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New, simplified versus standard photodynamic therapy (PDT) regimen for superficial and nodular basal cell carcinoma (BCC): A single-blind, non-inferiority, randomised controlled multicentre study.
Christensen, Eidi; Mørk, Erik; Foss, Olav Andreas; Mørk, Cato; Kroon, Susanne; Dotterud, Lars Kåre; Helsing, Per; Vatne, Øystein; Skogvoll, Eirik; Mjønes, Patricia; Bachmann, Ingeborg Margrethe.
Afiliación
  • Christensen E; Department of Dermatology, Clinic of Orthopaedics, Rheumatology and Dermatology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
  • Mørk E; Faculty of Medicine, Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
  • Foss OA; Faculty of Medicine, Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
  • Mørk C; Orthopaedic Research Centre, Clinic of Orthopaedics, Rheumatology and Dermatology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
  • Kroon S; Akershus Dermatology Centre, Lørenskog, Norway.
  • Dotterud LK; Department of Dermatology and Venerology, Stavanger University Hospital, Stavanger, Norway.
  • Helsing P; Lillehammer Dermatology Centre, Lillehammer, Norway.
  • Vatne Ø; Department of Dermatology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
  • Skogvoll E; Department of Dermatology, Førde Central Hospital, Førde, Norway.
  • Mjønes P; Faculty of Medicine, Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.
  • Bachmann IM; Department of Anaesthesiology and Intensive Care Medicine, St. Olav Hospital, Trondheim University Hospital, Trondheim, Norway.
PLoS One ; 19(3): e0299718, 2024.
Article en En | MEDLINE | ID: mdl-38457386
ABSTRACT

BACKGROUND:

Topical photodynamic therapy (PDT) is an approved and widely used treatment for low-risk basal cell carcinoma (BCC), comprising two sessions with an interval of 1 week. Simplification of the treatment course can be cost-effective, easier to organize, and cause less discomfort for the patients. METHODS AND

FINDINGS:

We performed an investigator-initiated, single-blind, non-inferiority, randomized controlled multicentre study with the objective of investigating whether a simpler and more flexible PDT regimen was not >10% less effective than the standard double PDT in the treatment of primary, superficial, and nodular ≤2 mm-thick BCC and evaluate the cosmetic outcome. With a non-inferiority margin of 0.1 and an expected probability complete response of 0.85, 190 tumours were required in each group. Histologically verified BCCs from seven centres in Norway were randomly assigned (11) to either receive a new regimen of single PDT with one possible re-treatment of non-complete responding tumours, or the standard regimen. The primary endpoint was the number of tumours with complete response or treatment failure at 36 months of follow-up, assessed by investigators blinded to the treatment regimen. Intention-to-treat and per-protocol analyses were performed. The cosmetic outcome was recorded. The study was registered with ClinicalTrials.gov, NCT-01482104, and EudraCT, 2011-004797-28. A total of 402 BCCs in 246 patients were included; 209 tumours assigned to the new and 193 to the standard regimen. After 36 months, there were 61 treatment failures with the new and 34 failures with the standard regimen. Complete response rate was 69.5% in the new and 81.1% in the standard treatment group. The difference was 11.6% (upper 97.5% CI 20.3), i.e. > than the non-inferiority margin of 10%. Cosmetic outcomes were excellent or good in 92% and 89% following the new and standard regimens, respectively.

CONCLUSIONS:

Single PDT with possible re-treatment of primary, superficial, and nodular ≤ 2-mm-thick BCC was significantly less effective than the approved standard double treatment. The cosmetic outcome was favorable and comparable between the two treatment groups.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Fotoquimioterapia / Neoplasias Cutáneas / Carcinoma Basocelular Límite: Humans Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: Noruega

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Fotoquimioterapia / Neoplasias Cutáneas / Carcinoma Basocelular Límite: Humans Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: Noruega