28 replies to this topic

[Dana]

I was on Gleevec for 5 yrs, then switched to Sprycel due to side effects. On Sprycel for 5 yrs then switched to Bosulif due to side effects. Been on Bosulif for 2 years. Within the first year of diagnosis, I was at <0.01% and have always stayed there but never at 0%. Is there a chance of cessation for me? I am tired of living my life with TKI's!

[gerry]

There is a trial being undertaken in the UK http://public.ukcrn....?StudyID=14492 

[gerry]

The initial part of this trial appears to be de-escalation, then stopping http://www.cmlsuppor...trials/destiny 

http://www.cmlsuppor...enrolled-trial 

[Trey]

If your PCR report does not clarify what "<0.01%" means, I would try to find out from your lab.  Your Onc may be able to ask the lab, or maybe you could call them.  It seems that your lab may have a -4 log cutoff for reporting actual numbers, which is not the standard -4.5 log cutoff.  If the actual number is not below -4.5 logs then odds of success are reduced.

[Pin]

I have this problem too - I have been told it is "essentially equivalent" but I guess we'll see. I am hoping I can reduce in the near future, that would make me very happy.

[gerry]

I have this problem too - I have been told it is "essentially equivalent" but I guess we'll see. I am hoping I can reduce in the near future, that would make me very happy.

Pin, who does the collection in your state is it S&N at all?

[scuba]

Dana,

 

My lab reports my PCR the same way (i.e. < 0.01%) and I was also told that "<0.01%" is the same as PCRU or 'undetectable'. They use to report <0.01% as PCRU/undetectable but no longer do so.

 

I stopped Sprycel 20mg for nine months after I maintained <0.01% for six months. In that time my PCR slowly rose in an up/down pattern when I decided to resume Sprycel. My PCR fell back very quickly to below 0.01% again where it is currently. I will try cessation again, but will let more time pass before the attempt.

 

You should consider lowering your dose first to eliminate side effects you can feel. And then try cessation if you want.

[VickiW]

I take my last dose of 20mg Sprycel tomorrow.  I actually qualified for the LAST trial but could not work out the logistics of all the travel to the site, etc. but if my latest QPCR came back with the big "0" again, my onc agreed to let me go ahead anyway.  Got my results email from the lab last night and I am good to go!  My onc will be calling me Monday with the "official" game plan.  I am a little apprehensive but also excited!

 

 Here's a bit of my background for those who don't know my story;

dxd 3/5/2007 with WBC count higher than could be accurately measured.  Bone marrow so packed it took 2 tries to get a biopsy sample.  Hospitalized.  Initially started on the interferon cocktail then put on Gleevec.  Long story short, horrible painful ride then after 2 years of increases etc. total failure.  Switched to Sprycel 100 mg and it took 2 years but I finally hit and held PCRU.  Over the next 4 years (initially due to complications) the dosage was slowly reduced until December 2014 I started 20 mg every OTHER day and been on that dose until today with no loss of PCRU.  That is a total of 5 years in chemical remission.

 

 Right now we are looking at "officially" taking an indefinite break.  There's always the possibility that I can be one of fortunate (80+% in the newer trials) that makes it to long term TFR and who knows, cure?

[kat73]

Oh, I hope so! Good luck and keep us posted!

[gerry]

Good luck Vicki. I never went on an 'official' trial as they are run out of a different state and I would have had to pay for flights etc. Usually the initial testing is monthly, my doc ran with every second month. Side effects gradually disappear, though there are quite a few members in my FB group who are having muscle and joint issues.

[Pin]

Pin, who does the collection in your state is it S&N at all?

I'm not sure - what's S&N?

[gerry]

You can't use the word cure, no way to tell, plus I know of it making a reoccurrence at 4.5 years, with that person having to restart the TKI.

[Buzzm1]

I take my last dose of 20mg Sprycel tomorrow.  I actually qualified for the LAST trial but could not work out the logistics of all the travel to the site, etc. but if my latest QPCR came back with the big "0" again, my onc agreed to let me go ahead anyway.  Got my results email from the lab last night and I am good to go!  My onc will be calling me Monday with the "official" game plan.  I am a little apprehensive but also excited!

 

 Here's a bit of my background for those who don't know my story;

dxd 3/5/2007 with WBC count higher than could be accurately measured.  Bone marrow so packed it took 2 tries to get a biopsy sample.  Hospitalized.  Initially started on the interferon cocktail then put on Gleevec.  Long story short, horrible painful ride then after 2 years of increases etc. total failure.  Switched to Sprycel 100 mg and it took 2 years but I finally hit and held PCRU.  Over the next 4 years (initially due to complications) the dosage was slowly reduced until December 2014 I started 20 mg every OTHER day and been on that dose until today with no loss of PCRU.  That is a total of 5 years in chemical remission.

 

 Right now we are looking at "officially" taking an indefinite break.  There's always the possibility that I can be one of fortunate (80+% in the newer trials) that makes it to long term TFR and who knows, cure?

vwoyak, Good Luck to you; with nine years of TKI, five of it undetectable, the odds of remaining TFR are in your favor.  In previous trials, the average undetectable duration was only 2+ years Stop Studies - Stop Study Compilation

 

re: There's always the possibility that I can be one of fortunate (80+% in the newer trials) that makes it to long term TFR and who knows, cure?

