12 replies to this topic

[wallystl]

Hello all, I'm faced with the dilemma in the headline.  For background; I'm 15 months into CML & have been on Sprycel since I "failed on Gleevec" in March of this year.  My initial experience with Sprycel was rough-significant side effects, struggled with dosage of 50 mg. 2 times a week, every other day, finally every day, took 2 months to get to a daily dose of 50 mg.  I was then jumped to 70 mg a day and my counts fell, and I was taken off Sprycel for a month.  Platelets were low 50's.  After a month my platelets slowly climbed & I resumed Sprycel at 50 mg per day.  My counts are still on the low side, side effects are less, platelets have climbed to 11

I just received results from Fish & BCR from the period beginning March through September.  I must confess I've had little success learning about these numbers.  My BCR ABL has remained consistent throughout this 7 month period Major @ 0.001 Minor @ 1.  My most recent FISH result from September is "Consistent With Relapse/Persistence 13%.

So I've been told that I will need to get my dosage of Sprycel up to 140 mg daily to achieve remission.  I'm still at 50 mg with fairly even counts.  So... do I stick with Sprycel and attempt another increase in dosage up to 70m mg and see how my counts react and if they stay even continue to work up to the 140 mg over a period of many months?  Or do I quit Sprycel and go the Clinical Trial route with a new drug? No blind with the trial by the way.

My Dr. seems to be pushing me into the trial, I'm less that excited because I've become more tolerant of the side effects with Sprycel & I'm not feeling as I have had enough time with Sprycel at a realistic dosage to say I've failed on it.  I'm also struggling with severe fatigue and I'm having difficulty maintaining a regular work schedule, If I move into the trial I'll experience "new" side effects and will need to participate in the testing and so on which will require some extra time at the hospital.

All that said, my goal of course is to find remission and get going with my life again by whatever means possible regardless of the cost.

I'd appreciate any and all advice on my numbers and on my situation in choosing between staying with Sprycel vs the clinical trial.

Much thanks in advance to all.  Wally

[CallMeLucky]

Which trial is your Dr considering?

[wallystl]

Trial drug is  Ponatinib

[CallMeLucky]

Ok so that is the Ariad drug trial. http://www.ariad.com...arypage/AP24534

Do you know if they have done any mutation tests on you?  Specifically, do you know if you have the T315I mutation?

From what I know, the main claim to fame with ponatinib is the fact that it works on people with T315I, which is a very difficult mutation to treat and causes people to not respond well ot the existing TKI drugs.  I believe it is also being tested for other resistance, but the T315I is the main differentiator with other TKI drugs.  So if you have that mutation then that would be a good reason to consider the trial.  I'm not too well read on how well ponatinib works on other resistance issues, but I guess that is what the trial is hoping to show.  There may be some good reasons your doctor wants you to be in the trial.

It seems Sprycel is not working for you at current dosage and higher dosage is not tolerable, so you need to think through if you can push through the side effects (although low counts is not necessarily something you can push through) or do you take a different route.

I think it comes down to how much faith you have in your doctor.  Are you being treated at a reputable cancer center by a doctor that has experience and specializes in CML?  If you are and you have faith in your doctor, then follow his lead.  If you have doubts, then you should seek out another opinion from a well regarded specialist.

Where are you located?

[wallystl]

Thanks, Lucky-  I DO NOT have any mutation, I'm happy with my Dr.  I'm thinking I've been such as sissy with the side effects that he is looking for new treatment based more on the side effects than the potential for remission.  I've had a very difficult time with side effects.  I'm a year into this with really no progress so I'm thinking I need to man up and muscle through whatever side effects come my way with whatever treatment I decide on. Frankly I'm worn out & just want to move forward at any cost and get this mess behind me.  I'm  in STL, MO.

[CallMeLucky]

I don't know how much is "manning up".  I try to push through most days, but some days the body just doesn't cooperate.  Be kind to yourself!

In addition to considering the ponatinib trial, you might want to talk to your doctor about the bosutinib trial.

