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Stopping (or not) the medication?

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Hello everyone,

I would like to open a discussion about stopping the TKIs outside of clinical trials.

I am amazed and worried at the number of entries about CML patients wanting to stop their medication. I think that we should be very cautious about this. So far, the patients only stopped the medication in trials with pcr every month and immediate access to the drug if/when they lost MMR (0.1% IS). So, what do we learn about the “stop the drug” trials?

1) It is pretty much a 50/50 chance of success. Which means that one patient out of two will have to go back on the drug as soon as possible. We need to remember that CML is a deadly disease if left untreated.

2) A better strategy might be to halve the dose, which would decrease the side effects and the financial burden. The results of a small trial (Destiny) show that for patients stable in MR4 (0.01% IS), the percentage of relapse is 2%. But the trial lasted only a year and nobody knows what will happen after that.

We have a lot of people who participated in the Destiny trial on this forum.What does everybody thinks? Am I being overly worried?

I think that would be a great discussion

Hi

Diagnosed in 2003. 1st in Wales prescribed Glivec off trial

Nilotunib about 6 years ago down to 150g.

Went to HH nearly 3 years ago. Came off all drugs in Jan 2015.

Latest PCR (HH) is 0.0004. They don't want to see me for another year in HH.

For the next 6 months I will have 2 visits to my local hospital for 2 more PCRs

I was told they like to see there is no progression for 36 months, I am at 33 months now

So far its worked for me ok

Regards

Simon

Hi Karinne,  Thanks for the post I would comment as follows.

Yes it seems 50% of patients will go back on treatment but of those so far 100% responded to treatment once more, that is many hundreds of patients now worldwide. CML is indeed deadly, but if managed well, PCR’s taken and TKI treatment adhered to the outlook for most is very good, albeit some with harder side effects.

I was on DESTINY and I feel the other way, to reduce particularly Imatinib can be more precarious. 2nd and 3rd generation TKI’s are stronger and so a lower does still effective, there is some debate if a lower dose Imatinib is still effective, or indeed if in effect you are off treatment at this point, and potentially allowing mutations in as the lower dose is perhaps ineffectually but still in the system to allow changes to happen rather than having actually stopped completely. I have heard this suggested by respected physicians.

Personally over 12 months I initially saw levels fall still ( perhaps still in the system / blood stream for the first few weeks ) and then maintain but by month 6-7 levels crept up, and by month 12 I was just, only just, still under MMR, how many other are the same, any, many ? If so then perhaps  this 2% relapse rate is misleading. …. I did ask this point at CML Horizons last month and was told this w as not the case so perhaps it’s just me. However, other specialist Drs there did question strongly the merit of ½ dose Imatinib.

Listening to the speeches there on Treatment Free Remission, and reading more I personally feel that trying to stop, after a minimum 7 years treatment, and at least 2 years MR4 or lower is a safe thing to do, so long as monthly good quality PCR’s are accessible as well as a willing, knowledge specialist, and of course access once more to TKI treatment if needed. I would say no one should try TFR without the above.  

I certainly intend to try again once I have met the criteria I have suggested above, which will be a few years as only diagnosed 5 years. Well, that’s my view and I am sure others will have their own. Thanks for raising the topic.

Ps; Great news Simon, getting past 2 years is the big one, relapse thereafter is quite rare.