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

Dermatology. 2022;238(6):1044-1049. doi: 10.1159/000524745. Epub 2022 May 20.

Authors

Lieke C J van Delft^{1

2}, Patty J Nelemans³, Janneke P H M Kessels⁴, Hilke Kreukels⁵, Marieke H Roozeboom⁶, Michette J M de Rooij⁷, Klara Mosterd^{1

2}, Ellen R M de Haas^{8

9}, Nicole W J Kelleners-Smeets^{1

2}

Affiliations

¹ Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands.
² GROW School for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.
³ Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.
⁴ Department of Dermatology, Zuyderland Hospital, Heerlen, The Netherlands.
⁵ Dermatology Clinic, De Blaak, Rotterdam, The Netherlands.
⁶ Department of Dermatology, Elkerliek Hospital, Helmond, The Netherlands.
⁷ Department of Dermatology, Viecuri Medical Center, Venlo, The Netherlands.
⁸ Department of Dermatology, Erasmus Medical Center, Rotterdam, The Netherlands.
⁹ Department of Dermatology, Havenziekenhuis, Rotterdam, The Netherlands.

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; Light fractionation; Long-term analysis; Photodynamic therapy; Superficial basal-cell carcinoma; Tumor-free survival.

Publication types

Randomized Controlled Trial
Multicenter Study

MeSH terms

Aminolevulinic Acid / therapeutic use
Carcinoma, Basal Cell* / drug therapy
Carcinoma, Basal Cell* / pathology
Humans
Photochemotherapy* / methods
Photosensitizing Agents / therapeutic use
Single-Blind Method
Skin Neoplasms* / pathology
Treatment Outcome

Substances

methyl 5-aminolevulinate
Aminolevulinic Acid
Photosensitizing Agents

Grants and funding

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.