* Are you tempted to try stopping treatment/dose reduction outside of a clinical trial? * Would your doctor be supportive of that decision? * If yes, would your doctor agree to monitor you more closely? * How often are you currently tested for levels of Bcr-AbL by PCR? * Are your samples for PCR testing sent to a specialist lab?
You are here
Question 4
Categories:
1. Yes
2. Maybe
3. That's the only way I'd be willing to do it in the short term
4. Every 3 months; current doc would like to push it to 6 monthly
5. Yes, Hammersmith
I've thought about the possibility of lowering my Tasigna dose under supervision. Currently on 2x300mg twice daily. I'd look to lower to 1x200mg twice daily and see how we get on.
Initial reports seem to indicate response can often be maintained with lower doses once in MMR+. I think this would be a great step to minimize toxicities and side effects and also save the NHS some money. Money shouldn't be a primary motive for altering treatment, but i do have a conscience about the cost of my healthcare.
1. Yes - already doing so
2. Yes - he suggested it
3. & 4. Yes - if I had stayed on 400mg, I would have changed from 3-monthly to 4-monthly and eventually 6-monthly checks. As it is, I'm staying on 3-monthly
5. My samples are tested in Edinburgh, I assume it's a specialist lab, but I'm not absolutely sure.
Thanks Chris and Olivia for answering Question 4 in our series of monthly questions.
Would anyone else like to answer? Your views are helpful for CML clinicians to gauge patient's feelings and attitudes to dose reduction and/or stopping.... and the chance to achieve TFR or at least a dose reduction.
Sandy
Sandy, Thanks for the questions - good idea!
* Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
Currently no, as I knew Destiny was going to and now is happening so preferred to wait on the result of that. I have been PCRU for over 2 years (8 years since DX) so doing well. I do have side effects, although none serious, but it does mean that I would at least be interested in dose reduction if that could reduce side effects. (Side question - does anyone know if the Destiny trial is measuring the effect of dose reduction on side effects?)
* Would your doctor be supportive of that decision?
Assuming this means consultant - yes and no. Probably because I am PCRU with no serious side effects I seem to see whichever one of the 4 consultants is available, which is okay with me. I am sure that I could find one that would be supportive.
* If yes, would your doctor agree to monitor you more closely?
See above.
* How often are you currently tested for levels of Bcr-AbL by PCR?
Every 3 months.
* Are your samples for PCR testing sent to a specialist lab?
Good question. To be honest, don't know. I am at Forth Valley Royal and I think they changed labs around the time I became PCRU. hmm! Will check next time which lab. (Guess I was not too bothered with which lab it is when they are telling you what you want to hear).
* Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
No. (But definitely in a trial)
* Would your doctor be supportive of that decision?
No
* If yes, would your doctor agree to monitor you more closely?
-
* How often are you currently tested for levels of Bcr-AbL
by PCR?
3 months
* Are your samples for PCR testing sent to a specialist lab?
Yes
1. No...would not even consider it unless recommended by my Consultant
2. Don't know as it has not been mentioned as something that might be possible
3. N/A at this moment in time
4. No idea...I assume that this is done from my blood test which is taken 1 week before my clinic appointment which is currently every 2 months
5. Again..no idea but trust that it is
1 - No. it was very hard to get a response. i had to change meds, it was stressful! I don't have many side effects, so i'm good with my meds.
2 - i don't think so.
4 - i'm testing every 3 months, but if my results continue to come good, i think they'll pass me to 6 months.
5 - sometimes yes, but sometimes they send my sample to a lab accredited to American's pathology society (this result always comes lower, but within the margin of error of the test - half log.)
1) Yes I would love to try reducing does and stopping treatment. My response has been very fast - I am 10 months since dx and am 0.001%. I would like to try to reduce dose as soon as I can.
2) Don't think consultant is supportive at the moment, but when I have been dx 2 years if still low I would hope they would be.
