Fractionated 5-aminolaevulinic acid-photodynamic therapy vs. surgical excision in the treatment of nodular basal cell carcinoma: results of a randomized controlled trial.

BACKGROUND: Skin cancer incidence rates have been increasing for decades and this increase is expected to continue. Surgical excision (SE) is the treatment of first choice for nodular basal cell carcinoma (nBCC). Photodynamic therapy (PDT) has proven to be an effective treatment for superficial basal cell carcinoma. Its long-term efficacy in nBCC has not yet been established.

OBJECTIVES: Prospectively compare the efficacy of 5-aminolaevulinic acid (ALA)-PDT and SE in terms of failure rates with long-term follow-up. Determinants of failure in the study population, such as the effect of tumour depth, were analysed retrospectively.

METHODS: A randomized controlled trial in 173 primary nBCCs in 149 patients. Primary nBCCs were randomly assigned either to PDT (n = 85) or to SE (n = 88). Tumours treated with PDT were illuminated twice on the same day, 4 h after application of ALA cream, 3 weeks after debulking. SE was performed under local anaesthesia with a 3-mm margin, followed by histological examination. An intention-to-treat analysis was performed.

RESULTS: In total, 171 primary nBCCs in 149 patients were treated. A 3-year interim analysis revealed that the cumulative incidence of failure was 2.3% for SE and 30.3% for PDT (P < 0.001). Tumour depth and other analysed determinants of failure were not significantly related to treatment failure.

CONCLUSIONS: SE proved to be significantly more effective than treatment with fractionated illumination ALA-PDT. Therefore, in the treatment of primary nBCC, SE is preferred over PDT following this treatment regimen.