Alexandra Sjöholm, Eva Backman, Maja Modin, Julia Fougelberg, Magdalena Claeson, John Paoli
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引用次数: 0
Abstract
Background: Photodynamic therapy (PDT) is a recognized treatment for superficial basal cell carcinoma (sBCC). Conventional PDT (C-PDT) has a relatively high clearance rate but is time-consuming and painful. Simulated daylight PDT (SDL-PDT) has the potential advantage of causing less pain, but its effectiveness has not been investigated thoroughly.
Objectives: To determine whether SDL-PDT is non-inferior to C-PDT in the treatment of clinically diagnosed sBCC and to assess adverse events during treatment and patient preferences.
Methods: In this single-centre, non-inferiority, randomized controlled trial, adult patients with sBCCs of any size and located on anatomical sites suitable for PDT were recruited. Lesions were randomized to two sessions of either SDL-PDT or C-PDT using aminolevulinic acid as the photosensitizer. Patient-perceived pain was measured using a numeric rating scale (NRS) ranging from 0 to 10. Self-report forms were used to measure patient preferences. Patients were evaluated after 3 months to assess early treatment failure and after 1 year to determine overall clearance rates.
Results: In total, 78 participants with 193 sBCCs were treated. Most lesions (47.2%) were located on the trunk and were diagnosed solely through dermoscopic evaluation (64.2%). After 1 year, the clearance rate was 62.4% for SDL-PDT and 91.8% for C-PDT (p < 0.001) disproving non-inferiority. Illumination was reported to be more painful during C-PDT (mean NRS score of 3.5 at session 1 and 3.7 at session 2) compared with SDL-PDT (mean NRS score of 0.1 at both sessions) (p < 0.001). Immediately after treatment, 87.5% of respondents expressed a preference for SDL-PDT.
Conclusions: SDL-PDT is less effective than C-PDT but is also less painful. Due to the lower clearance rate, this study does not support SDL-PDT as a primary treatment option for sBCC. The randomized controlled trial was registered at http://www.researchweb.org/ (project 264721).
期刊介绍:
The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV).
The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology.
The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.