Real-World Experience with Topical 5-Fluorouracil 4% (40 mg/g) Cream for the Treatment of Actinic Keratosis

Real-World Experience with Topical 5-Fluorouracil 4% (40 mg/g) Cream for the Treatment of Actinic Keratosis

Authors

  • Giulia Briatico Dermatology Unit, University of Campania, Naples, Italy
  • Gabriella Brancaccio Dermatology Unit, University of Campania, Naples, Italy
  • Camila Scharf Dermatology Unit, University of Campania, Naples, Italy
  • Eugenia Veronica Di Brizzi Dermatology Unit, University of Campania, Naples, Italy
  • Sebastiano Pellerone Dermatology Unit, University of Campania, Naples, Italy
  • Stefano Caccavale Dermatology Unit, University of Campania, Naples, Italy
  • Caterina Mariarosaria Giorgio Dermatology Unit, University of Campania, Naples, Italy
  • Enrico Maria Procaccini Dermatology Unit, University of Campania, Naples, Italy
  • Elvira Moscarella Dermatology Unit, University of Campania, Naples, Italy
  • Giuseppe Argenziano Dermatology Unit, University of Campania, Naples, Italy

Keywords:

actinic keratosis, 5-fluorouracil, treatment, efficacy, safety

Abstract

Introduction:5-fluorouracil (5-FU) is one of the most effective topical treatments for actinic keratosis (AK). A new 4% formulation of 5-FU was recently approved in Europe.

Objectives:This study aimed at evaluating 4% 5-FU cream safety and effectiveness in a real-world setting.

Methods:Adult AK patients were retrospectively selected from the University of Campania Dermatology Unit database. Selection criteria included a diagnosis of non-hyperkeratotic, non-hypertrophic AK (Olsen grade I and II) of the face, ears, and/or scalp, treatment with 4% 5-FU once daily for 4 weeks, and at least 3 follow-up visits (4 and 8 weeks after treatment initiation, and 6 months after treatment end). The primary objectives were to evaluate AK lesions improvement at 8 weeks and relapse rate at 6 months. Patient-reported erythema and burning sensation intensity were also assessed at 4 weeks.

Results: Ninety-eight patients were included in this analysis (male/female 80/18, mean age 74.7 years). AK lesions improvement at 8 weeks resulted complete or significant in 74.5% and 20.4% of the patients, respectively. At 6 months, 65.3% of the patients did not show AK relapses. Burning sensation at 4 weeks was reported as light, moderate, or absent by 44.9%, 22.4%, and 31.6% of the patients, respectively. Erythema was reported as light, moderate, or absent by 37.8%, 51%, and 10% of the patients, respectively. Burning sensation and erythema disappeared gradually during follow-up. No other side effects were reported.

Conclusions:In this real-world study 4% 5-FU proved to be highly effective for AK lesions clearance with a favorable safety profile.

References

Dianzani C, Conforti C, Giuffrida R, et al. Current therapies for actinic keratosis. Int J Dermatol. 2020;59(6):677-684. DOI:10.1111/ijd.14767. PMID: 32012240.

Fargnoli MC, Altomare G, Benati E, et al. Prevalence and risk factors of actinic keratosis in patients attending Italian dermatology clinics. Prevalence and risk factors of actinic keratosis in patients attending Italian dermatology clinics. Eur J Dermatol. 2017;27(6):599-608. DOI:10.1684/ejd.2017.3126. PMID: 29311040.

Calzavara-Pinton P, Calzavara-Pinton I, Rovati C, Rossi M. Topical Pharmacotherapy for Actinic Keratoses in Older Adults. Drugs Aging. 2022;39(2):143-152. DOI:10.1007/s40266-022-00919-0. PMID: 35156172. PMCID: PMC8873057.

Stockfleth E, Bégeault N, Delarue A. The Overall Number of Actinic Keratosis Lesions Is Not Predictable by the Number of Visible Lesions: Consequences for Field-Directed Therapies. Curr Ther Res Clin Exp. 2021;96:100661. DOI:10.1016/j.curtheres.2021.100661. PMID: 35035632. PMCID: PMC8752874.

