Photodynamic therapy does not prevent cutaneous squamous-cell carcinoma in organ-transplant recipients: results of a randomized-controlled trial.
A randomized-controlled trial with paired observations was performed with 40 organ-transplant recipients to assess the preventive effect of photodynamic therapy (PDT) on the development of new squamous-cell carcinomas and to evaluate the effect of PDT on the number of keratotic skin lesions. The treatment area consisted of a randomly assigned forearm and the corresponding hand, whereas the other forearm and hand served as the control area. After the initial visit, follow-up visits were scheduled at 3-monthly intervals during 2 years. No statistically significant difference was found in the occurrence of new squamous-cell carcinomas between the treated and untreated arms: after 2 years of follow-up, we observed 15 squamous-cell carcinomas in nine out of 40 PDT-treated arms and 10 squamous-cell carcinomas in nine out of 40 control arms. The number of keratotic skin lesions increased in both arms, but was less pronounced in the PDT-treated arm. After 1 year of follow-up, a trend in favor of the PDT-treated arm was observed, but statistical significance was not reached. Nearly 80% of the patients reported mild to severe adverse effects consisting of pain and a burning sensation, immediately after the treatment. No long-term adverse events were noted. In conclusion, PDT does not appear to prevent the occurrence of new squamous-cell carcinomas in organ-transplant recipients, but to some degree, reduces the increase of keratotic skin lesions.
de Graaf
Ymke G L
YG
Department of Dermatology, Leiden University Medical Center, Leiden, The Netherlands.
Kennedy
Cornelis
C
Wolterbeek
Ron
R
Collen
Annemie F S
AF
Willemze
Rein
R
Bouwes Bavinck
Jan N
JN
D000328:Adult; D000368:Aged; D000622:Aminolevulinic Acid / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007642:Keratosis / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000009:adverse effects*; D010778:Photochemotherapy; D012867:Skin / Q000473:pathology; D012878:Skin Neoplasms / Q000473:pathology / Q000517:prevention & control*
D000622:Aminolevulinic Acid