“A 10-years follow-up of Photodynamic Therapy for nodular basal cell carcinoma: a randomized comparing the effectiveness of Aminolevulinic acid-PDT, Methyl aminolevulinate-PDT, and surgery”

“A 10-years follow-up of Photodynamic Therapy for nodular basal cell carcinoma: a randomized comparing the effectiveness of Aminolevulinic acid-PDT, Methyl aminolevulinate-PDT, and surgery”

Background: Topical Photodynamic Therapy (PDT) is a well-studied and effective treatment for basal cell carcinoma (BCC) and pre-malignant lesions. Developing a cheaper approach to this treatment involves local production of aminolevulinic acid (ALA) and methyl aminolevulinate (MAL). Furthermore, a p...

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Main Authors: Ana Gabriela Salvio, Michelle Barreto Requena, Mirian Denise Stringasci, Ana Paula Silva, Hilde Barb Buzza, Donaldo Botelho Veneziano, Elisangela Ramos Oliveira, Maira Monique Medero, Natalia Mayumi Inada, Cristina Kurachi, Lilian Tan Moriyama, Marcelo Saito Nogueira, Dora Patricia Ramirez Angarita, Dirceu Volet-Filho, Vanderlei Salvador Bagnato
Format: Article
Language:English
Published: Elsevier 2025-08-01
Series:Photodiagnosis and Photodynamic Therapy
Subjects:
Photodynamic therapy
Clinical trial
Surgery
Aminolevulinic acid
Methyl aminolevulinate
Basal cell carcinoma
Online Access:http://www.sciencedirect.com/science/article/pii/S1572100025002340
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Summary:Background: Topical Photodynamic Therapy (PDT) is a well-studied and effective treatment for basal cell carcinoma (BCC) and pre-malignant lesions. Developing a cheaper approach to this treatment involves local production of aminolevulinic acid (ALA) and methyl aminolevulinate (MAL). Furthermore, a prospective study to verify its clinical effectiveness and advantages was required. Objective: This randomized, controlled trial evaluated the efficacy of MAL-PDT and ALA-PDT treatments for BCC using photosensitizers produced in Brazil, and compared with surgical treatment as a third arm, all with long-term follow-up. Methods: 567 patients with small nodular BCCs were randomized for ALA-PDT, MALPDT, or surgical treatment. Both PDT groups had a 30-day post-treatment biopsy for cure rate assessment, and a clinical 10 years-follow-up was performed. Results: The 30-day post-treatment biopsy showed a complete response of 90.4 % for ALA-PDT (171/189 patients) and 86.1 % for MAL-PDT (161/187), while surgery showed free margins in 97.2 % (177/182). Considering 5 and 10 years of follow-up, 93.7 % and 92.8 % of recurrence-free survival rate for surgery, respectively, while 78.6 % and 74.5 % for ALA-PDT, and 73.1 % and 69 % for MAL-PDT were observed. Conclusion: Surgery remains the gold standard treatment for nodular BCC; however, if non-surgical treatment is chosen, both ALA-PDT and MAL-PDT achieve similar effectiveness and recurrence-free survival rates. While surgery has already yielded optimal results, PDT still has room for great improvement as discussed here.
ISSN:1572-1000

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