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 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, 1 1.5 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. J Clin Oncol 13:1933-1938. (C) 1995 by American Society of Clinical Oncology.