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Treatment of post-transplant premalignant skin disease : a randomized intrapatient comparative study of 5-fluorouracil cream and topical photodynamic therapy

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Perrett, C. M., McGregor, J. M., Warwick, Jane, Karran, P., Leigh, I. M., Proby, C. M. and Harwood, C. A. (2007) Treatment of post-transplant premalignant skin disease : a randomized intrapatient comparative study of 5-fluorouracil cream and topical photodynamic therapy. British Journal of Dermatology, Volume 156 (Number 2). pp. 320-328. doi:10.1111/j.1365-2133.2006.07616.x ISSN 0007-0963.

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Official URL: http://dx.doi.org/10.1111/j.1365-2133.2006.07616.x

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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.

Objectives: 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.

Item Type: Journal Article
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title: British Journal of Dermatology
Publisher: Wiley-Blackwell Publishing Ltd.
ISSN: 0007-0963
Official Date: February 2007
Dates:
DateEvent
February 2007Published
Volume: Volume 156
Number: Number 2
Page Range: pp. 320-328
DOI: 10.1111/j.1365-2133.2006.07616.x
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access

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