Daylight photodynamic therapy for prevention of new actinic keratosis and keratinocyte carcinomas in organ transplants. A cryotherapy-controlled randomized clinical trial.


Journal

Journal of the European Academy of Dermatology and Venereology : JEADV
ISSN: 1468-3083
Titre abrégé: J Eur Acad Dermatol Venereol
Pays: England
ID NLM: 9216037

Informations de publication

Date de publication:
Jul 2020
Historique:
received: 14 05 2019
accepted: 18 11 2019
pubmed: 1 12 2019
medline: 15 5 2021
entrez: 1 12 2019
Statut: ppublish

Résumé

Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR. To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR. A randomized, intra-subject controlled, evaluator-blind, split-face and/or scalp trial, from April 2016 to October 2018. Participants were OTR older than 18 years, 1-year posttransplant, with at least 5 AK on each hemi-face/hemi-scalp. One side received six field treatments with DPDT: two sessions 15 days apart at baseline, two at 3 months and two at 9 months after baseline. Control side received lesion-directed treatment with cryotherapy (double freeze-thaw) at baseline, 3 and 9 months. Total number of lesions (AK and KC) at 21 months, number of new AK and KC at 3, 9, 15 and 21 months and treatment preferences were analysed. Of 24 men included, 23 were analysed at 3 months; and 21, at 9, 15 and 21 months. Mean (SD) age was 69.8 years (9.2). The total number of lesions at 21 months was 4.7 (4.3) for DPDT and 5.8 (5.0) for control side; P = 0.09. DPDT showed significantly lower means [SD] of new lesions compared to control side at 3 months (4.2 [3.4] vs. 6.8 [4.8]; P < 0.001), 9 months (3.0 [3.3] vs. 4.3 [3.4]; P = 0.04) and 15 months (3.0 [4.6] vs. 4.8 [5.0]; P = 0.02), and non-significant at 21 months (3.7 [3.5] vs. 5.0 [4.5]; P = 0.06). Most participants preferred DPDT. DPDT showed potential effectiveness in preventing new AK and KC in OTR by consecutive treatments of field cancerization. The preference for DPDT could facilitate adherence to the long-term treatment necessary in these patients.

Sections du résumé

BACKGROUND BACKGROUND
Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR.
OBJECTIVES OBJECTIVE
To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR.
METHODS METHODS
A randomized, intra-subject controlled, evaluator-blind, split-face and/or scalp trial, from April 2016 to October 2018. Participants were OTR older than 18 years, 1-year posttransplant, with at least 5 AK on each hemi-face/hemi-scalp. One side received six field treatments with DPDT: two sessions 15 days apart at baseline, two at 3 months and two at 9 months after baseline. Control side received lesion-directed treatment with cryotherapy (double freeze-thaw) at baseline, 3 and 9 months. Total number of lesions (AK and KC) at 21 months, number of new AK and KC at 3, 9, 15 and 21 months and treatment preferences were analysed.
RESULTS RESULTS
Of 24 men included, 23 were analysed at 3 months; and 21, at 9, 15 and 21 months. Mean (SD) age was 69.8 years (9.2). The total number of lesions at 21 months was 4.7 (4.3) for DPDT and 5.8 (5.0) for control side; P = 0.09. DPDT showed significantly lower means [SD] of new lesions compared to control side at 3 months (4.2 [3.4] vs. 6.8 [4.8]; P < 0.001), 9 months (3.0 [3.3] vs. 4.3 [3.4]; P = 0.04) and 15 months (3.0 [4.6] vs. 4.8 [5.0]; P = 0.02), and non-significant at 21 months (3.7 [3.5] vs. 5.0 [4.5]; P = 0.06). Most participants preferred DPDT.
CONCLUSION CONCLUSIONS
DPDT showed potential effectiveness in preventing new AK and KC in OTR by consecutive treatments of field cancerization. The preference for DPDT could facilitate adherence to the long-term treatment necessary in these patients.

Identifiants

pubmed: 31785169
doi: 10.1111/jdv.16125
doi:

Substances chimiques

Photosensitizing Agents 0
Aminolevulinic Acid 88755TAZ87

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1464-1470

Subventions

Organisme : Galderma Laboratories

Informations de copyright

© 2019 European Academy of Dermatology and Venereology.