3) No idea - situation hasn't arisen yet
4) Every 3 months
5) Yes sent to Kings I think....or Hammersmith..not sure.
Would agree if consultant agreed to reduce dose.
I'm sure he would monitor me more closely.
Tested for bcr/abl every 12 weeks.
Samples are sent to H/Smith.
In answer to your question whether DESTINY measures changes in side effects, yes, this is done. Trial participants have a daily diary/chart to complete asking about changes, if any, to side effects caused by medication.
Best
Chrissie
* Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
Yes I would and keep asking
* Would your doctor be supportive of that decision?
Not at the moment I keep asking but he says Kings have no trials
* If yes, would your doctor agree to monitor you more closely?
See above
* How often are you currently tested for levels of Bcr-AbL by PCR?
Every 3 months been MMR (0.003) for last 2 years
* Are your samples for PCR testing sent to a specialist lab?
Kings and don't think they are specialist
1) yes, I'd love to if I were in stable MMR, but still nowhere near. Being part of a clinical trial would be preferable.
2) not sure about the consultant in York but the one in Leeds would probably be supportive
3) I would certainly insist on a more frequent monitoring
4) 3 monthly
5) yes, samples sent to Leeds
Yes - after 10 years uninterrupted on 400mg I asked to reduce dose (Destiny not available in Edinburgh)
Consultant agreed to 300mg, which we stuck with for a year and now at my request down to 200mg ( 3 months to date)
Monitoring now 3 monthly - previously on 400mg had been 4 monthly
PCR results from Edinburgh - non specialist centre
I have waited till today for my answers, after seeing my consultant and getting my latest results:
* Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
Yes, I had to stop treatment for 2 month last October as I had become very anaemic.
Re-started in December (Glivec 400mg) after improvement and had a PCR in March.
* Would your doctor be supportive of that decision?
Yes, would have liked to join DESTINY trial if there had been one local.
* If yes, would your doctor agree to monitor you more closely?
Yes, now monitored every 2 months instead of 4 months.
* How often are you currently tested for levels of Bcr-AbL by PCR?
PCR every 6 months, undetectable for 8 years, even last one after stopping for 2 months.
* Are your samples for PCR testing sent to a specialist lab?
PCR’s sent to the Q.E. Birmingham.
After last results showed anaemia had returned I have had the Glivec reduced to 300mg.
Hi as I was not eligible for the Destiny Trial because I had taken dasatinib and imatinib and I am now on my third TKI I asked my consultant just over 3 months ago if I could reduce my current 600mg of Nilotinib to 300 along side the trial.
I believe he referred my case to Jane Apperley, as I also requested that I take it just once per day.
It was agreed I could do both. After 3 months my PCR was 0.008 slightly up from my previous of 0.004 but nothing to worry about.
I see my consultant 3 monthly but I have blood tests every month for monitoring
best wishes to you all
Jacqui
I am not from the UK but sharing, anyway :-)
Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
My husband, Roy, is a 13 year Imatinib patient. CMR from Aug 2012. Last year, due to eye problem, his consultant reduced his 400mg dose to 300mg. Reduction in side-effects. He is still in CMR after 1 year on reduced dose. We will be exploring 200mg dose, waiting for results of Destiny trial. Currently, he will be doing PK studies to correlate side-effects to his dose. All outside any trial. His consultant runs the PRISM (stop Imatinib) trial which has very strict monitoring. PCR every month for 6 months then PCR every 2 months in the PRISM trial. We are open to reduction in dose/stopping outside trial with our consultant since PCR monitoring will be similar to PRISM trial. However, we would like to see Roy in CMR on 300mg for a bit longer first and do the PK studies.
* Would your doctor be supportive of that decision?
Yes
* If yes, would your doctor agree to monitor you more closely?
See above. Very strict monitoring.
* How often are you currently tested for levels of Bcr-AbL by PCR?
6 months but now 3 months has been suggested and we will follow.
* Are your samples for PCR testing sent to a specialist lab?
