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ask about your risk of VERY serious side effects before starting 5-FU Chemotherapy
Announcements
Last update: 23 Oct 2024
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The Advocates for Universal DPD/DPYD Testing (AUDT) established themselves in 2021 -- see www.test4DPD.org the latest in advocacy efforts to include a listing of clinicians that are leading the way in testing.
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AUDT would also like to announce two new developments that will serve to improve the standard of care in the US:
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- The Dana Farber Cancer Institute, Boston MA, introduced pre-screening for patients preparing for chemotherapy to treat gastrointestinal and breast cancer in Dec 2022. If a person is found to have partial deficiency, they will receive a reduced level of 5-FU or capecitabine; if they are completely deficient, they will receive neither drug and be directed to another treatment regimen.
- The US FDA updated drug labels (Capecitabine in 2022, Fluorouracil in 2024) to address this important patient safety issue in response to a Citizen's Petition. The new labels suggest physicians should (note it is no longer the patient who needs to initiate the discussion, it is the physician):
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“Consider testing for genetic
variants of DPYD prior to initiating XELODA/Fluo rouracil to reduce the risk of serious adverse reactions if the patient’s clinical status permits and
based on clinical judgement [see Clinical Pharmacology (12.5)]. Serious adverse reactions may still occur even if no DPYD variants are identified.” (emphasis
added)
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Discussing with patients the risk of toxicity associated with DPD deficiency
and the possible benefits of pre-screening.
- Unfortunately, the FDA chose not to recommend universal pre-screening yet these drug label changes are a big step in the right direction.
- See the full response at: https://www.regulations.gov/document/FDA-2020-P-2213-0045
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“Consider testing for genetic
variants of DPYD prior to initiating XELODA/Fluo rouracil to reduce the risk of serious adverse reactions if the patient’s clinical status permits and
based on clinical judgement [see Clinical Pharmacology (12.5)]. Serious adverse reactions may still occur even if no DPYD variants are identified.” (emphasis
added)
- The National Community Oncology Dispensing Association’s (NCODA) has published a Positive Quality Intervention recommending screening for DPD/DPYD prior to the use of fluoropyrimidine based chemotherapy: see https://www.ncoda.org/dpyd-testing-prior-to-fluoropyrimidine-treatment/ . NCODA's mission is to "empower the medically-integrated oncology team to deliver positive, patient-centered outcomes (emphasis added) by providing leadership, expertise, quality standards and best practices."
- The Institute for Safe Medicine Practices recommends the start of pre-screening in the US. See ISMP's 15 July 2021 newsletter that asks "why not" screen?
- The European Medicines Agency published a letter to healthcare professionals recommending pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity in June 2020. Now it is time for the US to join the leaders in improving the standard of care for patients!