5-Fluorouracil (5FU) is proven to be the most effective therapy in field directed treatment for AK, with Jansen et al. reporting a 1-year probability of treatment success of 74.7%. However, treatment with 5FU is associated with side effects, like erythema, itching, a burning sensation and crusting, and a burdensome dosing regimen of twice daily application for four weeks. This long treatment duration in combination with side-effects and overall lifestyle adjustments during treatment can be the reason for poor adherence and premature termination, and it can also lead to future refusal of 5FU therapy. Therefore, room for improvement lies in increasing the tolerability, in terms of side effects or treatment duration, while maintaining the efficacy of 5FU in the treatment of AK.
Addition therapy, which can shorten the duration of treatment, might be the key to success. Calcipotriol (CAL) enhances thymic stromal lymphopoietin (TSLP), an epithelium-derived cytokine, which promotes antitumor immunity. Therefore, it is known to have a synergistic effect when combined with 5FU in the treatment of AK. This suggests that short-term treatment with 5FU-CAL is effective and provides the opportunity to shorten duration of treatment, thereby improving tolerability of treatment and full adherence to the treatment regimen.
However, no study compared 5FU-CAL combination therapy with standard 5FU treatment for a duration of 28 days. This study aims to evaluate whether a short course of combination therapy with 5FU-CAL is non-inferior to a full course of 5FU monotherapy with respect to the 1-year probability of treatment success.
Adults above 18 years of age
Face, ears, (balding) scalp
Neck/Shawl area, including the sun-exposed chest area
Upper extremities
Previous field treatment for AK within 2cm of the treatment area, within 3 months
(non) melanoma skin cancer in treatment area
Mucosal lesions
Genetic skin cancer disorder
Parallel
5FU-Calcipotriol
Drugtopical 5FU-CAL, twice daily, during 4 or 6 consecutive days, depending on the treatment location
5-FU 50 MG/ML Topical Cream
Drugtopical 5FU, twice daily, 7 days a week, during 4 weeks
Treatment success at 12 months post-treatment
Treatment success at 12 months post treatment, defined as ≥75% reduction in the number of AK lesions in the treatment area (partial clearance)
AK clearance rate
mean percentage change in AK lesions at 3 and 12 months post-treatment
Recurrence rate
New lesions and need for retreatment at 3 and 12 months post-treatment
Adverse effects
Patients experiencing moderate to severe adverse effects
Treatment compliance
Patients who are fully compliant to the prescribed treatment regimen (5FU-CAL or 5FU monotherapy)
Long-term risk for cSCC
The long-term probability of developing a cSCC
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