Ghussen F, Nagel K, Groth W, Müller J M, Stützer H
Ann Surg. 1984 Dec;200(6):764-8. doi: 10.1097/00000658-198412000-00016.
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.
107例四肢恶性黑色素瘤患者纳入一项前瞻性随机研究，该研究旨在评估辅助性热灌注化疗的有效性。对照组（A组，N = 54）行肿瘤广泛切除及区域淋巴结清扫。第二组（B组，N = 53）在上述治疗基础上接受美法仑42℃热灌注化疗。平均随访观察期为554天。我们选择无病生存时间作为成功标准。由于中期评估显示两组间存在高度显著差异（p = 0.0001），该研究可提前终止。我们观察到对照组有21例局部复发，灌注组有4例复发。按临床分期进行的回顾性分析也显示出显著差异。对照组I期复发率为27.8%，II期为31.6%，III期为58.8%。在灌注组，我们观察到I期复发率为5.6%，II期为5.5%，III期为12.5%。基于无病生存这一目标标准，两组间差异在I期的显著性水平为p = 0.09，II期为p = 0.03，III期为p = 0.003。基于上述研究结果所提供的证据，我们认为区域热灌注化疗的辅助应用已证明优于单纯的传统治疗方法。
