"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"

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Salvio, Ana Gabriela ; Requena, Michelle Barreto ; Stringasci, Mirian Denise ; Silva, Ana Paula ; Buzza, Hilde Barb ; Veneziano, Donaldo Botelho ; Oliveira, Elisangela Ramos ; Medero, Maira Monique ; Inada, Natalia Mayumi ; Kurachi, Cristina ; Moriyama, Lilian Tan ; Nogueira, Marcelo Saito ; Angarita, Dora Patricia Ramirez ; Filho, Jose Dirceu Vollet ; Bagnato, Vanderlei Salvador

• Document type: Journal article
• Source: Photodiagnosis and Photodynamic Therapy; v. 54, p. 6-pg., 2025-07-28.

Abstract

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 longterm 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. (AU)

• FAPESP's process: 13/07276-1 - CEPOF - Optics and Photonic Research Center
• Grantee: Vanderlei Salvador Bagnato
• Support Opportunities: Research Grants - Research, Innovation and Dissemination Centers - RIDC
• FAPESP's process: 14/50857-8 - National Institute in Basic Optics and Applied to Life Sciences
• Grantee: Vanderlei Salvador Bagnato
• Support Opportunities: Research Projects - Thematic Grants