Re: Summary of today's teleconference

[Guest guest]

Thanks very much Tracey, I appreciate you taking those notes and sharing them

with us.

:}

[ ] Summary of today's teleconference

Hi Everyone,

For anyone who wasn't able to listen to today's teleconference, (CML

Treatment: Measuring Your Progress with Dr. Nimer of MSKCC),

here are some notes that I took. Please note that this is the way I

heard it and may or may not be accurate as I didn't actually record

the talk.

He started out the talk with an overview of CML explaining that CML

is a myeloproliferative disease of the stem cells. It causes an

increase in white cells, platelets and sometimes can also cause the

Hgb to rise in patients. CML is easy to diagnose, they look for the

presence of the Philadelphia chromosome using either cytogenetics,

FISH or PCR. As soon as a diagnosis is made, treatment begins

(unlike some other leukemias like CLL where they can sit and watch

the disease for a while without treating it).

He mentioned that 400mg Gleevec is still the standard dose (although

600mg does appear to give more patients the 3 log reduction) but

studies are on going to compare the various doses. He said patients

can start the 400mg right away, there's no need to work up to it. He

also said that because the Gleevec kills off the bad cells quickly

and the healthy cells take a little while to grow, it's very common

to have to take a break from Gleevec in the first month or two. He

stressed that lowering the dose is not recommended, that it's far

more appropriate to take a break from the drug while the counts

recover.

He went over the data from the IRIS trial. Relapse rates in the 5th

year were less than that in the 4th year which indicates that Gleevec

works better and better over time.

He explained that the way to monitor responses is with FISH and PCR

every 3 months. As long as there is improvement, it doesn't really

matter how long it takes to get a zero FISH. Some patients who still

hadn't achieved CCR at 12 months, have gone on to get there at 18

months so the speed of getting there may not be that important, as

long as you get there.

He said that reaching PCRU is very rare and the goal of therapy is to

get a 3 log reduction which he explained is a thousand fold decrease

in bcr/abl transcripts. Although 93% of patients who get a 3 log

reduction, have managed to maintain their response over 5 years, it's

still important to monitor with PCR every 3 months so that if a

resistance develops, it will be identified early.

If a patient's response starts to slip, he suggested that it would

probably be better to switch drugs than to increase the dose of

Gleevec.

He mentioned that most mutations are responsive to Sprycel and he

also mentioned AMN-107 saying that it binds more tightly to bcr/abl

which makes it active on some mutations that Gleevec doesn't work on.

He talked about the famous cardiotoxicity report that caused such a

flap last year. He said that he hasn't seen any evidence to suggest

that Gleevec can cause heart problems or if it does, it's certainly

not a significant number of patients.

He talked about the dosing of Sprycel, mentioning that the two

standard doses are 70mg twice a day and 100mg once a day. He said

that the 70mg twice a day was causing more pleural effusions so there

is a trend towards the 100mg once a day dose which is less of a

problem.

He mentioned that very few patients are getting transplants now that

there are so many successful drug therapy options. He did suggest

however, those in accelerated or blast phase, should consider

transplant as an option because drug therapy in this group of people

doesn't seem to give durable responses.

At this point, the telephone lines were opened and people were given

a chance to ask questions.

The first question was about surgeries and should patients take any

precautions if they are planning for a surgery. He said that if

there is a high risk of infection from the surgery, then it would be

acceptable to stop taking Gleevec 1 week before the surgery to allow

the white count to rise a bit (which will help if the patient gets an

infection) but he said that for the majority of people on Gleevec,

they manage surgeries the exact same way any normal person does.

The second question was about resistance. He said that clinical

decisions shouldn't be based on one test alone. It's the trend over

time that matters. Especially with PCR's since they tend to bounce a

lot. He said that if the PCR rises significantly on one test and

then rises again on another, it should be watched closely.

Resistance can usually be confirmed in about 6 months time.

The third question was about myelodysplasia. He said that

myelodysplasia basically means " funny looking cells in the bone

marrow " . He said that there are a significant number of Gleevec

patients who appear to have " funny looking cells in their bone

marrow " but that they don't really have myelodysplastic disease and

the presence of these " funny cells " doesn't seem to have much

significance.

The fourth question was about survival expectations. He said that

after 5 years, only 5% of patients have actually died of CML, another

5% have died of unrelated causes such as car accidents so he

encouraged us all to look both ways before crossing the street

because he thinks there's a good chance that we can all live out a

normal life expectancy.

