Hyperthermic perfusion with chemotherapy for melanoma of the extremities.

A prospective randomized study was carried out to evaluate the effectiveness of additional regional cytostatic perfusion of the extremities in patients with malignant melanoma. In a control group (n = 54), the tumors were widely excised, and regional lymph nodes were dissected. The patients in the perfusion group (n = 53) received additional hyperthermic (42 degrees C) perfusion with Melphalan. The disease-free survival time was chosen as the criterion for evaluation. An intermediate analysis revealed a highly significant difference between the 2 groups (21 recurrences in the control group and 4 recurrences in the perfusion group, p less than 0.001). Therefore, the study was discontinued prematurely. In an analysis of the data performed after a median observation time of 5 years and 11 months, 26 recurrences were diagnosed in the control group, whereas 6 recurrences were noted in the perfusion group (p less than 0.001). The retrospective breakdown into different risk groups according to tumor thickness also demonstrates a significant difference. For patients with a primary tumor of 1.5-3.0-mm in thickness, 2 of 25 in the perfusion group and 10 of 25 in the control group have relapsed. For those with a primary tumor of greater than 3.0-mm in thickness, 4 of 28 in the perfusion group and 16 of 29 in the control group have relapsed. Eleven patients in the control group and 3 patients in the perfusion group have died due to metastatic spread of the melanoma (p less than 0.01). The results most clearly demonstrate the benefits of additional hyperthermic cytostatic perfusion.

RCT Entities:   Population Interventions Outcomes