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Report back from Basil in South Africa

Hi all, 

I thought is to be a good idea to give an update on my progress, after having taken my last 400mg Gleevec on 30 May 2009.

As you may remember the side effects of Gleevec after five and a half were really becoming a problem, with eye bleeds every other week. This was the main side effect that I experienced, but left me feeling like a freak when out in public.

My Haematologist agreed to let me take a Gleevec "holiday" as I had an "not detected" status for the previous 3 years using the QRT-PCR tests. I agreed to have QRT-PCR tests done every 3 months.

Herewith my results to date:

19/08/2009   Positive           BCR-ABL   0.00083%

15/10/2009   Not detected   BCR-ABL   0.00013%

06/01/2010   Not detected   BCR-ABL   0.00024%

15/03/2010   Positive            BCR-ABL   0.0011%

08/06/2010   Positive            BCR-ABL   0.0065%

10/09/2010   Positive            BCR-ABL    0.0005%

My next test will be due at the end of December and I will see my Specialist in mid January 2011.

Although my last test seems to prove that my last result improved, one must take into account that this is an "amplified" result and a slight error will thus result in a skewed figure. But that also applies to all the other test results.

So many conclusions can be drawn from the results, including that my immune system has been able to cope with the disease to a large extent. My relatively stable results proves this. This past winter I started taking an immune booster as the Anti Flu injection was not available in South Africa. The results was that I did not even have a sniffle whilst surrounded by Flu infected family members. 

BTW. My FBC's have all remained normal over this period.

I must stress that I am not part of any Trial at all - this is purely a once off thing which I embarked on with the blessing of my Haematologist.

Please feel free to post on this thread, and I will attempt to answer any questions that are raised.

Best wishes to all the "club" members out there.

Kind regards

Hi basil Thanks for putting the information on here it really helps new CMLers like me. I was diagnosed in may this year and I am on 400mg of glivec daily. I wanted to know have you not taken any other TKI's after stopping glivec. I understand if you stop taking glivec the the disease can come back and Sometime in more aggressive form. When were you diagnosed and how long have you taken glivec. Any information and advice is appreciated. Thanks Shaz

Dear Shaz,

There has been a clinical study for some time -called the STIM trial (STopping IMatinib)- initially started by Prof. Mahon's team in Bordeaux, France, but lately taken up by some other centre's in Europe.

This study is only for people who have been treated with imatinib and have been PCR U or all evidence of Bcr/abl is undetectable by current PCR testing for at least 2 years. In the Bordeaux study 50% of those taking part relapsed within 6 months, others within 9 months and the remainder managed to keep negative PCR's in the longer term. 

All those that relapsed were immediately restarted on imatinib and all responded again to the therapy and did not suffer progression. The initial study did not have a large patient cohort but the idea that some people might be able to stop therapy once they showed negativity by PCR for at least 2 years - this is not true for everyone and so remains under clinical trial. 

As Basil said in his post- he made the decision to do this with the full support of his doctor and is obviously being monitored very closely for signs of relapse- so far he has done well and his immune system seems to be coping with the residual disease, that we can see is still evident in his PCR tests, on its own.

I must add that even though PCR tests might not detect evidence of bcr/abl (the abnormal fusion protein that is looked for and proves the presence of PH+ cells/CML) when levels get below a certain level, this does not mean that there are no PH+cells in the marrow- it only means that currently PCR testing cannot detect levels below a certain level.

The tests will no doubt become even more sensitive over the next few years- but we must always remember that so far TKI therapy does not 'cure' CML. However- for some individuals imatinib seems to kill so many PH+ cells that it is possible for an individual's immune system to take over and deal very effectively with the small amount of abnormal cells that are left- i.e residual disease. 

No one should stop therapy without careful consideration of their individual 'disease picture' and should only do so within a study or with a clinician who knows what they are doing (as in Basil's case). 

I hope this has helped you to understand the current situation regarding TKI therapy and CML.

There are other trials which are trying different approaches. For example  in Germany people who have shown stable and very low bcr/abl levels (similar to Basil's) stop taking imatinib but then continue therapy with very low dose interferon (one shot every 10-4 days I think).

This has proven to be quite a good way of keeping bcr/abl at the same low molecular levels they were at before IM was stipped.

So in this study- IM is used to (imatinib/Glivec) your disease levels down to the molecular level (4 or even 5 logs from diagnosis level) and then low dose interferon keeps levels stable over the long term.

