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UNDETACTABLE LAST 7 YEARS

IMATINIB 600 DOSE

Fully fit....... Like normal person....

MY QUESTION IS

Current CBC REPORT diagnoses patient is cml patient???

( Medical test (cbc test and urine test require in Job)

PLEASE REPLY.........

Vikram,

I’m not sure I understand your question.

600mg of imatinib is a lot for someone undetectable for 7 years.

CBC cannot show CML. Impossible. It’s just commentary on the report. 

David.

Hi Vikram,  I suppose your blood report mentions CML because you are being treated for it by taking imatinib.  If your employer is concerned, then maybe your doctor could write an explanation for your employer that you are healthy due to your continuing treatment and there is no reason for concern on their part.

Or perhaps you could get your CBC report done at a lab that doesn't have your medical history and then there should be no mention of CML.  Maybe this wouldn't work in India, as I have no idea how your medical records are handled there.

You should really have a serious discussion with your doctor about reducing your dose or an attempt at treatment free remission.

Here is a transcript from three CML experts discussing treatment free remission:  https://www.onclive.com/peer-exchange/cml-management-advances/chronic-my...

Transcript:

Harry P. Erba, MD: We’re going to talk about the data. I’ll let you move right into that, Mike. But first, since we brought up treatment-free remission, they might achieve that beyond a TKI for at least 3 years and MR4.5 for the last year. Can you predict which patients are likely to remain in TFR? Are they prognostic factors? And then maybe tell us about the studies.

Michael Mauro, MD: I think we’ve been trying, that would be our Holy Grail. Can we, based on a patient, read the tea leaves? And I think it’s evolved through the different studies of treatment-free remission. In the beginning, we were dealing with 1 population: imatinib with or without interferon exposure. So, did prior interferon matter? It seemed to in some trials, but I don’t know if it was confirmed. We then asked a panoply of questions. What about the age, the sex, the so-called risk assessment? I think we had mixed feelings on those. I think there was some sense that high-risk patients may not do as well, particularly from the STIM trial. I think in the end, we’ve learned that most of the things early in CML tend to be erased, and we mainly have focused more recently on how long has someone been in a deep remission and how long have they been on treatment. But moreover, how long have they been in a deep remission?

That being said, the other questions that we needed answered in trials were if a patient enters this endeavor, what is the chance of mutations, resistance, and loss of chronic phase CML, which fortunately has been exceedingly low? Re-treatment success I think through all the trials has been exceedingly high with regaining MMR, and MR4, and MR4.5 at a very high rate, north of 90%, 95%. And those are the kind of questions people in the clinic will have. If I do this, what are my chances of losing my response, developing mutations, or not getting into the same quality remission I had before?
The largest data set we have from Europe, which I think we want to cover, are from the EURO-SKI trial. I think we’ve now learned that you probably need to be in a deep remission for a critical amount of time, particularly if you’re an imatinib-treated patient, that really matters, 3+ years. You probably need to be on a TKI for 5+ years. That’s how long it takes you to get into deep molecular remission and then sustain it for 3 years, so it’s pretty logical.

What’s interesting is that in my view, I think the bar has been moved back with aggressive depth of remission. You just heard, you guys just both mentioned MR4.5, MR4 for NCCN guidelines, I don’t know if we know the right answer there. I think we’ve been more generous and more liberal in who we can consider TFR. Honestly, I think the devil is in the details. An MR4 patient who’s sitting right at MR4 is kind of sitting close to it, it may be different than someone who is below MR4 but not consistently at MR4.5. But that has maybe fallen away. And then I think with newer trials, we’re also seeing that higher resistance may be falling away, which is most intriguing but probably not the most brittle form of resistance, patients with no response. Currently, we’re not going to do this endeavor in patients who have transformed, but I think we have data from, for example, optimizing with nilotinib. Some patients from dasatinib trials—where they had switched for intolerance, in some cases resistance—those patients have similar success. So, we’ve gone through all these iterations of the data, and we’ve come up with some conclusions. I think it continues to get more generous, which is encouraging for patients, but we have to be careful.

