Much to catch up on

So much has happened in the past week that I have to start at middle of next week, and go forward. I had left last entry that we were waiting on Insurance coverage to come through, and it got interesting from there.

Middle of last week, we got a preliminary denial from the insurance company, which at the time didn't seem to unreasonable given that we know that they do not cover Phase 1 trial drugs. We were told by OHSU that it is unfortunately common, and usually approved upon peer review. So my dr. at OHSU was going to talk to the medical director of my insurance company, Friday morning. As luck had it, it was the same time that I was scheduled for a transplant consultation at SCCA. This is being done to make sure that we proceed as far as possible with planning for the transplant, without actually doing one. The whole idea of the drug trial, is to hopefully finally get the results we are looking for from a single pill a day.

Cynthia had her blackberry with her into the meeting, and we knew an e-mail would be forthcoming. Towards the end of the meeting, we received word that we had been denied, even after the peer review. I think OHSU was simply floored, they had not experienced this before, and my participation was at risk to say the least. Literally when we walked out of the SCCA meeting, I was resigned that I was 3-4 weeks away from a transplant.

Now Cynthia has a more assertive approach to these things than me, and after some deliberation, we decided to reach out to OHSU and see if we could still enroll in the study, and pay our portion that the trial wouldn’t cover. We didn’t know the exact costs, but we knew that if we didn’t enroll on Friday, we would miss the window and have to possibly wait 1 more month, which did not seem like a good idea given that I am on no drugs at all….

OHSU did a quick check, and said that would be fine. Although I would need to get down to OHSU that afternoon, since there is a consent form that had to be signed in person with the Dr. he was going to be out of town the following week, so we looked at each other, and simply pointed the car south. We made Portland in a little more than 3 hours, which on a Friday afternoon is a small miracle.

When we got back, we knew that we had bought us some time. We were told there were other appeals avenues, but the problem we had was that I had to be enrolled on Friday, or wait. I reached out to a former manager at MS, who put me in touch with a Director in HR. I know realize how huge that was, since while we were sitting at OHSU on Monday, the nurse popped her head in and said that it was now approved and they were getting it in writing from the insurance company. I literally felt my shoulders drop 2 inches, due to the stress we were under.

So Monday turned out to be an all day screening day. Besides a blood pressure issue, I did very well, and the team understands that it’s stress/anxiety induced, but we are closely monitoring it.

 So today (Wednesday) I am literally sitting in the recliner at OHSU, with an IV hooked up to my arm so that they can take blood without poking me with another needle. I took my first dosage of 60 mg at 9:10, and I am getting blood draws very frequently. The last one today will be at 5:10.

I think in the last week, I lived through every possible roller coaster experience I could imagine. Through this all, I can’t express how much Cynthia has done, and made me able to do. I find that I lean on her more and more, since when it becomes overwhelming, she has the ability to see things clearer. We also have had incredible help from her mother and Aunt to help with the kids while I’m out of town.

Right now, it looks that I will be calling my address Portland for at least 10 days. I can’t go home this weekend which is a bummer, but I did bring my golf clubs, and my newly acquired Big Bertha driver from Brian. I plan to vent any frustrations over the past week, on some innocent range balls…

10 days off Sprcel

October 26

Oct 28th - 10 days off Sprycel and other updates

Being off Sprycel was kind of the reverse of going on the drug in the first place. Some mild headaches, that easily went away with Tylenol. Once through that, I am feeling better, and my weekly checkup numbers have shown that my White Count has increased slightly from 2.2k to 2.8k, and my platelets have gone up from 44k to 58k. My hemoglobin has also gone from 9.7 to 11.3, which is correlating to more energy.

 

On a different note, our friends gave us an absolute wonderful weekend. Between babysitting, bringing food, watching the kids so that Cynthia could finish up a project in the house, and a great round of golf, it was a very good weekend. Christian especially loved the sitters, he asked me today 'where are the guys' ?

 

So Plan A is still the drug study at OHSU. Hopefully we sorted out some insurance questions today, I've been told that I may start as early as this week. I'm eagerly awaiting a start date, we're ready to get going on this study. My numbers are slowly going up, so we're not greatly concerned, but I feel somewhat unprotected not taking any drugs. But with the T315 mutation, I know now that none of the existing meds would do anything for me long term.

