Results of the association of intralesional recombinant alpha-interferon-2a (alpha-IFN) plus 13-cis-retinoic Acid (13cra) in the treatment of Basal-cell carcinomas (bcc) of the skin.

In this phase II study, twenty-four patients (median age 72 years) with BCC of the skin were treated with intralesional alpha-IFN plus 13cRA. Alpha-IFN was administered intralesionally at the dose of 3x10(6) I.U. for injection, 3 times/week for 4 weeks (total dose 12x10(6) I.U./cycle); concomitantly, 13cRA was given per os at a 0.2-0.4 mg/kg/day dose. The 4-week cycles were repeated after a one week interval, in which only 13cRA was administered. Patients were evaluated after at least 2 cycles of treatment. Sixteen of the 20 assessable patients (80%) showed an objective response (OR), 12 of whom (60%) had a complete response (CR). The overall OR rate was 75% (12/16) in patients treated with 0.2 mg/kg/day of 13cRA, and 100% (4/4) in patients who received 0.4 mg/kg/day of the drug. The median response duration was 12 months (range, 6 to 20). Toxicity was mild and reversible in all cases; major side effects observed were fever, nausea, skin erythema, hypertriglyceridemia and hypercholesteremia. These results show the efficacy and the feasibility of alpha-IFN and 13cRA acid association in BCC treatment, with good compliance even in elderly patients; this medical approach could be a valid choice of therapy in addition to the traditional surgical modalities, as it also produces satisfactory aesthetical results.