EUTOS - Moinitoring

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" 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, 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. "

http://www.medicalnewstoday.com/articles/125886.php

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The EUTOS for CML Registry provides a unique opportunity for collaboration

between the ELN and Novartis, establishing a strong infrastructure for

evaluating the current state of treatment for CML. The EUTOS for CML Registry is

divided into three patient groups: in-study, out-study and prospective

(population-based). The electronic case report form (e-CRF) is intended for the

population-based section.

The EUTOS for CML Registry will collect baseline, treatment and outcome data on

patients with CML in Europe by implementing and enlarging the current European

CML Registry and its related sub-registries in order to:

a.. Provide a clear epidemiological picture of CML, and patient treatment and

outcomes.

b.. Promote understanding of how patients are treated in real life, outside of

the trial setting, and their outcomes.

c.. Develop a comprehensive prognostic model to optimize treatment.

d.. Evaluate quality-controlled outcomes and implementation of ELN

recommendations.

e.. Create data of high scientific value.

http://www.eutos.org/content/registry/data_entry/

FYI,

Lottie Duthu