 

On another note, during my blood draw today, Dr. P stuck his head in (I was only supposed to see the nurse), and he said "you better be nice to Tanya" ...it really caught me off guard, since I wasn't expecting to hear anything yet. While there is another test they do, he is pretty confident that she is a 10/10 match for me. We haven't heard back from Kristine yet, but having just one of them being a great match, is grealy comforting. I knew I had a good chance to find a good match on the registry, but of course a sibling match is ideal. Transplant is still Plan B, but it's nice to know that I have Tanya as a good match for me.

 

Smoking gun

One of the hardest things for me has been not able to explain what the heck is going on. I 'failed' Gleevec with no mutations found, and then I am having little effect with Sprycel. It's been extremely frustrating to not be able to explain what was going on. I have asked myself countless times, would I be better off going the transplant route, rather than the Ariad study, since we had no documented evidence that Ariad would be able to help me. I suppose because of that situation, starting the process of preparing for a transplant has been easy to accept, since I have no idea of what Ariad could do for me.

 

On Monday, I got a call from Dr. P, and he left me a message that he would try to reach me that afternoon. I’ve come to learn when a Dr. calls you and leaves a message with no content, it’s never good news. I learned that from my day of diagnosis, when my dr. asked me to come back the following day. I’ve also correlated the seriousness of the news with being able to discuss over the phone, or have to go in person.

 

He called back a little while later, and the news he had was related to my mutation report. For those who may remember, a mutation report was done back in June after failing Gleevec, and no mutations were found. This time, it came back and it showed that I have the infamous T315I mutation, which is known to resist both Gleevec and Sprycel (and Tasignia as well).  This is probably the most known mutation of CML, since it’s documented for quite some time, and no drug to date has managed to show good results against it.

 

Now we know why my CBC’s were very good, but my Cytogenetics were not improving. As Sprycel/Gleevec were killing off the non-mutated leukemia cells, they were being replaced by the T315I cells which the drug was not able to latch on to. This resulted in over time the percentage of T315I cells becoming more than 20% of the overall number of stem cells (which is when they typically show up in a mutation study). This replacement of bad with worse cells has been happening over time.

 

This helps address a nagging question, would increase dosage of Gleevec worked for me, would increased dosage of Sprycel do the trick, or switching to Tasignia ? The answer for all is no. It’s clinically shown that none of those will address the T315I mutation. In fact, without Ariad, there would only be one option on the table, a Bone Marrow Transplant.

 

So, in a way, this is good news. I am hesitant to share too much about other people’s result on Ariad and T315I, but it’s safe to say that I am now a better fit for Ariad than I was before, since that drug is designed to tackle the T315I mutation as its primary objective, among others. In fact, the press release in July calls out the effectiveness on that mutation.

 

So I remain cautiously optimistic, I have been told that they should be enrolling me no later than the end of this month. SCCA and OHSU is coordinating my treatment, and I just learned today that they want me to discontinue Sprycel to allow my numbers to rebound before starting the new drug. It does mean a month in Portland, so I’m reading myself on all levels to be down there and focus on what I need to do. Now it’s game on, we know within 3-4 months, there will either be good news on Ariad, or transplant will be the plan of record.

 

Thanks again to Mandy/Tyler, Amy and Beth and Bobby who have been a wealth of information and someone to lean on. My aunts have also as usual been able to provide encouragement and support that only they seem able to do.

2nd update of the day

Just a quick note talked to Dr. P today, and he and those he consulted didn't think that putting me on higher dosage of Sprycel or moving me over to Tasignia would get the desired effects. They just think it would be lowering my blood count numbers, and may not be a long term sustainable response.

 

They are running another mutation test, which may show us if it's mutated, or something else going on. We are in a wait and see until we get that back. I did schedule some time to go down to OSHU to meet with someone regarding the Ariad trial, and see if my profile is a good fit for the trial drug. It wasn't that long ago that Gleevec, Sprycel, Tasignia were all trial drugs, and they have done mirables for 1000's of people. So a 3rd generation may be worth exploring. They are in a phase 1 study, determining the right dosage. Tyler is going with me, we're heading down to Portland on Tuesday.

 

Speaking of Tyler, I feel blessed to have a friend like him. I truely feel blessed with all of our friends and our families, but having Tyler in our life has allowed me to turn to him when I need a friend to lean on, to talk CML about, and just about anything else in life. Thank you Tyler !