Références

Bottomley MJ, Thomson J, Harwood C, Leigh I. The role of the immune system in cutaneous squamous cell carcinoma. Int J Mol Sci 2019; 20.
Webb MC, Compton F, Andrews PA, Koffman CG. Skin tumours posttransplantation: a retrospective analysis of 28 years’ experience at a single centre. Transplant Proc 1997; 29: 828-830.
Euvrard S, Kanitakis J, Claudy A. Skin cancers after organ transplantation. N Engl J Med 2003; 348: 1681-1691.
Bouwes Bavinck JN, Hardie DR, Green A et al. The risk of skin cancer in renal transplant recipients in Queensland, Australia. A follow-up study. Transplantation 1996; 61: 715-721.
de Graaf YGL, Rebel H, Elghalbzouri A et al. More epidermal p53 patches adjacent to skin carcinomas in renal transplant recipients than in immunocompetent patients: the role of azathioprine. Exp Dermatol 2008; 17: 349-355.
Sharfaei S, Juzenas P, Moan J, Bissonnette R. Weekly topical application of methyl aminolevulinate followed by light exposure delays the appearance of UV-induced skin tumours in mice. Arch Dermatol Res 2002; 294: 237-242.
Stender IM, Bech-Thomsen N, Poulsen T, Wulf HC. Photodynamic therapy with topical delta-aminolevulinic acid delays UV photocarcinogenesis in hairless mice. Photochem Photobiol 1997; 66: 493-496.
Togsverd-Bo K, Lerche CM, Poulsen T, Wulf HC, Haedersdal M. Photodynamic therapy with topical methyl- and hexylaminolevulinate for prophylaxis and treatment of UV-induced SCC in hairless mice. Exp Dermatol 2010; 19: e166-e172.
Apalla Z, Sotiriou E, Chovarda E, Lefaki I, Devliotou-Panagiotidou D, Ioannides D. Skin cancer: preventive photodynamic therapy in patients with face and scalp cancerization. A randomized placebo-controlled study. Br J Dermatol 2010; 162: 171-175.
Wulf HC, Pavel S, Stender I, Bakker-Wensveen CA. Topical photodynamic therapy for prevention of new skin lesions in renal transplant recipients. Acta Derm Venereol 2006; 86: 25-28.
de Graaf YGL, Kennedy C, Wolterbeek R, Collen AFS, Willemze R, Bouwes Bavinck JN. Photodynamic therapy does not prevent cutaneous squamous-cell carcinoma in organ-transplant recipients: results of a randomized-controlled trial. J Invest Dermatol 2006; 126: 569-574.
Wennberg A-M, Stenquist B, Stockfleth E et al. Photodynamic therapy with methyl aminolevulinate for prevention of new skin lesions in transplant recipients: a randomized study. Transplantation 2008; 86: 423-429.
Togsverd-Bo K, Omland SH, Wulf HC, Sørensen SS, Haedersdal M. Primary prevention of skin dysplasia in renal transplant recipients with photodynamic therapy: a randomized controlled trial. Am J Transplant 2015; 15: 2986-2990.
Togsverd-Bo K, Halldin C, Sandberg C et al. Photodynamic therapy is more effective than imiquimod for actinic keratosis in organ transplant recipients: a randomized intraindividual controlled trial. Br J Dermatol 2018; 178: 903-909.
Rubel DM, Spelman L, Murrell DF et al. Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial. Br J Dermatol 2014; 171: 1164-1171.
Wiegell SR, Haedersdal M, Philipsen PA, Eriksen P, Enk CD, Wulf HC. Continuous activation of PpIX by daylight is as effective as and less painful than conventional photodynamic therapy for actinic keratoses; a randomized, controlled, single-blinded study. Br J Dermatol 2008; 158: 740-746.
Gilaberte Y, Aguilar M, Almagro M et al. Spanish-Portuguese consensus statement on use of daylight-mediated photodynamic therapy with methyl aminolevulinate in the treatment of actinic keratosis. Actas Dermosifiliogr 2015; 106: 623-631.
Piaserico S, Belloni Fortina A, Rigotti P et al. Topical photodynamic therapy of actinic keratosis in renal transplant recipients. Transplant Proc 2007; 39: 1847-1850.
Dragieva G, Prinz BM, Hafner J et al. A randomized controlled clinical trial of topical photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratoses in transplant recipients. Br J Dermatol 2004; 151: 196-200.
Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol 1997; 133: 1433-1440.
