Chronic Myelogenous Leukemia (CML) Support Group

CML expert doctors have said that 300-350mg of Gleevec a day is the minimum therapeutic dose. However, with the price of Gleevec being high and side-effects from long-term therapy, it is not unusual to see patients asking this question of CML experts as a patient did on a webcast by MD Anderson Cancer Center CML expert, Dr. Jorge Cortes, see below. At the same time, in 2007, a trial study of 200mg a day Gleevec was reported on 4 patients who achieved a PCR negative on 400mg a day Gleevec. They were followed for median 17 months. The problem with this trial is that only 4 patients, so a very small scale study and also follow-up time has to be longer.

I have only seen a handful of articles with doctors trying 200mg a day Gleevec but I have a few friends on 300mg a day Gleevec and they maintain PCR negative on this dose.

What does your doctor say? Are you aware that Novartis has a Patient Assistance Program in the US if there is trouble paying for 400mg Gleevec. The trials are still very new so the medical consensus is to have patients go on taking 400mg a day until large scale trials have been done to see whether there is a maintenance dose for PCRU patients and it is safe to reduce Gleevec dose.

Also, the Gleevec patent expires in 2015 and after that, generic Gleevec may be available at 1/10th the price of current Gleevec.

I had given a summary of Dr. Cortes' webcast for the Asian CML Group and I give that below, the entire transcript can be viewed at http://www.cmlinfo.org if you click on 'Physician Interviews' and then 'LLS webcasts'. I have given a link where you can hear the webcast below. Hope the link is still working.

Best Wishes,
Anjana
wife of Royston
d/x Jan 2002
400mg Gleevec
PCRU

1) Ann Hematol. 2007 Oct;86(10):749-52. Epub 2007 Jun 19. Links
Durable responses in chronic myeloid leukemia patients maintained with lower doses of imatinib mesylate after achieving molecular remission.

Carella AM, Lerma E.
Divisione Ematologia 1, Azienda Ospedaliera Universitaria San Martino, Monoblocco XI piano Ponente, L.go R. Benzi, 10, 16132, Genova, Italy. angelomichele.carella@hsanmartino.it

In the present report, we address the question if the reduction of standard dosage of imatinib mesylate (IM) in imatinib-intolerant chronic myeloid leukemia (CML) patients with undetectable residual disease may impair their outcome. Four patients are described. The median follow up from the beginning of IM therapy was 35 months (33-59). The median duration of real-time quantitative polymerase chain reaction (RQ-PCR) negativity on IM 200 mg daily was 17 months (4-37). We hypothesize that in IM intolerant CML patients with complete molecular remission, the compound dosage might be safely reduced to a lower than standard dose without to lose the response. A tight molecular monitoring of such patients should be required.


2) Here is the audio link to the Q/A Session with Dr. Cortes.

http://lls.hipcast.com/download/63...

The questions were fairly standard and here are some answers from Dr. C:

a.. Dr. Cortes apologized to a patient for not mentioning transplant in his
talk but conceded that this is an option for patients failing Gleevec therapy.
The person asking the question asked about umbilical cord blood transplant for a
patient doing very well on Gleevec. Dr. Cortes said that as long as the patient
does well on Gleevec, the recommendation remains not to do transplant but if
there is loss of response, transplant is a therapy option along with the new CML
drugs. He felt that for a patient in CCR and PCRU on Gleevec, the likelihood of
losing that response was extremely low. He also said that one unit of cord
blood was not enough for an adult transplant.

b.. For cramping as a Gleevec side-effect, Dr. C recommended tonic water and
calcium.

c.. A patient asked if Gleevec needs to be stopped during harvesting of eggs
and Dr. Cortes said there was not that much data on what exposure of eggs to
Gleevec may do but he did recommend the patient have a good molecular response
to Gleevec first and then take Gleevec off say for 3 months for harvesting of
eggs.

d.. A patient said she cannot tolerate more than 200mg a day Gleevec but is in
PCRU. Dr. C felt that frequent monitoring should be done and as long as the
response is maintained, the dose is okay for the particular patient. In
general, he said that doses below 300mg Gleevec a day are not recommended as the
low doses have not shown to give durable responses.

Just had a bone marrow biopsy today, been on gleevic for six monoths. cml is decreasing nicely, but my blood counts are very low, red, white and platelets. They think the gleevic may be targeting the good guys as well as the bad. anyone had this experience?

Is it possible that your blood cells haven't reorganized and healed to the level that you now have some good healthy ones that work correctly? I was told, initially, that if my counts dropped too low, they would back off the Gleevec and increase as mature and healthy cells started to come back. With CML, not only are there excessive wbc, they are also immature cells that aren't able to work effectively, but that will, over time, begin to mature into "good guys." ?Good luck.