The fifth question was about using Hydrea in treatment. He said some

people still get Hydrea to start out if they have very high counts

because it can reduce the counts quickly but Hydrea shouldn't be used

long term as a means of controlling CML. Patients should either be

on Gleevec or one of the other new drugs. If a patient is resistant

to a current dose of Gleevec, there is no sense in continuing with

that dose. It should be increased or changed for another drug.

And the last question was about the various transcripts that the

PCR's detect. He said most patients have only one transcript (ie

B2A2 or B3A2 which I think he said was the most common) but a few do

have more than one. He didn't really elaborate more on that.

And that was that.

Take care,

Tracey

[Guest guest]

Just a few things to add as I do have notes:

" prc is positive in most patients, even if FISH is normal.. "

" ..if patient presents with accelerated or blast phase the disease ,

the disease presents more aggressively...Imatinib will treat part of

the problem, but will not produce a long-term response-In this case

SCT/BMT needs to be done earlier, not left to later because of this

disease process...'

there was no mention that fewer BMTs are being done, but that is

obvious from the number of us on other meds

...although 400 mg was the dosage initially recommended from the IRIS

trial,may achieve a more rapid or profound response with higher (600

or 800 mg) doses

>

> Hi Everyone,

>

> For anyone who wasn't able to listen to today's teleconference,

(CML

> Treatment: Measuring Your Progress with Dr. Nimer of

MSKCC),

> here are some notes that I took. Please note that this is the way

I

> heard it and may or may not be accurate as I didn't actually record

> the talk.

>

> He started out the talk with an overview of CML explaining that CML

> is a myeloproliferative disease of the stem cells. It causes an

> increase in white cells, platelets and sometimes can also cause the

> Hgb to rise in patients. CML is easy to diagnose, they look for

the

> presence of the Philadelphia chromosome using either cytogenetics,

> FISH or PCR. As soon as a diagnosis is made, treatment begins

> (unlike some other leukemias like CLL where they can sit and watch

> the disease for a while without treating it).

>

> He mentioned that 400mg Gleevec is still the standard dose

(although

> 600mg does appear to give more patients the 3 log reduction) but

> studies are on going to compare the various doses. He said

patients

> can start the 400mg right away, there's no need to work up to it.

He

> also said that because the Gleevec kills off the bad cells quickly

> and the healthy cells take a little while to grow, it's very common

> to have to take a break from Gleevec in the first month or two. He

> stressed that lowering the dose is not recommended, that it's far

> more appropriate to take a break from the drug while the counts

> recover.

>

> He went over the data from the IRIS trial. Relapse rates in the

5th

> year were less than that in the 4th year which indicates that

Gleevec

> works better and better over time.

>

> He explained that the way to monitor responses is with FISH and PCR

> every 3 months. As long as there is improvement, it doesn't really

> matter how long it takes to get a zero FISH. Some patients who

still

> hadn't achieved CCR at 12 months, have gone on to get there at 18

> months so the speed of getting there may not be that important, as

> long as you get there.

>

> He said that reaching PCRU is very rare and the goal of therapy is

to

> get a 3 log reduction which he explained is a thousand fold

decrease

> in bcr/abl transcripts. Although 93% of patients who get a 3 log

> reduction, have managed to maintain their response over 5 years,

it's

> still important to monitor with PCR every 3 months so that if a

> resistance develops, it will be identified early.

>

> If a patient's response starts to slip, he suggested that it would

> probably be better to switch drugs than to increase the dose of

> Gleevec.

>

> He mentioned that most mutations are responsive to Sprycel and he

> also mentioned AMN-107 saying that it binds more tightly to bcr/abl

> which makes it active on some mutations that Gleevec doesn't work

on.

>

> He talked about the famous cardiotoxicity report that caused such a

> flap last year. He said that he hasn't seen any evidence to

suggest

> that Gleevec can cause heart problems or if it does, it's certainly

> not a significant number of patients.

>

> He talked about the dosing of Sprycel, mentioning that the two

> standard doses are 70mg twice a day and 100mg once a day. He said

> that the 70mg twice a day was causing more pleural effusions so

there

> is a trend towards the 100mg once a day dose which is less of a

> problem.

