KEY TAKEAWAYS
- The phase II pilot study aimed to assess the safety and efficacy of JI-PDT in treating pts with BCC.
- The results revealed that the Jet-injected ALA-PDT shows promise as a viable treatment option.
Photodynamic therapy (PDT) using δ-Aminolevulinic acid (ALA) topically demonstrated effectiveness in basal cell carcinoma (BCC) treatment but faced challenges due to inadequate penetration of ALA into deeper skin layers.
In this pilot trial, Leore Lavin and the team aimed to assess the safety and efficacy of photosensitizer jet injection (JI-PDT) for treating BCC. This open-label prospective study enrolled 15 patients (pts) with histologically confirmed, untreated, low-risk nodular BCCs.
Researchers noted that the intervention, JI-PDT pts (n = 11) received 2 sessions of jet-injected ALA with PDT separated by four to 6 weeks. Another group of pts (n = 4) underwent jet-injected ALA followed by tumor excision and fluorescence microscopy (JI-E). Treatment tolerability was assessed by local skin responses (LSR) score at 5 distinct time intervals.
Fluorescence microscopy evaluated 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 pts satisfaction, were scored on a 0-10 scale.
Results revealed that 15 participants, with a mean age of 58.3 years and all non-Hispanic White, enrolled in the study. The median composite LSR score immediately after JI-PDT was 5 (IQR = 3), decreasing significantly to 0.5 (IQR = 1) at the primary endpoint (P < 0.01). Immunofluorescence analysis of excised BCC tumors treated with jet-injected ALA revealed effective photosensitizer penetration into both papillary and reticular dermis.
Among the 13 tumors treated with JI-PDT, 11 achieved confirmed tumor clearance, while 1 recurred and 1 was lost to follow-up. 1 patient experienced a serious adverse event of cellulitis. At 3 months, 70% of pts exhibited local scarring. Pts reported an average pain level of 5.6 (SD = 2.3) during jet injection and 3.7 (SD = 1.8) during light illumination.
In conclusion, the JI of ALA for PDT in nodular low-risk BCC is viable and tolerable, which can prospectively offer a promising treatment approach.
The trial was sponsored by Memorial Sloan Kettering Cancer Center and the study was financially supported by LEO Pharma and P30 CA008748/NH/NIH HHS/United States.
Source: https://pubmed.ncbi.nlm.nih.gov/38804170/
Clinical Trial: https://www.clinicaltrials.gov/study/NCT04552990
Lavin L., Erlendsson A.M., Aleissa S., et al. (2024). “Jet-injection assisted photodynamic therapy for superficial and nodular basal cell carcinoma: A pilot study.” Lasers Surg Med. 2024 Jul;56(5):446-453. doi: 10.1002/lsm.23793. Epub 2024 May 28. PMID: 38804170.
