One hundred seven patients presenting with malignant melanoma of the extremities were included in a prospective randomized study, which was conducted to evaluate the effectiveness of adjuvant hyperthermic regional cytostatic perfusion. In a control group (A, N = 54) the tumors were excised widely and the regional lymph nodes were dissected. The patients in the second group (B, N = 53) received additional hyperthermic (42 C) perfusion with melphalan. The mean follow-up observation period was 554 days. We chose the disease-free survival time as the criterion for success. The study could be discontinued prematurely, since the intermediate evaluation revealed a highly significant difference between the groups (p = 0.0001). We observed 21 local recurrences in the control group and four recurrences in the perfusion group. The retrospective breakdown by clinical stages also showed significant differences. The recurrence rate in the control group was 27.8% in Stage I, 31.6% in Stage II, and 58.8% in Stage III. In the perfusion group we observed recurrences equaling 5.6% in Stage I, 5.5% in Stage II, and 12.5% in Stage III. The differences between the groups based on the target-criterion of disease-free survival represent significance levels of p = 0.09 in Stage I, p = 0.03 in Stage II, and p = 0.003 in Stage III. We feel that on the evidence provided by our study, shown in the above results, the adjuvant application of regional hyperthermic cytostatic perfusion has proven itself to be superior to conventional procedures alone.

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.

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A simple, reliable and efficient miniaturized extracorporeal circulation system for the use in small animals, especially for the perfusion of rat hind limbs, has been described. The system consists of a newly devised bubble oxygenator and heat exchanger and of commercially available roller pumps, polyethylene cannulas and silicone tubes. The minimal and maximal priming volume of the entire system is 4.7 and 16.7 ml, respectively. The efficiency of the system is reflected in a high value of oxygen uptake in the range of 0.061 ml O2 X min-1 X ml-1 blood, a heat transfer coefficient ranging from 0.96 to 0.31 at flow rates between 1 and 20 ml X min-1, a low pulsation amplitude of the roller pump, a constant flow resistance at the arterial cannula, which implies optimal flow conditions, and in a low blood trauma with plasma hemoglobin concentrations of 47.5 +/- 5 mg dl-1 after 60 min of in vitro perfusion.