Real-life practice study of the clinical outcome and cost-effectiveness of photodynamic therapy using methyl aminolevulinate (MAL-PDT) in the management of actinic keratosis and basal cell carcinoma
[en] Photodynamic therapy with methyl aminolevulinate (MAL-PDT) is a non-invasive therapy for superficial and nodular basal cell carcinoma (BCC). We performed an open-label trial to evaluate efficacy, safety, tolerability and cosmetic outcome of MAL-PDT in selected patients with superficial and nodular BCCs. Ninety-four superficial and 24 nodular BCCs in 69 patients were treated with 2 to 8 MAL-PDT sessions. Efficacy, safety, tolerability and cosmetic outcome were evaluated at months 1, 3, 6 and 12 after the last MAL-PDT treatment and then every 3 months. One patient discontinued the study for reasons unrelated to study procedures. Complete clinical regression was detected in 84/94 (89.4%) superficial BCCs, and 12/23 (52.2%) nodular BCCs one month after 2 MAL-PDT sessions. No further clinical improvement was observed in either superficial or nodular BCCs with treatment continuation up to a maximum of 8 MAL-PDT sessions. Adverse effects were limited to mild local skin reactions, and cosmetic outcome was rated as excellent or good. Recurrence was observed in 2/84 (2.4%) successfully treated superficial BCCs at 6 and 12 months after treatment discontinuation. Based on the efficacy, tolerability, cosmetic outcome and recurrence rate, our results support the use of MAL-PDT for treatment of superficial BCC and for selected cases of nodular BCC.
Disciplines :
Dermatology
Author, co-author :
Annemans, Lieven; Universitair Ziekenhuis Gent - UZ
Caekelbergh, Karin; IMS Health, Brussels
Roelandts, Rik; Universitair Ziekenhuis Leuven
Boonen, Hugo; H. Hart, Mol
Leys, Christophe ; Centre Hospitalier Universitaire de Liège - CHU > Dermatologie
Nikkels, Arjen ; Centre Hospitalier Universitaire de Liège - CHU > Dermatologie
van Den Haute, V.; Clinique 2 Alice, Uccle
van Quickenborne, L.; A.Z. Sint-Lucas Ghent
Verhaeghe, Evelien; Universitair Ziekenhuis Gent - UZ
Real-life practice study of the clinical outcome and cost-effectiveness of photodynamic therapy using methyl aminolevulinate (MAL-PDT) in the management of actinic keratosis and basal cell carcinoma
Frost CA, Green AC, Epidemiology of solar keratoses. Br J Dermatol 1994; 131(4): A55-64.
Lebwohl M. Actinic keratosis: epidemiology and progression to squamous cell carcinoma. Br J Dermatol 2003; 149(Suppl.66): 31-3.
Halpern AC, Kopp LJ. Awareness, knowledge and attitudes to non-melanoma skin cancer and actinic keratosis among general public. lnt J Dermatol 2005; 44: 107-11.
Bernard P, Derancourt C, Arnoult-Coucloux E, Picot R. Etude prospective de l'incidence des cancers cutanés dépistés en pratique dermatologique dans la région de Champagne-Ardenne. Ann Dermatol Venereol 2001; 128: 883-7.
Gold MH, Nestor MS. Current treatments of actinic keratosis. J Drugs Dermatol 2006; 5(2 Suppl): 17-25.
Nikkels AF, Pierard-Franchimont C, Nikkels-Tassoudji N, et al. Photodynamic therapy and imiquimod immunotherapy for basal cell carcinomas. Acta Clin Belg 2005; 60(5): 227-34.
Braathen LR, Szeimies RM, Basset-Sequin N, Bissonnette R, Foley P, Pariser D, Roelandts R, Wennberg AM, Morton CA, International Society for Photodynamic Therapy in Dermatology. Guidelines on the use of photodynamic therapy for nonmelanoma skin cancer: an international consensus. International Society for Photodynamic Therapy in Dermatology, 2005. J Am Acad Dermatol 2007; 56(1): 125-43.
Stockfleth E, Kerl H, Guideline Subcommittee of the European Dermatology Forum. Guidelines for the management of actinic keratoses. Eur J Dermatol 2006; 16(6): 599-606.
Babilas P, Landthaler M, Szeimies RM. Photodynamic therapy in dermatology. Eur J Dermatol 2006; 16(4): 340-8.
Bath-Hextall F, Perkins W, Bong J, Williams H. Interventions for basal cell carcinoma of the skin. Cochrane Database Syst Rev 2007(l); (CD003412).
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(2): 258-62.
Freeman M, Vinciullo C, Francis D, et al. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomised study. J Dermatolog Treat 2003; 14: 99-106.
Morton C, Campbell S, Gupta G, et al. AKtion Investigators. Intraindividual, right-left comparison of topical methyl aminolaevulinate-photodynamic therapy and cryotherapy in subjects with actinic keratoses: a multicentre, randomized controlied study. Br J Dermatol 2006; 155(5): 1029-36.
Foley P, Pariser D, Tarstedt M, et al. Patient satisfaction after treatment with MAL-PDT of basal Cell carcinoma and actinic keratoses with MAL-PDT compared to previous other therapies. J Eur Acad Dermatol Venereal 2005; 19(Suppl 2): 240.
Surrenti T, De Angelis L, Di Cesare A, Fargnoli MC, Peris K. Efficacy of photodynamic therapy with methyl aminolevulinate in the treatment of superficial and nodular basal cell carcinoma: an open-label trial. Eur J Dermatol 2007; 17(5): 412-5.
Basset-Seguin N, lbbatson S, Emtestam L, et al. Photodynamic therapy using methyl aminolevulinate is as efficacious as cryotherapy in superficial BCC, with better cosmetic results: results of a European randomized and multicenter study. Eur J Dermatol 2008; 18(5): 547-53.
Rhodes LE, de Rie M, Enstrom Y, et al. Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial. Arch Dermatol 2004; 140(1): 17-23.
Caekelbergh K, Annemans L, Lambert J, et al. Economic evaluation of methyl amniolaevulinate-based photodynamic therapy in the management of actinic keratosis and basal cell carcinoma. Br J Dermatol 2006; 155: 784-90.
Higashi MK, Veenstra DL, Langley PC. Health Economics Evaluation of non-melenoma skin cancer and actinic keratosis. Pharmacoeconomics 2004; 22(2): 83-94.
Warino L, Tusa M, Camacho F, et al. Frequency and cost of actinic keratosis treatment. Dermatol Surg 2006; 32(8): 1045-9.
Weston A, Fitzgerald P. Discrete choice experiment to derive willingness to pay for methyl aminolevulinate photodynamic therapy versus simple excision surgery in basal cell carcinoma. Pharmacoeconomics 2004; 22(18): 1195-208.
Murphy GM. Skin diseases with high public health impact. Eur J Dermatol 2007; 17(6): 559-62.
Horn M, Wolf P, Wulf HC, et al. Topical methyl aminolaevulinate photodynamic therapy in patients with basal cell carcinoma prone to complications and poor cosmetic outcome with conventional treatment. Br J Dermatol 2003; 149(6): 1242-9.
Spencer JM, Hazan C, Hsuing SH, et al. Therapeutic decision making in the therapy of actinic keratoses. J Drugs Dermatol 2005; 4(3): 296-301.
Tarstedt M, Rosdahl I, Berne B, et al. A randomised multicentre study to compare two treatment regimens of topical metyl aminovulinate (Metvix)-PDT in actinic keratosis of the face and scalp. Acta Derm Venereol 2005; 85 (5): 424-8.