>

> He mentioned that very few patients are getting transplants now

that

> there are so many successful drug therapy options. He did suggest

> however, those in accelerated or blast phase, should consider

> transplant as an option because drug therapy in this group of

people

> doesn't seem to give durable responses.

>

> At this point, the telephone lines were opened and people were

given

> a chance to ask questions.

>

> The first question was about surgeries and should patients take any

> precautions if they are planning for a surgery. He said that if

> there is a high risk of infection from the surgery, then it would

be

> acceptable to stop taking Gleevec 1 week before the surgery to

allow

> the white count to rise a bit (which will help if the patient gets

an

> infection) but he said that for the majority of people on Gleevec,

> they manage surgeries the exact same way any normal person does.

>

> The second question was about resistance. He said that clinical

> decisions shouldn't be based on one test alone. It's the trend

over

> time that matters. Especially with PCR's since they tend to bounce

a

> lot. He said that if the PCR rises significantly on one test and

> then rises again on another, it should be watched closely.

> Resistance can usually be confirmed in about 6 months time.

>

> The third question was about myelodysplasia. He said that

> myelodysplasia basically means " funny looking cells in the bone

> marrow " . He said that there are a significant number of Gleevec

> patients who appear to have " funny looking cells in their bone

> marrow " but that they don't really have myelodysplastic disease and

> the presence of these " funny cells " doesn't seem to have much

> significance.

>

> The fourth question was about survival expectations. He said that

> after 5 years, only 5% of patients have actually died of CML,

another

> 5% have died of unrelated causes such as car accidents so he

> encouraged us all to look both ways before crossing the street

> because he thinks there's a good chance that we can all live out a

> normal life expectancy.

>

> The fifth question was about using Hydrea in treatment. He said

some

> people still get Hydrea to start out if they have very high counts

> because it can reduce the counts quickly but Hydrea shouldn't be

used

> long term as a means of controlling CML. Patients should either be

> on Gleevec or one of the other new drugs. If a patient is

resistant

> to a current dose of Gleevec, there is no sense in continuing with

> that dose. It should be increased or changed for another drug.

>

> And the last question was about the various transcripts that the

> PCR's detect. He said most patients have only one transcript (ie

> B2A2 or B3A2 which I think he said was the most common) but a few

do

> have more than one. He didn't really elaborate more on that.

>

> And that was that.

> Take care,

> Tracey

>

[Guest guest]

Tracey,

Thank you for taking such excellent, solid notes, to share with the

group, regarding the teleconference today.

I too listened in and I feel that your summary is quite excellent!

You truly put my note taking to shame! (I wish I knew you in

college!)

It's great and reassuring to hear that we have great backup drugs,

progressing nicely, in our CML fight.

Thanks again for taking the time to write up that fine summary.

Sincerely, Lynn

>

> Hi Everyone,

>

> For anyone who wasn't able to listen to today's teleconference,

(CML

> Treatment: Measuring Your Progress with Dr. Nimer of

MSKCC),

> here are some notes that I took. Please note that this is the way

I

> heard it and may or may not be accurate as I didn't actually

record

> the talk.

>

> He started out the talk with an overview of CML explaining that

CML

> is a myeloproliferative disease of the stem cells. It causes an

> increase in white cells, platelets and sometimes can also cause

the

> Hgb to rise in patients. CML is easy to diagnose, they look for

the

> presence of the Philadelphia chromosome using either cytogenetics,

> FISH or PCR. As soon as a diagnosis is made, treatment begins

> (unlike some other leukemias like CLL where they can sit and watch

> the disease for a while without treating it).

>

> He mentioned that 400mg Gleevec is still the standard dose

(although

> 600mg does appear to give more patients the 3 log reduction) but

> studies are on going to compare the various doses. He said

patients

> can start the 400mg right away, there's no need to work up to it.

He

> also said that because the Gleevec kills off the bad cells quickly

> and the healthy cells take a little while to grow, it's very

common

> to have to take a break from Gleevec in the first month or two.

He

> stressed that lowering the dose is not recommended, that it's far

> more appropriate to take a break from the drug while the counts

> recover.

>

> He went over the data from the IRIS trial. Relapse rates in the

5th

> year were less than that in the 4th year which indicates that

Gleevec

> works better and better over time.

>

> He explained that the way to monitor responses is with FISH and

PCR

> every 3 months. As long as there is improvement, it doesn't really

> matter how long it takes to get a zero FISH. Some patients who

still

> hadn't achieved CCR at 12 months, have gone on to get there at 18

> months so the speed of getting there may not be that important, as

> long as you get there.

