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Put your reading glasses on and read these articles carefully, it's already

happening in Europe.

" The network means that patients will get treatment based on best practice,

which is followed up using molecular monitoring, cytogenetic analysis and

providing the chance to optimise their response and increase survival wherever

they are treated. "

This looks good to me. So, who is utilizing it in North America?????? More of

the good stuff:

" EUTOS for CML has standardized molecular monitoring techniques, used to track

disease status, in 27 of a target 50 laboratories in Europe, with complete

standardization on track for 2009. Patients in 27 countries can now access

state-of-the art, standardized techniques to monitor their disease.

" Molecular response to treatment, as measured by assessment of Bcr-Abl gene

transcript levels, has become widely available through the use of the real-time

quantitative polymerase chain reaction (RQ-PCR) methodology. This methodology is

the most sensitive to determine cytogenetic response - the elimination of

Ph-positive cells responsible for CML - which is also correlated with

progression-free survival.

" The use of different testing methods can produce variations in measured

responses among laboratories and, until now, it has been essential for patients

to be tested in the same laboratory over time to ensure comparable results, "

said Michele Baccarani, of the University of Bologna, Italy. " Reliable and

timely molecular monitoring will mean fewer tests for patients and also means

that their progress can be monitored no matter where they are in Europe. It also

allows doctors to compare results. "

Pharmacological monitoring

" A further key element of the EUTOS for CML program is the standardization and

expansion of imatinib blood level testing via the pharmacological monitoring

program which aims to optimize treatment response where needed. The majority of

patients treated with imatinib as first-line therapy achieve high overall rates

of complete hematologic and cytogenetic response,[iv] where the patient's blood

cell counts return to normal. Monitoring of imatinib blood levels is important

for those patients who may not be adhering to their treatment, those who are not

responding as expected or those who may be experiencing drug-drug interactions

or unusually severe side effects at the prescribed dosage.

" As of today more than 1,100 blood level samples from these types of patients

have been collected and analyzed by a central facility in Bordeaux.

Significantly, preliminary results indicate that around 60% of those samples had

imatinib levels lower than those associated with the best responses to imatinib

treatment5, indicating that there is a valuable correlation between testing and

a patient's response to imatinib treatment. The testing is provided as a free

service to patients and healthcare providers as part of the EUTOS for CML

initiative.

" A growing database of blood level measurements from EUTOS for CML may provide

evidence to support the incorporation of imatinib blood level testing as a part

of standard practice in the management of CML. Regular blood level testing is a

simple and effective way to evaluate patient treatment and may help improve

patient outcomes for patients.

" Novartis is delighted with the progress made by the EUTOS for CML program after

only one year. It is already having a significant impact on improving the

treatment of CML, " said Guido Guidi, Novartis Oncology Head, Region Europe.

" Novartis is committed to this unique partnership with the European LeukemiaNet,

which is the first collaboration of its kind. We very much look forward to the

availability of the final data analysis from the program. "

EUTOS for CML is a collaborative initiative between the European LeukemiaNet and

Novartis, funded by Novartis.

For further information, please visit the EUTOS for CML website at www.eutos.org

____________________________________

Data on 2,500 patients with chronic myeloid leukaemia (CML) and results from

state-of-the art monitoring are providing new insights into the management of

the condition, according to one-year data from a unique collaborative research

programme designed to optimise the treatment and monitoring of patients

throughout Europe.

The European Treatment and Outcome Study (EUTOS) for CML is collecting data in a

pan-European registry to provide a picture of the 'real world' incidence and

management of the condition, in addition to implementing systems to standardise

and increase access to molecular and pharmacological monitoring, and a major

education programme to encourage clinicians to follow evidence-based CML

recommendations.

One year after starting the programme, information on 2,500 patients has been

gathered by the new EUTOS for CML registry, with more than 20 countries across

Europe contributing data on patients. An additional 1,700 patients will be

recruited into a prospective study group of track the impact of implementing

recommendations.

In addition, more than 1,100 blood samples from patients not responding as well

as expected to therapy have been analysed by the programme's central laboratory

in Bordeaux, France, as part of the pharmacological monitoring programme, which

aims to optimise treatment response by standardising and expanding testing of

blood levels of imatinib. One-year results revealed that around 60% of the

samples had imatinib levels lower than those associated with best response to

treatment (1000ng/ml).

