Systematic review of randomized controlled trials of topicals for actinic keratosis field therapy.

Actinic keratosis Cutaneous field therapy Cutaneous squamous cell carcinoma Topicals

Journal

Archives of dermatological research
ISSN: 1432-069X
Titre abrégé: Arch Dermatol Res
Pays: Germany
ID NLM: 8000462

Informations de publication

Date de publication:
18 Mar 2024
Historique:
received: 20 10 2023
accepted: 06 02 2024
revised: 20 01 2024
medline: 18 3 2024
pubmed: 18 3 2024
entrez: 18 3 2024
Statut: epublish

Résumé

Cutaneous field cancerization in dermatology describes the anatomic region of photodamaged skin with actinic keratoses (AKs) or cutaneous squamous cell carcinoma (cSCC) that is surrounded by cellular atypia, forming a dysplastic field. The concept of field cancerization is especially relevant in dermatology, as actinic keratoses and the surrounding dysplastic region can progress to carcinomas, necessitating the treatment of the field. Recent research has focused on field-directed therapy using topical agents. This study aims to systematically review randomized controlled trials on topical treatments for actinic keratosis field cancerization, following the PRISMA guidelines. Clinical recommendations were based on the Oxford Centre for Evidence-Based Medicine. We identified 20 original randomized controlled trials for topical cutaneous field therapy. 0.5% 5-Fluorouracil/salicylic acid and 0.5% 5-fluorouracil received a clinical recommendation grade of A, while diclofenac sodium received a clinical recommendation grade of B. Calcipotriol/5-fluorouracil, Imiquimod, sunscreen combination therapies, and tirbanibulin received a recommendation grade of C. This review provides a framework for clinicians when considering topical treatments for patients with field cancerization.

Identifiants

DOI: 10.1007/s00403-024-02839-y PMID: 38498070
pubmed: 38498070
doi: 10.1007/s00403-024-02839-y
pii: 10.1007/s00403-024-02839-y
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

108

Informations de copyright

© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.

