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Lower dose sprycel (50mg) in newly diagnosed CP patients study.


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#1 TeddyB

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Posted 01 June 2017 - 01:31 AM

So 50mg seems to be working well for everyone in the trial.

 

http://abstracts.asc...199_185127.html

 

 

 



#2 scuba

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Posted 01 June 2017 - 06:57 AM

Notice that Dr. Cortes is a key author of this paper. He told me years ago that 100mg Sprycel is too toxic for most patients and that he preferred starting patients on a lower dose. This was based on the clinical trial data before the standard (100mg) was set.

 

This new study can help give cover to patients who can teach their doctors that 50mg starting dose can be an alternative dose-schedule standard of care. I hope this helps patients who want to lower their dose to 50mg (at least. I am on 20mg with great success).


Diagnosed 11 May 2011 (100% FiSH, 155% PCR)

with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein

 

Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate

6-8 grams Curcumin C3 complex.

 

2015 PCR: < 0.01% (M.D. Anderson scale)

2016 PCR: < 0.01% (M.D. Anderson scale) 

March        2017 PCR:     0.01% (M.D. Anderson scale)

June          2017 PCR:     "undetected"

September 2017 PCR:     "undetected"


#3 Kali

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Posted 01 June 2017 - 12:47 PM

Thanks Teddy for the article and Scuba for Dr. Cortes views on this.

It gives hope for reduction. I am now on 70mgm Sprycel (was on100) I am hopeful to go down to 50 at some point to reduce chance of side effects for the long term.

Diagnosed June 2014. WBC 34.6 and Platelets 710 at diagnosis. Bone Marrow Biopsy pre-op diagnosis: Leukocytosis. Post-op diagnosis: the same, Leukocytosis. No increase in blasts <1%. Quantitative BCR/ABL testing and formal chromosome analyses confirmed CML diagnosis.<p>Supplemental Report: Abnormal BCR/ABL1 FISH result t(9;22). Molecular test for BCR/ABL1 fusion transcript by RT-PCR positive for BCR/ABL1 transcripts, b3a2 at 133.561% and b2a2 at 0.001% and ela2 at 0.001%. Followup monitoring showed negative for ela2. BCRABL1 was 148.007 at diagnosis. Started Sprycel 100 mgm and blood work was normal at 3 weeks. MMR at 3 months: 10/4/14 was 0.106. Stayed in that range with one dip to 0.04 once and back to 0.1 range. Oct. 2015, BCRABL1 was not detected, following with 0.0126, 0.0092, <0.0069, 0.0000, <0.0069, 0.0000. Now on 70 mgm of Sprycel. Continuation of PCR test results: 07/07/2017, 0.0000%, now on 50 mgm of Sprycel, PCR 9/12/17 0.0074%, PCR 11/3/17 0.0000%, PCR 1/17/2018 0.0000%


#4 TeddyB

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Posted 01 June 2017 - 12:48 PM

Thanks Teddy for the article and Scuba for Dr. Cortes views on this.

It gives hope for reduction. I am now on 70mgm Sprycel (was on100) I am hopeful to go down to 50 at some point to reduce chance of side effects for the long term.

 

I will be keeping my fingers crossed for you :)



#5 Kali

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Posted 01 June 2017 - 02:37 PM

Thank you, Teddy ๐Ÿ˜Š

Diagnosed June 2014. WBC 34.6 and Platelets 710 at diagnosis. Bone Marrow Biopsy pre-op diagnosis: Leukocytosis. Post-op diagnosis: the same, Leukocytosis. No increase in blasts <1%. Quantitative BCR/ABL testing and formal chromosome analyses confirmed CML diagnosis.<p>Supplemental Report: Abnormal BCR/ABL1 FISH result t(9;22). Molecular test for BCR/ABL1 fusion transcript by RT-PCR positive for BCR/ABL1 transcripts, b3a2 at 133.561% and b2a2 at 0.001% and ela2 at 0.001%. Followup monitoring showed negative for ela2. BCRABL1 was 148.007 at diagnosis. Started Sprycel 100 mgm and blood work was normal at 3 weeks. MMR at 3 months: 10/4/14 was 0.106. Stayed in that range with one dip to 0.04 once and back to 0.1 range. Oct. 2015, BCRABL1 was not detected, following with 0.0126, 0.0092, <0.0069, 0.0000, <0.0069, 0.0000. Now on 70 mgm of Sprycel. Continuation of PCR test results: 07/07/2017, 0.0000%, now on 50 mgm of Sprycel, PCR 9/12/17 0.0074%, PCR 11/3/17 0.0000%, PCR 1/17/2018 0.0000%