Here's info on bosutinib

http://www.bosutinib.org/

http://clinicaltrials.gov/ct2/show/NCT00261846?term=bosutinib&rank=20 (this was the only one I could find that was open, but it may not be updated considering the expected end date)

http://www.clinicaltrials.gov/ct2/show/NCT00574873?term=bosutinib&rank=8 (this one is not accepting participants, but you never know)

http://media.pfizer.com/files/news/asco/bosutinib_study_3000_backgrounder_2010.pdf

Message was edited by: CallMeLucky

[Trey]

Wally,

Regarding your PCR, it appears that you have the e1a2 form of the Philadelphia Chromosome, and it is now up to 1.0% on the PCR?  If so, the e1a2 is something that must be watched closely.  It can be harder to control than the b2a2 and b3a2 forms of the Philadelphia Chromosome.

Please confirm if I am correct so far, and I will reply with more info.

[Tedsey]

I have been on Sprycel 2 months after failing Gleevec at 9 months.  It is unclear how or if I really failed Gleevec.  It was very scary and interesting watching my WBC and RBC start heading to 0.  Although I still have to be on WBC and RBC stim shots on Sprycel, my numbers have somewhat increased (WBC low to mid 1s and HGB in 6 and 7s).  So, it appears with the exception of PLT, the change helped for that.  I started on 100mg and remain on 100mg despite the low counts.  So, I am curious as to why your onc put you on Sprycel so slowly.  It is a different drug than Gleevec.  Although I do not know how low your counts got, from the PCR numbers you report, the dosage may not be enough to really give the drug a chance. 

I see you mention a BCR test.  When I was first dx, the cancer center called it's test that.  It was unlike the more common machines called RT-PCR and the like.  Do you know the machines's sensitivity?  Some cancer center's machines are only 1:10,000.  I found out that there are machines that are more sensitive at 1:100,000 which is more common.

I am unclear on how your PCR numbers have stayed consistant at 0.001 and .1  That looks like a pretty big increase.  Did your onc feel the need for a mutation test?

My PLT are in the 20s (and that is very low; lower they would probably transfuse me).  I see you wrote that your PLT were 50s and are now 11.  That seems to be dangerously low unless you mean 110,000, which would be much better and closer to normal.  Sorry, I am kind of new to how the CBCs and the like are reported.

Although it is still somewhat an unknown, standard doses appear to work the best unless your are CCyR, or better yet PCRU.  Lower doses of drugs appear to be fine to maintain the disease in some people, but not until they have reached the two milestones I mentioned.  So, is it bosutanib or stay with dasatinib (Sprycel)?  We would all love for these drugs to drive us to zero in 3 months with no side-effects.  And only about 50% of patients achieve CCyR on Sprycel at 1 year (so said my onc last Monday and the Bristol-Myers Squibb website).  I am sure there are more knowledgeable people here who know FISH and PCRs better.  They are both new to me.  But I have had low counts on G and S, so I thought my experience may help.  

[wallystl]

Thanks Trey-

Reading from my paperwork from yesterday regarding labs from 3/12/2010 through 9/08/2010, BCR-ABL,  keeping in mind that my dosage of Sprycel during this period in June & July was spotty at best as I struggled with side effects and blood level isuest.  Over the past 2 months I've had 50 mg daily, so no real measurement of my progress at a continuous dosage.

On 9/08/2010

Major e13a2-0.795%

Major e14a2-none detected

Major Combined-0.795%

Minor e1a2-0.002%

Combined Major on a graph over March through September is around 1.  Minor e1a2 is around 0.001

Thank you for taking the time to look at this.

Wally

[Trey]

Wally,

OK, so your "minor" (e1a2) is really .001%, which is good.  Your b2a2 (e13a2) is approx .8%.  You are doing well enough on Sprycel after about 9 months.  I don't see any reason to switch, unless you want to for side effects reasons.

[Tedsey]

Wally,

Thank goodness for Trey.  I should keep to what I really know.  Anyway, glad to hear you are doing well.  I also have e1a2.

Teds

[motomom]

Hi Wally,

I was changed from Gleevec to Sprycel in August.  I've been reading through everyone's posts to you and wanted to address side effects other than CBC levels.  As far as the daily side effects, headache, etc.  Like you, I was tapered at first, but in the end, found that every dose change increased the daily side effects for an initial period.  Turns out my body was happier with me if I found a dose and stuck with it.  After a couple of weeks the side effects seem to get better.  Hope this helps.  peg

[wallystl]

Thanks everyone for your feedback.  I think I'm going to skip the trial for now & increase Sprycel to 70 mg & see if my counts hold.  Tricky this CML....  Best to all- especially Trey!

Wally