>

> He said that reaching PCRU is very rare and the goal of therapy is

to

> get a 3 log reduction which he explained is a thousand fold

decrease

> in bcr/abl transcripts. Although 93% of patients who get a 3 log

> reduction, have managed to maintain their response over 5 years,

it's

> still important to monitor with PCR every 3 months so that if a

> resistance develops, it will be identified early.

>

> If a patient's response starts to slip, he suggested that it would

> probably be better to switch drugs than to increase the dose of

> Gleevec.

>

> He mentioned that most mutations are responsive to Sprycel and he

> also mentioned AMN-107 saying that it binds more tightly to

bcr/abl

> which makes it active on some mutations that Gleevec doesn't work

on.

>

> He talked about the famous cardiotoxicity report that caused such

a

> flap last year. He said that he hasn't seen any evidence to

suggest

> that Gleevec can cause heart problems or if it does, it's

certainly

> not a significant number of patients.

>

> He talked about the dosing of Sprycel, mentioning that the two

> standard doses are 70mg twice a day and 100mg once a day. He said

> that the 70mg twice a day was causing more pleural effusions so

there

> is a trend towards the 100mg once a day dose which is less of a

> problem.

>

> He mentioned that very few patients are getting transplants now

that

> there are so many successful drug therapy options. He did suggest

> however, those in accelerated or blast phase, should consider

> transplant as an option because drug therapy in this group of

people

> doesn't seem to give durable responses.

>

> At this point, the telephone lines were opened and people were

given

> a chance to ask questions.

>

> The first question was about surgeries and should patients take

any

> precautions if they are planning for a surgery. He said that if

> there is a high risk of infection from the surgery, then it would

be

> acceptable to stop taking Gleevec 1 week before the surgery to

allow

> the white count to rise a bit (which will help if the patient gets

an

> infection) but he said that for the majority of people on Gleevec,

> they manage surgeries the exact same way any normal person does.

>

> The second question was about resistance. He said that clinical

> decisions shouldn't be based on one test alone. It's the trend

over

> time that matters. Especially with PCR's since they tend to

bounce a

> lot. He said that if the PCR rises significantly on one test and

> then rises again on another, it should be watched closely.

> Resistance can usually be confirmed in about 6 months time.

>

> The third question was about myelodysplasia. He said that

> myelodysplasia basically means " funny looking cells in the bone

> marrow " . He said that there are a significant number of Gleevec

> patients who appear to have " funny looking cells in their bone

> marrow " but that they don't really have myelodysplastic disease

and

> the presence of these " funny cells " doesn't seem to have much

> significance.

>

> The fourth question was about survival expectations. He said that

> after 5 years, only 5% of patients have actually died of CML,

another

> 5% have died of unrelated causes such as car accidents so he

> encouraged us all to look both ways before crossing the street

> because he thinks there's a good chance that we can all live out a

> normal life expectancy.

>

> The fifth question was about using Hydrea in treatment. He said

some

> people still get Hydrea to start out if they have very high counts

> because it can reduce the counts quickly but Hydrea shouldn't be

used

> long term as a means of controlling CML. Patients should either

be

> on Gleevec or one of the other new drugs. If a patient is

resistant

> to a current dose of Gleevec, there is no sense in continuing with

> that dose. It should be increased or changed for another drug.

>

> And the last question was about the various transcripts that the

> PCR's detect. He said most patients have only one transcript (ie

> B2A2 or B3A2 which I think he said was the most common) but a few

do

> have more than one. He didn't really elaborate more on that.

>

> And that was that.

> Take care,

> Tracey

>

[Guest guest]

Hi Tracey,

Thanks for an excellent summary of the teleconference.

For those who missed it and would like to hear it, the L & L site will make it

available on line in about a month.

I hope that the newbies got a chance to listen to the teleconference. Dr

Nimer really gives you the confidence that with Gleevec treatment CML has

become a chronic disease.

Zavie

[ ] Summary of today's teleconference

Hi Everyone,

For anyone who wasn't able to listen to today's teleconference, (CML

Treatment: Measuring Your Progress with Dr. Nimer of MSKCC),

here are some notes that I took. Please note that this is the way I

heard it and may or may not be accurate as I didn't actually record

the talk.

