What enzyme level should be checked for patients using topical fluorouracil (5-fluorouracil)?

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Dihydropyrimidine Dehydrogenase (DPD) Testing for Topical Fluorouracil

Patients should be tested for dihydropyrimidine dehydrogenase (DPD) enzyme deficiency before starting treatment with topical fluorouracil. 1, 2

Rationale for DPD Testing

  • DPD is the initial and rate-limiting enzyme in the metabolic catabolism of 5-fluorouracil (5-FU) and its derivatives 3
  • Fluorouracil cream is contraindicated in patients with DPD enzyme deficiency as stated in the FDA drug label 2
  • A large percentage of fluorouracil is catabolized by the DPD enzyme, and DPD deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities 2
  • European Society for Medical Oncology (ESMO) guidelines explicitly recommend testing for DPD deficiency before initiating 5-FU-based chemotherapy 1

Clinical Significance of DPD Deficiency

  • Complete or partial deficiency of DPD activity has been demonstrated to induce severe toxicities in cancer patients treated with fluoropyrimidine therapy 3
  • Patients with DPD deficiency who receive systemic 5-FU are at risk for severe toxicity including:
    • Severe neutropenia 4, 5
    • Neurotoxicity (37% of DPD-deficient patients) 4
    • Potentially fatal reactions (documented cases of patient deaths) 4
  • Women appear particularly prone to DPD deficiency (79% of deficient patients in one study) 4

DPD Deficiency and Topical 5-FU

  • While systemic absorption of topical 5-FU is minimal in most cases, there have been documented cases of severe systemic toxicity from topical application 5
  • A case report documented severe neutropenia on day 11 of topical 5-FU treatment in a patient who was later found to have DPD deficiency 5
  • The most common clinically significant DPD mutation is IVS14+1G>A, detected in 24-28% of all patients suffering from severe 5-FU toxicity 6

Recent Evidence on Topical 5-FU in DPD Variant Carriers

  • A 2024 retrospective cohort study found that patients carrying a single DPYD variant allele did not have a significantly higher risk of grade 1+ toxicity from topical 5-FU (21.4% vs. 10.2%) 7
  • No patients in this study experienced grade 3+ toxicity, suggesting lower risk with topical application compared to systemic administration 7
  • However, the risk of severe toxicity in patients with complete DPD deficiency remains unknown, and topical 5-FU should be avoided in these patients 7

Recommendations for Clinical Practice

  • Test for DPD deficiency before initiating topical 5-FU treatment 1, 2
  • Avoid topical 5-FU in patients with known complete DPD deficiency 2, 7
  • For patients with partial DPD deficiency (heterozygous carriers):
    • Consider alternative treatments for actinic keratosis such as cryotherapy, imiquimod, or photodynamic therapy 1
    • If topical 5-FU must be used, consider treating smaller areas (less than the maximum 500 cm² recommended for 5-FU 5%) 1
    • Monitor closely for signs of systemic toxicity including blood count abnormalities, neurological symptoms, or severe local reactions 4, 5

Caveats and Considerations

  • The incidence of potentially severe 5-FU-induced toxicity associated with topical application may be greater than documented 5
  • Evaluation for DPD deficiency is not routinely performed in all clinical settings, which may lead to underdiagnosis 5
  • Patients with multiple DPYD variant alleles or complete DPD deficiency may be at higher risk than those with a single variant 7

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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