title: Topical methyl aminolaevulinate photodynamic therapy in patients with basal cell carcinoma prone to complications and poor cosmetic outcome with conventional treatment.
abstract: BACKGROUND
  Conventional treatment of basal cell carcinoma (BCC) causes morbidity and/or disfigurement in some patients because of the location (e.g. mid-face) and size of the lesion.
  
  
  OBJECTIVE
  Following reports that such difficult-to-treat BCC lesions have been treated successfully with topical methyl aminolaevulinate (MAL) photodynamic therapy (PDT), a multicentre study was performed to determine the response of such BCC to MAL-PDT.
  
  
  METHODS
  An open, uncontrolled, prospective, multicentre study was conducted comprising patients with superficial and/or nodular BCC who were at risk of complications, poor cosmetic outcome, disfigurement and/or recurrence using conventional therapy. Patients were given one or two cycles within 3 months of topical MAL-PDT, each consisting of two treatments 1 week apart. Tumour response was assessed clinically at 3 months after the last PDT, with histological confirmation of all lesions in clinical remission. The cosmetic outcome was rated. Patients with a BCC in remission will be followed up for 5 years for recurrence, of which the 24-month follow-up is reported here. Ninety-four patients with 123 lesions were enrolled and treated with MAL-PDT at nine European primary care and referral university hospitals. An independent blinded study review board (SRB) retrospectively excluded nine patients and a total of 15 lesions from the efficacy analysis, for not having a difficult-to-treat BCC according to the protocol.
  
  
  RESULTS
  The lesion remission rate at 3 months was 92% (45 of 49) for superficial BCC, 87% (45 of 52) for nodular BCC, and 57% (four of seven) for mixed BCC, as assessed by clinical examination, and 85% (40 of 47), 75% (38 of 51), and 43% (three of seven), respectively, as assessed by histological examination and verified by the SRB. At 24 months after treatment, the overall lesion recurrence rate was 18% (12 of 66). The cosmetic outcome was graded as excellent or good by the investigators in 76% of the cases after 3 months follow-up, rising to 85% at 12 months follow-up, and 94% at 24 months follow-up.
  
  
  CONCLUSIONS
  Topical MAL-PDT is effective in treating BCC at risk of complications and poor cosmetic outcome using conventional therapy. MAL-PDT preserves the skin and shows favourable cosmetic results.
authors.affiliation: Departments of Photodermatology and Dermatology, Karl-Franzens-University, Auenbruggerplatz 8, A-8036 Graz, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Horn
authors.forename: P
authors.initials: P
authors.lastname: Wolf
authors.forename: H C
authors.initials: HC
authors.lastname: Wulf
authors.forename: T
authors.initials: T
authors.lastname: Warloe
authors.forename: C
authors.initials: C
authors.lastname: Fritsch
authors.forename: L E
authors.initials: LE
authors.lastname: Rhodes
authors.forename: R
authors.initials: R
authors.lastname: Kaufmann
authors.forename: M
authors.initials: M
authors.lastname: De Rie
authors.forename: F J
authors.initials: FJ
authors.lastname: Legat
authors.forename: I M
authors.initials: IM
authors.lastname: Stender
authors.forename: A M
authors.initials: AM
authors.lastname: Solér
authors.forename: A-M
authors.initials: AM
authors.lastname: Wennberg
authors.forename: G A E
authors.initials: GA
authors.lastname: Wong
authors.forename: O
authors.initials: O
authors.lastname: Larkö
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D002280:Basal Cell Carcinoma / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D011446:Prospective Studies; D012008:Recurrence; D012878:Skin Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid