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PCR at 9 months

Hi everyone,
I was diagnosed CP CML last year on my 42nd birthday. I am a father of four and it came as a big shock. My WBC was 240,000 and over 98% of cells in my marrow were PH+.

I was put on Imatinib 400 mg and was very thankful to achieve CHR at 3 months. At the time I was thrilled (still am) but now realize that this was just the first of three levels of remission to achieve. My doctors did not conduct a FISH test but rather went straight to quantitative PCR.

At 9 months my PCR was 5%. This has me pretty concerned as I had hoped for a better response (don't we all). I understand that the basic "goal" for initial treatment is to reach CCyR at 12 months with MMR following at 18 months.

I have another PCR test in 3 months but I am not sure how to equate the results of the PCR to reflect my progress toward CCyR. Does 5% PCR translate to 5% PH+?

Also, is anyone aware of anything that might impede the response to Imatinib? I take a PPI called Pantaprazole for reflux and have read that this might be the case but haven't found a clear recommendation on this. How about alcohol? Is 1 - 2 drinks OK or should it be avoided?

Thank you all for reading, and I really appreciate any feedback you might have.

Bill

Hi Bill,

Welcome to this forum. I hope I can answer at least some of your questions, I am sure others will comment too.

First: The 2009 ELNet recommendations for chronic phase CML do cite CHR (complete haematological response) within the first 3 months.

However, they have recently updated the recommendations and I believe they cite an optimal response (and yes we would all want one of those) as a reduction of PH+ cells to less than 10% by 3 months and CCyR (less than 1-1.5% Ph+) within 6-12 months.

Second: a result of 5% by Q-PCR would translate to 5% Ph+ cells.

It also depends on where your tests are done...i.e which lab and is their Q-PCR method tied to the International Scale?

FISH is usually used as the initial test because when the Ph+ cells are at a high level (65-100%) RT Q-PCR is not entirely accurate. As the level of Ph+ cells comes down much lower it is then an extremely accurate test- far more than FISH or cytogenetics.

As far as drugs that interact with imatinib- it might well be that the one you take for reflux has an effect on your digestive enzymes and so on your ability to absorb an optimal dose of imatinib. You could ask your doctor if it is possible to check your imatinib plasma level which should be at or around 1000ng/ml. If it is less than that, then you know something is interacting with your absorption of the drug.

Third: Alcohol is only an issue in that it can affect the liver- as do all TKIs including imatinib as they are metabolised by the liver. Your doctor can reassure you as your blood test should show the levels of your liver enzymes.

For most- one of two alcoholic drinks seem to be OK so I would not worry too much unless your liver is under stress.

Here is an outline of the % of BCR-ABL translated into MR according to the IS.

On the international scale (IS) an RT Q-PCR test result of:
0.1% BCR-ABL = MR 3 (3 log reduction from 100% - IRIS)
0.01% BCR-ABL = MR 4
0.0032% BCR-ABL = MR 4.5
0.001% BCR-ABL = MR 5

Sandy

Hi Sandy,
Thanks very much for the feedback. I will ask my oncologist about the imatinib plasma level testing and be sure that the lab is on the International Scale (I believe it is).

Certainly the goal is to have the PCR going down and ideally under 1.5% on my next visit, which would mark 12 months on Imatinib therapy. Fingers crossed.

I understand that some of the 2nd generation TKIs such as dasatinib demonstrate higher levels of CCyR and MMR than Imatinib. It's interesting to me that Imatinib nevertheless remains the first drug of choice.

Thanks again,

Bill

Hi Bill

Like you I was diagnosed at 42 (in May 2009) - the other thing we have in common is PPI usage on imatinib. I also have reflux on imatinib and was prescribed omeprazole. I was told PPIs are fine with imatinib (at least, omeprazole 10mg daily). I can't recall which of the other TKIs require an acid environment for good absorption but imatinib is fine on PPIs.. In my own case, I know my plasma levels are good - and my response to imatinib was quick and deep - if your own plasma levels turn out to be less good there may be a different cause.

Re alcohol - I was also told this was fine. I cut right back at least for the first couple of years, mainly because I just didn't fancy it and with the GI issues I had (and have, to a lesser extent) on imatinib, I didn't really miss it. But I still enjoy a glass of wine or 2 (I just never over do it nowadays).

Good luck and hopefully your PCR will continue to drop.

Richard

Hi

How are you doing ? What is your latest pcr ?

Thomas

i was diagnosed 6 months back with 100 % cell translocation after 3 months it was 5.836 & afte 6 months it is 1.40. am i doin well or should i change the drug
currently i am on imatinib

Hi,

Are results from the lab your doctor uses reported on the IS (international scale) or is it a local lab generated result? If so you might ask your doctor if the lab has a 'conversion factor' so that you can compare your results to the ELNet (European Leukaemia Net) and/or NCCN guidelines and recommendations.

1.4% on the IS is, at 6 months, generally considered to be a good result- it indicates you have responded well and have achieved a complete cytogenetic response (CCyR).

Both ELNet and NCCN identify a major molecular response -0.1% IS- within the first 12 months from start of therapy to be an optimal response, as well as a realistic goal of TKI therapy.

Ideally testing should be done every 3 months until MMR (0.1%), then once the molecular response (MR) is stable, testing changes to every 6 months.

If you continue to respond well and your next PCR shows a further drop to MMR, and as long as you do not suffer from side effects that affect your quality of life, then your doctor may advise that you stay on imatinib.

You really need to have this discussion with your doctor,

Here are some links that might help.

Pocket Card LeukemiaNet recommendations for the Management of CML (
2013 http://www.leukemia-net.org/content/leukemias/cml/recommendations/e8078/...

NCCN Guidelines for CML patients: Version 1:2014: http://www.nccn.org/patients/guidelines/cml/index.html#1

Best wishes,
Sandy

1.4 is on international scale.my doctor told me that is should be below 1.0.but still i am doin good and to repeat pcr after three months.
i have rather no side effect, i do my gym , go to job10 am to 7 pm.my family life is good. married exactly on date when i came to know about my disease and discussed it with my wife too.
at start my translocation was 100 % at three month 5.836.
i love to drink, should i stop at all?
and yes very thankfull for your quick response.

Hi Bill,

I took omeprazole, a PPI similar to pantaprazole. Omeprazole significantly interacts with my TKI, dasatinib. But as far as I am aware imatinib doesn't require an acidic environment to be digested so the use of a PPI with it should not be a problem.

All the same, if you want to read a bit about my experience with PPIs and TKIs have a quick search on this forum for the word "fundoplication". I went for the surgical route to rid me of the PPIs, and it's worked out really well. Or, drop me a message!

David.

If your liver is standing up to the TKIs combined with alcohol then you may be lucky and get away without too much damage. Depends on how much you drink on a daily basis- ;o)

Best wishes,
Sandy

hi sandy,
hope i am not irritating you,but my concerns are too much.
i have married six months back could you please tell me , that can i be the father on imatanibs or not? what precaution should i take? can the child may have any abnormalities due to this drug?

It seems that imatinib does not have an adverse effect on sperm and so the clinical opinion is that males on treatment with imatinib can father children with only the same level of risk of abnormalities as the normal- non CML- male population.

The risk of foetal abnormality for women on treatment with IM is increased as the drug (including 2nd Gen TKIs) can have an effect in the first 3 months of gestation.

Once again, I suggest that you talk to your doctor and ask for his/her opinion on this issue.

Best wishes,
Sandy