Rhodes et al 2004

Title: Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial.

Author: Rhodes LE, de Rie M, Enström Y, Groves R, Morken T, Goulden V, et al. 

Journal Reference: Arch Dermatol 2004;140:17-23. (by clicking on this link you will be leaving this site - Galderma is not responsible for the content)

Objective: to compare the efficacy and cosmetic outcome of topical photodynamic therapy using methyl aminolevulinate (MAL; Metvix®) with standard simple excision surgery in nodular basal cell carcinoma.

Design: this was a European, prospective, multicentre, parallel-group, randomised trial. A total of 101 adult patients with previously untreated, primary nodular basal cell carcinoma received either photodynamic therapy (PDT) with MAL (52 patients) or surgery (49 patients). Lesions were prepared by gentle curettage before treatment. Photodynamic therapy was repeated a week later.  Simple excision surgery was performed under local anaesthetic in accordance with each centre's normal clinical practice.

Lesions were assessed at 3-months following initial treatment; lesions that showed non-complete response to PDT were re-treated and re-evaluated 3 months later. Further assessments were performed 12- and 24-months after last treatment.

Key Results:

  • At 3 months, a complete clinical response was seen in 91% of lesions treated with MAL-PDT and 98% with surgery.
  • Acceptable clearance rates were seen after a single cycle of photodynamic therapy (two sessions) in 76% of cases.
  • At 12-months, tumour free rates were 96% with surgery compared with 83% (44/53) for PDT. At 24-months, an additional 3 lesions recurred in the MAL-PDT group version 1 in the surgery group.
  • Cosmesis assessments favoured MAL-PDT at all time points. At 2 years, 97% of patients in the MAL-PDT group rated the cosmetic outcome as excellent or good compared with 75% in the surgery group (P=0.04).
  • More patients reported adverse events in the MAL-PDT group than in the surgery groups (52% and 29%, respectively). This was expected, as local anaesthesia was provided with surgery. In general, adverse effects were mild to moderate in intensity and resolved rapidly.

Conclusion: photodynamic therapy with methyl aminolevulinate cream (MAL; Metvix®) is a promising, non-invasive treatment for nodular basal cell carcinoma. Despite a trend for higher tumour recurrence that requires further study, this modality shows distinct cosmetic advantages over surgery. The treatment remains cosmetically superior to surgery even at two years post treatment when healing from surgery is likely to be complete.