Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolaevulinic acid 20% vs. two-stage topical methyl aminolaevulinate: results of a randomized controlled trial

J. P. H. M. Kessels*, H. Kreukels, P. J. Nelemans, M. H. Roozeboom, H. van Pelt, K. Mosterd, E. R. M. de Haas, N. W. J. Kelleners-Smeets

*Corresponding author for this work

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Abstract

Background Basal cell carcinoma (BCC) is the most common type of skin cancer and incidence rates are increasing. Photodynamic therapy (PDT) is a frequently used treatment, especially for superficial BCC (sBCC). Two topical photosensitizing agents are currently used to treat sBCC, namely 5-aminolaevulinic acid (ALA) and its ester, methyl aminolaevulinate (MAL). Previous research showed a high efficacy for ALA-PDT using a twofold fractionated illumination scheme in which two light fractions of 20 J cm(-2) and 80 J cm(-2) were delivered 4 h and 6 h after ALA application. Objectives To evaluate whether twofold ALA-PDT is superior to conventional MAL-PDT for sBCC. Methods We performed a single-blind, randomized, multicentre trial in the Netherlands. Results Overall, 162 patients were randomized either to conventional MAL-PDT or twofold ALA-PDT. After 12 months, a total of six treatment failures occurred following ALA-PDT and 13 treatment failures occurred following MAL-PDT. The 12-month cumulative probability of remaining free from treatment failure was 92.3% [95% confidence interval (CI) (83.7-96.5)] for ALA-PDT and 83.4% (95% CI 73.1-90.0) for MAL-PDT (P = 0.091). Conclusions The twofold ALA-PDT scheme resulted in fewer recurrences, although the difference between both treatment groups was not statistically significant. However, ALA-PDT resulted in higher pain scores and more post-treatment side-effects compared with MAL-PDT.
Original languageEnglish
Pages (from-to)1056-1063
Number of pages8
JournalBritish Journal of Dermatology
Volume178
Issue number5
DOIs
Publication statusPublished - 1 May 2018

Keywords

  • NORMAL MOUSE SKIN
  • 5-YEAR FOLLOW-UP
  • LIGHT FRACTIONATION
  • SIGNIFICANTLY IMPROVES
  • 2-FOLD ILLUMINATION
  • FLUORESCENCE
  • SURGERY
  • CANCER
  • METAANALYSIS
  • GUIDELINES

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