title: Photodynamic therapy with topical methyl aminolaevulinate for 'difficult-to-treat' basal cell carcinoma.
abstract: BACKGROUND
  Basal cell carcinoma (BCC) may be difficult to treat by conventional means, particularly if the lesions are large or located in the mid-face (H-zone). Photodynamic therapy (PDT) using topical methyl aminolaevulinate (MAL) may be a good noninvasive option for these patients.
  
  
  OBJECTIVE
  To investigate the efficacy and safety of PDT using MAL for BCCs defined as 'difficult to treat', i.e. large lesions, in the H-zone, or in patients at high risk of surgical complications.
  
  
  METHODS
  This was a prospective, multicentre, noncomparative study. Patients were assessed 3, 12 and 24 months after the last PDT treatment. One hundred and two patients with 'difficult-to-treat' BCC were treated with MAL PDT, using 160 mg g(-1) cream and 75 J cm(-2) red light (570-670 nm), after lesion preparation and 3 h of cream exposure. Results Ninety-five patients with 148 lesions were included in the per protocol analysis. The histologically confirmed lesion complete response rate at 3 months was 89% (131 of 148). At 12 months, 10 lesions had reappeared, and therefore the cumulative treatment failure rate was 18% (27 of 148). At 24 months, an additional nine lesions had reappeared, resulting in a cumulative treatment failure rate of 24% (36 of 148). The estimated sustained lesion complete response rate (assessed using a time-to-event approach) was 90% at 3 months, 84% at 12 months and 78% at 24 months. Overall cosmetic outcome was judged as excellent or good in 79% and 84% of the patients at 12 and 24 months, respectively. Follow-up is continuing for up to 5 years.
  
  
  CONCLUSIONS
  MAL PDT is an attractive option for 'difficult-to-treat' BCC. Because of the excellent cosmetic results, the treatment is particularly well suited for lesions that would otherwise require extensive surgical procedures.
authors.affiliation: Fremantle Hospital, Fremantle, Western Australia, Australia. vinco@dermlaser.com.au
authors.forename: C
authors.initials: C
authors.lastname: Vinciullo
authors.forename: T
authors.initials: T
authors.lastname: Elliott
authors.forename: D
authors.initials: D
authors.lastname: Francis
authors.forename: K
authors.initials: K
authors.lastname: Gebauer
authors.forename: L
authors.initials: L
authors.lastname: Spelman
authors.forename: R
authors.initials: R
authors.lastname: Nguyen
authors.forename: W
authors.initials: W
authors.lastname: Weightman
authors.forename: A
authors.initials: A
authors.lastname: Sheridan
authors.forename: C
authors.initials: C
authors.lastname: Reid
authors.forename: D
authors.initials: D
authors.lastname: Czarnecki
authors.forename: D
authors.initials: D
authors.lastname: Murrell
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012307:Risk Factors; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid