11 replies to this topic

[houtex54]

Copying this post from Discussion Boards heading:

 

My oncologist informed me at my regular six month checkup that the Tasigna clinical trial I have been participating in since July 2007 is completed and will end March 31.  I am confused as to what to do next - and what the group thinks.  

 

I might like to participate in a TKI cessation trial, but the hospital where I am currently being treated in Houston doesn't seem to be participating in TKI cessation trials. 

 

I first thought that I could not swing the $10K/month cost of continuing the medication, but we checked with my Rx coverage insurer and my cost should be much less than that - and although still expensive, at least it is affordable (something like paying an extra car note).  

 

The clinical trial protocol was 400 mg 2x per day,  I think I'd like to decrease dosage to no more than 300 mg 2x per day -  but I'm reluctant to try something like that outside of a clinical trial protocol.  

 

Tasigna has been a very good drug for me.  Side effects have been tolerable and controllable - if indeed they are side effects of Tasigna and not side effects of being 61 years old.  Tasigna got my disease level to CMR in less than a year, and has kept me PCRU since 2008.  

[Buzzm1]

houtex54, you have been PCRU since 2008 ... the odds of you successfully ceasing TKI treatment are in your favor, STOP study, or no STOP study ... duration of TKI treatment and duration of PCRU are factors in your favor.

 

Here are quick summaries of some of the STOP studies: http://bit.ly/1XyGyL5

 

STOP conclusions bit.ly/22UI6zh

STOPPING bit.ly/1P1MMZB

[Harper3994]

I was diagnosed July 2015 and was told starting dose is 300 mg twice a day. This is what I have been taking. Had a BMB in October to check to see how med was working...was MMR. Check with drug company and Cancer Society to see if there are any foundations to help with paying for your meds.

[story]

I don't know if this works for you houtex54, but you don't have to live near a hospital participating in the LAST study to participate. Your local hospital can do the blood draws. You do have to travel to one of the participating centers every six months.

[story]

Nearest center to you would likely be Durham,NC

[story]

Oops, I guess Tampa or Atlanta would be closer,sorry

[Trey]

There is no absolute formula for who would most likely succeed at drug cessation, but speed of initial response is one of the most often cited factors.  So you could be a good candidate with your quick initial response and 7 years PCRU.  Cessation really only requires regular PCRs, and you could try to get your local Onc to set up a personal cessation outside of a formal clinical trial.  For most I would not encourage this, but sometimes financial considerations apply. 

[scuba]

You have near 50% chance of remaining progression free during your cessation. One in two. To do this safely you would have to have monthly PCR blood tests to monitor your PCRU status. You should weigh the cost of monthly lab tests against continuation of the drug + quarterly PCR tests. 

 

Your Oncologist should be able to monitor you during this cessation attempt. If he is not willing to do this, you could consider M.D. Anderson since you are in Houston and will work with their patients involving non trial cessation attempts.

 

Your risk of trying is very very low. If PCRU is lost you simply go back onto the drug and PCRU will be quickly re-attained.

 

But ... if you succeed - you will test monthly for the first year, Every two months the second year and then twice a year after that. 

[houtex54]

Thanks everyone for the quick feedback on this.  

 

I had looked at the STOP trial results before and the 50-60% initial success rates look promising to me as a patient, but I suspect it might not give a physician enough confidence to define a cessation protocol on his own.  The pre-requisites for a clinical trial are not strictly met either compared with the in vitro testing necessary before the FDA approved the drug trials.  I doubt in vitro results would mean much anyway since the setting is so much different than the in vivo setting (for example, how does one simulate the blood-brain lipid barrier in a petrie dish?).   If I had been experiencing severe side effects or developed any severe adverse affects, I'd most likely give cessation a shot.  The excellent rate of returning response for patients who began to relapse is also very promising.  These tests are still a beginning, and are not providing much for a physician to base a course of treatment cessation upon as yet.  

 

The LAST trial protocol looks like a good first crack at defining a safe cessation protocol.  Unfortunately for me, no hospitals in Texas are participating.  The nearest location is indeed Atlanta.  I believe M.D Anderson's current position on cessation protocols is that they are not yet worth the risk for patients who are successfully in molecular remission and tolerating the drugs' side effects. I am personally not comfortable going counter to their medical advice and best judgment.  In fact, it looks like there is a clinical trial recruiting at MDA to continue providing TKIs for patients who were previously enrolled in the Tasigna GIST studies (a trial that completed last year).  If that protocol opens up to include CMLTasigna trial participants, I will most definitely apply for inclusion.   

 

The financial considerations are something to consider, but the fact is, if my Rx insurance covers what they told us on the phone, then it is clear that I can afford the monetary cost to continue treatment.  Rx insurance providers revise their formularies and protocols frequently so this situation could easily change in the future.  Medicare coverage may also be a different scenario, but given that Federal programs are subject to the vagaries of politics, I'll cross that bridge when I come to it (in four years).  

 

I'm still very interested in the entire subject of TKI cessation and I would like to encourage this group to continue posting information and experiences with it.  

[Gail's]

I was very surprised to find out that my oncologist (the same on I disliked so much at first) is completely on board with me about getting to pcru for 2 years then either really reducing dose or stopping TKI. I expected more of a fuss from her but she's totally on board. Now if I'd hurry up and get to pcru, I'd start the 2 year clock ticking!

[AllTheseYears]

Just FYI:  I began cessation in early September, under supervision of  my hem/onc.  No clinical trials near me, either.  I have been PCRU for more than a decade on Gleevec.  My hem/onc is checking me only every three to four months; first check next week since I began my "personal cessation trial." I must add that I was quite insistent on stopping my TKI. 

[Buzzm1]

Just FYI:  I began cessation in early September, under supervision of  my hem/onc.  No clinical trials near me, either.  I have been PCRU for more than a decade on Gleevec.  My hem/onc is checking me only every three to four months; first check next week since I began my "personal cessation trial." I must add that I was quite insistent on stopping my TKI. 

another 5 1/2 months of PCRU and I'll be doing the same thing AllTheseYears.  

 

Best of Luck to you.