42 replies to this topic

[pamsouth]

Hi Judy,

I would like to hear Treys answer to that as well.  I did search for one of his websites, which answers it pretty good.

http://community.lls...s/DOC-1276    

This was one of the discussion I had last November when I went to the CML expert for a second opinion or consolation.

He drew his little diagram on the board, like they do, when you are going for a consultation, you  know explaining the CHR, CCR, MMR.  After he got done drawing, he said "I don't care if you stay in the middle here as long as you don't have an upward trend, where it looks like you are losing your response to G"  If it continuously goes up, then we would have to do some testing, and see what the problem is.

I can see by Trey's web, that supposing the deeper the response the better chance of longer survival.  However I noticed in the middle it said something about being just being stable as be good to.

I was impressed when he the oncologist said he didn't go by guidelines, like my former onc did. 

My grip about this deep response thing is.  You got to have some quality of life, or what is the sense of it all!  So as long as I reach a happy stable medium I don't care if it is not an MMR.  Yes some people do well with the TKI and quality of life, but other do not.  I think Trey only has to take 200 mg of G and I think Scuba only takes 20mg of Sprycel, now how many can take that low of a dose and still have a good response?

I mean if I get this right in my head even if you had an MMR which means the TKI are killing more cells, you still have millions of leukemia cells that something can still go wrong.  Maybe not as many bad cells as an MMR then if you had an CCR.  That is all I really care about is have a good FISH report that is between 92 % and 100 % negative.  I mean these PCR have so much room for error, even both onc admitted that. 

So I would just be happy to stay in the middle somewhere and be able to live somewhat a normal life, without being sick everyday with rashes and headaches and fluids, etc.

PamSouth

[scuba]

Hi Judy,

An excellent prognosis is associated with a deep PCR response of 3 log or more drop* below your baseline coupled with complete cytogenetics remission in 12 to 18 months from start of continuous therapy. I was also told by Dr. Cortes that if a patient re-starts therapy with a new drug, he starts the clock over meaning a new baseline and timeline for response with that new drug.

There are exceptions to this general data observation. Many patients do well with no progression of disease with PCR log response lower than reported (i.e. 2 log response or PCR that goes up and down). But it is very important that Cytogenetics show no Ph+ chromosomes. That is most important in prognosis. Everyone wants to get their FISH to zero as quickly as possible. Durability of this is indicated by how fast PCR falls along side.

p.s. * A 3 log drop is typically from 100% PCR through to 10%, then 1% then .1% (hence the 3 log drop). 0.1% PCR sets the benchmark for MMR (major molecular response). So if someone had a baseline PCR of 155% - then the 3 log indicator for MMR would be 0.15%. Personally - this is all fuzzy math since PCR is such a problematic test. What's important is that the PCR drops to below 1 and either keeps dropping or stays there while cytogenetics = zero. All I care about is that I have zero's to the right of the decimal point in my PCR report. If my PCR goes up by more than one log, then I will have a bone marrow cytogenetics test done.

[hannibellemo]

Hi, Judy!

Yesterday I could not get my head around my job so I spent the afternoon reviewing the NCCN CML Guidelines.   I don't know how pertinent the CML specialists find them because they all seem comfortable doing what ever they think might work for their patients. However, for those of us who don't see specialists, they are helpful for us and our docs.

What I found interesting is that while MMR and PCRU (CMR) are listed in the definitions of the guidelines they are not listed as the "goal" of treatment. The highest goal is CCyR to be reached within 18 months. Now common sense dictates that if we reach MMR or CMR within that timeline or, ever, for that matter, and maintain it we are ahead of the game.

These guidelines lead me to believe that those of us who have a stable CCyR for years are doing fine! It also leads me to believe I would shy away from any doc who has "PCRU or bust" as his/her goal for their patients regardless of how the patients are doing on their current drug.

Just my two cents worth.

Have a great weekend!

Pat

[Judy2]

Thanks Scuba and Pam South,

I understand it better now.  I started my third TKI 2 months ago so in a sense I guess it's like I'm at the beginning of treatment again. I had heard that how you do in the first 3 months of treatment is an indicator of  your long term prognosis but since we now have 3 TKIs I'm assuming this is no longer the case. The other thing I think about is this. Since with CML we do not have solid tumors, like other cancers, we have the PCR tests instead of, say, an MRI to see if we have cancerous cells in our body. If someone had a solid tumor cancer and their MRI showed even a tiny tumor the onc. would consider this as less than favorable. In that case the person would have to continue their chemo regimen indefinitely as we have to continue ours. When I think of it this way I wonder how long can our medicine overcome this? I know statistics say 30 years but no one has been on the medicine for 30 years so how do the researchers know this? If our body is continually churning out these cancerous cells how good that that be for us? It seems like it would eventually compromise our health in other ways, you know, wear our body down. Any thoughts on this?

Judy

[pamsouth]

Judy2. 

Those your thoughts have been my thoughts from day one.  These are new drugs. It is not like they have been studied like 10-15-20 years, like other patents are before they become generic.  I think Sprycel with trial in 2007 and patent in 2009 not sure, Of course it is with good reason, in that we need these new drugs now, so the history data is not in!  I think it would be fair to say we are somewhat the guinea pig.