#6 mscl

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Posted 02 June 2017 - 09:20 PM

So far I have been successful on 20 mg for about six months now.
Dx 2/10/12.
Sprycel 100. mg.
10/2015, Pleural effusions, both sides, about a 3-4 week break in Rx, reduced to 70 mg.
PEs, weren't completely gone, started building back up, about a 6-8 week break in Rx.
01/2016, Reduced to sprycel 50 mg.
10/2016, developed severe skin rash, mainly upper arms and upper legs, smaller rashes on lower arms, lower legs, upper back/neck. Rx break of about 6 weeks.
1/25/17, reduced to Sprycel 20 mg.
7/19/17, still at 20 mg Sprycel, undetectable.
11/9/17, 20 mg Sprycel, undetectable.

#7 Kali

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Posted 03 June 2017 - 10:56 AM

That is so encouraging isn't it? I love hearing that good news, mscl!

Diagnosed June 2014. WBC 34.6 and Platelets 710 at diagnosis. Bone Marrow Biopsy pre-op diagnosis: Leukocytosis. Post-op diagnosis: the same, Leukocytosis. No increase in blasts <1%. Quantitative BCR/ABL testing and formal chromosome analyses confirmed CML diagnosis.<p>Supplemental Report: Abnormal BCR/ABL1 FISH result t(9;22). Molecular test for BCR/ABL1 fusion transcript by RT-PCR positive for BCR/ABL1 transcripts, b3a2 at 133.561% and b2a2 at 0.001% and ela2 at 0.001%. Followup monitoring showed negative for ela2. BCRABL1 was 148.007 at diagnosis. Started Sprycel 100 mgm and blood work was normal at 3 weeks. MMR at 3 months: 10/4/14 was 0.106. Stayed in that range with one dip to 0.04 once and back to 0.1 range. Oct. 2015, BCRABL1 was not detected, following with 0.0126, 0.0092, <0.0069, 0.0000, <0.0069, 0.0000. Now on 70 mgm of Sprycel. Continuation of PCR test results: 07/07/2017, 0.0000%, now on 50 mgm of Sprycel, PCR 9/12/17 0.0074%, PCR 11/3/17 0.0000%, PCR 1/17/2018 0.0000%


#8 Kali

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Posted 08 June 2017 - 08:39 AM

I have been giving a lot of thought to these reductions in dose which is such good news to hear that several on the board are doing well with reduction of dosage.

Is there a guideline on how long one needs to be either nondedectible or at least have very low numbers to give a reduction in dose a try?

What about the theory of knocking out these bad cells for a long time first and then try reduction?

Is the new thinking to reduce side effect risks and maintain MMR or below as good enough since these drugs don't cure our disease anyway? If that is the goal, and reduction still maintains that goal, then that could potentially be a new discussion to have with our ones?

I know all of us want our best shot at a cure someday. The idea of driving these bad cells into practically nonexistence is appealing. But now that we know more about the toxity of the drugs it is also concerning if it takes really high doses of TKI to do that.

Just looking for any thoughts or insights on this paradigm shift in thinking about treatment ideas. Dr. Cortes, who sounds awesome, is obviously starting a sampling of newly diagnosed patients on 50 MGM instead of 100 as stated in the article above. And we know these patients, just like us at one time, are not pcru when diagnosed and the report indicated this is working well.

I am currently on 70 MGM Sprycel a day and would like to reduce further but not sure when to push that idea with my onc since I just started my reduction dose 1 month ago. I also like the idea of driving the bad cells into oblivion, so it is a judgment call. I know there aren't specific answers to all of this. I love reading your thoughts and opinions. Thanks!

