A Prospective Randomized Study of Regional Extremity Perfusion in Patients with Malignant Melanoma
A Prospective Randomized Study of Regional Extremity Perfusion in Patients with Malignant Melanoma
复制标题
恶性黑色素瘤患者局部肢体灌注的前瞻性随机研究
作者：
F. Ghussen;K. Nagel;W. Groth;J. Müller;H. Stützer
107名四肢恶性黑色素瘤患者被纳入一项前瞻性随机研究，该研究旨在评估辅助热疗区域细胞抑素灌流的有效性。在对照组(A，N=54)，肿瘤被广泛切除并清扫区域淋巴结。第二组(B组，n=53)接受马法兰加温(42℃)灌流。平均随访时间为554天。我们选择无病生存时间作为成功的标准。这项研究可能会过早停止，因为中期评估显示两组之间存在非常显著的差异(p=0.0001)。我们观察到对照组有21例局部复发，而灌注组有4例复发。临床分期的回溯性细分也显示出显著差异。对照组I期复发率为27.8%，II期复发率为31.6%，III期复发率为58.8%。灌注组I期复发率为5.6%，II期复发率为5.5%，III期复发率为12.5%。以无瘤生存为目标标准的各组间差异有统计学意义，P=0.09I期，P=0.03，P=0.003。我们认为，根据我们的研究提供的证据，上述结果显示，辅助应用局部热凝细胞灌流已证明其优于单独的常规方法。
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.