Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma

Lieke C.J. Van Delft; Patty J. Nelemans; Janneke P.H.M. Kessels; Hilke Kreukels; Marieke H. Roozeboom; Michette J.M. De Rooij; Klara Mosterd; Ellen R.M. De Haas; Nicole W.J. Kelleners-Smeets

doi:10.1159/000524745

Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma

Lieke C.J. Van Delft^*, Patty J. Nelemans, Janneke P.H.M. Kessels, Hilke Kreukels, Marieke H. Roozeboom, Michette J.M. De Rooij, Klara Mosterd, Ellen R.M. De Haas, Nicole W.J. Kelleners-Smeets

^*Corresponding author for this work

Child and Adolescent Psychiatry / Psychology

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Background: Photodynamic therapy (PDT) is a noninvasive treatment for patients with superficial basal-cell carcinoma (sBCC). The efficacy of PDT may vary with different photosensitizers and treatment schedules. Objective: Our objective was to evaluate whether fractionated 5-aminolevulinic acid 20% (ALA)-PDT is superior to conventional two-stage methyl aminolevulinate (MAL)-PDT for sBCC. Methods: We present the 5 years results of a single-blind, randomized, multicenter trial. 162 patients with a histologically confirmed primary sBCC were randomized to fractionated ALA-PDT or MAL-PDT. Results: The 5-year tumor-free survival rate was 70.7% (95% CI 58.2-80.1%) for ALA-PDT and 76.5% (95% CI 64.4-85.0%) for MAL-PDT. In the first 3 years, there was no significant difference in risk of treatment failure (HR = 1.53, p = 0.283), but in the long-term, the risk of recurrence was significantly lower following MAL-PDT compared to ALA-PDT (HR = 0.125, p = 0.049). As judged by patients, the esthetic result was good-excellent in 96.8% (61/63) and 94.4% (56/59) of patients treated with ALA-PDT and MAL-PDT, respectively (p = 0.631). Conclusion: The long-term efficacy is significantly higher for conventional two-stage MAL-PDT than for fractionated ALA-PDT, whereas there was no significant difference in esthetic outcome between the treatments at 5 years after treatment. These results indicate that fractionated ALA-PDT offers no benefit over conventional two-stage MAL-PDT.

Original language	English
Pages (from-to)	1044-1049
Number of pages	6
Journal	Dermatology
Volume	238
Issue number	6
DOIs	https://doi.org/10.1159/000524745
Publication status	Published - Nov 2022

Bibliographical note

Funding Information:
This study was funded by a grant from the Health Foundation Limburg, the Netherlands. The funding source was not involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.

Publisher Copyright:
© 2022 The Author(s). Published by S. Karger AG, Basel.

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Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell CarcinomaFinal published version, 260 KBLicence: CC BY-NC

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Van Delft, L. C. J., Nelemans, P. J., Kessels, J. P. H. M., Kreukels, H., Roozeboom, M. H., De Rooij, M. J. M., Mosterd, K., De Haas, E. R. M., & Kelleners-Smeets, N. W. J. (2022). Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma. Dermatology, 238(6), 1044-1049. https://doi.org/10.1159/000524745

@article{9053fad19a0246bb9f842d3b7b260688,

title = "Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma",

abstract = "Background: Photodynamic therapy (PDT) is a noninvasive treatment for patients with superficial basal-cell carcinoma (sBCC). The efficacy of PDT may vary with different photosensitizers and treatment schedules. Objective: Our objective was to evaluate whether fractionated 5-aminolevulinic acid 20% (ALA)-PDT is superior to conventional two-stage methyl aminolevulinate (MAL)-PDT for sBCC. Methods: We present the 5 years results of a single-blind, randomized, multicenter trial. 162 patients with a histologically confirmed primary sBCC were randomized to fractionated ALA-PDT or MAL-PDT. Results: The 5-year tumor-free survival rate was 70.7% (95% CI 58.2-80.1%) for ALA-PDT and 76.5% (95% CI 64.4-85.0%) for MAL-PDT. In the first 3 years, there was no significant difference in risk of treatment failure (HR = 1.53, p = 0.283), but in the long-term, the risk of recurrence was significantly lower following MAL-PDT compared to ALA-PDT (HR = 0.125, p = 0.049). As judged by patients, the esthetic result was good-excellent in 96.8% (61/63) and 94.4% (56/59) of patients treated with ALA-PDT and MAL-PDT, respectively (p = 0.631). Conclusion: The long-term efficacy is significantly higher for conventional two-stage MAL-PDT than for fractionated ALA-PDT, whereas there was no significant difference in esthetic outcome between the treatments at 5 years after treatment. These results indicate that fractionated ALA-PDT offers no benefit over conventional two-stage MAL-PDT.",

author = "{Van Delft}, {Lieke C.J.} and Nelemans, {Patty J.} and Kessels, {Janneke P.H.M.} and Hilke Kreukels and Roozeboom, {Marieke H.} and {De Rooij}, {Michette J.M.} and Klara Mosterd and {De Haas}, {Ellen R.M.} and Kelleners-Smeets, {Nicole W.J.}",

note = "Funding Information: This study was funded by a grant from the Health Foundation Limburg, the Netherlands. The funding source was not involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. Publisher Copyright: {\textcopyright} 2022 The Author(s). Published by S. Karger AG, Basel.",

year = "2022",

month = nov,

doi = "10.1159/000524745",

language = "English",

volume = "238",

pages = "1044--1049",

journal = "Dermatology",

issn = "1018-8665",

publisher = "Karger",

number = "6",

}

Van Delft, LCJ, Nelemans, PJ, Kessels, JPHM, Kreukels, H, Roozeboom, MH, De Rooij, MJM, Mosterd, K, De Haas, ERM & Kelleners-Smeets, NWJ 2022, 'Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma', Dermatology, vol. 238, no. 6, pp. 1044-1049. https://doi.org/10.1159/000524745

Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma. / Van Delft, Lieke C.J.; Nelemans, Patty J.; Kessels, Janneke P.H.M. et al.
In: Dermatology, Vol. 238, No. 6, 11.2022, p. 1044-1049.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma

AU - Van Delft, Lieke C.J.

AU - Nelemans, Patty J.

AU - Kessels, Janneke P.H.M.

AU - Kreukels, Hilke

AU - Roozeboom, Marieke H.

AU - De Rooij, Michette J.M.

AU - Mosterd, Klara

AU - De Haas, Ellen R.M.

AU - Kelleners-Smeets, Nicole W.J.

N1 - Funding Information: This study was funded by a grant from the Health Foundation Limburg, the Netherlands. The funding source was not involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. Publisher Copyright: © 2022 The Author(s). Published by S. Karger AG, Basel.

PY - 2022/11

Y1 - 2022/11

N2 - Background: Photodynamic therapy (PDT) is a noninvasive treatment for patients with superficial basal-cell carcinoma (sBCC). The efficacy of PDT may vary with different photosensitizers and treatment schedules. Objective: Our objective was to evaluate whether fractionated 5-aminolevulinic acid 20% (ALA)-PDT is superior to conventional two-stage methyl aminolevulinate (MAL)-PDT for sBCC. Methods: We present the 5 years results of a single-blind, randomized, multicenter trial. 162 patients with a histologically confirmed primary sBCC were randomized to fractionated ALA-PDT or MAL-PDT. Results: The 5-year tumor-free survival rate was 70.7% (95% CI 58.2-80.1%) for ALA-PDT and 76.5% (95% CI 64.4-85.0%) for MAL-PDT. In the first 3 years, there was no significant difference in risk of treatment failure (HR = 1.53, p = 0.283), but in the long-term, the risk of recurrence was significantly lower following MAL-PDT compared to ALA-PDT (HR = 0.125, p = 0.049). As judged by patients, the esthetic result was good-excellent in 96.8% (61/63) and 94.4% (56/59) of patients treated with ALA-PDT and MAL-PDT, respectively (p = 0.631). Conclusion: The long-term efficacy is significantly higher for conventional two-stage MAL-PDT than for fractionated ALA-PDT, whereas there was no significant difference in esthetic outcome between the treatments at 5 years after treatment. These results indicate that fractionated ALA-PDT offers no benefit over conventional two-stage MAL-PDT.

AB - Background: Photodynamic therapy (PDT) is a noninvasive treatment for patients with superficial basal-cell carcinoma (sBCC). The efficacy of PDT may vary with different photosensitizers and treatment schedules. Objective: Our objective was to evaluate whether fractionated 5-aminolevulinic acid 20% (ALA)-PDT is superior to conventional two-stage methyl aminolevulinate (MAL)-PDT for sBCC. Methods: We present the 5 years results of a single-blind, randomized, multicenter trial. 162 patients with a histologically confirmed primary sBCC were randomized to fractionated ALA-PDT or MAL-PDT. Results: The 5-year tumor-free survival rate was 70.7% (95% CI 58.2-80.1%) for ALA-PDT and 76.5% (95% CI 64.4-85.0%) for MAL-PDT. In the first 3 years, there was no significant difference in risk of treatment failure (HR = 1.53, p = 0.283), but in the long-term, the risk of recurrence was significantly lower following MAL-PDT compared to ALA-PDT (HR = 0.125, p = 0.049). As judged by patients, the esthetic result was good-excellent in 96.8% (61/63) and 94.4% (56/59) of patients treated with ALA-PDT and MAL-PDT, respectively (p = 0.631). Conclusion: The long-term efficacy is significantly higher for conventional two-stage MAL-PDT than for fractionated ALA-PDT, whereas there was no significant difference in esthetic outcome between the treatments at 5 years after treatment. These results indicate that fractionated ALA-PDT offers no benefit over conventional two-stage MAL-PDT.

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U2 - 10.1159/000524745

DO - 10.1159/000524745

M3 - Article

C2 - 35598594

AN - SCOPUS:85131304347

SN - 1018-8665

VL - 238

SP - 1044

EP - 1049

JO - Dermatology

JF - Dermatology

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ER -

Long-Term Efficacy of Photodynamic Therapy with Fractionated 5-Aminolevulinic Acid 20% versus Conventional Two-Stage Topical Methyl Aminolevulinate for Superficial Basal-Cell Carcinoma

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