Références

Willenbrink TJ et al (2020) Field cancerization: definition, epidemiology, risk factors, and outcomes. J Am Acad Dermatol 83(3):709–717
pubmed: 32387665 doi: 10.1016/j.jaad.2020.03.126
Huang A et al (2019) Updates on treatment approaches for cutaneous field cancerization. Curr Dermatol Rep 8(3):122–132
pubmed: 31475077 pmcid: 6716609 doi: 10.1007/s13671-019-00265-2
Lanoue J, Chen C, Goldenberg G (2016) Actinic keratosis as a marker of field cancerization in excision specimens of cutaneous malignancies. Cutis 97(6):415–420
pubmed: 27416085
Christensen SR (2018) Recent advances in field cancerization and management of multiple cutaneous squamous cell carcinomas. F1000Res. https://doi.org/10.12688/f1000research.12837.1
doi: 10.12688/f1000research.12837.1 pubmed: 29904586 pmcid: 5989149
Rogers HW et al (2015) Incidence estimate of nonmelanoma skin cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol 151(10):1081–1086
pubmed: 25928283 doi: 10.1001/jamadermatol.2015.1187
Figueras Nart I et al (2018) Defining the actinic keratosis field: a literature review and discussion. J Eur Acad Dermatol Venereol 32(4):544–563
pubmed: 29055153 doi: 10.1111/jdv.14652
Torezan LA, Festa-Neto C (2013) Cutaneous field cancerization: clinical, histopathological and therapeutic aspects. An Bras Dermatol 88(5):775–786
pubmed: 24173184 pmcid: 3798355 doi: 10.1590/abd1806-4841.20132300
Cheraghlou S, Feng H, Cohen JM (2020) Trends in the access and cost of photodynamic therapy among Medicare beneficiaries in the United States, 2012–2017. JAMA Dermatol 156(9):1021–1022
pubmed: 32697282 pmcid: 7376476 doi: 10.1001/jamadermatol.2020.2427
Jansen MHE et al (2020) A trial-based cost-effectiveness analysis of topical 5-fluorouracil vs. imiquimod vs. ingenol mebutate vs. methyl aminolaevulinate conventional photodynamic therapy for the treatment of actinic keratosis in the head and neck area performed in the Netherlands. Br J Dermatol 183(4):738–744
pubmed: 31961446 pmcid: 7586971 doi: 10.1111/bjd.18884
Nelson CG (2011) Diclofenac gel in the treatment of actinic keratoses. Ther Clin Risk Manag 7:207–211
pubmed: 21753882 pmcid: 3132090 doi: 10.2147/TCRM.S12498
Korman N et al (2005) Dosing with 5% imiquimod cream 3 times per week for the treatment of actinic keratosis: results of two phase 3, randomized, double-blind, parallel-group, vehicle-controlled trials. Arch Dermatol 141(4):467–473
pubmed: 15837864 doi: 10.1001/archderm.141.4.467
Heron CE, Feldman SR (2021) Ingenol mebutate and the treatment of actinic keratosis. J Drugs Dermatol 20(1):102–104
pubmed: 33400406 doi: 10.36849/JDD.5328
Rosso JD et al (2021) Advances and considerations in the management of actinic keratosis: an expert consensus panel report. J Drugs Dermatol 20(8):888–893
pubmed: 34397199 doi: 10.36849/JDD.6078
Jansen MHE et al (2019) Randomized trial of four treatment approaches for actinic keratosis. N Engl J Med 380(10):935–946
pubmed: 30855743 doi: 10.1056/NEJMoa1811850
Oxford Centre for Evidence-Based Medicine: levels of evidence (March 2009). Centre for Evidence Based Medicine 2009. cited 7 Aug 2023.
Ghafouri-Fard S et al (2021) 5-Fluorouracil: a narrative review on the role of regulatory mechanisms in driving resistance to this chemotherapeutic agent. Front Oncol 11:658636
pubmed: 33954114 pmcid: 8092118 doi: 10.3389/fonc.2021.658636
Stockfleth E et al (2017) Efficacy and safety of 5-fluorouracil 0.5%/salicylic acid 10% in the field-directed treatment of actinic keratosis: a phase III, randomized, double-blind, vehicle-controlled trial. Dermatol Ther (Heidelb) 7(1):81–96
pubmed: 27995485 doi: 10.1007/s13555-016-0161-2
Stockfleth E et al (2011) Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol 165(5):1101–1108
pubmed: 21517801 doi: 10.1111/j.1365-2133.2011.10387.x
Jorizzo J et al (2002) Randomized trial evaluating a new 0.5% fluorouracil formulation demonstrates efficacy after 1-, 2-, or 4-week treatment in patients with actinic keratosis. Cutis 70(6):335–339
pubmed: 12502122
Loven K et al (2002) Evaluation of the efficacy and tolerability of 0.5% fluorouracil cream and 5% fluorouracil cream applied to each side of the face in patients with actinic keratosis. Clin Ther 24(6):990–1000
pubmed: 12117087 doi: 10.1016/S0149-2918(02)80012-1
Wolf JE Jr et al (2001) Topical 3.0% diclofenac in 2.5% hyaluronan gel in the treatment of actinic keratoses. Int J Dermatol 40(11):709–713
pubmed: 11737438 doi: 10.1046/j.1365-4362.2001.01324.x
Mazzella C et al (2018) Management of clinical and subclinical actinic keratoses with histological and immunohistochemical assessments by confocal microscopy. Dermatol Ther 31(5):e12672
pubmed: 30207022 doi: 10.1111/dth.12672
Ulrich M et al (2010) Reflectance confocal microscopy for noninvasive monitoring of therapy and detection of subclinical actinic keratoses. Dermatology 220(1):15–24
pubmed: 19907131 doi: 10.1159/000254893
Rivers JK et al (2002) Topical treatment of actinic keratoses with 3.0% diclofenac in 2.5% hyaluronan gel. Br J Dermatol 146(1):94–100
pubmed: 11841372 doi: 10.1046/j.1365-2133.2002.04561.x
Kim GK (2010) The rationale behind topical vitamin d analogs in the treatment of psoriasis: where does topical calcitriol fit in? J Clin Aesthet Dermatol 3(8):46–53
pubmed: 20877542 pmcid: 2945865
Cunningham TJ et al (2017) Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy. J Clin Invest 127(1):106–116
pubmed: 27869649 doi: 10.1172/JCI89820
Bubna AK (2015) Imiquimod—its role in the treatment of cutaneous malignancies. Indian J Pharmacol 47(4):354–359
pubmed: 26288465 pmcid: 4527053 doi: 10.4103/0253-7613.161249
Ulrich C et al (2007) Topical immunomodulation under systemic immunosuppression: results of a multicentre, randomized, placebo-controlled safety and efficacy study of imiquimod 5% cream for the treatment of actinic keratoses in kidney, heart, and liver transplant patients. Br J Dermatol 157(Suppl 2):25–31
pubmed: 18067628 pmcid: 2493058 doi: 10.1111/j.1365-2133.2007.08269.x
Chen K et al (2003) Short-course therapy with imiquimod 5% cream for solar keratoses: a randomized controlled trial. Australas J Dermatol 44(4):250–255
pubmed: 14616490 doi: 10.1046/j.1440-0960.2003.00003.x
Swanson N et al (2010) Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles. J Am Acad Dermatol 62(4):582–590
pubmed: 20133013 doi: 10.1016/j.jaad.2009.07.004
Jorizzo J et al (2007) Vehicle-controlled, double-blind, randomized study of imiquimod 5% cream applied 3 days per week in one or two courses of treatment for actinic keratoses on the head. J Am Acad Dermatol 57(2):265–268
pubmed: 17512087 doi: 10.1016/j.jaad.2007.01.047
Alomar A, Bichel J, McRae S (2007) Vehicle-controlled, randomized, double-blind study to assess safety and efficacy of imiquimod 5% cream applied once daily 3 days per week in one or two courses of treatment of actinic keratoses on the head. Br J Dermatol 157(1):133–141
pubmed: 17501955 doi: 10.1111/j.1365-2133.2007.07942.x
Szeimies RM et al (2004) Imiquimod 5% cream for the treatment of actinic keratosis: results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology. J Am Acad Dermatol 51(4):547–555
pubmed: 15389189 doi: 10.1016/j.jaad.2004.02.022
Gebauer K, Shumack S, Cowen PS (2009) Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial. Br J Dermatol 161(4):897–903
pubmed: 19545297 doi: 10.1111/j.1365-2133.2009.09260.x
Carducci M et al (2015) Comparative effects of sunscreens alone vs sunscreens plus DNA repair enzymes in patients with actinic keratosis: clinical and molecular findings from a 6-month, randomized. Clinical Study J Drugs Dermatol 14(9):986–990
pubmed: 26355618
Bobyr I et al (2019) Fluorescent photodiagnostic evaluation of field cancerization treated with a medical device containing piroxicam 08% and sunscreen SPF 50+ for actinic keratosis. Photodermatol Photoimmunol Photomed 35(4):277–279
pubmed: 30690758 doi: 10.1111/phpp.12452
Alvares BA et al (2022) Efficacy of sunscreen with photolyase or regular sunscreen associated with topical antioxidants in treating advanced photodamage and cutaneous field cancerization: a randomized clinical trial. An Bras Dermatol 97(2):157–165
pubmed: 35039206 pmcid: 9073224 doi: 10.1016/j.abd.2021.06.005
Luze H et al (2020) DNA repair enzymes in sunscreens and their impact on photoageing-A systematic review. Photodermatol Photoimmunol Photomed 36(6):424–432
pubmed: 32772409 pmcid: 7693079 doi: 10.1111/phpp.12597
Berman B, Grada A, Berman DK (2022) Profile of tirbanibulin for the treatment of actinic keratosis. J Clin Aesthet Dermatol 15(10 Suppl 1):S3–S10
pubmed: 36408375 pmcid: 9586524
Blauvelt A et al (2021) Phase 3 trials of tirbanibulin ointment for actinic keratosis. N Engl J Med 384(6):512–520
pubmed: 33567191 doi: 10.1056/NEJMoa2024040
Kishi P, Price CJ (2018) Life-threatening reaction with topical 5-fluorouracil. Drug Saf Case Rep 5(1):4
pubmed: 29330682 pmcid: 5766445 doi: 10.1007/s40800-017-0068-6
Johnson MR et al (1999) Life-threatening toxicity in a dihydropyrimidine dehydrogenase-deficient patient after treatment with topical 5-fluorouracil. Clin Cancer Res 5(8):2006–2011
pubmed: 10473079
Papanastasopoulos P, Stebbing J (2014) Molecular basis of 5-fluorouracil-related toxicity: lessons from clinical practice. Anticancer Res 34(4):1531–1535
pubmed: 24692679
Suh SA-O et al (2020) The banned sunscreen ingredients and their impact on human health: a systematic review. Int J Dermatol 59:1365–4632
doi: 10.1111/ijd.14824
Ortonne JP et al (2010) Effectiveness of cross polarized light and fluorescence diagnosis for detection of sub-clinical and clinical actinic keratosis during imiquimod treatment. Exp Dermatol 19(7):641–647
pubmed: 20201959 doi: 10.1111/j.1600-0625.2009.01047.x
Baker C et al (2022) Method of Assessing Skin Cancerization and Keratoses(TM) (MASCK): development and photographic validation in multiple anatomical sites of a novel assessment tool intended for clinical evaluation of patients with extensive skin field cancerization. Clin Exp Dermatol 47(6):1144–1153
pubmed: 35150158 pmcid: 9313559 doi: 10.1111/ced.15136

