Summary of Today's Teleconference

[Guest guest]

Hi Everyone,

For those of you who weren't able to listen to today's teleconference

that was put on by the L & L Society, I took some notes to share. It

was given by Dr. Neil Shah who works at UCSF School of Medicine in

San Francisco, CA.

Dr. Shah gave a few statistics that I think we've all heard before

but I'll mention them again for anyone who hasn't. 90% of people who

started Gleevec as frontline treatment in chronic phase, are still

alive after 5 years of follow-up. 5% of patients have died from

their disease and 5% have died for reasons that had nothing to do

with CML. Needless to say that Gleevec (and the other Tyrosine

Kinase Inhibitors) have dramatically changed the course of CML.

Before Gleevec, 50% of patients were dead within 5-7 years.

About 15% of patients will not reach CCR after a year on Gleevec.

These are the patients who obviously need to move onto another

treatment before their disease accelerates.

Dr. Shah mentioned that CML patients are typically very well educated

about their disease which he said was a good thing because some

doctors aren't all that up to date with the ever evolving

information.

He stressed the importance of regular monitoring to identify problems

such as sub-optimal responses so that treatments can be changed when

needed.

He mentioned that Sprycel (Dasatinib) has been very effective at

treating many of the kinase domain mutations that Gleevec hasn't been

able to control.

He talked about the dosing of Sprycel and mentioned that they did

a " Dose Optimization Study " to determine what the best dose of

Dasatinib would be. They had 4 arms in the trial, one arm was given

70mg twice a day (for a total of 140mg), another group was given

100mg once a day and there were two other groups that he didn't even

mention because all 4 groups produced the same results in terms of

responses.

He said that the 140mg group had more side effects and found the drug

more difficult to tolerate but had the exact same efficacy as the

100mg dose so he said that very soon there will be a change in the

recommended " standard dose " since currently it is still technically

140mg.

He said that the 140mg dose also gave more pleural effusions than the

100mg dose (water around the lungs) which is a potentially serious

side effect and he said that interestingly, for those who had their

disease progress while on Dasatinib, double as many came from the

140mg group than the 100mg group.

He said that cytopenias (low blood counts) were very common (50% of

patients) with Sprycel treatment which is why close monitoring in the

beginning is essential. Most notable were low white counts and

platelet counts.

Currently Sprycel is the only approved 2nd generation drug to treat

Gleevec resistance/intolerance but Nilotinib (Tasigna) is on its way

to being approved. There are also several other exciting drugs in

trials right now. Bosutinib (SKI 606) was mentioned that is showing

exciting results as being more effective than Gleevec. It seems to

be easier tolerated as well, producing less cytopenias and less side

effects. The most common side effects with Bosutinib so far have

been diarrhea and rash.

So far neither Imatinib (Gleevec), Dasatinib (Sprycel), Nilotinib

(Tasigna) nor Bosutinib (don't known brand name yet), have been

successful at treating patients with the T315I mutation but other

drugs are in trials for that mutation right now. Drugs that are

being worked on for this mutation are called Aurora Kinase

Inhibitors. He specifically mentioned one that Merck is making which

they're calling MK0457 right now. (By the way, I found an

interesting article on the web that talks about his drug):

http://www.vrtx.com/Pressreleases2006/pr122106.html

He mentioned that the side effects for Nilotinib are a bit different

than for Dasatinib and Gleevec. Dasatinib side effects include

pleural effusions whereas that hasn't been a problem with Nilotinib.

Nilotinib has caused pancreatitis and liver toxicity in some patients.

Although the toxicity issues were different in Sprycel and Tasigna,

about the same percentage of people experienced serious enough

problems that they had to discontinue the drug. 13% of Sprycel

patients and 15% of Tasigna patients.

