Photodynamic therapy using topical 5-aminolaevulinic acid vs. surgery for basal cell carcinoma.

BACKGROUND: Photodynamic therapy (PDT) is an attractive modality for the treatment of BCC, based on its generally favorable efficacy, adverse effect profile and its excellent cosmetic outcome.

OBJECTIVES: The purpose of the study is to compare the efficacy and cosmetic outcome of photodynamic therapy with topical 5-aminolaevulinic acid (ALA-PDT) vs. simple excision surgery for superficial and nodular basal cell carcinoma (BCC).

METHODS: A total of 72 patients, 32 with 48 lesions, were treated with ALA- PDT, and 40 with 46 lesions treated by excision were included in this prospective, comparative, controlled, clinical study. The patients have been followed for 16-37 months (mean 25 months). The PDT was performed in combination with 5-aminolaevulinic acid twice, one month apart. Surgical excision was performed under local anesthesia with a 3-mm margin, followed by histological examination. The cosmetic outcome was evaluated by the physician according to a 4-point scale.

RESULTS: Overall 94 BCC were treated. Complete healing rates did not differ significantly between groups, P = 0.64 (46/48 [95.83%] lesions treated with PDT vs. 44/46 [95.65%] lesions with surgery). In the first 12 months of follow-up, 4 lesions had recurred, 2 of which were in the PDT group while 2 lesions after surgery. The mean follow-up was 25 months. The recurrence rate in the ALA-PDT group was 4.16% vs. 4.34% in the surgery group, p = 0.64. The cosmetic outcome was superior for ALA-PDT at all time points. At 12 months, 100% lesions treated with ALA-PDT had an excellent or good cosmetic outcome, according to the investigator, compared with 88.86% with surgery, P = 0.01.

CONCLUSION: ALA-PDT offers a similarly high efficacy, and a better cosmetic outcome than simple excision surgery in the treatment of BCC.