Low‐dose 5‐fluorouracil in combination with salicylic acid for the treatment of actinic keratoses on the hands and/or forearms – results of a non‐interventional study

• Published in: Journal of the European Academy of Dermatology and Venereology 2017-03, Vol.31 (3), p.455-462
• Main Authors: Reinhold, U., Hadshiew, I., Melzer, A., Prechtl, A.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - adverse effects; Drug Combinations; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Forearm; Hand; Humans; Keratolytic Agents - adverse effects; Keratolytic Agents - therapeutic use; Keratosis, Actinic - drug therapy; Male; Middle Aged; Salicylic Acid - adverse effects; Salicylic Acid - therapeutic use
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/jdv.13935

Background As an in situ carcinoma, actinic keratoses should be treated early. Previous studies on the efficacy of a low‐dose 0.5% 5‐fluorouracil solution in combination with 10% salicylic acid (low‐dose 5‐FU/SA) are mostly related to lesions appearing on the head and face. In contrast, actinic keratoses (AK) lesions of the upper extremities are considered to be difficult to treat. Objective The efficacy of low‐dose 5‐FU/SA in the treatment of actinic keratoses on the hands and/or forearms was studied for the first time in this non‐interventional study (NIS) under practical conditions in a large patient population. In addition to the clinical course during therapy and a follow‐up period, the length of application and adherence were documented. Methods As part of this NIS, 649 patients with AK were treated at 207 centres with low‐dose 5‐FU/SA. The data of the study were recorded at baseline, optionally during an intermediate examination, at the end of therapy and during a final assessment. Results The average number of AK lesions decreased during the entire observation period by 92%. Side‐effects were documented only rarely in the form of local skin reactions (2%). The attending physicians assessed the efficacy, tolerability and safety of the therapy as being predominantly very good or good (in each case ≥90%). Conclusion AK lesions on the hands and/or forearms were effectively treated with low‐dose 5‐FU/SA under routine conditions in dermatological practice and the treatment was well tolerated.