title: Treatment of post-transplant premalignant skin disease: a randomized intrapatient comparative study of 5-fluorouracil cream and topical photodynamic therapy.
abstract: BACKGROUND
  Organ transplant recipients (OTR) are at high risk of developing nonmelanoma skin cancer and premalignant epidermal dysplasia (carcinoma in situ/ Bowen's disease and actinic keratoses). Epidermal dysplasia is often widespread and there are few comparative studies of available treatments.
  
  
  OBJECTIVE
  To compare topical methylaminolaevulinate (MAL) photodynamic therapy (PDT) with topical 5% fluorouracil (5-FU) cream in the treatment of post-transplant epidermal dysplasia.
  
  
  METHODS
  Eight OTRs with epidermal dysplasia were recruited to an open-label, single-centre, randomized, intrapatient comparative study. Treatment with two cycles of topical MAL PDT 1 week apart was randomly assigned to one area of epidermal dysplasia, and 5-FU cream was applied twice daily for 3 weeks to a clinically and histologically comparable area. Patients were reviewed at 1, 3 and 6 months after treatment. The main outcome measures were complete resolution rate (CRR), overall reduction in lesional area, treatment-associated pain and erythema, cosmetic outcome and global patient preference.
  
  
  RESULTS
  At all time points evaluated after completion of treatment, PDT was more effective than 5-FU in achieving complete resolution: eight of nine lesional areas cleared with PDT (CRR 89%, 95% CI: 0.52-0.99), compared with one of nine lesional areas treated with 5-FU (CRR 11%, 95% CI: 0.003-0.48) (P = 0.02). The mean lesional area reduction was also proportionately greater with PDT than with 5-FU (100% vs. 79% respectively). Cosmetic outcome and patient preference were also superior in the PDT-treated group.
  
  
  CONCLUSIONS
  Compared with topical 5-FU, MAL PDT was a more effective and cosmetically acceptable treatment for epidermal dysplasia in OTRs and was preferred by patients. Further studies are now required to confirm these results and to examine the effect of treating epidermal dysplasia with PDT on subsequent development of squamous cell carcinoma in this high risk population.
authors.affiliation: Centre for Cutaneous Research and Department of Dermatology, Institute of Cell and Molecular Science, Bart's and The London, Queen Mary School of Medicine and Dentistry, London, UK. conalperrett@hotmail.com
authors.forename: C M
authors.initials: CM
authors.lastname: Perrett
authors.forename: J M
authors.initials: JM
authors.lastname: McGregor
authors.forename: J
authors.initials: J
authors.lastname: Warwick
authors.forename: P
authors.initials: P
authors.lastname: Karran
authors.forename: I M
authors.initials: IM
authors.lastname: Leigh
authors.forename: C M
authors.initials: CM
authors.lastname: Proby
authors.forename: C A
authors.initials: CA
authors.lastname: Harwood
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000622:Aminolevulinic Acid / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001913:Bowen's Disease / Q000188:drug therapy / Q000209:etiology; D002278:Carcinoma in Situ / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007642:Keratosis / Q000188:drug therapy / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000379:methods*; D011230:Precancerous Conditions / Q000188:drug therapy*; D012307:Risk Factors; D012878:Skin Neoplasms / Q000188:drug therapy*; D014180:Transplantation / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000622:Aminolevulinic Acid; D005472:Fluorouracil