Time Flies When You are Having Fun (or NOT!)

I can’t believe that it has been almost 9 months since my last update.  So, first things first.  Yes, I am alive, well and still kicking.  End of Short Report.

The world is still a very strange place, not at all what we were used to a year ago.  As an immunocompromised patient I have been a little more careful than the general population because the preliminary statistics for CLL patients that are hospitalized, is pretty grim.  Between 25-30% mortality.  Granted this information is from very early in the pandemic and the courses of treatment have changed for the better, but it still gives me pause to be cautious.  Bottom line, ‘stay out of the hospital’. 
But, as with everyone, the world doesn’t stand still.  I still have doctor appointments, some I can do via telemedicine, but some have to be done in person.  I had a long overdue colonoscopy in May and it was a good thing I did, as they found 7 polyps (all benign) and they removed them. I do need to make a dentist and eye appointments, which were put off because of the pandemic. 

One sad piece of news is that my father, Paul Henry Evans, passed away in September.  He was almost 94 years old and had been in failing health for about 6-12 months.  He did not die of COVID, but his passing was a huge loss for the family.  We could not have a funeral, so we had a Zoom memorial service which was nice in some ways, but very sad in other ways.  He will be greatly missed by many.

So, to update my CLL journey, here is a refresher.  I won’t go back to 2000, the year I was diagnosed, but will start with my last 2 (out of 6) treatments.  If you remember, in 2013 I was allowed to crossover and start taking a new class of drug called Ibrutinib.  I was part of the Clinical Trial the FDA used to approve the drug for all CLL patients.  I had very good luck with Ibrutinib and remained in Clinical Remission until January 2018, or 4 ½ years after I started.  In January of 2018 things started to change very slowly, and both myself and my doctor could tell that I was relapsing, even if it was at a very slow pace.  I started look around for my next steps and was disappointed to find that there were almost NO options for a patient with my treatment background.  Because of prior treatments I was excluded from almost every option of treatment.  I guess my situation got my doctor’s attention because he CREATED what is called an Investigator Initiated Clinical Trial.  This is a case where the medical team proposes the treatment protocol and the drug companies agree to let them initiate it.  I wound up being patient #1 on this trial.  The new trial allowed me to stay on Ibrutinib, mainly because it was still working, just not as well as before, and because he wanted to add another drug (Venetoclax) to see if there could be some synergy using both drugs at the same time.  There had already been some preliminary studies at this time that had shown that they worked together in front line settings, but not much data on people like me, in a relapsed setting.    As you may have read in previous posts, this combination for me, was amazing.  Within weeks of starting Venetoclax, my blood numbers were all back in normal range.  After several months there was a test done to see if they could find ANY CLL cells and the test came back negative. 

This was all great news, but we had to now figure out what to do.  I know this may seem strange to many of you, because the logical thing to say is ‘keep doing, what you are doing’.  But it is never as simple as that.  Most of the trials that had been done with Venetoclax had been done in what is called a ‘fixed duration’ setting.  Which means, you take it until you test Negative for disease, and then you stop.  I think the main reason that this was done, is if you continue taking it, would there be a possibility that even if you are negative, would you develop resistance to the drug after some period of time?  Because my particular situation does not fit into one of the categories that were done in earlier trials, we had to decide on what to do after I became Minimal Residual Disease Undetected (of MRDu).  So, we kept on having tests to measure for disease, first in the peripheral blood and then thru a deeper test using the bone marrow.  Tests were run at different intervals and they all have come back negative.  But in October of 2020 we were at a decision point.  ‘how much value was I getting by staying on Venetoclax?’.  The short answer is that no one knows.  But a couple of points led me to a decision that I should stop the Venetoclax, but remain on Ibrutinib.

 
First off, I had not relapsed on Venetoclax.  It was still effective.  If I had relapsed while on Venetoclax, we would know that it had STOPPED working and I would have to find another class of drug.  There were also some studies published in December that in a small group of patients that stopped Venetoclax while they still had no disease, and then relapsed, they were able to RESTART Venetoclax and they mostly had very positive results upon restarting.

Secondly, I had to pay for the Venetoclax on the trial (the Ibrutinib was paid for by the pharmaceutical company).  It is a very expensive drug, retail cost about $12,000 / month.  If you don’t have Medicare Part D for prescription drug coverage, forget it.  Luckily, I do have a Part D plan, even with that and falling into what they call Catastrophic Coverage in the FIRST month of the prescription, you still have a lot of out-of-pocket expenses (about $10-12,000) per year.  The coverage is base on Calendar year, no matter when you started.  So, in my case, this bill would have hit in January 2021. 

Thirdly, I was still having some Adverse Events (fancy name for side effects) that we were not able to control completely.  I won’t go into detail, but let’s just say I had some GI issues.  So, stopping the Venetoclax would hopefully clear those up as well. 

Based on all of that, we decided to stop the Venetoclax on December 31, 2020.  Now the real question (and the reason for this post) is what will happen to my CLL after I stop.  I am happy to inform everyone that I just got the results back from the test that was done on March 10^th and they still cannot find any disease. 

Good news for sure, but it is never the end.  The question is what happens when I relapse again?  Certainly, my situation was not as dire as it was in January 2018, when there just weren’t many options, but there still needs to be a plan in place as to what to do when that happens.  My first option would to go back on Venetoclax and see if it would work again.  My second option would be to look at a third-generation version of Ibrutinib.  This newer version is supposed to ignore the mutation that caused me to start relapsing on Ibrutinib.  There are also several new and exciting drugs that are in Clinical Trials, but I don’t know if I would qualify for one of them or not.  My last option, but maybe the most important one that I am considering is something I have mentioned before called CAR T therapy.  It is in Clinical Trials right now and has the potential of completely getting rid of the disease.  I know of several people that have done this and they are disease free after 3 years.  This one certainly looks like a potential ‘cure’.  There are no guarantees with this treatment as it doesn’t work for everyone, but it is certainly on my radar and actually have an appointment in April with a doctor at City of Hope that specializes in this treatment for CLL patients. 

I know there is a lot of talk about the COVID vaccine and how it may be a way out of this pandemic, but for those of us that are immune compromised it is still not a pretty picture.  Because our immune system doesn’t work the way that it does in normal people (I’m not saying I’m abnormal, just different), we really don’t know if we will develop any response to a vaccine.  This is not only true for the COVID vaccine, but also for pneumonia, flu, tetanus, etc.  I hope I got some response to the vaccine, but only time will tell how effective it really is going to be, how long it will last, and will we have to get another one next year, like the Annual Flu Shot.

I am still involved in Patient Advocacy and still leading my support group.  I have also been involved in several online webinars with teams of doctors discussing the patient’s role in dealing with CLL.  I have been interviewed for two podcasts, one published, and one yet to be published where I discuss my journey.  Here is a link to the Podcast that was done for THE GREG KRINO SHOW  (Click the link to listen to the show).  Greg has created a Podcast where he interviews people that have had interesting life experiences.  I was fortunate to have been interviewed by him for his show.  Check out his list of over 30 Podcasts.  His Facebook Link  The Greg Krino Show Facebook Page .

See you again in another 6 months or so…ha ha.  I hope you all stay well.
Terry