but have had it over 30 times during various treatments.  The people at Genentech know of my situation, but for some reason they still think that I can provide some information to their marketing teams.  This time there were over 30 participants that I spoke to and I think they got something out of it.  I also got a tour of their research and development lab, which gives me a greater understanding on why these drugs cost so much. I also had an hour long web interview with a company that is marketing a new CLL drug.  At least I am putting some of my experience to good use.

Being on this drug has allowed me to better PLAN my life.  For the last 6 months I have been trying to figure out what my schedule will be.  Now I know what it will be for at least the next 6-12 months.  That is a relief.  I am now able to visit friends in the desert, to go up to Seattle and visit my family up there, plan another trip to Spring Training in Arizona and think about a River boat trip to Europe next year.  Life is good.

Happy Thanksgiving to all.

Adopt the pace of nature: her secret is patience.

Well, after 13 weeks, I finally got the 'official' word that I will begin my new treatment on Tuesday the 29th of October.  After being told on August 8th, that the drug company had officially requested that a 'crossover' be allowed on the trial I was previously on, it has taken all this time to put all the paperwork in motion to allow me to have the pill.  As far as I can tell, I am only the 2nd patient in the U.S. that has been approved for this extension.  End of short report.

This has been an especially challenging ordeal for me.  In the past, when I have needed treatment, it usually started in less than 4 weeks, and there were few issues, just usually some paperwork to sign and maybe a couple of extra tests like bone marrow biopsies, or CT's.  But this time, it was all about waiting.  Waiting on the FDA, the European Medicines Agency, the drug company, the Institutional Review Board at UCSD.  I know in my heart that there are procedures that need to be followed, but when you are the lone guy at the end of the decision making process and you have NO input as to when the decision gets made, it is frustrating.  There was never any doubt that this was going to happen.  But drug company should have put it in the original trial protocol, after it was left out, they should have started to get it added to the protocol instead of waiting until the trial was over.  It was only after the open criticism by three of the top CLL doctors in the world, that there was any movement to allow the 180 of us who got Ofatumumab to crossover to Ibrutinib if we relapsed. 

Even though the CLL is progressing as shown by blood tests, I am lucky that I am continue to feel fine, with no B symptoms like fatigue, night sweats, anemia, etc. 

This drug, Ibrutinib, has had about a 71% success rate in previously treated patients.  So even though there is a lot of promise with this drug, there are those patients that do not respond or have side effects that can't be managed.  I personally know 4 people on this drug, and they all have shared their side effects with me.  For some, they are minor, and for the most part fleeting.  For others it has been a daily struggle to manage the side effects.  However, all four have responded positively to the drug, so I am hopeful I will also fall into this category.

So starting on Tuesday I will go to La Jolla once a week for 4 weeks, then once a month for 6 months, and then every 3 months indefinitely.  The treatment consists of a pill taken once a day, so compared to my other 5 treatments, this should be a piece of cake.

I don't think that this is the end all treatment.  I think there are new drugs on the horizon that may give a more durable response.  But for now, I will take my pill daily and be happy that I have been given the option.

On an editorial note, there is something called the Parity for Oral Cancer drugs.  What this means is that usually an IV infused cancer drug is mostly covered by insurance companies and Medicare.  If your drug is a pill (which mine will be), you are lucky if the insurance companies and Medicare pay 50% of the cost.  With the estimated cost of my new drug somewhere in the range of $8,000-$10,000 per month, you can quickly see how grave this issue is.  Right now only about 19 states have oral parity laws on the books, which makes them treat all cancer drugs the same, no matter how they are given.  Unfortunately I live in a state where there is no law requiring this.  There was a bill passed by both houses in California and for some strange reason Governor Jerry ' Moonbeam' Brown vetoed it.  I do not know the details of why he decided to do this, but it was probably because someone added a rider to the bill that made it objectionable.  This is trying to be addressed at the Federal Level, but you can imagine how that may work out. 

I am off again next Wednesday to fly to San Francisco for the day to speak at Genentech (the makers of Rituxan).  They have asked me to present a 'patient experience' to a group of new drug reps and marketing people.  I have done this once before and think that I was able to give them a personal view of how the drugs they are marketing affect the actual patients.  They must have thought it was a positive experience because they invited me back to do it a second time.

I feel blessed to be in this position now.  To be able to see my grandchildren Wyatt and Naomi growing up is something I doubted I would see.  My team of faith, family, friends and doctors keeps me going.  I have yet to break 80 in golf, but my 81 last Monday was close, just ask my friend Rick.

Terry

Sometimes good things fall apart, so better things can fall together

Well, after I posted my disappointing news on Wednesday, I get a call from UCSD on Thursday informing me that they just got done with a teleconference with the Pharmacyclics people.  If you remember, Pharmacyclics is the company whose trial I was on, and the one developing Ibrutinib.

Through some process I am not fully aware of, they have decided that the 180 people that were on  Ofatumumab (the side of the trial I was on) are now eligible to receive Ibrutinib.  There is no time frame given, but the guess is 6-8 weeks.  So all I have to do now is to remain relatively stable and healthy for the next month or two and I will hopefully get Ibrutinib.  I will get blood tests every two weeks to make sure I am staying stable.

When I got the call, I was still actively pursuing the Revlimid + Rituxan regimen and went so far as to confer with my prescription drug insurance company to find out what my cost would be.  I did find out that it would have been $2,800 for the first month, and then $300 per month after that.  If I do get the Ibrutinib as part of the trial it will be no cost to me for some time, so that is another reason to get the Ibrutinib.

 I will post an update when I actually get the pills in my hand, because by now, I know that things can change on a daily basis.

Terry

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