17 replies to this topic

[Jerry.s]

Hello Everyone

 

 

Has anyone done a stop study and they were on Gleevec? I am interested in doing one in the future but I am not sure if its even possible. My OC hasn't done a lot of research  on stop studies so he is not a fan. If there is a chance that I could stop taking gleevec in the future I believe its worth trying it out. 

 

 

 

[Trey]

There are several patients here (about 4 or so) who have stopped TKI drugs.

 

Several clinical trials have provided data on stopping TKI drugs.  Some of the trials are STIM, STIM2, A-STIM, and TWISTER.  Some new trials are underway such as DESTINY.  The data so far is relatively small sampling, but shows that roughly 45% of patients can stop and either maintain PCRU or stabilize in MMR, but the timeframe is still rather short to know whether the stabilization will continue over the long term.  There is still much to learn, but the results so far are fairly encouraging, although most patients relapse.  Remember also that reduced "maintenance" dosage over the longer term is also an option, and some have chosen that route (myself included -- on 200mg Gleevec for last 5 years maintaining PCRU).

 

You can search on the trial names provided above, and here are a few summaries:

 

http://www.jscimedce...atment-1026.pdf

http://www.medscape....warticle/818862

http://www.medscape....warticle/818862

http://www.ncbi.nlm....pubmed/23704092

[Jerry.s]

Thanks trey good news ! I'll read up on the links you provided .

[Msbovee]

I am a newbie on this list.  I am looking for anyone in the Detroit area who has been on Gleevec and who is a patient at Karmanos.  I really need to talk to someone who has experienced a hard sell for going off of Gleevec.  I will not go off of it, but my doc certainly is on the bandwagon to get more people to join his study.  I have been on Gleevec for 14 years and I am 68 years old.  My insurance pays for the drug.  Seems like a no brainer to stay on Gleevec.  Am I missing something here?

[Trey]

Not missing anything.  We also answered this here:

 

http://community.lls...being-a-turtle/

[Buzzm1]

reduced "maintenance" dosage 

 

Hoping to reduce my dosage, Sunday will be my first day on 300mg Gleevec after having been on 400mg for almost 5 years.  My next scheduled BCR-ABL test is in the third week of January; I'll report the results. 

 

Buzz

[gerry]

I've been off Gleevec now for over a year. For me most side effects of Gleevec disappeared over six months, Muscle and joint issues still seem to be a problem for some. I've just hit menopause, so now seem to be having some of the issues I had on Gleevec - can't win. lol

 

I was down to 300mg before I stopped, it does make a difference to the 400mg.

 

I know Trey is keen on reduced dosage, though not sure how long he views that you need to be on it before the CML has ceased to exist..

 

Perhaps the CML never really goes away and is just controlled by our immune system.

[patcanfield]

Everything i read is about gleevec. is there any one out there on tasigna? i started 600mg a day sept 4 2014  had my 3rd bmb nov 19 2014 and i am in remission but still on 600 mg . 

[Widgeonus]

Everything i read is about gleevec. is there any one out there on tasigna? i started 600mg a day sept 4 2014  had my 3rd bmb nov 19 2014 and i am in remission but still on 600 mg . 

 

What are your latest PCR numbers? There are various levels of "remission" so to speak. CHR, CCyR, MMR, PCRU and such.

[patcanfield]

wbc6.7 hgb 13.5 mcv 94FL platelet264neutrophlis49.8% lymphs 35.2% monos 10.5% eos 3.4% basos 0.7% immature granulocytes 0.4%                                                                                                                                                                                                             Bone marrow differential blasts 1 progranualcytes 1 mylocytes 8  metomyecytes 11  granulcytes 31 eosinophils 2 lymphocytes 17  plasma cells 1  monocytes 4 reticulum 0 pronormoblasts 0 normoblasts 25 m e ratio 2.1 at the bottom of bone marrow it says no morphologic evidence of cml the dr put on my chart for bone marrow " in remission" my blood work said complete cutogenetic response 

[Widgeonus]

Looks like Complete Cytogenetic Response, so the next step is for PCR tests to test for minimum residual disease which will show very small traces of leukemia. You'll get those results in hopefully tenths of a percent and anything below .1% International Standard would be Major Molecular Remission. Ultimately, the goal is to be undetectable, but anything below .1% is ideal. 

[patcanfield]

just got molecular results .it says the percentage of BCR-ABL1 transcripts is 0.04 hopefully this is ideal

[Trey]

We discussed the TKI drug cessation issue in another post, and I will add some key information here since people may search on this subject in the future and find this post.

