15 replies to this topic

[Tex]

I didn't know if everyone saw the blogs at this site.  I was this this morning and thought it might be something some of you wanted to look into:

 

http://community.lls...eir-medication/

[scuba]

I didn't know if everyone saw the blogs at this site.  I was this this morning and thought it might be something some of you wanted to look into:

 

http://community.lls...eir-medication/

 

In the European STIM ("stop Imatinib" (Gleevec)) trial they learned that over 40% of the patients were able to maintain remission after stopping. An additional 20% who did lose PCRU status were nevertheless able to maintain MMR and continue in the trial (60% total) and not progress. 

 

This is a signficant cohort of patients who could largley remain disease free and avoid TKI side effects. What is most promising is that even if relapse does occur (PCR levels go above MMR) - all patients who resumed their TKI resumed their response and all re-achieved PCRU.

 

This is why more and more trials are being done to identify who can stop and who needs to continue. If half of the CML population for which MMR/PCRU was achieved can safely stop their medication, this is terrific.

 

There is a psychology to stopping. Most patients when given the opportunity to discontinue their TKI - choose not to stop (Dr. Cortes, pers. comm.). They feel their TKI is a life saver and the unknown of "cancer" returning will be lurking. This is very real and understandable. 

 

In my case, I was only "undetectable" for a very short time (I would not qualify for this trial) at six months before I decided to test discontinuation. So far - since February - I have not had to resume Sprycel (20mg). My next monthly test is this coming Tuesday. My approach is approved locally because my Oncologist is a researcher in the field. I go month to month and if this next test is PCRU/MMR I will move to every other month testing. 

 

What I can tell you is that the psychological release from not having to take the little white pill on fear of death is wonderful. But it is a decision that one should make with support from their doctor. 

[Gail's]

Scuba, do you know anything about those who had to resume TKIs? I'm wondering how tough the side effects are if you've had a break then resume.

[TeddyB]

Glad to see there are more discontinuation trials on the way.

 

Discontinuation would the ultimate nirvana, but dose reduction would also be a great step forward. I hope more dose reduction trials come soon as well.

 

Or hopefully someone will find a cure and we would be able to kill off the CML stemcells.

[scuba]

Scuba, do you know anything about those who had to resume TKIs? I'm wondering how tough the side effects are if you've had a break then resume.

 

In my case, I was forced to take a break for 3 months and then resumed with a different drug. I didn't notice anything different. But I resumed on a much reduced dose of the second TKI - 20mg instead of 100 mg.

 

I do not know of any reports in the literature documenting side effects following resumption of therapy after loss of PCRU.

[scuba]

Glad to see there are more discontinuation trials on the way.

 

Discontinuation would the ultimate nirvana, but dose reduction would also be a great step forward. I hope more dose reduction trials come soon as well.

 

Or hopefully someone will find a cure and we would be able to kill off the CML stemcells.

 

Dose reduction is a very good way to test response and move towards TKI cessation. My doctor started me out on a reduced dose to manage initial myelosuppression. Because I had a dramatic and great response on the reduced dose, he just kept me there and I was able to continue until my first PCRU. I decided to stop altogether after six months of success in order to test durability. Normally they would require me to remain PCRU for two years before stopping, but I have a theory that I wanted to test personally and decided to stop after only six months.

 

So far it has worked. I have had six months of no TKI and no relative change in PCR levels, although I did blip above PCRU but still within margin of error. I test again next week (every month until fall then every two months and then every 3 months like before when I was on a TKI if I can remain below MMR). I am planning on success - and a TKI free life - but I have no delusions. If my PCR rises above MMR (PCR > 0.1%), I will resume taking Sprycel. 

[TeddyB]

Dose reduction is a very good way to test response and move towards TKI cessation. My doctor started me out on a reduced dose to manage initial myelosuppression. Because I had a dramatic and great response on the reduced dose, he just kept me there and I was able to continue until my first PCRU. I decided to stop altogether after six months of success in order to test durability. Normally they would require me to remain PCRU for two years before stopping, but I have a theory that I wanted to test personally and decided to stop after only six months.

 

So far it has worked. I have had six months of no TKI and no relative change in PCR levels, although I did blip above PCRU but still within margin of error. I test again next week (every month until fall then every two months and then every 3 months like before when I was on a TKI if I can remain below MMR). I am planning on success - and a TKI free life - but I have no delusions. If my PCR rises above MMR (PCR > 0.1%), I will resume taking Sprycel. 

 

 

I have been following your progress Scuba, and i will keep my fingers crossed for you

[Pin]

Scuba, do you know anything about those who had to resume TKIs? I'm wondering how tough the side effects are if you've had a break then resume.

My doctor mentioned last time I saw her that some patients who've had a short break for side effects reasons reported less severe side effects after resuming. Of course, this may be psychological, but it'd feel the same!!

[gerry]

Scuba, do you know anything about those who had to resume TKIs? I'm wondering how tough the side effects are if you've had a break then resume.

 

Hi Gail,

I asked for some feedback on restarting TKI after cessation trial, one of our people kindly wrote some information for me. Their reply is as follows - 

 

I changed meds when I restarted which meant a new and different side effect situation. Restarting bore no resemblance to what I experienced when I started taking TKIs right after diagnosis. Overall I have fewer side effects on the new TKI which is likely also due to having now lived with CML for several years. I think people who get into the position where they need to restart a TKI should carefully research their options on the basis of their clinical situation and chose the best option for long term success rather than automatically going back on the TKI they stopped taking. We have more options now and hem/oncs have much greater understanding of the personalization of treatment.

