Document Detail

Photodynamic therapy using methyl aminolevulinate in the management of primary superficial basal cell carcinoma: clinical and health economic outcomes.
MedLine Citation:
PMID:  19894366     Owner:  NLM     Status:  MEDLINE    
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). OBJECTIVES: 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.). CONCLUSION: 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.
Karin Caekelbergh; Arjen F Nikkels; Bernard Leroy; Evelien Verhaeghe; Mark Lamotte; Rives Vincent
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of drugs in dermatology : JDD     Volume:  8     ISSN:  1545-9616     ISO Abbreviation:  J Drugs Dermatol     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-11-09     Completed Date:  2009-12-03     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101160020     Medline TA:  J Drugs Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  992-6     Citation Subset:  IM    
Health Economics and Outcomes Research, IMS Health, Brussels, Belgium.
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MeSH Terms
Aminolevulinic Acid / adverse effects,  analogs & derivatives*,  economics,  therapeutic use
Carcinoma, Basal Cell / drug therapy*,  economics
Middle Aged
Photochemotherapy / adverse effects,  economics,  methods*
Photosensitizing Agents / adverse effects,  economics,  therapeutic use*
Prospective Studies
Skin Neoplasms / drug therapy*,  economics
Treatment Outcome
Reg. No./Substance:
0/Photosensitizing Agents; 0/methyl 5-aminolevulinate; 106-60-5/Aminolevulinic Acid

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