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Safer Medicine for Children

Gerlind Bode, ICCCPO advisor

A new EU funded project, called EPOC, deals with the research of the drug doxorubicin to provide better understanding of the effects and side effects.

Today’ treatment of children with cancer is standardized by national and international protocols which are the result of long term experiences in treating these patients. However, many of the used drugs are not officially approved for children. Their administration and dosage result form the (often long term) history of clinical trials. When pure survival had been the primary goal about thirty years ago, today – with increased survival rate – the safety of the drugs used, their side effects and late effects have now become more into the focus of attention.

In its striving for safer medicines for children EMA, the European Medicine Agency, is calling for specific studies which clearly identify the effects of drugs used in children. The European Union grants money for this kind of studies such as planned by EPOC (EuropeanPaediatric Oncology off-patent medicines Consortium) which is a group of British, German, French and Italian paediatric oncologists with special interest in pharmacokinetics. EPOC designed a study which will provide better understanding of the effects (and side effects) of the drug doxorubicin used in children.

Doxurubicin is one of the key components used in the treatment of many different types of can in children. EPOC’s pharmacokinetic study aims to assess the age-dependency of the clearance of doxorubicin in paediatric patients with solid tumours and leukaemias. The age dependent levels of cardiac toxicity of doxorubicin which may result in heart failure even many years after treatment will be closely monitored in patients between the age <1 an 18. A significant number of the patients with different types of cancer ho are being treated according to current stat of the art trials in various European paediatric oncology centres will be enrolled in this study. Thepharmacokinetics of the drug as well as the patients’ cardiac functioning will be closely monitored in order to identify possible age dependent specifics of the drug. Precise measurements of the doxorubicin clearance and the genotyping of these patients will help to identify patients with a specific predisposition and the need for lower doses.

Currently 23 patients from 21 different centres in the four participating countries are enrolled. The aim is to recruit 100 patients within fur years. The results of this study will provide better understanding of the pharmacokinetic mechanisms of this drug in children and will lead to more precise dose recommendations for the different age groups which in turn should result in less toxicity while still maintaining the drug’s efficacy.

A delegation of ICCCPO is involved in this consortium as the patient/parent representative monitoring the ethical aspects of the trail design and its implementation.

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