Foley et al

Title: MAL-PDT or placebo cream in nodular basal cell carcinoma: results of an Australian double-blind randomized multicentre study.

Author: Foley P, Freeman M, Siller G, Gebauer K, Murrell D, Barnetson R, et al.

Reference: Abstract book of the International Skin Cancer Conference 2004, P22

Objective: to compare the efficacy and safety of photodynamic therapy using methyl aminolevulinate (MAL; Metvix®), which has high lesion selectivity, with placebo cream in the treatment of nodular basal cell carcinoma.

Design: this was a randomised, parallel group, placebo-controlled double-blind study. A total of 66 adult patients with nodular basal cell carcinoma were randomised to receive photodynamic treatment (PDT) with either 160mg/g MAL or placebo cream (33 patients per group). Lesions were debrided before treatment. Treatment was repeated seven days later.

Lesions showing partial clinical response (>50% decrease) at three-months were re-treated as before; those showing no response or progression were surgically excised. At six-months after the last treatment, lesions showing complete clinical response were excised for histological examination. Assessments of treatment efficacy were made at three- and six-months after last treatment.

Key Results:

  • MAL-PDT was found to be superior to placebo (p<0.001).
  • In the active treatment group the overall complete histological response (i.e. no signs of malignancy) was 73% compared with 21% for the placebo.
  • Response rate was higher on the face (100%) than on the trunk (73%) or on the extremities (60%).
  • Almost all patients (95%) in the active treatment group judged the cosmetic outcome as good or excellent.
  • Only local adverse events were reported in both groups. Most reactions were transient and mild or moderate.

Conclusion: MAL-PDT (Metvix®) is superior to photodynamic therapy with placebo in the treatment of nodular basal cell carcinomas. Its effectiveness combined with an excellent cosmetic profile offers a valuable alternative to existing therapies, especially for tumours located in areas where cosmetic results are of particular importance e.g. the face.