Toffoli Ludovica, Dianzani Caterina, Bonin Serena, Guarneri Claudio, Guarneri Fabrizio, Giuffrida Roberta, Zalaudek Iris, Conforti Claudio
Dermatology Clinic of Trieste, Maggiore Hospital, University of Trieste, 34125 Trieste, Italy.
Department of Plastic Surgery Unit, Section of Dermatology, University Campus Biomedico of Rome, 00128 Rome, Italy.
Cancers (Basel). 2023 May 28;15(11):2956. doi: 10.3390/cancers15112956.
Actinic keratosis (AK) is one of the most common skin diseases, with a low risk of progression into invasive squamous cell carcinoma. We aim to assess efficacy and safety of a novel formulation of 5-Fluorouracil (5-FU) 4% with once daily application for the treatment of multiple AKs.
A pilot study was performed on 30 patients with a clinical and dermoscopic diagnosis of multiple AKs, enrolled between September 2021 and May 2022 at the Dermatology Departments of two Italian hospitals. Patients were treated with 5-FU 4% cream once daily for 30 consecutive days. The Actinic Keratosis Area and Severity Index (AKASI) was calculated before starting therapy, and at each follow-up, to assess objective clinical response.
The cohort analyzed included 14 (47%) males and 16 (53%) females (mean age: 71 ± 12 years). A significant decrease in AKASI score at both 6 and 12 weeks ( < 0.0001) was observed. Only three patients (10%) discontinued therapy, and 13 patients (43%) did not report any adverse reactions; no unexpected adverse events were observed.
In the setting of topical chemotherapy and immunotherapy, the new formulation of 5-FU 4% proved to be a highly effective treatment for AKs and field cancerization.
光化性角化病（AK）是最常见的皮肤病之一，进展为浸润性鳞状细胞癌的风险较低。我们旨在评估一种新型4% 5-氟尿嘧啶（5-FU）制剂每日一次应用于治疗多发性AK的疗效和安全性。
对30例经临床和皮肤镜诊断为多发性AK的患者进行了一项前瞻性研究，这些患者于2021年9月至2022年5月在两家意大利医院的皮肤科登记入组。患者连续30天每天使用一次4% 5-FU乳膏进行治疗。在开始治疗前及每次随访时计算光化性角化病面积和严重程度指数（AKASI），以评估客观临床反应。
分析的队列包括14名（47%）男性和16名（53%）女性（平均年龄：71±12岁）。在6周和12周时均观察到AKASI评分显著降低（<0.0001）。只有3名患者（10%）停止治疗，13名患者（43%）未报告任何不良反应；未观察到意外不良事件。
在局部化疗和免疫治疗的背景下，新型4% 5-FU制剂被证明是治疗AK和场癌化的高效疗法。
