Journal of Clinical Oncology, Vol 13, 1933-1938, Copyright © 1995 by American Society of Clinical Oncology
Prevention of skin cancer and reduction of keratotic skin lesions during acitretin therapy in renal transplant recipients: a double- blind, placebo-controlled study
JN Bavinck, LM Tieben, FJ Van der Woude, AM Tegzess, J Hermans, J ter Schegget and BJ Vermeer
Department of Dermatology, University Hospital, Leiden, The Netherlands.
PURPOSE: The purpose of this study was to investigate the effect of
acitretin on the development of keratotic skin lesions, and on squamous
cell carcinomas and basal cell carcinomas in a group of renal transplant
recipients. PATIENTS AND METHODS: Forty-four renal transplant recipients
with more than 10 keratotic skin lesions on the hands and forearms were
enrolled onto a randomized, double-blind, placebo-controlled trial to test
the possible skin cancer-preventing effect of a 6-month treatment with
acitretin 30 mg/d. RESULTS: No deterioration in renal function occurred in
any of the 38 assessable patients treated. During the 6-month treatment
period, two of 19 patients (11%) in the acitretin group reported a total of
two new squamous cell carcinomas, compared with nine of 19 patients (47%)
in the placebo group who developed a total of 18 new carcinomas (chi 2 =
6.27, P = .01). The relative decrease in the number of keratotic skin
lesions in the acitretin group was 13.4%, as compared with a relative
increase in the placebo group of 28.2% (difference, 41.6%; 95% confidence
interval, 11.5 to 71.7). Most patients treated with acitretin had mild
mucocutaneous side effects, but these were easily manageable. Some patients
experienced mild hair loss. With the exception of three patients, no
increase in serum cholesterol or triglyceride above pretreatment levels was
observed, and liver function remained unchanged in all patients.
CONCLUSION: Acitretin 30 mg/d over 6 months had significantly more effect
than placebo in the prevention of squamous cell carcinomas and reduced the
occurrence of keratotic skin lesions in a group of renal transplant
recipients with severe lesions. This effect was most pronounced in patients
with a history of squamous cell carcinomas and basal cell carcinomas.

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