He started out the talk with an overview of CML explaining that CML

is a myeloproliferative disease of the stem cells. It causes an

increase in white cells, platelets and sometimes can also cause the

Hgb to rise in patients. CML is easy to diagnose, they look for the

presence of the Philadelphia chromosome using either cytogenetics,

FISH or PCR. As soon as a diagnosis is made, treatment begins

(unlike some other leukemias like CLL where they can sit and watch

the disease for a while without treating it).

He mentioned that 400mg Gleevec is still the standard dose (although

600mg does appear to give more patients the 3 log reduction) but

studies are on going to compare the various doses. He said patients

can start the 400mg right away, there's no need to work up to it. He

also said that because the Gleevec kills off the bad cells quickly

and the healthy cells take a little while to grow, it's very common

to have to take a break from Gleevec in the first month or two. He

stressed that lowering the dose is not recommended, that it's far

more appropriate to take a break from the drug while the counts

recover.

He went over the data from the IRIS trial. Relapse rates in the 5th

year were less than that in the 4th year which indicates that Gleevec

works better and better over time.

He explained that the way to monitor responses is with FISH and PCR

every 3 months. As long as there is improvement, it doesn't really

matter how long it takes to get a zero FISH. Some patients who still

hadn't achieved CCR at 12 months, have gone on to get there at 18

months so the speed of getting there may not be that important, as

long as you get there.

He said that reaching PCRU is very rare and the goal of therapy is to

get a 3 log reduction which he explained is a thousand fold decrease

in bcr/abl transcripts. Although 93% of patients who get a 3 log

reduction, have managed to maintain their response over 5 years, it's

still important to monitor with PCR every 3 months so that if a

resistance develops, it will be identified early.

If a patient's response starts to slip, he suggested that it would

probably be better to switch drugs than to increase the dose of

Gleevec.

He mentioned that most mutations are responsive to Sprycel and he

also mentioned AMN-107 saying that it binds more tightly to bcr/abl

which makes it active on some mutations that Gleevec doesn't work on.

He talked about the famous cardiotoxicity report that caused such a

flap last year. He said that he hasn't seen any evidence to suggest

that Gleevec can cause heart problems or if it does, it's certainly

not a significant number of patients.

He talked about the dosing of Sprycel, mentioning that the two

standard doses are 70mg twice a day and 100mg once a day. He said

that the 70mg twice a day was causing more pleural effusions so there

is a trend towards the 100mg once a day dose which is less of a

problem.

He mentioned that very few patients are getting transplants now that

there are so many successful drug therapy options. He did suggest

however, those in accelerated or blast phase, should consider

transplant as an option because drug therapy in this group of people

doesn't seem to give durable responses.

At this point, the telephone lines were opened and people were given

a chance to ask questions.

The first question was about surgeries and should patients take any

precautions if they are planning for a surgery. He said that if

there is a high risk of infection from the surgery, then it would be

acceptable to stop taking Gleevec 1 week before the surgery to allow

the white count to rise a bit (which will help if the patient gets an

infection) but he said that for the majority of people on Gleevec,

they manage surgeries the exact same way any normal person does.

The second question was about resistance. He said that clinical

decisions shouldn't be based on one test alone. It's the trend over

time that matters. Especially with PCR's since they tend to bounce a

lot. He said that if the PCR rises significantly on one test and

then rises again on another, it should be watched closely.

Resistance can usually be confirmed in about 6 months time.

The third question was about myelodysplasia. He said that

myelodysplasia basically means " funny looking cells in the bone

marrow " . He said that there are a significant number of Gleevec

patients who appear to have " funny looking cells in their bone

marrow " but that they don't really have myelodysplastic disease and

the presence of these " funny cells " doesn't seem to have much

significance.

The fourth question was about survival expectations. He said that

after 5 years, only 5% of patients have actually died of CML, another

5% have died of unrelated causes such as car accidents so he

encouraged us all to look both ways before crossing the street

because he thinks there's a good chance that we can all live out a

normal life expectancy.

The fifth question was about using Hydrea in treatment. He said some

people still get Hydrea to start out if they have very high counts

because it can reduce the counts quickly but Hydrea shouldn't be used

long term as a means of controlling CML. Patients should either be

on Gleevec or one of the other new drugs. If a patient is resistant

to a current dose of Gleevec, there is no sense in continuing with

that dose. It should be increased or changed for another drug.

