"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"

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 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.

Keywords: Aminolevulinic acid; Basal cell carcinoma; Clinical trial; Methyl aminolevulinate; Photodynamic therapy; Surgery.