Jorge E. Cortes, MD: I’d like to make a couple observations. One is the duration of deep molecular response. I think that we’re starting to differentiate between the minimum requirement and the optimal requirement, just like we have for the response, the optimal versus the warning. The 2-year was the initial criteria set by these studies and it works, so that’s good. But we learned in our series that we’ve published earlier, and we updated recently at ASH, the patients who have a 5-year duration of MR4.5 or longer, they have a very low risk of relapse after treatment discontinuation, about 10% to 15%. So, I think that underscores that duration as an important factor, the longer, the better.

The other question is the level of response. And as mentioned, the earlier studies went to even 5 logs, and then 4.5, and other studies with 4. It’s difficult to assess because there are subtleties between one study and the other and how to tell. But when I look at the data of the bigger studies, for example, the STIM and then the EURO-SKI, the EURO-SKI is 4 logs. And I see 2 things that are a little different than the STIM. One is that the curve has continued to drop little by little, but it has continued to drop, whereas the STIM has appeared to reach that plateau where there has been a relapse after 2 years, I believe, or something like that. Whereas the other one, little by little, has continued to drop. And the other thing is that it has dropped a little bit below the 50%, whereas the STIM is sitting at around 60%. So, I’m extrapolating, but I think that I feel more comfortable with 4.5.

And particularly, do you do this in clinical trials or you do it in standard practice? I think that if you’re going to do it in standard practice, I prefer to stick into the more established conventional criteria. In clinical trials, I think it is a very worthy question, MR4, 1 year, 2 years. Now, I don’t have a doubt that we’re going to have patients who, with a lower level of response with a more superficial response and less durable, are going to be able to maintain the response, and we don’t understand why yet, by the way. But some are going to do it. But the question is, are we going to get to the same levels, globally, of responses? And that needs more follow-up, more studies.

Michael Mauro, MD: One other thing to mention that we learned in earlier studies was I don’t know if we have all of the pieces of the puzzle yet, and I think there may be something different about the patients who do or don’t relapse, irrespective of the CML, irrespective of the time and their depth of remission—being their immune system and their immune repertoire. So, I think that potentially needs further exploration and may give us the answer.

Harry P. Erba, MD: OK, guys. I do this every day, and you 2 have just given me a big headache because what I’ve heard is this is a goal of our therapy and we have all of these clinical trials. But the length, the duration that people have been on a TKI, the duration they’ve been in a deep response, how we define the deep response, and when you reinitiate therapy, these vary between all of these studies. And so, yes, we can do it. So, for the practicing clinician who wants to do this, we need to have some clear recommendations. The NCCN has some and quite honestly, one of them that I agree with is to get a second opinion from doctors who’ve done this. Your experience, Jorge, is remarkable. I mean, 200 patients stopping a TKI is similar to some studies that have added to the nilotinib label. So, getting that opinion from someone who does this all the time before just embarking on it, I think, might be very important.

Transcript Edited for Clarity

CML UNDER CONTROL LAST 7 YEARS.... REPORT UNDETACTABLE

In government job, medical test COMPULSORY

(CBC REPORT (blood test) and URINE REPORT)

CBC REPORT and urine test diagnoses cml.....

doctors know I am cml patients?? (Only cbc and urine test....)

CML Patients undetectable...

CBC REPORT and urine test diagnoses cml.... (I am UNDETACTABLE)

(I hide cml....)

GOVERNMENT JOB.... CBC REPORT AND URINE TEST COMPELCERY...

Hello Vikram,

I do not think CML will be diagnosed from a CBC. I am sure others will correct me if I am wrong, but a complete blood count will just look at your blood counts in general. CML is only diagnosed from specific tests so if you are undetectable and healthy, your blood counts will show normal results. Do not worry for your job.

Thanks..for reply....

100% Sure...????

PLEASE REPLY

Please suggest...... And advice.... This question.......

Vikram,

As everyone has said, you cannot diagnose CML from a plain old blood test (e.g. full blood count, biochemistry etc.).

Blood tests are not as simple as running one and seeing everything. You have to know what you you are looking for, and then run the appropriate test to check for that. So unless someone is looking for CML when someone is in MMR, they will not find it. 

For an employment test, typically you’d see a full blood count run because it’s about the most basic, and then some biochemistry run to look for things like liver function. But they will be extremely simple tests and cannot in themselves see CML. Impossible.

David.

I understand Vikram's question differently.

Now that his CML is under control and "undetected". His question (to me) is, does he have CML?

The answer is "maybe". Odds are he continues to have the bcr-abl protein being made by bcr-abl cells, just that they are undetected (too few of them). Whether those are enough to grow into CML if he should stop taking his TKI is unknown - until he stops taking his drug to test for treatment free remission.

In a practical sense - once someone is diagnosed with CML - you always have it because you will always have to have PCR testing. Forever.

So I define not having CML as treatment free remission. And for the rest of my life I will always have a PCR test (at least every six months) to verify remission.

As far as employment is concerned - any requirement to list what drugs you are taking identifies what disease you have in terms of TKI's. Whether you can hide that from employers I have no idea (depends on local laws). A CBC for an "undetected" person or even a person who is "detected", but under control will never reveal that one has CML. The whole point of taking a TKI is to return the blood system to normal function. TKI's tend to do that pretty quickly for most patients (hematologic remission).

(side note: It is actually quite amazing (to me) how it doesn't take much lowering of CML in order for the blood system to return to normal function (i.e. blood counts) even when CML is still raging at 50%+ FISH and 80% + PCR ! Just goes to show how much our bodies fight for homeostasis even when disease is raging. Most people have no idea they have CML until FISH is 100% and PCR is off the charts)

Only for information......Perpous......

Last 8 years UNDETACTABLE

CBC REPORT not diagnose cml current time

(1) Fish test born merrow test diagnoses I cml.......???? (last 8 years UNDETACTABLE and continue......)

I diagnose cml in any test? (meny year undetectable status... Current status UNDETACTABLE).....

(2) my cbc test every 4 months and pcr test every 8 month (last 3 years)

Any International Guideline for test timing?
Every 3 months? 4 month? Six months? (cbc report) and pcr report....

PLEASE REPLY any idea.........

The NCCN CML guidelines say that after two years of successful treatment (major molecular response) you should get checkups every 3 to 6 months as long as your PCR score stays below 0.1% IS.  If your PCR ever increases 1 log, then another PCR should be done in 1 to 3 months.

Only for information......Perpous......

Last 8 years UNDETACTABLE

CBC REPORT not diagnose cml current time

(1) Fish test born merrow test diagnoses I cml.......???? (last 8 years UNDETACTABLE and continue......)

any test diagnosis I am cml ? (meny year undetectable status... Current status UNDETACTABLE).....

PLEASE REPLY......

Any suggestions.....

Hi Vikram,

The PCR test for BCR/ABL1 is the most sensitive test for PH+ CML.  If your PCR score has been undetectable for the past 8 years, then it's likely that your CML will remain undetectable if you continue TKI treatment.

The FISH test usually examines 200 cells for BCR/ABL1 and would almost always show undetected when the PCR test report is undetected.

The CBC test cannot test for CML.  It can only tell if your blood counts are abnormal.

You may have achieved a cure for your CML.  The test for that is to stop TKI treatment under the care of your doctor with frequent testing to make sure CML doesn't return.  There is about a 50% chance that you can remain off of TKI treatment.  If you can stay off of treatment then you will still need regular testing to confirm your CML status for the rest of your life.

I hope this has answered your questions.

Kirk