And the last question was about the various transcripts that the

PCR's detect. He said most patients have only one transcript (ie

B2A2 or B3A2 which I think he said was the most common) but a few do

have more than one. He didn't really elaborate more on that.

And that was that.

Take care,

Tracey

[Guest guest]

Hi Tracey,

Your notes on the conference were just great. Thank you for taking the time

to inform those of us that did not hear the conference. I really didn't know

there was one. I had listened to the one a few months ago. How do we find out

when they will be.

Again thank you for all this great information.

Ceil

Dx 6/06

0n 400 mgs Gleevec

Am in Zavies 0 club-Had another cytogenetic test Tues so hope I am still a

member of the 0 club.

New York City<BR><BR><BR>**************************************<BR> AOL now

offers free email

to everyone. Find out more about what's free from AOL at

http://www.aol.com.</HTML>

[Guest guest]

You're very welcome Ceil. Often someone will post the information

when a teleconference is going to be offered but you could also check

the Leukemia Lymphoma Society website to see if any are scheduled:

http://www.leukemia-lymphoma.org/hm_lls

There aren't any scheduled right now but I'm sure there will be

another one in a couple of months. They tend to have one every 3

months or so.

Let us know how your cytogenetics comes back. I'm confident it will

be as big of a zero as the last one was though

Take care,

Tracey

dx Jan 2002

>

> Hi Tracey,

>

> Your notes on the conference were just great. Thank you for taking

the time

> to inform those of us that did not hear the conference. I really

didn't know

> there was one. I had listened to the one a few months ago. How do

we find out

> when they will be.

>

> Again thank you for all this great information.

>

> Ceil

> Dx 6/06

> 0n 400 mgs Gleevec

> Am in Zavies 0 club-Had another cytogenetic test Tues so hope I am

still a

> member of the 0 club.

> New York City<BR><BR><BR>**************************************<BR>

AOL now offers free email

> to everyone. Find out more about what's free from AOL at

http://www.aol.com.</HTML>

>

>

>

[Guest guest]

Thank you very much Tracey..

Yusuf

Tracey <traceyincanada@...> wrote:

Hi Everyone,

For anyone who wasn't able to listen to today's teleconference, (CML

Treatment: Measuring Your Progress with Dr. Nimer of MSKCC),

here are some notes that I took. Please note that this is the way I

heard it and may or may not be accurate as I didn't actually record

the talk.

He started out the talk with an overview of CML explaining that CML

is a myeloproliferative disease of the stem cells. It causes an

increase in white cells, platelets and sometimes can also cause the

Hgb to rise in patients. CML is easy to diagnose, they look for the

presence of the Philadelphia chromosome using either cytogenetics,

FISH or PCR. As soon as a diagnosis is made, treatment begins

(unlike some other leukemias like CLL where they can sit and watch

the disease for a while without treating it).

He mentioned that 400mg Gleevec is still the standard dose (although

600mg does appear to give more patients the 3 log reduction) but

studies are on going to compare the various doses. He said patients

can start the 400mg right away, there's no need to work up to it. He

also said that because the Gleevec kills off the bad cells quickly

and the healthy cells take a little while to grow, it's very common

to have to take a break from Gleevec in the first month or two. He

stressed that lowering the dose is not recommended, that it's far

more appropriate to take a break from the drug while the counts

recover.

He went over the data from the IRIS trial. Relapse rates in the 5th

year were less than that in the 4th year which indicates that Gleevec

works better and better over time.

He explained that the way to monitor responses is with FISH and PCR

every 3 months. As long as there is improvement, it doesn't really

matter how long it takes to get a zero FISH. Some patients who still

hadn't achieved CCR at 12 months, have gone on to get there at 18

months so the speed of getting there may not be that important, as

long as you get there.

He said that reaching PCRU is very rare and the goal of therapy is to

get a 3 log reduction which he explained is a thousand fold decrease

in bcr/abl transcripts. Although 93% of patients who get a 3 log

reduction, have managed to maintain their response over 5 years, it's

still important to monitor with PCR every 3 months so that if a

resistance develops, it will be identified early.

If a patient's response starts to slip, he suggested that it would

probably be better to switch drugs than to increase the dose of

Gleevec.

He mentioned that most mutations are responsive to Sprycel and he

also mentioned AMN-107 saying that it binds more tightly to bcr/abl

which makes it active on some mutations that Gleevec doesn't work on.

