Horn et al

Title: Topical photodynamic therapy in patients with basal cell carcinoma prone to complications and poor cosmetic outcome with conventional treatment.

Author: Horn M, Wolf P, Wulf HC, Warloe T, Fritsch C, Rhodes LE, et al.

Journal Reference: Br J Dermatol 2003;149:1242-9. (by clicking on this link you will be leaving this site - Galderma is not responsible for the content)

Objective: to determine the efficacy and cosmetic acceptability of topical photodynamic therapy using methyl aminolevulinate (MAL; Metvix®) in difficult-to-treat basal cell carcinoma lesions. 

Design: this was an open, uncontrolled, prospective, multicentre European study. Ninety-four patients with superficial and/or nodular basal cell carcinoma (BCC), who were considered difficult-to-treat because of possible complications, poor cosmetic outcome, disfigurement and/or recurrence after conventional treatment, were included.

Lesions were debrided before treatment to facilitate MAL penetration. Treatment was repeated seven days later. Three months after the first treatment cycle, lesions showing complete clinical remission were biopsied. Histologically positive tumours, and those showing partial clinical remission (=50% decrease), received a further 2 treatments (separated by 7 days). Patients with no clinical response were removed from the study. Any tumours remaining at 3-monthly follow-up after the second treatment cycle were considered treatment failures and patients received alternative therapies.  Lesions were assessed at 3, 12 and 24 months after last treatment.

Key Results:

  • Results presented are the primary response rates and the 2nd year of a 5-year follow-up period.
  • The complete lesion response rate assessed clinically at three months after last treatment was 87% overall, 92% for superficial BCCs and 87% for nodular BCCs.
  • The overall histological remission rate was 77% (85% for superficial BCC; 75% for nodular BCCs). The patient-based histological remission rate was 75%.
  • Only one treatment cycle was needed and completed for 59% of patients.
  • The total lesion recurrence rate at 24 months was 18% (22% for superficial BCCs; 14% for nodular BCCs). The recurrence rate appeared to increase with increasing lesion size.
  • Investigators considered cosmetic outcome as good or excellent in 94% of patients at 24 months.
  • Local, adverse reactions were reported by 63 patients. The majority of reactions were mild and all were transient in nature, none required discontinuation of treatment.

Conclusion: difficult-to-treat basal cell carcinomas respond well to photodynamic therapy with methyl aminolevulinate cream (MAL; Metvix®) with a high remission rate and excellent cosmetic outcome two years after treatment. This represents a promising treatment modality for difficult-to-treat basal cell carcinomas combining clinical efficacy with important cosmetic advantages, unlike in surgical procedures the skin is preserved, which should increase patient satisfaction with treatment.