16 replies to this topic

[BklynCML]

I'm not new here, but I had to create a new account because the old one seems to have gone away. I am 47, dx Jan. 2011. started on Gleevec and reached CCyR quickly (a few months), MMR at around a year. I switched to Sprycel in 2/12 in the hope of fewer SEs and achieved PCRU, where I have stayed ever since. I got rid of the GI SEs, was a bit less tired, but still had significant musculoskeletal pain. Although I can't definitively tie it to the TKIs, my first winter after I was dx I developed a severe case of seasonal affective disorder, which has persisted. I am able to take the edge off with light therapy and Wellbutrin, but my functioning is significantly impaired.

I have been following with great interest the posts by those of you who have stopped taking TKIs. I have thought about it a lot and decided that I would like to try doing the same. I have three kids, and I used to have a great career I loved, and sports I enjoyed, but my lack of stamina and chronic pain limit my ability to participate. It's hard to think about decades more of this. I tend to be pretty anxious and risk-averse, so the fact that I have gotten to this place surprises me.

My regular onc would allow me short breaks and might even consider dosage reduction if I really pushed, but he does not favor stopping outside of a trial. I live in NYC and identified Columbia as one of the sites for the DASFREE trial, which is only for Sprycel patients. Assuming my most recent PCR is negative, I satisfy all the criteria.

For those of you in clinical trials, how does insurance coverage work? Did you have any trouble getting your insurance to cover more frequent appointments, blood draws, and the like? Did you inform your pharmacy benefit company (mine is Express Scripts, now Accredo, ugh) in some formal way?

I realize this is a long shot, but is anyone already on the DASFREE trial?

I would also love to hear from anyone who had significant musculoskeletal pain or depression and stopped their TKI. Did these SEs improve much? I realize we are all different, of course.

Beth

[mikefromillinois]

Hi Beth,

 

I'm in a TKI stop trial right now at the University of Chicago.  I was on Sprycel for about 4 years before stopping meds in the trial.  The trial itself pays for all bloodwork and most of the doctor visits, so there is no issue with my insurance company at all.  When I stopped taking the Sprycel I just matter-of-factly called the specialty pharmacy and told them that my doctor has me stopping the meds "for now" and they said no problem - just let them know when I would like more meds shipped.  I didn't get into the whole trial thing with them.  No need to complicate things right now until I have a feel for whether or not I will be off meds for a long time.  Certainly the insurance company will not complain about being off the hook for about $9,000 a month for the Sprycel cost.

 

I have never had any mood issues while on Sprycel.  But I have had a ton of other side effects - many of which I didn't REALLY know were caused directly by the Sprycel.  Now that I am Sprycel-free my fatigue has disappeared as well as most of my aches and pains.  I sincerely feel about 10 years younger.  I will be praying that I don't have to return to the Sprycel.

 

You will of course want to confirm with your particular trial the cost issue before joining if that's the course you choose.

 

Good luck either way...

 

Mike

[scuba]

Hi Beth,

 

I stopped Sprycel (20mg) but am not in any formal trial. I just decided to stop. Dr. Cortes is one of the primary researchers in the field and has some sway with the insurance companies in terms of what he does with his patients. And as Mike said above, stopping saves the insurance company a lot of money vs. monthly testing. Dr. Cortes was agreeable with my personal "test" and now is working with me to continue the cessation.

 

I 'hear' the anxiety in your note. What may be reasonable for you to try first is dose reduction. I was able to achieve PCRU while on 20mg Sprycel only. I stayed on 20mg for another 7 or so months before deciding to stop completely and test remission durability. Dropping dose first may alleviate your side effects enough that you may just stay at that dose and have peace of mind. Because you are a fast responder both on Gleevec and Sprycel, you probably are a great candidate for successful cessation. But you have to have no fear in doing so. Each day you go without your Sprycel could be a big issue for your mind. So a slow withdrawal with testing can be a big help. Toe in the water sort of speak. If you reduce to 20mg - you would only need to be tested like you are currently (every 3 months). If you stop completely, then you should be tested every month in order to catch any jump in PCR.

