title: Photodynamic therapy using methyl aminolevulinate in the management of primary superficial basal cell carcinoma: clinical and health economic outcomes.
abstract: BACKGROUND
  Basal cell carcinoma (BCC) is the most common form of skin cancer worldwide. Different treatment options exist. The efficacy of photodynamic therapy with methyl aminolevulinate (MAL-PDT) has been established in several randomized controlled trials (RCTs). Real life data can differ greatly from data derived from randomized controlled trials (RCTs).
  
  
  OBJECTIVE
  To describe the results of a Belgian observational study concerning superficial BCC (sBCC) vis-a-vis clinical and health economic outcomes in order to evaluate the real-life practice of MAL-PDT.
  
  
  METHODS
  This study was a prospective, single-arm, open study conducted at eight dermatological institutions during six months after the first MAL-PDT treatment. Eligible patients had to present with lesions, suitable for MAL-PDT according to Belgian reimbursement criteria. Resource use was collected during the study period. Clinical Response (CR) and Cosmetic Outcome (CO), as well as cost of care were evaluated. A subset analysis of patients with sBCC only was conducted.
  
  
  RESULTS
  Ninety patients were identified for the analysis (mean age 65 years; 61% female). The mean number of lesions per patient was 1.6, mostly located on the face, the back and the chest. For the entire period, the mean number of visits to a dermatologist was 4 per patient including two MAL-PDT sessions. The average, cumulative amount of MAL used per treatment was 1,256 mg. Two patients experienced adverse events at the application site, none of them serious; all resolved completely. The CR rate was 89% at the end of the study. The CO was "excellent" or "good" in 96% of the patients. Total cost of care was Euro 289 ($414 U.S.) per patient. Cost per lesion was Euro 195 ($280 U.S.).
  
  
  CONCLUSIONS
  The results from the real-life practice study confirm the efficacy found in prior, prospective randomized trials. About four visits and less than one tube of MAL are needed for the full treatment of sBCC in one patient.
authors.affiliation: Health Economics and Outcomes Research, IMS Health, Brussels, Belgium. KCaekelbergh@be.imshealth.com
authors.forename: Karin
authors.initials: K
authors.lastname: Caekelbergh
authors.forename: Arjen F
authors.initials: AF
authors.lastname: Nikkels
authors.forename: Bernard
authors.initials: B
authors.lastname: Leroy
authors.forename: Evelien
authors.initials: E
authors.lastname: Verhaeghe
authors.forename: Mark
authors.initials: M
authors.lastname: Lamotte
authors.forename: Rives
authors.initials: R
authors.lastname: Vincent
mesh_terms: D000368:Aged; D000622:Aminolevulinic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D001530:Belgium; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000191:economics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000191:economics; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid