Unique Collaborative Research Program Between Novartis And Leukaemia Physicians Across Europe Moves CML Management Forward

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Main Category: Lymphoma / Leukemia
Also Included In: Blood / Hematology;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 18 Oct 2008 - 1:00 PDT

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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).

Francois Guilhot, Head of Oncology, Hematology and Cell Therapy, University Hospital Center, Poitiers, France, commented: "The results confirm that pharmacological testing is not widely used in clinical practice. But it is a simple and effective way to help ensure patients benefit from their treatment and that treatment is used cost-effectively." He was speaking during an update on EUTOS for CML at a meeting of European LeukemiaNet, a network of CML physicians and researchers, in Cannes, France (17-19 October, 2008).

During the first year of the molecular monitoring arm of the EUTOS for CML programme, standardised monitoring techniques have been introduced in 43 laboratories across Europe, which indicates the initiative is on track to achieve complete standardisation by 2009, Dr Guilhot said.

Michele Baccarani, Professor of Hematology, University of Bologna, Italy, noted: "Reliable and timely molecular monitoring will mean patients' can be monitored no matter where they are in Europe. It also allows doctors to compare results." He added: "An important result of EUTOS for CML, which can't be quantified in figures, is that it has established a network among CML physicians, companies, and researchers. This means co-operation for the future of CML across Europe."

The programme will also drive up standards in CML care to the level currently provided by centres of excellence, Professor Baccarini explained. "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."

"The EUTOS for CML one year data demonstrate that access to this monitoring programme will allow patients to achieve improved response to treatment, and have a better chance of survival," said Rudiger Hehlmann, Professor of Medicine, Mannheim Medical Faculty, University of Heidelberg, Germany, and chair of the European LeukemiaNet.

The EUTOS for CML programme represents a unique collaboration between doctors throughout Europe working in CML and Novartis. Guido Guidi, Head of Region Europe, Novartis Oncology, said: "EUTOS is the first example of a unique collaboration between academia and industry with the ultimate aim of improving the care of patients with CML across Europe."

European Treatment and Outcome Study (EUTOS)

Written by Susan Mayor PhD
susanmayo(at)mac.com
Susan Mayor PhD, medical journalist, London, UK
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