 

One big benefit of being off the drug completely once I had confirmation that relapse is not occurring is when I travel. I no longer have that "fear" .... "did I forget to pack my Sprycel!". It's a surprisingly nice feeling. Makes me feel normal again.

 

All the best,

 

Michael

[mikefromillinois]

My trial is not the DASFREE trial but the LAST trial - which is not Sprycel Specific.  DASFREE is a currently running worldwide study sponsored by Bristol Myers.  This is the US contact info:

 

United States

 

California
City of Hope Medical Center
Duarte, California, 91010
David Snyder

 

Ucsf Division Of Hematology And Oncology
San Francisco, California, 94143
Neil P. Sha

 

Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, 60611
Jessica Altman

 

New Jersey
John Theurer Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, 07601
Stefan Faderl

 

New York
Columbia University Medical Center (Cumc)
New York, New York, 10032
Mark Heaney

 

Texas
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Moshe Levy

 

The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jorge E. Cortes

[scuba]

"The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jorge E. Cortes"

 

 

Now that makes sense - no wonder I had no issue with stopping in terms of insurance. I bet BM wants a heads up on whether their revenue stream will dry up if more patients have success with stopping. Better to not be blind sided.

 

By the way, in my recent meeting with Dr. Cortes (first face to face in years - and only because of Tropical Storm Bill), he mentioned that he has suggested cessation to many of his patients, but they elect to keep taking their drug! The "C" word is powerful.

[Trey]

TKI cessation trials are important to advancing the knowledge base regarding long term CML treatment.  So it is a good thing that some are participating.  It is also important to remember that TKI cessation is experimental and usually fails to deliver the intended result.  The overall risks are low but not zero.  It is not for those who are uncomfortable about it because it would keep you up at night. 

 

Dosage reduction is much lower risk and also important to the advancement of the knowledge base.  It can be a reasonable choice for the longer term "maintenance" stage for those who responded well to a drug.

 

You know your own limits, so staying within them is usually the best approach. 

[Dom]

I can't address cessation or low dosage, I'm still on gleevec 400 as I have been since dx 18 months ago. But I can address muscle aches.

It was pretty severe for me at the 1 year mark. I tore a leg muscle just standing still in the shower and I had a month of extreme pain, requiring a cane just to walk, and sleep was impossible with a Percocet. I'm still not sure if it is age, or the TKI, or even the cancer itself. With some advise from this board, I approached it as though the TKI was the cause, and supplemented things with Centrum and magnesium 300. Worked like a charm. Now I make a point of doing simple exercises each morning. My legs are a little stiff, and getting up is a chore, but it's much better than it once was.

[scuba]

When I told Dr. Cortes of the leg muscle aches (on both Gleevec and Sprycel) he suggested I take 400 mg. Magnesium (as Citrate) per day. I did - and never had a leg muscle ache again. I now take 250mg. Magnesium Taurate because I am more concerned about heart issues than I am about CML because my family has a history of cardiovascular issues (diet induced). I also eat magnesium rich foods:

 

http://www.everydayh...-magnesium/#all

 

http://www.naturalne...absorption.html

[Dom]

Scuba, I have a family history of heart disease too. No male in my family ever made it past 60 without dying of a heart attack, and I'm 63 now. Why magnesium taurate? My doctor said to take magnesium oxide. I really don't know the difference.

[gerry]

Hi Bklyn,

 

I've been 18 months of Gleevec - working with my doc. I did a dose reduction to 300mg Gleevec after the first year of PCRU, then stopped after another year of PCRU.