Auteurs

Paras Patel (P)

Dermatology Service, Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus, Brooklyn, NY, USA.
Rowan University School of Osteopathic Medicine, Stratford, NJ, USA.

Jennifer Wang (J)

Dermatology Service, Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus, Brooklyn, NY, USA.
Department of Dermatology, State University of New York, Downstate Health Sciences University, 450 Clarkson Avenue, 8 Floor, Brooklyn, NY, 11203, USA.

David Bitterman (D)

Dermatology Service, Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus, Brooklyn, NY, USA.
New York Medical College, Valhalla, NY, USA.

Jessica Mineroff (J)

Dermatology Service, Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus, Brooklyn, NY, USA.
Department of Dermatology, State University of New York, Downstate Health Sciences University, 450 Clarkson Avenue, 8 Floor, Brooklyn, NY, 11203, USA.

Evan Austin (E)

Dermatology Service, Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus, Brooklyn, NY, USA.
Department of Dermatology, State University of New York, Downstate Health Sciences University, 450 Clarkson Avenue, 8 Floor, Brooklyn, NY, 11203, USA.

Jared Jagdeo (J)

Dermatology Service, Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus, Brooklyn, NY, USA. jrjagdeo@gmail.com.
Department of Dermatology, State University of New York, Downstate Health Sciences University, 450 Clarkson Avenue, 8 Floor, Brooklyn, NY, 11203, USA. jrjagdeo@gmail.com.

Classifications MeSH