Light fractionation significantly improves the response of superficial basal cell carcinoma to aminolaevulinic acid photodynamic therapy: five-year follow-up of a randomized, prospective trial.

Photodynamic therapy (PDT) using topical porphyrin-precursors is a promising treatment for superficial basal cell carcinoma (sBCC), but it needs further optimization. The aim of this study was to compare 5-year lesion (complete) response rates of sBCC treated with topical aminolaevulinic acid (ALA)-PDT using a single illumination vs. ALA-PDT using a 2-fold illumination scheme. A prospective, randomized study was performed, in which 91 patients with 299 lesions were treated with a 2-fold illumination scheme with 2 light fractions of 20 and 80 J/cm2 delivered 4 and 6 h after a single application of 20% ALA, and 106 patients with 274 lesions were treated with a single illumination of 75 J/cm2 4 h after a single application of 20% ALA. All lesions were treated at a fluence rate of 50 mW/cm2. An interim time to event analysis of complete response (CR) rates at 12 months showed encouraging results, and therefore lesions were followed for 5 years post-therapy. A third group of 50 patients with 172 lesions treated with 2-fold illumination were included after the initial period and analysed separately. The CR rate was significantly greater following the 2-fold illumination than the single illumination (p = 0.0002, log-rank test). Five years after therapy the CR rate after 2-fold illumination was 88%, whereas the CR rate after single illumination was 75%. The CR rate in the third group of lesions, treated with 2-fold illumination was 97% and 88% at 12 months and 5 years after therapy, respectively. Long-term follow-up indicates superior efficacy in sBCC of ALA-PDT with 2-fold illumination compared with ALA-PDT with single illumination.

RCT Entities:   Population Interventions Outcomes