 

i have had a direct route to doing this with my CML dropping down to negative fairly quickly and easily. I haven't experienced any blips in the 18 months I have been off. But have observed what other members of my FB TFR group have gone through when the CML makes an appearance, even when it is still at very low levels and doesn't progress any further. I have also observed the strong disappointment of people who have relapsed in the first six months.  I don't tell you this to stop you, but you need to be aware it is not all plain sailing for everyone and you always need to keep in the back of your mind there is the potential to have to return to a TKI. 

 

Good luck with which ever way you choose to go. 

[scuba]

Scuba, I have a family history of heart disease too. No male in my family ever made it past 60 without dying of a heart attack, and I'm 63 now. Why magnesium taurate? My doctor said to take magnesium oxide. I really don't know the difference.

 

Here is a good summary of the different Magnesium's available and what they do:

 

http://peoplesrx.com...nesium-for-you/

 

I take Magnesium Taurate for the heart benefits of the Taurate complex.

 

In addition I make sure I get plenty of vitamin K2 (Japanese Natto and K2 supplements (180 mgc) along with vitamin D3. The two work together to scavenge Calcium out of soft tissues (i..e arteries) and move it to bone. Do an internet search on vitamin K2 (not the same as vitamin K).

[BklynCML]

Thank you for all of your responses. I have experimented a lot with stuff to address the muscle/joint pain, including magnesium, but nothing has made a noticeable difference. One of the worst things has been that I injure my tendons very easily (including old injuries resurfacing seemingly without provocation) and then they never heal completely. Over time, this has led me to feel like an 80-year-old.

I agree with the comments about staying within my limits and knowing myself. I am concerned that I will be anxious if I stop taking Sprycel, but even a dose reduction will be somewhat anxiety-producing. The idea of monthly monitoring in the trial is appealing for this reason. I have to balance the anxiety of stopping/reducing against the fact that the SEs themselves also cause anxieties of a different type: I have a strong family history of cardiovascular disease but I'm able to do very little exercise, which is not great. I get ridiculously sore just from carrying in groceries from the car, so I worry when I can't shop while my husband or oldest child is at home to help me. It sounds vain, but I hate that I have such puffy eyelids and appear to have aged 15 years in the last 4.

My onc has not been receptive to the idea of dose reduction in the past. I think he views my situation as not that challenging because I have a treatable cancer (unlike many of his patients) and I do not have any of the serious SEs like pleural effusion or PAH. (After all, he did come into the exam room after viewing my initial BMB smear with a smile and "good news." To be fair, my MD sister had already told him to find a bed for me in case I had AML, so CML was good news in comparison. That didn't stop her from fuming about it for weeks.) His view is that I have a good response and I'm pretty functional--why mess with it? According to my sister, many med oncs have a kind of "toughen up" attitude.

@scuba, my theory about BMS and the trial is that they see the writing on the wall with the high cost of cancer and other specialty drugs, in terms of payors' willingness to play hardball (see Express Scripts and hep C drugs, which Express Scripts says is just the beginning). I think BMS would like to have data showing that starting on Sprycel gives pts a better chance of staying in response after discontinuation, which could help counterbalance lost revenue from pts going off the drugs rather than staying on indefinitely.

Thanks to all again for your input--
Beth

[story]

Just got through the second PCR screening to participate in the LAST study. Today is my first day without Tasigna. The study is well thought out and I am comfortable that the monitoring intervals will give me plenty of time to begin TKI again if necessary. One thing to consider, you don't have to live close to a study site to participate, I drove five hours for the initial intake and blood draw, subsequent draws are taken at my local docs office. Hoping for the best....

[rcase13]

Do you have to be PCRU for two years to participate in the LAST study?

[gerry]

LAST study

 

http://www.cmladvoca.../435-last-trial

[mikefromillinois]

More info on the LAST trial:  https://clinicaltria...L "LAST"&rank=1

[SUE]

LAST study

 

http://www.cmladvoca.../435-last-trial

 

More info on the LAST trial:  https://clinicaltria...L "LAST"&rank=1

 

Thanks for the info.

 

Good luck to Mike and all the participants.