8 replies to this topic

[gerry]

In the British DESTINY (De-escalation and Stopping Treatment of Imatinib, Nilotinib, or Sprycel [dasatinib]) study, also reported at the 2016 ASH annual meeting, Mhairi Copland, MD, PhD, of the University of Glasgow in Scotland, and colleagues enrolled patients with undetectable disease as well as those with stable, low-level disease and molecular responses of MR3 or better, defined as a minimum of three consecutive tests each with more than 10,000 ABL control transcripts following a minimum of 3 years on a TKI at standard prescribed doses.

"We hypothesized that more patients would be able to reduce therapy safely, and a proportion of these would be able to go on to stop therapy; also that the patients on half-dose therapy would have fewer side effects compared with those on full-dose therapy," Copland said.

The median duration of TKI therapy for all patients was 7 years. Dose reductions in the trial were as follows:

• Imatinib: 400 to 200 mg daily
• Nilotinib: 400 to 200 mg bid
• Dasatinib: 100 to 50 mg daily

The primary endpoint, molecular relapse, was defined as a loss of MR3 on two consecutive samples. Among 174 patients in the trial, there were 12 molecular relapses after 12 months of half-dose therapy. Relapses occurred in nine of 49 patients (18.4%) labeled as having a baseline remission of "MR3 but not MR4," with a median time to relapse of 4.4 months; and in three of 125 patients (2.4%) with MR4 or better remissions compared with three of 125 patients (2.4%) with MR4 or better remissions (P < .001).

All of the patients regained MR3 within 4 months of restarting on their respective TKIs at the full prescribed dose.

In multivariate analysis, there was no association between age, sex, performance status, type of TKI, or duration of TKI therapy with risk for recurrence.

Reassuring to the investigators, they said, no patients had disease progression to advanced phase, or experienced loss of a cytogenetic response. There were 15 serious adverse events during the course of follow-up and one patient death. All of the events were judged to be unrelated to either TKI treatment or to CML.

Patient-reported side effects -- including lethargy, diarrhea, rash, nausea, periorbital edema, and hair thinning -- decreased during the first 1 to 2 months of de-escalation, but not beyond that point. The investigators noted that patients had generally good quality-of-life scores at study entry, suggesting that they were not particularly troubled by TKI side effects before the dose-reduction trial.

 

 

http://www.medpageto...65329d0r&pos=1 

[cleocans]

I am hoping reduced dosage works for me since cessation did not.  This fatigue is killing me again.

[IGotCML]

Thanks for posting the information. I have been on Tasigna for 4 years and have had a 4 log reduction for just under 3 years so it has been very effective. I am interested in reducing my dosage to decrease the fatigue.

[Trey]

Having to halve is not having it all, which is better by half.  If a person had halved from initial PCRU, then they might not half to have ever halved later.  Which is all good.

[roamingdoc83]

I was diagnosed in Oct, 09. On Cobra. Could not get private insuarnce after (Cobra was not considered 'real' insurance as I understand it but foggy) and CML ate my 401K. I had one year where LLS helped immensely. Then I had two years of Novartis Assist and that was great. Now I am coming up on 8 years and have "halved" my dosage on my own.

I would love to do a BCR/Abl but I'm having a hard time finding any proof that Medicare will pay for it? (anyone?). My Oncologist indicates it is a "medically necessary" test but I've read some stories that indicate Medicare doesn't always believe/think that? I can't afford $1100-1500 out of pocket so was hoping I could find some 'solid' informatoin on Medicare and the test (their website is rather obtuse).

So I've been halving the dose now for 2 years. Because of surgery I stopped taking Gleevec and haven't taken one since Nov 10, 16. Regular WBC tests are good, no changes... so who knows. Thanks for any information.

[Trey]

You must have Medicare Part B to be covered for testing:

https://www.medicare...b-services.html

[roamingdoc83]

You must have Medicare Part B to be covered for testing:

https://www.medicare...b-services.html

 Hi Trey

Yeah, I've been there but cannot find an actual listing of the test... I will try again. Many thanks.

 

40 minutes later:

This link "seems" to indicate partial payments (anyone care to confirm, evaluate?) Just hit 'accept' to view.

https://med.noridian...ap-filled-codes

[Melanie]

It should be covered if you have "original" Medicare as long as the lab you use accepts Medicare. If you have a Medicare advantage plan then you would have to check with whatever insurance company carries your advantage plan. I have original Medicare and my PCR test have bee covered as well as all my other labs.

[roamingdoc83]

Melanie, thank you. I have "original" Medicare (is that like Original Pepsi?)... anyway I also have a Plan F... United Health care. My LabCorp lab does accept Medicare however they were unfamiliar with the test. I will prode them a bit. Thank you again!