Diagnosed June 2014. WBC 34.6 and Platelets 710 at diagnosis. Bone Marrow Biopsy pre-op diagnosis: Leukocytosis. Post-op diagnosis: the same, Leukocytosis. No increase in blasts <1%. Quantitative BCR/ABL testing and formal chromosome analyses confirmed CML diagnosis.<p>Supplemental Report: Abnormal BCR/ABL1 FISH result t(9;22). Molecular test for BCR/ABL1 fusion transcript by RT-PCR positive for BCR/ABL1 transcripts, b3a2 at 133.561% and b2a2 at 0.001% and ela2 at 0.001%. Followup monitoring showed negative for ela2. BCRABL1 was 148.007 at diagnosis. Started Sprycel 100 mgm and blood work was normal at 3 weeks. MMR at 3 months: 10/4/14 was 0.106. Stayed in that range with one dip to 0.04 once and back to 0.1 range. Oct. 2015, BCRABL1 was not detected, following with 0.0126, 0.0092, <0.0069, 0.0000, <0.0069, 0.0000. Now on 70 mgm of Sprycel. Continuation of PCR test results: 07/07/2017, 0.0000%, now on 50 mgm of Sprycel, PCR 9/12/17 0.0074%, PCR 11/3/17 0.0000%, PCR 1/17/2018 0.0000%


#9 scuba

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Posted 08 June 2017 - 09:57 AM

Kali wrote,

"I am currently on 70 MGM Sprycel a day and would like to reduce further but not sure when to push that idea with my onc since I just started my reduction dose 1 month ago. I also like the idea of driving the bad cells into oblivion, so it is a judgment call. I know there aren't specific answers to all of this. I love reading your thoughts and opinions. Thanks! "

 

What is your current PCR level? (consider putting your history in the signature line for others to see).

 

When I was at or near 100% FISH and PCR, I was never able to handle full dose TKI's (Gleevec or Sprycel). My first oncologist wanted me to increase my dose and manage side effects. I sought out Dr. Cortes who told me straight out that he is going to switch me to Spyrcel at low dose. He repeated what the article linked above reported.  And he was concerned about pleural effustion and sprycel.

 

One key advantage of working with a research oncologist is that they know results before they are presented and published to the general practicing community. He said Sprycel is very potent at low dose and he has had much success with patients who had severe side effects and put on lower dose. I went from high FISH and high PCR to near PCRU on only 20mg Sprycel in less than a year. In my view, patients could start at 20mg Sprycel and likely have tremendous response out of the gate as well as avoid having to experience pleural effusion and other side effects.

 

It seems reasonable more is better when trying to kill something - especially cml cells. But the reality is cml control is a dynamic balance between population growth or collapse of the system which produces the bad cells. Tipping the balance in favor of collapse is all that is necessary. Once a dose is achieved that does that - more does not change the outcome. More is not better - more is more toxic. But each of us are unique in what threshold is required. 

 

The very good news is that while we can maintain population control of cml cells with little drug - research is progressing to address the root cause of the disease (cml stem cells). Like killing the queen of a fire ant colony destroys the colony, killing cml stem cells could lead to complete cml collapse and cure. Staying on as low a dose of a TKI which works is prudent. But it takes experimenting on an individual basis to find the ideal minimum dose. For some - full FDA approved dose is the minimum dose that works. But for many others, it does not need to be anywhere near as high.


Diagnosed 11 May 2011 (100% FiSH, 155% PCR)

with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein

 

Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate

6-8 grams Curcumin C3 complex.

 

2015 PCR: < 0.01% (M.D. Anderson scale)

2016 PCR: < 0.01% (M.D. Anderson scale) 

March        2017 PCR:     0.01% (M.D. Anderson scale)

June          2017 PCR:     "undetected"

September 2017 PCR:     "undetected"


#10 kat73

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Posted 08 June 2017 - 11:23 AM

OK, since I'm among friends here, I'm going to bare all my ignorance and faulty memory.  My onc, a CML specialist on the "biggy list," has told me he will never go as low as 20 mg Sprycel - even at deep response PCR level - because "underdosing causes drug resistance."  Period.  Explain to me one more time why he is wrong?  I just simply don't understand why the analogy to antibiotic misuse is not the correct model here.