He talked about the famous cardiotoxicity report that caused such a

flap last year. He said that he hasn't seen any evidence to suggest

that Gleevec can cause heart problems or if it does, it's certainly

not a significant number of patients.

He talked about the dosing of Sprycel, mentioning that the two

standard doses are 70mg twice a day and 100mg once a day. He said

that the 70mg twice a day was causing more pleural effusions so there

is a trend towards the 100mg once a day dose which is less of a

problem.

He mentioned that very few patients are getting transplants now that

there are so many successful drug therapy options. He did suggest

however, those in accelerated or blast phase, should consider

transplant as an option because drug therapy in this group of people

doesn't seem to give durable responses.

At this point, the telephone lines were opened and people were given

a chance to ask questions.

The first question was about surgeries and should patients take any

precautions if they are planning for a surgery. He said that if

there is a high risk of infection from the surgery, then it would be

acceptable to stop taking Gleevec 1 week before the surgery to allow

the white count to rise a bit (which will help if the patient gets an

infection) but he said that for the majority of people on Gleevec,

they manage surgeries the exact same way any normal person does.

The second question was about resistance. He said that clinical

decisions shouldn't be based on one test alone. It's the trend over

time that matters. Especially with PCR's since they tend to bounce a

lot. He said that if the PCR rises significantly on one test and

then rises again on another, it should be watched closely.

Resistance can usually be confirmed in about 6 months time.

The third question was about myelodysplasia. He said that

myelodysplasia basically means " funny looking cells in the bone

marrow " . He said that there are a significant number of Gleevec

patients who appear to have " funny looking cells in their bone

marrow " but that they don't really have myelodysplastic disease and

the presence of these " funny cells " doesn't seem to have much

significance.

The fourth question was about survival expectations. He said that

after 5 years, only 5% of patients have actually died of CML, another

5% have died of unrelated causes such as car accidents so he

encouraged us all to look both ways before crossing the street

because he thinks there's a good chance that we can all live out a

normal life expectancy.

The fifth question was about using Hydrea in treatment. He said some

people still get Hydrea to start out if they have very high counts

because it can reduce the counts quickly but Hydrea shouldn't be used

long term as a means of controlling CML. Patients should either be

on Gleevec or one of the other new drugs. If a patient is resistant

to a current dose of Gleevec, there is no sense in continuing with

that dose. It should be increased or changed for another drug.

And the last question was about the various transcripts that the

PCR's detect. He said most patients have only one transcript (ie

B2A2 or B3A2 which I think he said was the most common) but a few do

have more than one. He didn't really elaborate more on that.

And that was that.

Take care,

Tracey

---------------------------------

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[Guest guest]

Hi, Tracey,

Thank you for the information.

Healthy hugs

Ceil<BR><BR><BR>**************************************<BR> AOL now offers free

email to

everyone. Find out more about what's free from AOL at

http://www.aol.com.</HTML>

[Guest guest]

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

>

>

_________________________________________________________________

Like puzzles? Play free games & earn great prizes. Play Clink now.

http://club.live.com/clink.aspx?icid=clink_hotmailtextlink2

[Guest guest]

Hi Tracey,

Thank you so much for writing up such a complete summary of the

teleconference and sharing it with us.

I had signed up for the teleconference, and then had a " Gleevec

Moment " and completely forgot about it! Go figure! ;-)

You take excellent notes, and so does your daughter. If I ever go

back to college, I think I'll hire you to take my lecture notes! You

rock!

Lynn

Dx'd 12/10

PCRU

>

> 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]

Thank you very much for the summary Tracey;

Yusuf

---------------------------------

Pinpoint customers who are looking for what you sell.

[Guest guest]

Thanks Tracey for the notes. Timing was not so practical for me and it was a

pretty useful read.

I hope everybody is having a very good week-end. No diving here (we tried

but too much wind and way too much current) but the sky is blue and the sun

warm.

Cheers,

Marcos.

On 6/28/07, Tracey <traceyincanada@...> wrote:

>

> 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

>

>

>

--

Marcos Perreau Guimaraes

Suppes Brain Lab

Ventura Hall - CSLI

Stanford University

220 Panama street

Stanford CA 94305-4101

650 329 9920 x 305

650 630 5015 (cell)

marcospg@...

montereyunderwater@...

www.stanford.edu/~marcospg/