Maastricht, the Netherlands—What is the best treatment for actinic keratosis? A new Dutch study sought to answer that question.
“Actinic keratosis is the most frequent premalignant skin disease in the white population. In current guidelines, no clear recommendations are made about which treatment is preferred,” point out Maastricht University–led researchers. Their results were published in the New England Journal of Medicine.
The effectiveness of four frequently used field-directed treatments for multiple lesions in a continuous area was investigated. For the study, patients with a clinical diagnosis of five or more actinic keratosis lesions on the head, involving one continuous area of 25 to 100 cm2, were enrolled at four Dutch hospitals.
Participants were randomly assigned to treatment with:
• 5% fluorouracil cream
• 5% imiquimod cream
• Methyl aminolevulinate photodynamic therapy (MAL-PDT) or
• 0.015% ingenol mebutate gel
The focus of the study was the proportion of the 624 patients with a reduction of 75% or more in the number of actinic keratosis lesions from baseline to 12 months after the end of treatment. The trial was conducted from November 2014 through March 2017.
Results indicate that, at a year after the end of treatment, the cumulative probability of remaining free from treatment failure was significantly higher among patients who received fluorouracil (74.7%; 95% confidence interval [CI], 66.8-81.0) than among those who received imiquimod (53.9%; 95% CI, 45.4-61.6), MAL-PDT (37.7%; 95% CI, 30.0-45.3), or ingenol mebutate (28.9%; 95% CI, 21.8- 36.3).
Compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36-3.04) with imiquimod, 2.73 (95% CI, 1.87-3.99) with MAL-PDT, and 3.33 (95% CI, 2.29-4.85) with ingenol mebutate (P ≤.001 for all comparisons), report the researchers, who also add that no unexpected toxic effects were documented.
“At 12 months after the end of treatment in patients with multiple actinic keratosis lesions on the head, 5% fluorouracil cream was the most effective of four field-directed treatments,” the study authors conclude.
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“Actinic keratosis is the most frequent premalignant skin disease in the white population. In current guidelines, no clear recommendations are made about which treatment is preferred,” point out Maastricht University–led researchers. Their results were published in the New England Journal of Medicine.
The effectiveness of four frequently used field-directed treatments for multiple lesions in a continuous area was investigated. For the study, patients with a clinical diagnosis of five or more actinic keratosis lesions on the head, involving one continuous area of 25 to 100 cm2, were enrolled at four Dutch hospitals.
Participants were randomly assigned to treatment with:
• 5% fluorouracil cream
• 5% imiquimod cream
• Methyl aminolevulinate photodynamic therapy (MAL-PDT) or
• 0.015% ingenol mebutate gel
The focus of the study was the proportion of the 624 patients with a reduction of 75% or more in the number of actinic keratosis lesions from baseline to 12 months after the end of treatment. The trial was conducted from November 2014 through March 2017.
Results indicate that, at a year after the end of treatment, the cumulative probability of remaining free from treatment failure was significantly higher among patients who received fluorouracil (74.7%; 95% confidence interval [CI], 66.8-81.0) than among those who received imiquimod (53.9%; 95% CI, 45.4-61.6), MAL-PDT (37.7%; 95% CI, 30.0-45.3), or ingenol mebutate (28.9%; 95% CI, 21.8- 36.3).
Compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36-3.04) with imiquimod, 2.73 (95% CI, 1.87-3.99) with MAL-PDT, and 3.33 (95% CI, 2.29-4.85) with ingenol mebutate (P ≤.001 for all comparisons), report the researchers, who also add that no unexpected toxic effects were documented.
“At 12 months after the end of treatment in patients with multiple actinic keratosis lesions on the head, 5% fluorouracil cream was the most effective of four field-directed treatments,” the study authors conclude.
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