Jones-Caballero M, Peñas PF, García-Díez A, Badía X, Chren MM. The Spanish version of Skindex-29. Int J Dermatol 2000; 39: 907-912.
Basset-Seguin N, Baumann Conzett K, Gerritsen MJP et al. Photodynamic therapy for actinic keratosis in organ transplant patients. J Eur Acad Dermatol Venereol 2013; 27: 57-66.
Willey A, Mehta S, Lee PK. Reduction in the incidence of squamous cell carcinoma in solid organ transplant recipients treated with cyclic photodynamic therapy. Dermatol Surg 2010; 36: 652-658.
Togsverd-Bo K, Lei U, Erlendsson AM et al. Combination of ablative fractional laser and daylight-mediated photodynamic therapy for actinic keratosis in organ transplant recipients - a randomized controlled trial. Br J Dermatol 2015; 172: 467-474.
Dragieva G, Hafner J, Dummer R et al. Topical photodynamic therapy in the treatment of actinic keratoses and Bowen's disease in transplant recipients. Transplantation 2004; 77: 115-121.
Schleier P, Hyckel P, Berndt A et al. Photodynamic therapy of virus-associated epithelial tumours of the face in organ transplant recipients. J Cancer Res Clin Oncol 2004; 130: 279-284.
Perrett CM, McGregor JM, Warwick J et al. Treatment of post-transplant premalignant skin disease: a randomized intrapatient comparative study of 5-fluorouracil cream and topical photodynamic therapy. Br J Dermatol 2007; 156: 320-328.
Hasson A, Navarrete-Dechent C, Nicklas C, de la Cruz C. Topical photodynamic therapy with methylaminolevulinate for the treatment of actinic keratosis and reduction of photodamage in organ transplant recipients: a case-series of 16 patients. Indian J Dermatol Venereol Leprol 2012; 78: 448-453.
Helsing P, Togsverd-Bo K, Veierød MB, Mørk G, Haedersdal M. Intensified fractional CO2 laser-assisted photodynamic therapy vs. laser alone for organ transplant recipients with multiple actinic keratoses and wart-like lesions: a randomized half-side comparative trial on dorsal hands. Br J Dermatol 2013; 169: 1087-1092.
Jambusaria-Pahlajani A, Ortman S, Schmults CD, Liang C. Sequential curettage, 5-fluorouracil, and photodynamic therapy for field cancerization of the scalp and face in solid organ transplant recipients. Dermatol Surg 2016; 42(Suppl 1): S66-S72.
Morton C, Campbell S, Gupta G et al. Intraindividual, right-left comparison of topical methyl aminolaevulinate-photodynamic therapy and cryotherapy in subjects with actinic keratoses: a multicentre, randomized controlled study. Br J Dermatol 2006; 155: 1029-1036.
Szeimies RM, Karrer S, Radakovic-Fijan S et al. Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: A prospective, randomized study. J Am Acad Dermatol 2002; 47: 258-262.
Wiegell SR, Haedersdal M, Eriksen P, Wulf HC. Photodynamic therapy of actinic keratoses with 8% and 16% methyl aminolaevulinate and home-based daylight exposure: a double-blinded randomized clinical trial. Br J Dermatol 2009; 160: 1308-1314.
Wiegell SR, Wulf HC, Szeimies R-M et al. Daylight photodynamic therapy for actinic keratosis: an international consensus. J Eur Acad Dermatol Venereol 2012; 26: 673-679.
Wiegell SR, Fabricius S, Stender IM et al. A randomized, multicentre study of directed daylight exposure times of 1½ vs. 2½ h in daylight-mediated photodynamic therapy with methyl aminolaevulinate in patients with multiple thin actinic keratoses of the face and scalp. Br J Dermatol 2011; 164: 1083-1090.
Lacour J-P, Ulrich C, Gilaberte Y et al. Daylight photodynamic therapy with methyl aminolevulinate cream is effective and nearly painless in treating actinic keratoses: a randomised, investigator-blinded, controlled, phase III study throughout Europe. J Eur Acad Dermatol Venereol 2015; 29: 2342-2348.

Auteurs

I Bernad (I)

Department of Dermatology, Clínica Universidad de Navarra, Pamplona, Spain.

L Aguado (L)

Department of Dermatology, Clínica Universidad de Navarra, Pamplona, Spain.

J M Núñez-Córdoba (JM)

Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.

P Redondo (P)

Department of Dermatology, Clínica Universidad de Navarra, Pamplona, Spain.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH