FENRETINIDE (4-HPR) IN CHEMOPREVENTION OF ORAL LEUKOPLAKIA

A controlled clinical trial has been underway at the Istituto Nazional e Tumori (INT) of Milan since 1988. The goal of the trial is to evalua te the effectiveness of fenretinide (4-HPR) in preventing relapses, ne w localizations, and carcinomas in patients with benign postoperative diagnoses who have been surgically treated for oral leukoplakias. This paper presents the design and the preliminary results of this study. To date, 137 patients have been randomized, following surgical excisio n of oral leukoplakia, to receive either 200 mg 4-HPR daily for 52 wee ks or no intervention. Twenty local relapses or new localizations have occurred so far in the control group and 9 in the 4-HPR group. Seven patients have interrupted the, intervention because of toxicity. No im paired dark adaptation has been observed. We conclude that 4-HPR is we ll-tolerated and appears to be effective in preventing relapses and ne w localizations during the treatment period. (C) 1993 Wiley-Liss, Inc.