"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".

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
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引用次数: 0

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.

《结节性基底细胞癌光动力治疗的10年随访:随机比较氨基乙酰丙酸- pdt、甲基氨基乙酰丙酸- pdt和手术的有效性》。
背景:局部光动力疗法(PDT)是一种研究充分且有效的治疗基底细胞癌(BCC)和癌前病变的方法。开发一种更便宜的治疗方法涉及在当地生产氨基乙酰丙酸(ALA)和氨基乙酰丙酸甲酯(MAL)。此外,还需要前瞻性研究来验证其临床疗效和优势。目的:这项随机对照试验评估了使用巴西生产的光敏剂进行MAL-PDT和ALA-PDT治疗BCC的疗效,并将其与手术治疗作为第三组进行了比较,均进行了长期随访。方法:567例小结节性bcc患者随机接受ALA-PDT、MALPDT或手术治疗。两个PDT组在治疗后30天进行活检以评估治愈率,并进行了10年的临床随访。结果:治疗后30天的活检显示,ALA-PDT(171/189例)的完全缓解率为90.4%,MAL-PDT(161/187例)的完全缓解率为86.1%,而手术显示97.2%(177/182)的游离边缘。随访5年和10年,手术组无复发生存率分别为93.7%和92.8%,ALA-PDT组为78.6%和74.5%,MAL-PDT组为73.1%和69%。结论:手术仍是治疗结节性基底细胞癌的金标准;然而,如果选择非手术治疗,ALA-PDT和MAL-PDT的疗效和无复发生存率相似。虽然手术已经取得了最佳效果,但正如本文所讨论的,PDT仍有很大的改进空间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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