However Interferon does have unwanted side effects and even at very low doses can cause a few days of flu like symptoms and maybe even psychological effects such as mood swings/depression. 

All in all for most people IM is a miraculous drug and keeps most in stable remission over the very long term- there is very little evidence of long term damage with TKI therapy.

If there is an existing health issue (like Long QT syndrome for example) or other cardiac problems,  all TKI's can have an effect on the cardiovascular system- but this is rare and should not worry you if your health is generally good. 

I hope this has answered some of your questions and allayed some of your worries.

Best wishes,

Sandy

Dear Basil,

thanks so much for the update on your current situation. I am glad your doctor is monitoring you very closely. It looks like you are in a good and stable  'holding pattern'. I think you are just about at the 6 months mark? this is the point at which to hope for another low result - which you did get at 0.0005%. I know you are a one man experiment given that you had evidence of residual disease when you stopped IM and you are not part of a clinical study, but it looks like - as you say- your immune system is in control. Good luck for another low pcr in December. 

What is the 'immune booster' you are taking?

Best wishes,

Sandy

Shaz

hope it's going well for you on Glivec so far.

To expand a little on what Sandy says, there is talk of trials to come involving vaccination as opposed to interferon to help patients who reach PCRU maintain PCRU without Glivec, in due course. So far, in limited trials vaccines have proven quite good for patients who don't quite reach PCRU to get them there but work continues and the suggestion I mention is I suppose and extension of that. The idea is to stimulate the immune system to mop up the remaining undetectable leukaemia cells and/or to keep any new ones under control via the immune system.

However, no patient will be considered for any stop therapy trial unless they have been PCRU for 2 years.  Even then, work is being done to explore the use of more sensitive PCR testing that will be patient specific - ie based on the specific DNA sequence of your own, personal translocation. That's more sensitive than what is currently done (which is quite sensitive already).  The hope is that they can then see in advance, based on data and learning from the STIM and others stop trials, which patients are more likely to maintain PCRU when stopping. 

So, there is hope that more patients can stop but research is needed and I for one would want some more signs that I would stay PCRU before stopping.  In your case, keep taking the tablets (like me!) and wait and see. Even if you don't reach PCRU, Glivec (and other TKIs) are great at keeping things under control.

Richard

Greetings, 

I am way passed the crucial 6 months mark. In fact it will be 17 months at the end of September 2010.

Although my tests have been "positive" most of the time, my immune system has managed to control the PH+.

What has happened to Des who went off Gleevec about a month before I did last year? I trust he is still doing well.

Kind regards

Basil

Hi Shaz, and thanks for the response.

I was dx. in mid 2003 and immediately put on Interferon Alpha. My responses were good, but the side effects nearly killed me. So in November I switched doctors and started on Gleevec 400mg/day. My progress was good, but we only had FISH tests to go on as QRT-PCR testing was not available in South Africa at that time. During the latter half of 2004 our NHLS developed the QRT-PCR test and my first official came back in April 2005 as "not detected". I think it was during this period that my doctor increased the dose to 600mg/day to speed up the results, but I soon reverted to 400mg/day as the side effects were unbearable.

I managed to maintain this status until I stopped taking Gleevec at the end of April 2009.

As to whether the disease returns in a more aggressive form, that depends on many circumstances, including luck. I do feel that the immune system can cope with CML if certain criteria are met with. This seems to be happening in my case - but for how long is anybody's guess.

I have not had any other drug treatment for my CML since May 2009, but see my Haematologist quarterly and obviously do PCR tests in the same cycle.

Unfortunately as with many treatments the results will differ from patient to patient, but any progress is PROGRESS! The ability to remain positive is crucial to the healing process. My greatest inspiration after I was dx.ed  was meeting a fellow CML patient who was on the trials here in SA in about 2000. Meeting someone at that stage who had survived from that time and was well was all I needed to be positive and remain so until today.Shaun Watts of Cape Town take a bow.

BTW: Gleevec is not an incorrect spelling. That's how it is spelled here.

Best wishes and kind regards

Basil

Well explained Sandy. I must stress that the decision to stop Imatinib was mine alone. At first my doctor resisted but later agreed to go along with it, as long as I could be carefully monitored along the way. 