Our Singapore General Hospital lab is standardized with the Australian Adelaide lab.
Questions are
Q1 * Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
• I have been offered numerous times to go into a TFR one to one program as there are no trials in my Capital City.
Summary
The reason in not doing so is the lack of knowledge in STOP Programs in relation to Musculoskeletal Pain both Muscle and Joint Pain.
Many people have communicated of bone pain from weeks to 2 years when being TF and their management is to have a drug manage their pain.
This is my belief , this is not treatment free - one is still managing side effects of either CML or drug management
Another reason I have not stopped is because there does not seem to be a standard to how to management side effects after TKI use being ceased.
It seems that many of the side effects of CML and TKIs are not being monitored in both large and small scale stop management trials and therefore there
Is not any reporting to evaluate against others.
Q2 *.Would your doctor be supportive of that decision?
Very much so, as I have been 8 years with CML and 7 years PCRU
However, I have had breathing issues due to Whooping Cough and an induced exercise asthma and so specialist conservative in management until the breathing issue has been dealt with and responding to ventalin. Then a further discussion.
At present due to questions of bone pain and what type of management – continuing on drug dose but I have been able to reduce glivec to standard dose and will be looking at Reducing to 300ml further in the year under close supervision (from 800mg short time to 600mg many years and recently 400mg standard and to reduce further in the future)
The thought from specialist on join and bone pain is that perhaps glivec has some sort of anti-inflammatory benefit and when people are off the TKIs – the condition manifests itself.
Maybe the TKI masks pain?
Further question and comment
Question:
In clinical trials to STOP Treatment - has there been a structured way to evaluate the clinical response of this issue of musculosketal and bone pain in a standard way to be reported at both the time of discontinuation and after discontinuation.
What is meant by Withdrawal Syndrome in relation to Imatinib Stop Treatment?
The link is the only information I have found from any STOP Trials that have comment of Musculoskeletal Pain or Joint Pain - 25 % of STOP Patients had reported joint pain
http://learningcenter.ehaweb.org/eha/2014/19th/53737/sukjoong.oh.changes...
There is also a medical thought (informal) among some Haematologists that GLivec (Imatinib) may have an anti-inflammatory side effect and when people stop treatment pain from the CML Condition itself is felt or another reason ??
Thoughts and to discuss
This is the major reason I have not continued to STOP Treatment until further information and research is communicated and published in the global environment of CML
Q3 * If yes, would your doctor agree to monitor you more closely?
Monthly and then towards three monthly
Q4 * How often are you currently tested for levels of Bcr-AbL by PCR?
Every 3 months
Q5 * Are your samples for PCR testing sent to a specialist lab?
Yes – PCR Testing is being sent to a City Hospital Laboratory where all PCR for all CML Patients in the State – Under International Standard but at 5 log reduction as this lab does not have the new 6 log reduction super sensitive testing.
My wife has been desperate for some time to try reducing or stopping Imatinib. She pressed her consultant to help her join the DESTINY trial and was bitterly disappointed when she was rejected because she had spent a few months on a higher than standard dose about 10 years ago. She therefore asked if she could follow the same protocol as the trial without being on it. She was met with sympathy and the promise to look into it but after several months was no further forward so she recently decided to go it alone. On her last visit to her clinic, she told the doctor that she had started taking a 400mg tablet every other day. She chose that rather than 200mg per day because it was easier than trying to cut a 400mg tablet in half. The doctor noted her comments and said her case would be reviewed by her consultant but did not offer to change her prescription to 100mg tablets. She is therefore continuing with 400mg every other day. Until now, she has had a PCR test every six months. The doctor sent off a sample at this visit but it was almost 6 months since the last test anyway. She will go to the hospital every two months now instead of every three months so maybe PCR tests will also be done more frequently but we are not sure of that. We do not know where the PCR tests are carried out.
Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
No way! Never! Not in a month of Sundays! That would be stark staring bonkers!
