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Dr. Gabriel A. Brooks discusses the recent FDA product labeling update for Xeloda and 5-FU which aims to highlight risks associated with DPD deficiency.
According to an update from the Food and Drug Administration (FDA), the labeling for Xeloda (capecitabine) and fluorouracil (5-FU) chemotherapy treatment has been changed to emphasize the risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency; this can affect patients receiving the chemotherapy treatment for their cancer.
Patients with partial or complete DPD deficiency are at increased risk for severe, potentially fatal toxicities, including mucositis, diarrhea, neutropenia and neurotoxicity. The agency advises oncologists and other healthcare providers to inform patients of these risks and consider genetic testing before initiating treatment.
Dihydropyrimidine dehydrogenase (DPD): an enzyme that breaks down fluoropyrimidines, such as 5-FU and Xeloda.
Mucositis: an inflammation of the mucous membranes.
Neurotoxicity: the damage or dysfunction of the nervous system caused by exposure to toxic substances, such as chemotherapy.
Neutropenia: a condition in which there is an abnormally low number of neutrophils, a type of white blood cell, in the bloodstream.
In an interview with CURE®, Dr. Gabriel A. Brooks discussed the recent FDA product labeling update for Xeloda and 5-FU which specifically aims to bring awareness to the risks associated with DPD deficiency and expanded on what he would like patients to know about DPD deficiency.
Brooks currently serves as an associate professor of medicine and an associate professor of The Dartmouth Institute, Dartmouth Cancer Center, The Dartmouth Institute for Health Policy and Clinical Practice. He is also a member of the Cancer Population Sciences Research Program, and a member of the Gastrointestinal Clinical Oncology Group, at Dartmouth Geisel School of Medicine, in Lebanon, New Hampshire.
The main takeaway message would be to encourage patients to ask their doctors about DPD deficiency, and to ask patients to open up a conversation with their doctors about getting tested for DPD deficiency before starting 5-FU and [Xeloda].
Right now, the FDA recommends that doctors discuss DPD deficiency with their patients, but we know that many doctors are not doing that. The guidelines out there have been a little mixed. In Europe, it is standard of care to offer this test before starting chemotherapy. In many centers in the United States, this is becoming standard of care before starting 5-FU and [Xeloda] chemotherapy; however, in other centers, this test is not uniformly used. I am a believer that it should be used before treatment, and I encourage patients to discuss it with their doctors, as advised on the FDA drug labels for 5-FU and [Xeloda].
This test is not uniformly used, so it's worth bringing this up for discussion with your doctor and understanding that your doctor may not be planning to order this test unless you bring it up for discussion with them.
Transcript has been edited for clarity and conciseness.
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