 

do you have a link to the 80+% in the newer trials?  I haven't seen that published

[gerry]

I'm not sure - what's S&N?

Sullivan & Nicolades ( not sure of the exact spelling). Normally I would go to them and they would do the blood draw and it would be sent to the hospital for them to do the PCR part. They have now bought their own testing equipment which goes deeper than the hospital. Some people previously PCRU came back with the CML showing up. Wasn't sure how yours was being done in you state.

[Trey]

....do you have a link to the 80+% in the newer trials?  I haven't seen that published

 

There is no such 80%+ success rate for cessation.  Results are about 40 - 50%, and that only counts those who were very well qualified to start a cessation trial.  I'm sure that 80%+ number was misreading the study results, most likely this:

"Results: Most pts in ENESTcmr had received > 3 y of prior IM (NIL 400 mg BID arm, 83%; IM arm, 80%)."

That just means 83% had been taking Tasigna (NIL) and 80% had been taking Gleevec (IM) before starting the cessation trial.  In that trial the success rate at 2 years was about 45%.

 

Even the 40 - 50% success rates are somewhat misleading since it does not include those who were never qualified to start the cessation trials.  So of those who first became qualified to start a cessation trial, less than half of those "optimal achievers" succeeded.  So the overall ability to succeed is probably somewhere around 15 - 20% for the entire population of CML patients.

[scuba]

Trey wrote:

 

"Even the 40 - 50% success rates are somewhat misleading since it does not include those who were never qualified to start the cessation trials.  So of those who first became qualified to start a cessation trial, less than half of those "optimal achievers" succeeded.  So the overall ability to succeed is probably somewhere around 15 - 20% for the entire population of CML patients."

 

Trey - your statement is misleading. Cessation success is not determined from the entire population of CML patients. That is an erroneous way to look at it. Cessation success is determined from the population of PCRU patients who have maintained "undetected" status for two years. In this population, as many as 50% of this population have been able to remain off therapy with no progression. 

 

This is an important result. As many as 1 out of 2 (not one out of five that you imply) two-year PCRU patients have success. And of those who 'relapsed' none had CML progress once they resumed therapy. They all returned to PCRU status.

 

There is discussion in the clinical setting on whether PCR < 0.01% (I.S. scale) can be considered "PCRU" for the purposes of cessation and patient success at either maintaining this status or below - no progression can be properly evaluated. That is the point of Dana's thread. Data on success rate for patients who have reported PCRU's < 0.01% (i.e. detectable) in a clinical trial does not exist (for which I am aware). M.D. Anderson, for example considers PCR's less than 0.01% M.D. Anderson scale (~ 0.003% I.S.) to be essentially the same as "undetectable" since many false positives occur at that level. 

 

(on a personal note, I tried cessation after holding PCR < 0.01% (M.D. Anderson scale) for six months. My personal test was completely outside the normal trial setting. It took nine months for my PCR to go above that level (i.e. PCR > 0.01%) and in fact came close to MMR. My lack of success in this attempt is not part of any statistics. It simply didn't work for me. I felt it was worth a try and I am now once again below 0.01% after only a couple of months back on Sprycel 20mg therapy. My point is patients should not be scared away from trying cessation - even if they only achieved PCR < 0.01%, but otherwise are considered detectable. And that is the point of Dana's question. 

[gerry]

I would be slightly concerned if my doc was quoting 80% success rate. Definitely no evidence of that at the moment. You also have to be prepared to possibly not succeed and have to restart your TKI. Testing needs to be done monthly, that way any loss of MMR is picked up quickly.

[Marnie]

 

"Trey - your statement is misleading. Cessation success is not determined from the entire population of CML patients. That is an erroneous way to look at it. Cessation success is determined from the population of PCRU patients who have maintained "undetected" status for two years. In this population, as many as 50% of this population have been able to remain off therapy with no progression. "

 

Sorry, Scuba. . .gotta disagree.  Seems to me that the entire CML population is interested in and looking at cessation, and so it's important that success rates consider the entire population.  Saying that the success rate is 50% doesn't tell the whole story.  I only WISH the success rate were 50%.  I was off Sprycel for a couple of weeks after being PCRu, and my numbers immediately jumped up significantly.  I'm still not down to zero, which is very disheartening. 

 

My 2 cents.

[Marnie]

Didn't post that quite right, sorry.  Part of the greyed in portion is me, not Scuba. 

[scuba]

Marnie - my point is that among those "qualified" to try cessation (i.e. PCRU for two years) - there is almost a 50% success rate.

Anyone who has not achieved "pcru" and held it for two years is not part of the data. I tried cessation and it didn't work for me, but I wasn't part of the pre-qualified pool. I don't recall how long you remained PCRU before stopping.

 

What I would like to know - and haven't investigated - is what percentage of patients who are diagnosed with CML, managed to achieve PCRU and have held it for two years?