 

Meanwhile we're getting the process started on getting my sisters HLA typed, since I have to face it, a transplant is a good possibility as my treatment of choice. I still think that we're in a little shell shock that our list of options is shrinking.....

3 month results on Sprycel

We met with Dr. P yesterday, the results were in from the BMA last week. Unfortunately, it's still not the numbers we're looking for, my Cytogenetic moved a whopping 1, from 20/20 to 19/20...The other (FISH/PCR) stayed roughly the same. We're mostly focused on the Cytogenetics since that is the one we first have to get down (goal is 0/20).

Now the words of Dr.D are still ringing in our minds, "don't expect too much from the first 3 months on Sprycel", so we're not quite flipping out yet. We had hoped to see something, since my counts had all been pushed lower on Sprycel. Dr. P is already consulting with Dr. D on what options we may have, since we can up my dosage, look at Tasignia, or possibly a trial drug. I'm even considering the option of going to 800 mg Gleevec (not sure they will give me that option). What is compelling about Gleevec to me is that there is a test to measure what your concentration of Gleevec is in your blood, where as there is no test like that for Sprycel. I keep wondering how much of the drug is getting to where it needs to go, and would a dosage increase help. Given that my blood counts are soo steady, the drug is doing something good, it's just not getting us the last 10% of the way there....

We did start the process of getting me HLA typed and also going to be getting my sisters typed. This is still plan B or C, but it's prudent to at least know. I do have 115 now on the Leukemia site that are a 6/6 match for me (up from 107 in March), so there is a very good chance that we can find a good unrelated donor if needed.

I purposely try not to put too much emotion into blogging, but I can't hide that I'm definately disappointed. I think getting HLA typed yesterday and have to even have the conversation with Dr. P makes you face the reality that I may have to follow Tyler's route one day.

The good news is that I'm still just chronic, in that my marrow is being kept in control by the meds, I'm not failing with increasing white counts. It is just this is going to hang over my head, until we get the numbers down.  I'm now just waiting to hear back from Dr. P after he has consulted with Dr. D on what to do next. It appears I just have a very stubborn form of CML that the meds have a tough time penetrating. Since my CBC numbers are soo steady, it's surprising us since the meds are clearly having an impact, just not the fully desired effect.

3 month biopsy on Sprycel

Just a quick note, today was my 3rd BMA (Bone Marrow Aspiration) since Diagnosis. At least I know what to expect each time now, and the dr's have it down to a relatively simple procedure. I had been toying with the idea of not taking one of the 2 pain medications, but sure glad I did. He had to do it twice today, and it was a little more painful than I remember on the 2nd try. But I think they got some good samples, now I wait for a week until I see him next week to talk about the results. Normally he would simply call me, but this time we're going to meet.

 

The reason to meet, is that he wants me to have a CBC (Complete Blood Count) run again, this one is pretty straight forward, and happens everytime I walk into the building. Draw blood, and the results are ready by the time I see him upstairs. The reason he wanted to run CBC again, is that my White count has dropped even further, to a new record low of 2800 and my platelets that seemed to have done a drop from 200 to 80, then back to 90, are now at 48k. Pretty much all my numbers dropped, also making me a little anemic and fatigued. I must be more plugged into my body lately, since I had been feeling more tired than usual.

 

So, again, in this game anytime you're numbers are dropping, it's usually a good thing. He thinks our discussion in a week *may* include dosage if I fall too low, possible a short break, or just a reduction from my current 100 mg a day. Both scenarios are totally normal, and it seems like a majority of CML patients have experienced these situations.

 

I'm just coming off the drugs, so my hip throbbing in pain, but that too shall subside....

2 months checkup on Sprycel

Had a checkup last week, with Dr. P. My WBC have stabalized at 3k, and the platelets were back down to 80k. Since they had bounced a little back and forth, he's comfortable that it's stablized with this new baseline. On Gleevec, my platelets held around 200k, but on Sprycel they seem to be in the 80-90 range. The other WBC numbers are also staying steady at around 50% less than Gleevec. The data guy in me wants to do a time series analysis, but I'll leave it with 'something is going on'.

 

My next appointment is 6 weeks out, in end of September to do the always fun Bone Marrow Aspiration. This will be my first since Sprycel, although I keep hearing dr. Dukers voice say not to expect too much in the first 3-6 months.