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

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

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
Early online date	20 May 2022
DOIs	https://doi.org/10.1159/000524745
Publication status	Published - Nov 2022

Keywords

Cosmetic result
HAIRLESS MOUSE SKIN
IMIQUIMOD
LIGHT FRACTIONATION
Light fractionation
Long-term analysis
Photodynamic therapy
Superficial basal-cell carcinoma
Tumor-free survival

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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{c20d98a95c514412bddab349f68ea792,

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.",

keywords = "Cosmetic result, HAIRLESS MOUSE SKIN, IMIQUIMOD, LIGHT FRACTIONATION, Light fractionation, Long-term analysis, Photodynamic therapy, Superficial basal-cell carcinoma, Tumor-free survival",

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 = "{\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 = "S. Karger AG",

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

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.

KW - Cosmetic result

KW - HAIRLESS MOUSE SKIN

KW - IMIQUIMOD

KW - LIGHT FRACTIONATION

KW - Light fractionation

KW - Long-term analysis

KW - Photodynamic therapy

KW - Superficial basal-cell carcinoma

KW - Tumor-free survival

U2 - 10.1159/000524745

DO - 10.1159/000524745

M3 - Article

C2 - 35598594

SN - 1018-8665

VL - 238

SP - 1044

EP - 1049

JO - Dermatology

JF - Dermatology

IS - 6

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

Abstract

Keywords

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