 

I want to believe everyone here on the forum, but I have to deal with this guy.


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#11 Kali

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Posted 08 June 2017 - 12:18 PM

Hi Scuba,

Will you give me instructions on how to put history on the signature line. I don't know where to find the signature line. Thanks

Diagnosed June 2014. WBC 34.6 and Platelets 710 at diagnosis. Bone Marrow Biopsy pre-op diagnosis: Leukocytosis. Post-op diagnosis: the same, Leukocytosis. No increase in blasts <1%. Quantitative BCR/ABL testing and formal chromosome analyses confirmed CML diagnosis.<p>Supplemental Report: Abnormal BCR/ABL1 FISH result t(9;22). Molecular test for BCR/ABL1 fusion transcript by RT-PCR positive for BCR/ABL1 transcripts, b3a2 at 133.561% and b2a2 at 0.001% and ela2 at 0.001%. Followup monitoring showed negative for ela2. BCRABL1 was 148.007 at diagnosis. Started Sprycel 100 mgm and blood work was normal at 3 weeks. MMR at 3 months: 10/4/14 was 0.106. Stayed in that range with one dip to 0.04 once and back to 0.1 range. Oct. 2015, BCRABL1 was not detected, following with 0.0126, 0.0092, <0.0069, 0.0000, <0.0069, 0.0000. Now on 70 mgm of Sprycel. Continuation of PCR test results: 07/07/2017, 0.0000%, now on 50 mgm of Sprycel, PCR 9/12/17 0.0074%, PCR 11/3/17 0.0000%, PCR 1/17/2018 0.0000%


#12 scuba

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Posted 08 June 2017 - 12:28 PM

Hi Scuba,

Will you give me instructions on how to put history on the signature line. I don't know where to find the signature line. Thanks

 

At the top of this page you have open, you will see your name next to "sign out".

 

Click on your name and then click on "my profile".

In the profile page just below your name you will see "edit my profile" - click on that.

 

In the new page that comes up, you will see 'my settings' and below that a line - "signature". Click on signature.

 

You will see in the page that comes up your current signature (which in your case is currently empty) and a place below to "edit signature". Type in that box what you would like to be repeated every time you post. You can see by my signature a given style. It is similar to what others are using. Feel free to include:

 

when were you diagnosed,

What was the initial test results.

What drug do you take and how much and your testing history over time to show progress.


Diagnosed 11 May 2011 (100% FiSH, 155% PCR)

with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein

 

Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate

6-8 grams Curcumin C3 complex.

 

2015 PCR: < 0.01% (M.D. Anderson scale)

2016 PCR: < 0.01% (M.D. Anderson scale) 

March        2017 PCR:     0.01% (M.D. Anderson scale)

June          2017 PCR:     "undetected"

September 2017 PCR:     "undetected"


#13 Kali

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Posted 08 June 2017 - 12:34 PM

Thanks, Scuba. I will do that later today.

Diagnosed June 2014. WBC 34.6 and Platelets 710 at diagnosis. Bone Marrow Biopsy pre-op diagnosis: Leukocytosis. Post-op diagnosis: the same, Leukocytosis. No increase in blasts <1%. Quantitative BCR/ABL testing and formal chromosome analyses confirmed CML diagnosis.<p>Supplemental Report: Abnormal BCR/ABL1 FISH result t(9;22). Molecular test for BCR/ABL1 fusion transcript by RT-PCR positive for BCR/ABL1 transcripts, b3a2 at 133.561% and b2a2 at 0.001% and ela2 at 0.001%. Followup monitoring showed negative for ela2. BCRABL1 was 148.007 at diagnosis. Started Sprycel 100 mgm and blood work was normal at 3 weeks. MMR at 3 months: 10/4/14 was 0.106. Stayed in that range with one dip to 0.04 once and back to 0.1 range. Oct. 2015, BCRABL1 was not detected, following with 0.0126, 0.0092, <0.0069, 0.0000, <0.0069, 0.0000. Now on 70 mgm of Sprycel. Continuation of PCR test results: 07/07/2017, 0.0000%, now on 50 mgm of Sprycel, PCR 9/12/17 0.0074%, PCR 11/3/17 0.0000%, PCR 1/17/2018 0.0000%


#14 kat73

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Posted 08 June 2017 - 01:19 PM

OK, since I'm among friends here, I'm going to bare all my ignorance and faulty memory.  My onc, a CML specialist on the "biggy list," has told me he will never go as low as 20 mg Sprycel - even at deep response PCR level - because "underdosing causes drug resistance."  Period.  Explain to me one more time why he is wrong?  I just simply don't understand why the analogy to antibiotic misuse is not the correct model here.

 

I want to believe everyone here on the forum, but I have to deal with this guy.


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#15 SUE

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Posted 08 June 2017 - 05:56 PM

My Onc told me last year that reduction below 40 mg Sprycel daily was not advisable.  But she apparently has changed her mind because she has been encouraging about my reduction to 20 mg(due to PAH).  Despite a "blip" in March, she continued to be encouraging, and I was PCRU again in May.


Dx  April 2013, FISH 62,  BMB not enough for PCR test; put on Gleevec 400;

 August 2013, FISH 8.7;

Oct 2013, FISH 5.6

Stopped Gleevec Nov 2013 for 6 weeks due to terrible side effects; Jan 2014 started Sprycel 50mg;

Feb, 2014 PCR  6.8

May,2014  PCR   .149

Aug, 2014 PCR    .015

Nov. 2014 PCRU

March, 2016  went down to 40mg Sprycel

Oct. 2016   stopped Sprycel for a couple weeks due to concern about shortness of breath.  Echo showed mild PAH.

Nov 1 2016  resumed Sprycel 20 mg daily 

Dec 2016  PCRU

March 2017  PCR 0.020

May 2017     PCRU

Sept  2017   PCRU

Dec    2017  PCRU

 


#16 Calvink669

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Posted 08 June 2017 - 08:35 PM

I've been on 20mg sprycel (down from 100mg) since Jan 2016.  I was about .08 IS at the time and Dr. Kantarjian at MD Anderson reduced to 20mg after pleural effusion and high bp.  Since then, as of Jan 2017 I am down to .045 IS.

 

The difference in energy is night and day between 100mg and 20mg.  I feel normal again.

 

Regards,

 

Calvink669



#17 Pin

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Posted 09 June 2017 - 08:16 AM

OK, since I'm among friends here, I'm going to bare all my ignorance and faulty memory. My onc, a CML specialist on the "biggy list," has told me he will never go as low as 20 mg Sprycel - even at deep response PCR level - because "underdosing causes drug resistance." Period. Explain to me one more time why he is wrong? I just simply don't understand why the analogy to antibiotic misuse is not the correct model here.

I want to believe everyone here on the forum, but I have to deal with this guy.


My haemotologist said the same thing, I think it was something they have drummed into them in blood school...better to be safe than sorry, that sort of thing. When I saw the CML specialist recently, he said it was perfectly safe to reduce, it's just about making sure you are maintaining your response.

But really, I don't know the answer to your question, except to say that experts often disagree with each other!

Diagnosed 9 June 2011, Glivec 400mg June 2011-July 2017, Tasigna 600mg July 2017-present (switched due to intolerable side effects, and desire for future cessation attempt).

Commenced monthly testing when MR4.0 lost during 2012.

 

2017: <0.01, <0.01, 0.005 (200mg Glivec, Adelaide) <0.01, 0.001 (new test sensitivity)

2016: <0.01, <0.01, PCRU, 0.002 (Adelaide)

2015: <0.01, <0.01, <0.01, 0.013

2014: PCRU, <0.01, <0.01, <0.01, <0.01

2013: 0.01, 0.014, 0.016, 0.026, 0.041, <0.01, <0.01 

2012: <0.01, <0.01, 0.013, 0.032, 0.021

2011: 38.00, 12.00, 0.14


#18 kat73

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Posted 09 June 2017 - 11:34 AM

Can anyone say, unequivocally, that it is false that taking too low a dose causes resistance to the drug?


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.





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