Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Lasers Surg Med. 2024 Jul;56(5):446-453. doi: 10.1002/lsm.23793. Epub 2024 May 28.
Photodynamic therapy (PDT) with topical δ-Aminolevulinic acid (ALA) has efficacy in treating basal cell carcinoma (BCC) but is limited by incomplete penetration of ALA into the deeper dermis. This prospective open-label pilot trial investigated the safety and efficacy of photosensitizer jet injection for PDT (JI-PDT) for BCC treatment. It was performed with 15 patients (n = 15) with histologically confirmed, untreated, low-risk nodular BCCs at a single institution.
For the intervention, JI-PDT patients (n = 11) received two sessions of jet-injected ALA with PDT separated by four to 6 weeks. To further understand treatment technique, another group of patients (n = 4) received jet-injected ALA followed by tumor excision and fluorescence microscopy (JI-E). Treatment tolerability was assessed by local skin responses (LSR) score at five distinct time intervals. Fluorescence microscopy assessed protoporphyrin IX penetration depth and biodistribution within the tumor. At the primary endpoint, tumor clearance was evaluated via visual inspection, dermoscopy and reflectance confocal microscopy. Postinjection and postillumination pain levels, and patient satisfaction, were scored on a 0-10 scale.
Fifteen participants with mean age of 58.3, who were 15/15 White, non-Hispanic enrolled. The median composite LSR score immediately after JI-PDT was 5 (interquartile range [IQR] = 3) which decreased to 0.5 (IQR = 1) at primary endpoint (p < 0.01). Immunofluorescence of excised BCC tumors with jet-injected ALA showed photosensitizer penetration into papillary and reticular dermis. Of the 13 JI-PDT tumors, 11 had tumor clearance confirmed, 1 recurred, and 1 was lost to follow-up. 1/11 patients experienced a serious adverse event of cellulitis. 70% of patients had local scarring at 3 months. Patients reported an average pain level of 5.6 (standard deviation [SD] = 2.3) during jet injection and 3.7 (SD = 1.8) during light illumination.
Jet injection of ALA for PDT treatment of nodular low-risk BCC is tolerable and feasible and may represent a novel modality to improve PDT.
局部δ-氨基酮戊酸（ALA）光动力疗法（PDT）在治疗基底细胞癌（BCC）方面具有疗效，但ALA 向更深的真皮层渗透不完全限制了其疗效。本前瞻性开放标签试验研究了光敏剂喷射注射 PDT（JI-PDT）治疗 BCC 的安全性和疗效。在一家机构中对 15 名经组织学证实、未经治疗、低危结节性 BCC 的患者（n=15）进行了此项研究。
对于干预，11 名 JI-PDT 患者（n=11）接受了两次喷射注射 ALA 联合 PDT，两次治疗间隔 4 至 6 周。为了进一步了解治疗技术，另一组患者（n=4）接受了喷射注射 ALA 后肿瘤切除术和荧光显微镜检查（JI-E）。通过在五个不同时间间隔的局部皮肤反应（LSR）评分评估治疗耐受性。荧光显微镜评估原卟啉 IX 在肿瘤内的渗透深度和分布。在主要终点时，通过肉眼观察、皮肤镜和反射共聚焦显微镜评估肿瘤清除情况。在注射后和光照后，根据疼痛程度和患者满意度进行 0-10 分评分。
15 名参与者的平均年龄为 58.3 岁，均为 15/15 名白种人，非西班牙裔。在 JI-PDT 后即刻，中位复合 LSR 评分为 5（四分位距 [IQR] = 3），在主要终点时降至 0.5（IQR = 1）（p < 0.01）。用喷射注射 ALA 对切除的 BCC 肿瘤进行免疫荧光检测显示光敏剂渗透到乳头层和网状真皮层。在 13 个 JI-PDT 肿瘤中，11 个肿瘤完全清除，1 个复发，1 个失访。1/11 名患者发生蜂窝织炎严重不良事件。11 名患者中有 70%在 3 个月时有局部瘢痕。患者在喷射注射时的平均疼痛评分为 5.6（标准差 [SD] = 2.3），在光照时为 3.7（SD = 1.8）。
喷射注射 ALA 联合 PDT 治疗结节性低危 BCC 是耐受和可行的，可能代表改善 PDT 的一种新方法。