I went on Imatanib when it was in clinical trial and following a post MUD BMT. At that time I was also on a trial whereby they were using PCR blood tests to detect any change and that's the reason why I went on imatanib. When imatanib had positive outcome I was in a place where no one had really been.... My consultant and I discussed "what next?" Come off the medication? Reduce it? Between us we both agreed it wasn't worth the risk.
Having suffered a mass of treatment in the old days and even including a Matched Unrelated Bone Marrow Transplant we were firmly of the view that staying on tablets was the safest option.
I'm now on the destiny trial though. Month 8 of that.
* Would your doctor be supportive of that decision?
I sincerely hope not. If he were supportive then I'd be concerned that he wasn't acting in my best interests.
* If yes, would your doctor agree to monitor you more closely?
Absolutely not applicable.
* How often are you currently tested for levels of Bcr-AbL by PCR?
Monthly since I went on the DESTINY trial. Prior to that though it was 2 monthly.
* Are your samples for PCR testing sent to a specialist lab?
Yes
Hi Simon
You mention in your post that it's hard to cut a 400mg tablet in half. Did you know there is such a thing as a tablet cutter - available in any pharmacy? It cuts it inside a container so there is no chance of the tablet crumbling. I got one when I thought I was going to have to go back on full dose Imatinib at the advice of my research nurse,
best
Chrissie
* Are you tempted to try stopping treatment/dose reduction outside of a clinical trial?
I am not on trial but hope I can add my two pennies worth so to speak. Yes to the question and I have done on guidance of Consultant. 1st time Imatinib 400mg, 6 weeks due to what was considered joint/bone/muslce pain. 2nd time Nilotinib 300mg bd, 10 weeks for same issue. PCR went from 0.00 to 7.0 in that time. Now on Dasatinib 20mg with worst degree if pain for the side effects mentioned to date.
* Would your doctor be supportive of that decision?
Consultant gives me autonomy, which I am not too sure is best stance at times as I am not the professional. My wife hates the "what do you want to do now?" Question I get asked on each visit.
* If yes, would your doctor agree to monitor you more closely?
Yes I get PCR between 1 and 2 months at a time to be fair. However I feel if my "bloods are fine" then that's ok. I get told I am not going to die of Luekemia imminently and take that away. My opinion is of course this is the main issue, that goes without saying, but the reason most CML patients will deviate from their treatment is side effect profile experienced by the individual, hence most forums. When I attending the CML day at Newcastle last year, most hands that were raised, were to questions related to side effects and lack of communication between GP, Onc, Rheumatology etc in their management or progression.
For example currently I am given Codeine, Pregabalin, and Naproxen, laxatives from GP, 20mg Dasatinib from Consultant. When I seek guidance on interaction, times to take pills, plans for going forward from medical professionals I get no guidance, none at all! Just take these, see how you fair.
I sincerely hope a more proactive information gathering mindset develops as time goes on toward side effects. I hope more studies commence away from the initial pharma side effect trials. Studies based on time before manifestation and areas of pain. These drugs are amazing, they are simply a life saver, but I hope proactive evolution on side effects ramps up.
* How often are you currently tested for levels of Bcr-AbL by PCR?
As above.
* Are your samples for PCR testing sent to a specialist lab?
Newcastle I believe.
Well done Sandy for asking these questions and raising topics that will be no doubt on the lips of most CML patients.
I stopped twice since dx. First time, 2 months into Glivic treatment my platelets went below 40, in fact white cell is also down to 1. After consulting with my doctor, I stopped for 1 week followed by 1 week on half dosage. Second time because of heart problem, I stopped sprycel for 1 week without consulting my specialist as he was overseas. Now back on sprycel.
I would love to stop or lower my dosage, but I don't think my doctor will support that. Side effects come and go one after another.
I am currently being tested for Pcr every 2-3 months, it is supposed to be 3 months but my doctor also test my Pcr everytime I stop meds, so the interval becomes irregular. I had them done at 2 months, 6 months, 8 month and due for another one in one month time.