ISOLATED HYPERTHERMIC PERFUSION WITH MITOXANTRONE OR MELPHALAN IN MALIGNANT-MELANOMA OF THE LIMB

BACKGROUND: Melphalan administered by isolated hyperthermic perfusion of the affected limb is an accepted treatment for malignant melanoma o f the extremities, In contrast, pharmacologic and phase I studies sugg est that, because of its high uptake, mitoxantrone may give even bette r local control, but data on survival, onset of metastases, and local and systemic toxicities have not yet been reported. METHODS: A matched -pairs comparison was performed to examine differences in the tolerabi lity and effectiveness of isolated hyperthermic extremity perfusion wi th mitoxantrone (n = 44) and melphalan (n = 44) in high risk and locor egionally metastatic malignant melanoma, Criteria evaluated were local and systemic complications, and recurrence-free and overall survival. RESULTS: Local complications, such as delayed wound healing, were mor e frequent in the mitoxantrone (27.9%) than in the melphalan group (9. 8%) (P <0.05). Systemic toxicity, in particular bone marrow toxicity, was also more severe with mitoxantrone (78.6% versus 15.4%, P <0.001), Hepatotoxic effects were more frequent among patients in the melphala n group who were older and had lower tissue perfusion temperatures (P <0.05), There was no difference between the two groups in overall or r ecurrence-free survival (P <0.41). CONCLUSIONS: Local and systemic tox icity seem to be higher with mitoxantrone. Survival rates were similar with both drugs, The data obtained suggest a randomized phase II stud y with an appropriate number of patients,