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The European Medicines Agency (EMA) has begun a screening of patients before they start treatment with certain drugs.
Most of the drugs in question are chemotherapies and include 5-fluorouracil (5-FU) and related drugs, capecitabine (Xeloda, Genentech) and tegafur, which are converted to fluorouracil in the body. These chemotherapies are widely used in the treatment of various types of cancer, including colorectal cancer, bad cancer and head and neck cancer.
This clbad of drugs also includes flucytosine (Ancobon, Valeant Pharmaceuticals), which is used for serious fungal infections.
The review will examine existing screening methods and their usefulness in identifying patients at increased risk for serious side effects with these treatments, notes the agency.
Screening methods are designed to identify individuals deficient in the enzyme dihydropyrimidine dehydrogenase (DPD) necessary for the breakdown of fluorouracil.
Without this enzyme, the body can reach toxic levels, even fatal, in the body, resulting in side effects such as neutropenia, neurotoxicity, severe diarrhea and stomatitis, the agency says.
"Patients with complete DPD deficiency should therefore not receive fluorouracil or drugs that can form it in the body," says the agency. The product information for most of these drugs indicates that they should not be used in patients with a complete DPD deficiency, he adds.
Genetic testing for DPD deficiency is recommended for most drugs used in cancer treatment, but routine detection of DPD deficiency before the start of treatment is not compulsory. In addition, new data on genetic testing and other methods of detecting DPD have recently been released and could affect current recommendations, notes the agency.
Experts debating the issue
The EMA review comes right after several high-profile cases of fatal reactions.
In France, the families of four patients who died as a result of fatal reactions to these chemotherapies filed a lawsuit demanding to know why these patients had not been tested before the start of treatment. the argument is that such tests may have prevented these deaths.
In the UK, a fatal reaction in an untested patient has been highlighted in the media.
This has led some European experts to openly question whether the DPD test should be integrated with oncology practice to protect patients from potentially life-threatening consequences of fluoropyrimidine treatment.
In his Medscape Video Commentary, David Kerr, MD, professor of anticancer medicine at the Oxford Center for Cancer and Hematology, Oxford, England, argues for a germ line test for the deficit in DPD, and discusses a recent study on the issue the Oncology Lancet
However, another British expert, Karol Sikora, Ph.D., MB BChir, professor of anticancer medicine at Buckingham University, opposes such tests in his video commentary.
With the American medical community not in the shelter of a dispute, Medscape Medical News wanted to find out what the oncology experts in the United States thought about screening for DPD deficiency in each patient before starting treatment with 5-FU / capecitabine.
The three American experts interviewed opposed the routine testing of DPD, arguing that it is widespread chemotherapy, that the DPD deficiency is very rare, that patients sometimes react badly even if they do not. are not and that there is an antidote to overdoses.
Review by PRAC
In its announcement, EMA announced that it will now evaluate available data in relation to existing screening methods for detecting DPD deficiency, and will recommend whether any changes are needed in the way these drugs are used to ensure their safe use.
The review is conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA committee responsible for evaluating the safety issues of medicines for human use, which will form a set of recommendations.
The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which deals with issues relating to medicinal products for human use, which will adopt an opinion.
The last stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
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