[scuba]

I have been following your progress Scuba, and i will keep my fingers crossed for you

 

Thanks Teddy!

[missjoy]

Hi Scuba,

I have read some of your postings. I admire your determination. Good luck with your TKI cessation trial!

You mentioned your doctor reduced your dose because you had myelosuppression. Would you mind if I ask you
what your blood counts were? How long Were you on the TKI before you had myelosuppression.

Thanks!

[scuba]

Hi Scuba,

I have read some of your postings. I admire your determination. Good luck with your TKI cessation trial!

You mentioned your doctor reduced your dose because you had myelosuppression. Would you mind if I ask you
what your blood counts were? How long Were you on the TKI before you had myelosuppression.

Thanks!

 

The blood cell type that affected me the most were Neutrophils. Base normal is 1.7 (1700 cells per microliter). Below 1.7 is deficient. Below 1.0 is warning. Below 0.5 is risky. ANC <= 0.1 is dangerous.

 

My ANC level fell below 1.0 almost immediately when as I first started taking 400mg Gleevec.  I was stopped (TKI) until my ANC rose above 1.0. I was restarted on Sprycel 70 mg. and my ANC fell to 0.1 within a few weeks (pretty bad and dangerous). I had to stop therapy at that time and considered stim shots. My Oncologist suggested we just start and stop until I normalize. I had few Blasts and risk of immediate progression was considered low.

 

I remained off Sprycel for more than 3 months as my ANC count slowly increased. It rose from 0.1 to 0.5 quickly (out of danger) and then slowly climbed from 0.5 to 1.0 over the next few months. My FISH level during that time remained constant and actually fell somewhat - so my doctor kept me off Sprycel until my ANC went above 1.0. I was taking a lot of Curcumin by this time.

 

When my ANC achieved 1.0 I was restarted on Sprycel, but at a much lower dose (20 mg.). My ANC began to fall again, but slower. It stabilized around 0.5 which was adequate. I was able to continue taking 20mg Sprycel and over the next several months my ANC rose slowly to about 1.5 and near normal. While on 20mg Sprycel, my FISH went to zero in a few months and my PCR went to MMR and hovered just above PCRU for more than a year. I would have to check my records to know the exact length of time. I added vitamin D3 to my program to raise it from 17ng/ml to around 60-70ng/ml where it is today. After I started vitamin D3 I achieved PCRU for the first time and my blast count went to zero for the first time. Not a scientific correlation - but it is interesting.

 

I stopped Sprycel in February this year to test durability and had several months post cessation remaining below 0.01 (m.d. anderson scale). I had a bump up and a bump back down (all significantly below MMR) over the last two months so I was able to remain off Sprycel.

[scuba]

Thank you Scuba for the detailed information. it is amazing you became undetectable with 70mg then, 20mg Sprycel. Vitamin D is very important. you are lucky your doctor support your experiment. Is Dr. Cortes your doctor?

 

Dr. Cortes supports my 'experiment'. But with data. As long as my PCR is below 0.1% I.S. scale he is fine with me staying off Sprycel. I still have to be checked once a month to develop a baseline (a few more months) and then I can go every two months - then every three months. I would like to see "undetectable" without a TKI since others have been able to achieve that level. We'll see if time will do that for me. I feel confident I could re-start Sprycel (20mg) and put me back to PCRU again, but I want to see if my nutritional approach can keep me TKI free. As long as I monitor with PCR tests the risk of progression is acceptable to me (I believe it is as close to zero without saying zero).

 

He gives me a 50-50 chance that I can continue this way long term. If I make it to next February this way, my odds of success go up substantially and if I can make it two years, my odds of success get to 90% or better. 

[missjoy]

I wish you the very best ,Scuba. Your success will inspire many others. Keep us posted please!

[Buzzm1]

Dr. Cortes supports my 'experiment'. But with data. As long as my PCR is below 0.1% I.S. scale he is fine with me staying off Sprycel. I still have to be checked once a month to develop a baseline (a few more months) and then I can go every two months - then every three months. I would like to see "undetectable" without a TKI since others have been able to achieve that level. We'll see if time will do that for me. I feel confident I could re-start Sprycel (20mg) and put me back to PCRU again, but I want to see if my nutritional approach can keep me TKI free. As long as I monitor with PCR tests the risk of progression is acceptable to me (I believe it is as close to zero without saying zero).

 

He gives me a 50-50 chance that I can continue this way long term. If I make it to next February this way, my odds of success go up substantially and if I can make it two years, my odds of success get to 90% or better. 

 

scuba, could you please post a short chronology of your PCR tests, over your last few years, showing changes/including dosage/duration of PCRU, etc thanks

 

Aug 2015 <0.05

July 2015 <0.01

??? 2015 PCRU

 

thanks,

Buzz

[scuba]

scuba, could you please post a short chronology of your PCR tests, over your last few years, showing changes/including dosage/duration of PCRU, etc thanks

 

Aug 2015 <0.05

July 2015 <0.01

??? 2015 PCRU

 

thanks,

Buzz

 

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