Today's Teleconference-the Q&A part

[Guest guest]

Q:

Has Sprycel shown any side effects involving severe mood swings such

as those seen in Bi-Polar Disorder or difficulty in concentration.

A:

Difficulty in concentrating has been seen but not severe enough to

impact a patient's life. Extreme mood disorders have not been seen.

Q:

What is the likelihood of patients developing a secondary resistance

once a patient achieves CCR or MMR?

A:

It depends how quickly you achieve your response. 100% of patients

who have achieved a CCR in 12 months of therapy are alive after 5

years. The likelihood of patients losing their response after

achieving a MMR is very low, not impossible, but very very low which

is why we need to continue monitoring. MMR is the goal of therapy

because there is such a low chance of losing response at that point.

Q:

Should a slow responder increase their Gleevec dose or move to

Sprycel?

A:

Not achieving a MMR is not considered a failure to therapy. MMR is a

goal but if you don't get there, you haven't failed Imatinib. For

patients who have some sort of P-loop mutation, Sprycel seems to be

better than an increase in Gleevec but for those who have a sub-

optimal response, it's not yet clear which route to take.

Q:

Can a male patient father a child while on Gleevec.

A:

There is no formal recommendation that males should not impregnate

females while on Gleevec. Some doctors will recommend a wash out

period to protect sperm from the effects of Gleevec but there is

nothing formal regarding this issue and there have been several

successful pregnancies with men on Gleevec fathering babies.

Q:

Has there been any issues of avascular necrosis for patients on

Gleevec?

A:

It has been seen but we can't be sure that it's the Gleevec that is

causing it.

Q:

Are patients who are PCRU cured?

PCRU does not mean cure and stopping therapy is not recommended.

More than half of patients who stop therapy when PCRU, relapse. PCRU

does not mean there is no leukemia, it means that no leukemia was

found because the level of detection wasn't sensitive enough.

Q:

Can a patient who has Bi-Polar Disorder be treated successfully with

Gleevec for CML?

A:

Leukemia can always be treated. There are no diagnosis's that will

rule out treatment for leukemia although different drugs will require

some monitoring and/or adjusting.

Q:

What is the standard dose of Gleevec and how high of a dose can

someone take?

A:

400mg is the standard dose for chronic phase and 600mg for

accelerated/blast. Doses below 300mg are not recommended unless the

plasma concentrations show that there are adequate levels of Gleevec

in the blood. 800mg to 1000mg are sometimes used but he doesn't

recommend going higher than 800mg.

Q:

What role does a BMT play in someone who hasn't achieved the desired

response after a year or 18 months?

A:

Transplant is still an important option to consider but not as a

front line treatment. 93% of patients are still alive after 5 years

who haven't had a MMR so the risk of transplant is higher than the

risk for someone who has had a partial response to Imatinib, even if

it hasn't been an optimal response. For a very young patient with no

response after a year then BMT could be considered.

Q:

Gleevec is very expensive, will the costs go down at some point?

A:

Hopefully as more drugs become available, the price will start to

decline but this is beyond his control.

Q:

How can a patient achieve a CCR but not a MMR?

A:

The difference between using a cytogenetics test and a PCR test is

like using a magnifying glass vs a microscope. The more powerful the

tool, the more chance you'll find some leukemia cells. That's why a

PCR can be positive (it can look at 100,000 cells) but the

cytogenetics test is negative (it looks at only 20-100 cells).