The Chromosone damage (9/22) will not be resolved by an existing single TKI, as far as I understand. Combination theraphy can boost the immune system and keep the BCR-ABL count down to an undetectable level with the testing technology available at present. In order for a the damage to the 9/22 Chromosones to be corrected, the "silver bullet" is necessary. This can occur with a BMT only at this stage as far as I am aware. In other words it's like treating the symptoms without correcting the root problem.

I know I may sound foolish, but I think it is necessary for the envelope to be pushed, to establish our immune capabilities after a successful period on Gleevec. Unfortunately we have no access to trials here in South Africa, so as patients we must take decisions to plot the path ahead. Fortunately I had the foresight of the STIM Trials to base my decisions on.

Boy would I love to be involved an official trial.

Regards

Basil

Hi Basil - I am a fellow S. African living in the UK (a long time!) and was dx last Nov. Unfortunately Gleevec has not worked for me - my blood levels dropped dramatically and suddenly, so The Gleevec has been stopped.

My question is .... what have you been doing to support your immune system? Do you take suppliments also and if so, which ones? Do you have any dietary advice?

Good luck with your stopping the TKI - I know I feel brilliant after just a two week break! We are awaiting dNA tests to see how to progress to another TKI or whatever....

All the best

Beth

Dear Sandy

Thanks for your help in explaining in such detail. It is very helpful and has cleared many confusions in my mind. I am not having many side effects at the moment with glivec, i am also waiting for the results of  the bone marrow biopsy so fingers crossed. When i was diagnosed with CML i searched for information about the disease and the drug online and came to know that in the clinical trials of imatinib some people developed cardiac/other problems.

If you have read my previous adds i have asked people (taking imatinib) about it and i got a satisfying answer, also the information You, Richard and Basil (thanks guys) provided is very helpful.

I did not know about STIM and other trials, and when i read that basil had stopped taking glivec last year i was surprised and wanted to know more about it.

Kind Regards

Shaz

Hi all,

just to add that the French study was a national one with several centres participating, including Lyon;  Dr Nicolini has told me that those who are going to relapse do so in the forst 6 months & that if they manage to get past this mark then they should be Ok.

Dr Nicolini told a fellow French patient last week that the rate of patients who remain PCR-u has been reviewed & is now 65%.

The STIM trial is currently closed but will be reopening shortly with a new cohort of 200 patients - I am eligible & hope to take part if my last PCr taken at the start of the study remains PCR-U on Boreaux' machine which is more sensitive than ours here at Lyon,.

will keep you posted,

Barbara

It's really great to meet another South African on this great forum.

I am sorry to hear that Gleevec did not not work for you. But there are a few alternatives now available and I am positive the right one will come along. There is so much going on in research and we are very fortunate to be living in this era.

I started taking an Immune Booster in April this year when I could not get hold of an anti flue jab. (We had limited supplies available  as there seemed to be a world shortage) The name of the product is: Probiotics Probiflora Intensive  9, (www.nutrilida.com) Well for the first time I did not get a cold or any sniffles, although surrounded by suffering family members. Fortunately my blood cell counts are all normal, so this product may have helped to boost my immune system. I will continue to take one capsule a day just in case.

I try to eat healthy foods and cut out the junk stuff as far as possible. I have never been one for fats so I try to avoid all fatty foods. December a year ago I had my Gall bladder removed due to the presence of Gall Stones and now I am reminded soon after something fatty that it was a mistake, and have to dash to the toilet to post a letter.

Vegetables meat and fish form the nucleus of my diet with bananas when I remember. 

And the main thing as far as I am concerned is to keep a positive and healthy state of mind. My religious devotion has also assisted me through the dark times in the past

Best wishes and kind regards

Basil

Dear Barbara, many thanks for your update on the STIM study in France. I am really pleased to hear the increase in % of people who are sustaining their PCR-u status. I assume that as more and more people are enrolled on this study - the bigger the cohort- the more chance that many more patients will be able to stop treatment and let their immune system take over the job. This is all fascinating stuff!

I am also glad that you have decided to take part when the new STIM study opens-- as you say if your PCR is undetectable at the Bordeaux lab then you can't get much better than that.

Best wishes,

Sandy 

Hi Basil.... wow that is really impressive. As I said to Barbara above- this is all really fascinating stuff! The way the immune system works. You forgot to mention the immune booster that you said you have been supplementing with.

Many congratulations on your continued stable pcr's

Sandy