Sixteen patients with oral leukoplakia were treated with oral 13-cis-retinoic acid (cRA) at progressively increasing doses. The initial dose, given for 3 months, was 0.2 mg/kg/day, increased by a further 0.2 mg/kg/day in the following 3-month cycles. The maximum dosage reached at 1.0 mg/kg/day, was given to only 2 patients (who received a total of 15 months treatment). However, 10 patients completed the cycle at 0.8 mg/kg/day (12 months treatment in total), but treatment could not continue due to toxicity (grade I and II), which was cutaneous, mucosal, and haematological (hypertriglyceridemia and hypercholesterolemia). There was grade III toxicity in the skin and mucosa in only 1 case, a patient treated at the dose of 1.0 mg/kg/day. The toxicity was reversible in all cases at the end of treatment. On the 14 evaluable patients there were 4 partial responses (PR), 3 of whom obtained at 0.2 mg/kg/day and 1 at 0.6; one complete response (CR) was reached at 0.4 mg/kg/day. The overall objective response rate was 36%, with 50% or more reduction in lesion size. After the retinoic acid treatment was stopped, patients were followed-up for 12 months; 2 patients showed regression of the responses obtained after 6 and 9 months, respectively. This study shows that oral treatment with cRA at low doses is effective and with minimal toxicity. It also suggests that a long-term duration treatment is not feasible, with doses above 0.8 mg/kg/day, mainly due to poor compliance, rather than the actual treatment-related toxicity.
|Translated title of the contribution||13-cis-retinoic acid in the treatment of oral leukoplakia|
|Number of pages||4|
|Publication status||Published - 1994|
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