More at this website: http://www.medicalnewstoday.com/articles/125940.php

FYI,

Lottie

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Thanks Lottie for sharing this article and all the others you share with us.

I'm responding with my experience with one area the article describes. Imatinib

blood level testing really helped my medical team decide on an acceptable dose

that gives me good quality of life. I have mostly been on 300mg of Gleevec since

2001 and have remained PCRU. At one point my dose was increased with a

significant increase in negative side effects and then with 400mg now being the

accepted minimal dose, my doc was hesitant about putting me back to 300mg. After

agreeing to a trial at 300mg, and following that with imatinib blood level

testing, it was found that on 300mg, I have the level of imatinib in my blood

that most people have on 400mg. The testing helped us decide that the lower

dose could be appropriate for me and has allowed me to stay PCRU with fewer side

effects than the standard dose. Imatinib blood level testing is available and

can help those on both side of responses--those who are not getting a full

response and those who have the response but are plagued by side effects on

higher doses. Others on this list probably know more about the research related

to blood levels and results but at least for me the comparison of my blood level

of imatinib to others on the currently accepted minimal dose was helpful to

treatment decisions.

Fran

dx 5/99

Int/AraC 2000-2001, CCR

Gleevec 2001-present, PCRU

Zero Club #23

>

> Put your reading glasses on and read these articles carefully, it's already

happening in Europe......

..................

> " A further key element of the EUTOS for CML program is the standardization and

expansion of imatinib blood level testing via the pharmacological monitoring

program which aims to optimize treatment response where needed. The majority of

patients treated with imatinib as first-line therapy achieve high overall rates

of complete hematologic and cytogenetic response,[iv] where the patient's blood

cell counts return to normal. Monitoring of imatinib blood levels is important

for those patients who may not be adhering to their treatment, those who are not

responding as expected or those who may be experiencing drug-drug interactions

or unusually severe side effects at the prescribed dosage.

>

> " As of today more than 1,100 blood level samples from these types of patients

have been collected and analyzed by a central facility in Bordeaux.

Significantly, preliminary results indicate that around 60% of those samples had

imatinib levels lower than those associated with the best responses to imatinib

treatment5, indicating that there is a valuable correlation between testing and

a patient's response to imatinib treatment. The testing is provided as a free

service to patients and healthcare providers as part of the EUTOS for CML

initiative.

>

> " A growing database of blood level measurements from EUTOS for CML may provide

evidence to support the incorporation of imatinib blood level testing as a part

of standard practice in the management of CML. Regular blood level testing is a

simple and effective way to evaluate patient treatment and may help improve

patient outcomes for patients.

>

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Seeing a cml specialist in Paris (Hospital St Louis has one of the

leading hematology departments in Europe) costs 25 euros (in 2006, may

be 30 now) so if anybody is visiting there you can always get an

appointment and see a dr in between your tour of the Louvre and a

glass of wine at some cafe in front of the Seine. Just call some time

in advance if you want to see somebody that specializes in cml as

there aren't that many (a couple of months maybe). You don't have to

be French or from the EU, although speaking some French would help for

the appointment call (although it d may work in English depending on

how helpful is the assistant you get on the phone, like here it's

variable) , the drs all speak English. For tests you may have to pay

something more significant than 25 euros, but most of it is pretty

reasonable (you pay only the patient part, the hospital pays the

other) and you can always get advice and then get the test through

your provider here. That is also true in some other EU countries but

not all.

Marcos.

On Wed, May 20, 2009 at 4:38 PM, Lottie Duthu <lotajam@...> wrote:

>

>

> Put your reading glasses on and read these articles carefully, it's already

> happening in Europe.

> " The network means that patients will get treatment based on best practice,

> which is followed up using molecular monitoring, cytogenetic analysis and

> providing the chance to optimise their response and increase survival

> wherever they are treated. "

> This looks good to me. So, who is utilizing it in North America?????? More

> of the good stuff:

>

> " EUTOS for CML has standardized molecular monitoring techniques, used to

> track disease status, in 27 of a target 50 laboratories in Europe, with

> complete standardization on track for 2009. Patients in 27 countries can now

> access state-of-the art, standardized techniques to monitor their disease.

>

> " Molecular response to treatment, as measured by assessment of Bcr-Abl gene

> transcript levels, has become widely available through the use of the

> real-time quantitative polymerase chain reaction (RQ-PCR) methodology. This

> methodology is the most sensitive to determine cytogenetic response - the

> elimination of Ph-positive cells responsible for CML - which is also

> correlated with progression-free survival.

>

> " The use of different testing methods can produce variations in measured

> responses among laboratories and, until now, it has been essential for

> patients to be tested in the same laboratory over time to ensure comparable

> results, " said Michele Baccarani, of the University of Bologna, Italy.

> " Reliable and timely molecular monitoring will mean fewer tests for patients

> and also means that their progress can be monitored no matter where they are

> in Europe. It also allows doctors to compare results. "

>

> Pharmacological monitoring

>

> " A further key element of the EUTOS for CML program is the standardization

> and expansion of imatinib blood level testing via the pharmacological

> monitoring program which aims to optimize treatment response where needed.

> The majority of patients treated with imatinib as first-line therapy achieve

> high overall rates of complete hematologic and cytogenetic response,[iv]

> where the patient's blood cell counts return to normal. Monitoring of

> imatinib blood levels is important for those patients who may not be

> adhering to their treatment, those who are not responding as expected or

> those who may be experiencing drug-drug interactions or unusually severe

> side effects at the prescribed dosage.

>

> " As of today more than 1,100 blood level samples from these types of

> patients have been collected and analyzed by a central facility in Bordeaux.

> Significantly, preliminary results indicate that around 60% of those samples

> had imatinib levels lower than those associated with the best responses to

> imatinib treatment5, indicating that there is a valuable correlation between

> testing and a patient's response to imatinib treatment. The testing is

> provided as a free service to patients and healthcare providers as part of

> the EUTOS for CML initiative.

>

> " A growing database of blood level measurements from EUTOS for CML may

> provide evidence to support the incorporation of imatinib blood level

> testing as a part of standard practice in the management of CML. Regular

> blood level testing is a simple and effective way to evaluate patient

> treatment and may help improve patient outcomes for patients.

>

> " Novartis is delighted with the progress made by the EUTOS for CML program

> after only one year. It is already having a significant impact on improving

> the treatment of CML, " said Guido Guidi, Novartis Oncology Head, Region

> Europe. " Novartis is committed to this unique partnership with the European

> LeukemiaNet, which is the first collaboration of its kind. We very much look

> forward to the availability of the final data analysis from the program. "

>

> EUTOS for CML is a collaborative initiative between the European LeukemiaNet

> and Novartis, funded by Novartis.

>

> For further information, please visit the EUTOS for CML website at

> www.eutos.org

> ____________________________________

> Data on 2,500 patients with chronic myeloid leukaemia (CML) and results from

> state-of-the art monitoring are providing new insights into the management

> of the condition, according to one-year data from a unique collaborative

> research programme designed to optimise the treatment and monitoring of

> patients throughout Europe.

>

> The European Treatment and Outcome Study (EUTOS) for CML is collecting data

> in a pan-European registry to provide a picture of the 'real world'

> incidence and management of the condition, in addition to implementing

> systems to standardise and increase access to molecular and pharmacological

> monitoring, and a major education programme to encourage clinicians to

> follow evidence-based CML recommendations.

>

> One year after starting the programme, information on 2,500 patients has

> been gathered by the new EUTOS for CML registry, with more than 20 countries

> across Europe contributing data on patients. An additional 1,700 patients

> will be recruited into a prospective study group of track the impact of

> implementing recommendations.

>

> In addition, more than 1,100 blood samples from patients not responding as

> well as expected to therapy have been analysed by the programme's central

> laboratory in Bordeaux, France, as part of the pharmacological monitoring

> programme, which aims to optimise treatment response by standardising and

> expanding testing of blood levels of imatinib. One-year results revealed

> that around 60% of the samples had imatinib levels lower than those

> associated with best response to treatment (1000ng/ml).

>

> More at this website: http://www.medicalnewstoday.com/articles/125940.php

> FYI,

> Lottie

>

>

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