PREVENTION OF SKIN-CANCER AND REDUCTION OF KERATOTIC SKIN-LESIONS DURING ACITRETIN THERAPY IN RENAL-TRANSPLANT RECIPIENTS - A DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY

Purpose: The purpose of this study was to investigate the effect of ac itretin on the development of keratotic skin lesions, and on squamous cell carcinomas and basal cell carcinomas in a group of renal transpla nt recipients. Patients and Methods: Forty-four renal transplant recip ients with more than 10 keratotic skin lesions on the hands and forear ms were enrolled onto a randomized, double-blind, placebo-controlled t rial to test the possible skin cancer-preventing effect of a 6-month t reatment with acitretin 30 mg/d. Results: No deterioration in renal fu nction occurred in any of the 38 assessable patients treated. During t he 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 to tal of 18 new carcinomas (chi(2) = 6.27, P = .01), The relative decrea se 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, 1 1.5 to 71.7), Most patients treated with acitretin had mild mucocutaneous side effects, b ut these were easily manageable, Some patients experienced mild hair l oss, With the exception of three patients, no increase in serum choles terol or triglyceride above pretreatment levels was observed, and live r function remained unchanged in all patients. Conclusion: Acitretin 3 0 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 his tory of squamous cell carcinomas and basal cell carcinomas. J Clin Onc ol 13:1933-1938. (C) 1995 by American Society of Clinical Oncology.