Salmivuori M, Grönroos M, Tani T, Räsänen J, Snellman E, Neittaanmäki N
Department of Dermatology and Allergology, Wellbeing services of Päijät-Häme and Päijät-Häme Central Hospital, Keskussairaalankatu 7 15850 Lahti, Finland; Department of Dermatology, Allergology and Venereology, Helsinki University Hospital and University of Helsinki, Finland.
Department of Dermatology and Allergology, Wellbeing services of Päijät-Häme and Päijät-Häme Central Hospital, Keskussairaalankatu 7 15850 Lahti, Finland; Skin Hospital/Suomen Ihosairaala, Finland.
Photodiagnosis Photodyn Ther. 2025 Feb;51:104432. doi: 10.1016/j.pdpdt.2024.104432. Epub 2024 Dec 5.
Non-surgical treatments are cost-effective options for low-risk basal cell carcinomas (BCCs) i.e. superficial or small nodular BCCs located outside the high-risk locations. Hexyl aminolevulinate (HAL) and 5-aminolevulinic acid nanoemulsion (BF-200 ALA) with enhanced penetration depth enables the use of lower concentrations compared to methylaminolevulinate (MAL) in photodynamic therapy (PDT). We have previously reported comparable short-term efficacies for MAL 16 %, BF-200 ALA 7.8 % and HAL 2 % in PDT of low-risk BCC, and here we report the long-term results.
The goal of this trial was to compare long-term outcomes of HAL and BF-200 ALA, compared to MAL in PDT of low-risk BCCs.
Ninety-eight histologically verified low-risk BCCs on the trunk or extremities were included and randomized into three arms to receive PDT in two sessions with MAL, BF-200 ALA or HAL. A blinded dermatologist assessed the response, cosmetic outcome, and obtained biopsies for histological verification at three months, one year and five years. Histologically verified non-responsive lesions were excised. Patients' satisfaction with the treatment was also queried.
According to intention-to-treat (ITT) analyses, the cumulative response rate at one year was 90.6 % for MAL, 81.3 % for BF-200 ALA, and 75.8 % for HAL, and correspondingly at five years 71.9 %, 54.6 % and 60.6 %. There were no statistically significant differences between interventions and comparator. The overall cumulative response rate for PDT was 82.5 % at one year and 62.2 % at five, and 48.6 % of the treatment failures were recorded at five years. The recurrent lesions were excised as second line treatment. No aggressive subtypes were reported, with only superficial or nodular growth in the final histopathological report. There were no significant differences in cosmetic outcome or patient satisfaction.
This trial shows that HAL has potential for dermatological PDT. However, the long-term efficacy of PDT in the treatment of low-risk BCCs remains rather low.
对于低风险基底细胞癌（BCC），即位于高风险部位以外的浅表或小结节性BCC，非手术治疗是具有成本效益的选择。与甲基氨基乙酰丙酸（MAL）相比，具有更深穿透深度的己基氨基乙酰丙酸（HAL）和5-氨基乙酰丙酸纳米乳剂（BF-200 ALA）能够在光动力疗法（PDT）中使用更低的浓度。我们之前报道了在低风险BCC的PDT中，16%的MAL、7.8%的BF-200 ALA和2%的HAL具有相当的短期疗效，在此我们报告长期结果。
本试验的目的是比较HAL和BF-200 ALA与MAL在低风险BCC的PDT中的长期疗效。
纳入98例经组织学证实的躯干或四肢低风险BCC，随机分为三组，接受两次MAL、BF-200 ALA或HAL的PDT治疗。一位盲法皮肤科医生在三个月、一年和五年时评估反应、美容效果，并获取活检组织进行组织学验证。对组织学证实无反应的病变进行切除。还询问了患者对治疗的满意度。
根据意向性分析（ITT），MAL在一年时的累积反应率为90.6%，BF-200 ALA为81.3%，HAL为75.8%，五年时相应为71.9%、54.6%和60.6%。各干预组与对照之间无统计学显著差异。PDT的总体累积反应率在一年时为82.5%，五年时为62.2%，48.6%的治疗失败记录在五年时。复发病变作为二线治疗进行切除。未报告侵袭性亚型，最终组织病理学报告中仅为浅表或结节性生长。美容效果或患者满意度无显著差异。
本试验表明HAL在皮肤科PDT中有应用潜力。然而，PDT治疗低风险BCC的长期疗效仍然较低。