I would venture to guess in answer to your question about living 30 years.  That would be the hope that the drug companies would keep new drugs coming along, so if one failed another one would work. 

Yes I do agree with you, basically who know the medium, long term effects.  I am sure it will become an individual thing in the end or ongoing  studies.  Ex; some people on this board have been on Gleevec since it went to trial in 1997, (thus more data, although I do thinking sometimes, they are pushing patients, on to the newer TKI's before G loses it's patent, need research money and patients for research as CML is rare). I don't know the latest percent still on Gleevec, but a lot of them, I think, are still doing good, I don't really know, maybe I should google it.  Your question, For how long, 30 years, what if G doesn't work, how will the other drugs work, and how long, what quality of life.  etc. The Unknown, They don't know they are new drugs!!

I think lots of onc playing the guessing game, trial and error.

I think the big concern among scientist and the drug makers is the side effects and the quality of life.  How deep of a response can we get and still not damage are 5 organs and still not have serious side effects from the toxicity and have a quality of life.

These drugs only kill the PH+ at the lower level.  We are not killing the ancient bad mother stem cell.  I hear she can live for a long time.  I believe I read from one of Treys blogs, that she goes into hiding up close to the bone where there is no oxygen and your T cells can't get to her to kill her off.

So for me, Yes the TKI are the best we have.  But I don't agree that CML is a simple cancer I think it is much more complicated then just killing leukemia cells at the lower level.  I mean that stem cell is close to the top of the change before it even makes the Red Cells, White cells, Platelets.  It's just the White cells are nucleus with with 23 pair of chromosome, while the red cells and platelets are not nucleus.  So it is the white cells with the chromosome that are turning on and making copies, I think that is right.  If wrong Trey will get after me to just paste a link. 

I am still patiently waiting on the promise cure, which at this time is only a Transplant.

PamSouth

[Judy2]

Hi Pat and Pam S.,

Pat, thanks for your 2¢, I  think I am well into brain fog and therefore need all the extra brain power I can get. I'm wondering when the guidlines were written or updated. If it was before Tasigna and Sprycel maybe the oncs could only anticipate a fair response where the prognosis wasn't as good. Now with T. and S. perhaps we are able to have a better long term outcome so if people are not doing as well on Gleevec they can be switched with the hopes of a better prognosis. Just a thought.

Pam S., I have to say I got a laugh when you posted that if you are wrong Trey will get after you to post a  link.

Judy

[pamsouth]

Hanni,  I am with you.

     ""These guidelines lead me to believe that those of us who have a stable CCyR for years are doing fine! It also leads me to believe I would shy away from any doc who has "PCRU or bust" as his/her goal for their patients regardless of how the patients are doing on their current drug.""

Hanni, I think that is worth a lot more then 2c.  That is exactly where my thinking.  I mean if you look at all the documentation from the leading CML Experts, I think that is about the most general truest statement you can make, without making it more complicated.

PamSouth

[pamsouth]

Got Cha Billie, 

I have a pot roast in the crock pot for  tomorrow.  I wish you could come an join me. Oh heck the whole lot of you, Judy2, Pam M, Oh just bring the gang and, a side dish.  Maybe a little whine and cheese.  Ya Cheese Cake with some Strawberries.

PamSouth

[hannibellemo]

Judy,

The NCCN guidelines were updated in 2011. I believe they are updated frequently. Here is the link:

http://www.nccn.org/...n.asp?FlashID=8

Scroll down left side to NCCN Patient Guidelines.

Pat

[Judy2]

Hi Pat,

Thanks for the link.

Judy

[Trey]

The most important thing in CML treatment is a stable and durable drug response.  Deeper responses are statistically more likely to be both stable and durable.  But many can meet these two criteria in CCyR or better; and Dr Druker has suggested that he believes CCyR is the most important of the treatment milestones.  It would be unusual to meet these two criteria with less than CCyR, but it can happen. 

[Judy2]

Hi Trey,

Thanks. I know this is going to sound like a stupid question but I am very "fogged out" right now. When I was dx my BMB showed 20 out of 20 cells positive for the Philadelphia Chromosome. Would I be able to tell how many were positive from the level of my PCR , say if I was down to 1% PCR then could I assume I was in CCyR, or would I have to have another BMB? Thanks.

Judy

[Trey]

A single PCR number by itself does not mean anything since lab numbers vary widely.  Ask your Onc if your PCR shows a 2 log reduction, which is roughly equivalent to CCyR.  After CCyR BMBs are no longer necessary unless the patient has other high risk factors.

[Judy2]

Hi Trey,

Thanks, now I know when I hit a 2 log reduction I will be CCyR, not there yet.

Judy

[pammartin]

Hey, I was invited to a party and didn't know it!  Heading out for choc covered strawberries and sangria, summer food and beverages!

[pammartin]

Judy,

Hang in there, it will happen!

Pam

[Judy2]

Hi Pam M.,

Thanks for your support, I know it will. My night sweats have improved so I think my next PCR test will be much lower, fingers crossed.

Judy

[pammartin]

Hi Judy, awesome!  It is funny, my night sweats are at an all time high, but the labs say things are good.  Perhaps it is menopause.    Nice to see you, I have been worried.