Improving the safety of cancer drugs

Deutsche Krebshilfe funds trial designed to improve treatment with new oral anti-cancer agents

At the beginning of this month an interdisciplinary working group consisting of physicians and pharmacists from FAU and Universitätsklinikum Erlangen started a ground-breaking research project in close cooperation with the Comprehensive Cancer Center Erlangen. Over the next three years, a controlled trial involving 300 patients is to be undertaken to determine whether and to what extent structured and accompanying intensified clinical pharmaceutical/pharmacological support over a period of twelve weeks can lead to an improvement in patient safety, patient awareness and patient well-being (management of side-effects) in patients starting a course of treatment with new, orally administered anti-cancer agents. The cancer research foundation Stiftung Deutsche Krebshilfe is funding the project with 353,000 euros.

The clinical pharmacist/pharmacologist will first prepare a comprehensive analysis of the prescribed medication being given to the subjects in the trial group and will report on any anomalies to the attending oncologist. Each patient will receive information relating to their treatment in four structured, additional patient education sessions. The patients in the control group will continue to receive the standard treatment with no modifications. “If this large-scale clinical study produces positive results, the systematic insights gained and the education and supervision reports will be made available to other oncological treatment facilities with the aim of achieving the broadest possible patient benefit,” affirms Prof. Dr. Frank Dörje, chief pharmacist at Universitätsklinikum Erlangen, who is supervising the trial together with Prof. Dr. Martin F. Fromm, director of the Institute of Experimental and Clinical Pharmacology and Toxicology at FAU.

As Prof. Fromm explains, the number of orally administered cancer drugs has increased continuously since the beginning of this century due to the significant advances achieved in the field of molecular medicine. Orally administered anti-cancer agents are already a well-established feature of many treatment protocols and, as a result, the number of prescriptions for drugs administered orally in the form of capsules and tablets is also rapidly on the rise. For many patients, this development is associated with greater convenience as there is no need for the strict hygiene measures that go hand in hand with intravenous drug administration in the form of injections or infusions. In addition, there is enhanced flexibility with regard to treatment location and it is even possible to reduce the number of visits to the doctor’s surgery or the hospital as a result.

The basic problems of oral anti-cancer treatments

“However, it is still by no means possible to see oral anti-cancer therapy as a simple and straightforward procedure,” warns Prof. Dörje. Every oral anti-cancer regime always requires intensive support in the form of patient advice and education, as oral anti-cancer agents are usually administered by the patients themselves at home. Treatment success depends to a large extent on the patient’s compliance with the drug administration schedule and on their understanding of the purpose of oncological therapy. “Patients must be comprehensively educated on how to take their medication properly and also how to recognise potential undesirable side-effects of the drugs. Furthermore, unknown drug risks and potential pharmacological interactions with other non-oncological medications the patient may be taking can put the success of the treatment at risk,” concludes Prof. Fromm. Because the number of prescriptions of anti-cancer agents is growing, there is an increased need for patient support measures designed to help and inform those using these drugs.

More information:

Prof. Dr. Martin Fromm
Phone: +49 9131 8522772
Prof. Dr. Frank Dörje
Phone: +49 9131 8533591