He mentioned that they are (or have done) a pilot study that looked

at newly diagnosed patients who were put into one of two arms, either

100mg once daily Sprycel (since this is considered to be the best

dose now) or the other group who were put on 400mg Gleevec. After

one year, 85% of the Sprycel patients achieved CCR compared to just

under 70% in the Gleevec group so it would appear that Sprycel is

more effective at this point at getting patients to CCR in one year's

time.

He stressed the importance of clinical trials and how it's thanks to

patients who are willing to participate in these trials that we can

learn which drugs are effective and how they work etc. The more

options we have in terms of drugs, the better off the patients will

be in terms of finding the right one for them. That means the one

that is not only effective but also delivers the fewest side effects

for that particular patient.

He mentioned that from all the patients he's had who have switched

from Gleevec to Sprycel, half have said that Gleevec was an easier

drug to take and half said that Sprycel has been easier to take so it

really is individualized as to which drug is easier to take.

At this point, questions were taken from the audience that included

some 1200 people from around the world. I'll post that summary in

another post though because this one seems long enough

Tracey

[Guest guest]

Hi ,

I thought of you (and ) right away when Dr. Shah started talking

about the Sprycel dosing. The best thing I could suggest to you is

that you mention this to 's doctor and if she still fusses about

the dose, ask her if she wouldn't mind consulting with Dr. Shah or

even Dr. Druker for that matter since these are the doctors that were

involved in the trials and who would have the most accurate

information.

Tracey

PS I'm almost done working on the question/answer period of the

teleconference so stay tuned for part two of my summary

>

> Wow, --once again, thanks so much! The info on the doseage of

Sprycel

> is sooooo helpful, started today on the 140mg doseage, knowing

it was

> high. When we emphasized this to his onc. she said " That is still

the

> recommended doseage, and I want to stick with it. " He is about 6

hours into

> it and said he feels really " weird " , throat is really dry and

scratchy, is

> coughing clearing his throat alot and he said it feels like his

ears are

> plugged...crazy how things can start happening so quickly...

>

> We now have your summary as sort of " proof " to his onc. that the

140 doseage

> is really aggressive and maybe not necessary....and maybe now she

can be

> convinved of the 100 doseage, we'll see...he sees her again on

Monday to

> take a look at counts.

>

> Thanks again!

>

>

>

> >From: " Tracey " <traceyincanada@...>

> >Reply-

> >

> >Subject: [ ] Summary of Today's Teleconference

> >Date: Thu, 28 Jun 2007 22:18:20 -0000

> >

> >Hi Everyone,

> >

> >For those of you who weren't able to listen to today's

teleconference

> >that was put on by the L & L Society, I took some notes to share. It

> >was given by Dr. Neil Shah who works at UCSF School of Medicine in

> >San Francisco, CA.

> >

> >Dr. Shah gave a few statistics that I think we've all heard before

> >but I'll mention them again for anyone who hasn't. 90% of people

who

> >started Gleevec as frontline treatment in chronic phase, are still

> >alive after 5 years of follow-up. 5% of patients have died from

> >their disease and 5% have died for reasons that had nothing to do

> >with CML. Needless to say that Gleevec (and the other Tyrosine

> >Kinase Inhibitors) have dramatically changed the course of CML.

> >Before Gleevec, 50% of patients were dead within 5-7 years.

> >

> >About 15% of patients will not reach CCR after a year on Gleevec.

> >These are the patients who obviously need to move onto another

> >treatment before their disease accelerates.

> >

> >Dr. Shah mentioned that CML patients are typically very well

educated

> >about their disease which he said was a good thing because some

> >doctors aren't all that up to date with the ever evolving

> >information.

> >

> >He stressed the importance of regular monitoring to identify

problems

> >such as sub-optimal responses so that treatments can be changed

when

> >needed.

> >

> >He mentioned that Sprycel (Dasatinib) has been very effective at

> >treating many of the kinase domain mutations that Gleevec hasn't

been

> >able to control.