 

https://ash.confex.c...Paper74060.html

 

The part about "Recurrence of CML, defined as loss of MMR, was observed in 43/92 pts (47%) treated <8 years, as compared to 23/87 pts (26%) treated for >8 years" is significant for those contemplating stopping drug therapy.  In plain language it says:

It is better to take the CML TKI drugs 8 years or longer before stopping drug therapy because the success rate is roughly doubled.

[SandyG353]

My daughter , Robyn, fits the bill for the required study on stopping Gleevec which is ongoing in our state of New Jersey.  However, she has had unusually bad eyebleeds which hurt , take a long time to go away and come back in a few days.  The eyebleeds are beyond what is normal for the patients on the medication. I e-mailed Dr. Druker about her condition and told him that she reached molecular remission on Gleevec with 3- 5 months of being on Gleevec.  I added that the trial is going on.  However, Dr. Drukler's response was that she was doing well on Gleevec  and he would like her to have a special test to see how the body is metabolizing the Gleevec.  He believes that it is slowly metabolizing and building up in her system.  After the special test is done by a special lab and tested, he will look at the findings and if she is metabolizing it slowly, he would reduce her doseage.  I found this interesting because he didn't recommend her going in to the trial even though she has been in remission for over 5 years.

[Trey]

I assume the test is the Gleevec Plasma Level Test.  That would tell what the concentration levels are at the times the blood samples are taken.  The test does not actually test the Gleevec metabolization rate, just plasma concentrations at specific points in time. 

 

His assumption is the concentrations could possibly be too high, which would suggest the dosage could be lowered.  I have lowered my Gleevec dosage to 200mg per day for the past 5 years or so and maintained PCR negativity.  The reduction in side effects from a lowered dosage can be significant, although they can take some time to take effect after lowering the dosage.  I would ask about that, since I know that Dr Druker recommends such dosage reductions in cases such as your daughter.

 

Does she take any other medications?  Various meds can cause higher level plasma concentrations.  But whether that has anything to do with the eyebleeds would be conjecture. 

 

The eyebleeds are caused by the TKI drug inhibiting certain growth factors other than BCR-ABL, such as PDGF and VEGF which can affect the blood vessels and possibly weaken them, especially the tiny capillaries in the conjunctiva of the eye.  Overall they are not harmful, but they are not pleasant.

[SandyG353]

Hi Trey.

You may be right about the test.  I only know that it is one that is done by Saladax Biochemical Lab. in Pa.  The test is called My Imatinib.

Dr. Druker explained in his e-mail that my daughter may be metabolizing it slowly which is leading to a buildup and causing the abnormal eyebleeds with pain.  Actually, she takes synthroid which should have the opposite effect of what she is experiencing. This frequent, painful, and horrible looking eyebleed is occurring more often after 5 and a half years on Gleevec.  Dr. Druker said that only that lab does the test and there are specific instructions for taking it and handling it.  The results can be sent to the lab which provided me with a  prepaid fed ex ,or to Dr. Durker.   My guess is that her doseage will be reduced to 200 like you.  If anyone wants this test, the lab is doing it for free for three months.  The test will take place in her oncologist's lab. and sent to Saladax Biochemical Lab.  Her ocologist told her to stop the Gleevec until her eye clears.  Then after 28 days on it, the test can be done.

Sandy

Edited by SandyG353, 13 December 2014 - 05:27 PM.

[Trey]

I believe it is a Gleevec Plasma Level Test.  Novartis was promoting this test until the FDA beat them up for doing it, saying it was just a trick to sell more drug.  That was dumb on the FDA's part.  But now Saladax has started doing the test for Gleevec and several other drugs, promoting "personalized drug dosage" for individual patients (yippee!!!).  I think it is a good idea in many cases, including for your daughter.

 

http://www.saladax.c...tinib-PR-v3.pdf

[SandyG353]

Wow!  it looks like my daughter's oncologist was right. When she first mentioned the test to him, he said that Novartis does it.  We have Novartis right here in New Jersey.  My daughter passes it every day on her way to work.  It would have been easier for her to do there..   She appears in a DVD. made by  Novartis for the use of oncologists to show to newly diagnosed patients .  It shows 3 people and each tells how their lives changed when first diagnosed, the fear they had, included were discussions of their families and caretakers, and showed them interacting with people important in their lives  -like my daughter playing ball with my grandson.  It told how they were able to gradually get back to where they were before the diagnosis of CML.   It was put out there to provide newly diagnosed patients with hope.

Sandy