Actinic keratosis: fluorouracil cream tops other options in randomized trial

  • N Engl J Med

  • International Clinical Digest
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Takeaway

  • 5% fluorouracil cream is the most effective of 4 field-directed treatments for patients with multiple actinic keratosis (AK) lesions, according to data from a head-to-head randomized trial.

Why this matters

  • No clear recommendations for treatment type are included in the current guidelines.

Key results

  • At 3 and 12 months, fluorouracil was associated with higher rates of freedom from treatment failure (90.6% and 74.7%, respectively) compared with:
    • imiquimod (75.8% and 53.9%, respectively; HR, 2.03; P=.001 for treatment failure),
    • methyl aminolevulinate photodynamic therapy (MAL-PDT; 76.0% and 37.7%, respectively; HR, 2.73; P<.001 for treatment failure and>
    • ingenol mebutate (67.3% and 28.9%, respectively; HR, 3.33; P<.001 for treatment failure>
  • There were no serious treatment-related adverse events.
  • The percentage of patients with 100% adherence was higher in the ingenol mebutate group (98.7%) and the MAL-PDT group (96.8%) than in the fluorouracil group (88.7%) and the imiquimod group (88.2%).

Study design

  • 624 patients with ≥5 AK lesions were randomly assigned to 5% fluorouracil cream (N=155), 5% imiquimod cream (N=156), MAL-PDT (N=156), or 0.015% ingenol mebutate gel (N=157) and analyzed for efficacy.
  • Funding: Netherlands Organization for Health Research and Development.

Limitations

  • Overrepresentation of men in the trial population.
  • Adherence in a trial may not reflect actual practice.

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