> >

> >He talked about the dosing of Sprycel and mentioned that they did

> >a " Dose Optimization Study " to determine what the best dose of

> >Dasatinib would be. They had 4 arms in the trial, one arm was

given

> >70mg twice a day (for a total of 140mg), another group was given

> >100mg once a day and there were two other groups that he didn't

even

> >mention because all 4 groups produced the same results in terms of

> >responses.

> >

> >He said that the 140mg group had more side effects and found the

drug

> >more difficult to tolerate but had the exact same efficacy as the

> >100mg dose so he said that very soon there will be a change in the

> >recommended " standard dose " since currently it is still technically

> >140mg.

> >

> >He said that the 140mg dose also gave more pleural effusions than

the

> >100mg dose (water around the lungs) which is a potentially serious

> >side effect and he said that interestingly, for those who had

their

> >disease progress while on Dasatinib, double as many came from the

> >140mg group than the 100mg group.

> >

> >He said that cytopenias (low blood counts) were very common (50% of

> >patients) with Sprycel treatment which is why close monitoring in

the

> >beginning is essential. Most notable were low white counts and

> >platelet counts.

> >

> >Currently Sprycel is the only approved 2nd generation drug to treat

> >Gleevec resistance/intolerance but Nilotinib (Tasigna) is on its

way

> >to being approved. There are also several other exciting drugs in

> >trials right now. Bosutinib (SKI 606) was mentioned that is showing

> >exciting results as being more effective than Gleevec. It seems to

> >be easier tolerated as well, producing less cytopenias and less

side

> >effects. The most common side effects with Bosutinib so far have

> >been diarrhea and rash.

> >

> >So far neither Imatinib (Gleevec), Dasatinib (Sprycel), Nilotinib

> >(Tasigna) nor Bosutinib (don't known brand name yet), have been

> >successful at treating patients with the T315I mutation but other

> >drugs are in trials for that mutation right now. Drugs that are

> >being worked on for this mutation are called Aurora Kinase

> >Inhibitors. He specifically mentioned one that Merck is making

which

> >they're calling MK0457 right now. (By the way, I found an

> >interesting article on the web that talks about his drug):

> >http://www.vrtx.com/Pressreleases2006/pr122106.html

> >

> >He mentioned that the side effects for Nilotinib are a bit

different

> >than for Dasatinib and Gleevec. Dasatinib side effects include

> >pleural effusions whereas that hasn't been a problem with

Nilotinib.

> >Nilotinib has caused pancreatitis and liver toxicity in some

patients.

> >

> >Although the toxicity issues were different in Sprycel and Tasigna,

> >about the same percentage of people experienced serious enough

> >problems that they had to discontinue the drug. 13% of Sprycel

> >patients and 15% of Tasigna patients.

> >

> >He mentioned that they are (or have done) a pilot study that looked

> >at newly diagnosed patients who were put into one of two arms,

either

> >100mg once daily Sprycel (since this is considered to be the best

> >dose now) or the other group who were put on 400mg Gleevec. After

> >one year, 85% of the Sprycel patients achieved CCR compared to just

> >under 70% in the Gleevec group so it would appear that Sprycel is

> >more effective at this point at getting patients to CCR in one

year's

> >time.

> >

> >He stressed the importance of clinical trials and how it's thanks

to

> >patients who are willing to participate in these trials that we can

> >learn which drugs are effective and how they work etc. The more

> >options we have in terms of drugs, the better off the patients will

> >be in terms of finding the right one for them. That means the one

> >that is not only effective but also delivers the fewest side

effects

> >for that particular patient.

> >

> >He mentioned that from all the patients he's had who have switched

> >from Gleevec to Sprycel, half have said that Gleevec was an easier

> >drug to take and half said that Sprycel has been easier to take so

it

> >really is individualized as to which drug is easier to take.

> >

> >At this point, questions were taken from the audience that

included

> >some 1200 people from around the world. I'll post that summary in

> >another post though because this one seems long enough

> >

> >Tracey

> >

> >

>

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