Martin GM. Impact of interval and combination therapies on the management of actinic keratosis: review and clinical considerations. J Dermatolog Treat. 2011;22(5):288-297. DOI:10.3109/09546631003797072. PMID: 20528483.

Willenbrink TJ, Ruiz ES, Cornejo CM, Schmults CD, Arron ST, Jambusaria-Pahlajani A. Field cancerization: Definition, epidemiology, risk factors, and outcomes. J Am Acad Dermatol. 2020;83(3):709-717. DOI:10.1016/j.jaad.2020.03.126. PMID: 32387665.

Wu Y, Tang N, Cai L, Li Q. Relative efficacy of 5-fluorouracil compared with other treatments among patients with actinic keratosis: A network meta-analysis. Dermatol Ther. 2019;32(3):e12822. DOI:10.1111/dth.12822. PMID: 30638294.

Reinehr CPH, Bakos RM. Actinic keratoses: review of clinical, dermoscopic, and therapeutic aspects. An Bras Dermatol. 2019;94(6):637-657. DOI:10.1016/j.abd.2019.10.004. PMID: 31789244. PMCID: PMC6939186.

Jansen MHE, Kessels JPHM, Nelemans PJ, et al. Randomized Trial of Four Treatment Approaches for Actinic Keratosis. N Engl J Med. 2019;380(10):935-946. DOI:10.1056/NEJMoa1811850. PMID: 30855743.

Ahmady S, Jansen MHE, Nelemans PJ, et al. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2022;158(6):634-640. DOI:10.1001/jamadermatol.2022.1034. PMID: 35475852. PMCID: PMC9047727.

Tolerak® 40 mg/g cream, Summary of Product Characteristics (Pierre Fabre Italia).

Del Regno L, Catapano S, Di Stefani A, Cappilli S, Peris K. A Review of Existing Therapies for Actinic Keratosis: Current Status and Future Directions [published correction appears in Am J Clin Dermatol. 2022 Apr 22]. Am J Clin Dermatol. 2022;23(3):339-352. DOI:10.1007/s40257-022-00674-3. PMID: 35182332. PMCID: PMC9142445.

Dohil MA. Efficacy, Safety, and Tolerability of 4% 5-Fluorouracil Cream in a Novel Patented Aqueous Cream Containing Peanut Oil Once Daily Compared With 5% 5-Fluorouracil Cream Twice Daily: Meeting the Challenge in the Treatment of Actinic Keratosis. J Drugs Dermatol. 2016;15(10):1218-1224. PMID: 27741339.

Ezzedine K, Painchault C, Brignone M. Systematic Literature Review and Network Meta-analysis of the Efficacy and Acceptability of Interventions in Actinic Keratoses. Acta Derm Venereol. 2021;101(1):adv00358. DOI:10.2340/00015555-3690. PMID: 33170301. PMCID: PMC9309865.

Sinclair R, Baker C, Spelman L, Supranowicz M, MacMahon B. A review of actinic keratosis, skin field cancerisation and the efficacy of topical therapies. Australas J Dermatol. 2021;62(2):119-123. DOI:10.1111/ajd.13447. PMID: 32840870. PMCID: PMC8247342.

Ingham AI, Weightman W. The efficacy and safety of topical 5% 5-fluorouracil in renal transplant recipients for the treatment of actinic keratoses. Australas J Dermatol. 2014;55(3):204-208. DOI:10.1111/ajd.12158. PMID: 24627952.

Couch SM, Custer PL. Topical 5-fluorouracil for the treatment of periocular actinic keratosis and low-grade squamous malignancy. Ophthalmic Plast Reconstr Surg. 2012;28(3):181-183. DOI:10.1097/IOP.0b013e3182467c68. PMID: 22460673.

Downloads

Published

2023-04-29

How to Cite

1.
Briatico G, Brancaccio G, Scharf C, et al. Real-World Experience with Topical 5-Fluorouracil 4% (40 mg/g) Cream for the Treatment of Actinic Keratosis. Dermatol Pract Concept. 2023;13(2):e2023151. doi:10.5826/dpc.1302a151

Share