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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
Author(s) -
Kessels J.P.H.M.,
Kreukels H.,
Nelemans P.J.,
Roozeboom M.H.,
Pelt H.,
Mosterd K.,
Haas E.R.M.,
KellenersSmeets N.W.J.
Publication year - 2018
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.15967
Subject(s) - photodynamic therapy , medicine , confidence interval , randomized controlled trial , basal cell carcinoma , skin cancer , cancer , stage (stratigraphy) , dermatology , surgery , gastroenterology , basal cell , chemistry , biology , organic chemistry , paleontology
Summary 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 .