Immediate or delayed dissection of regional nodes in patients with melanoma of the trunk: a randomised trial
Immediate or delayed dissection of regional nodes in patients with melanoma of the trunk: a randomised trial
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DOI：
10.1016/s0140-6736(97)08260-3
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发表时间：
1998-03-14
期刊：
影响因子：
168.9
通讯作者：
Belli, F
中科院分区：
文献类型：
--
作者：
Cascinelli, N;Morabito, A;Belli, F
背景：在没有任何转移扩散临床证据的皮肤黑色素瘤患者中，选择性区域淋巴结清扫术的使用仍有争议。我们的目的是评估即时淋巴结清扫术的疗效与黑色素瘤的躯干和没有临床证据的区域节点和远处metastasis.Methods一个国际多中心随机试验进行了世界卫生组织黑色素瘤计划从1982年至1989年。该试验仅包括躯干黑色素瘤厚度为1.5 mm或以上的患者。原发性黑色素瘤广泛切除后，患者被随机分配到立即区域淋巴结清扫术或区域淋巴结清扫术，直到出现区域淋巴结转移。其中122例被随机分配至即刻淋巴结清扫。5-延迟淋巴结清扫患者的年生存率为51.3%（95% CI 41.7-60.1），而立即淋巴结清扫患者的年生存率为61.7%（52.0-70.1）（p=0.09）。5-隐匿性区域淋巴结转移患者的年生存率为48.2%（28.0-65.8），而延迟区域淋巴结清扫至出现区域淋巴结转移时的年生存率为26.6%（13.4-41.8，p=0.04）。多变量分析显示，常规使用即时淋巴结清扫对生存率没有影响（风险比0.72，95% CI 0.5-1.02），而区域淋巴结的状态显著影响生存率（p=0.007）。在随访期间临床和组织学阳性的区域淋巴结患者预后最差。解释淋巴结清扫仅增加淋巴结转移患者的生存率。前哨淋巴结活检可能成为一种工具，以确定患者的隐匿性淋巴结转移，谁可以接受淋巴结清扫。
Background The use of elective regional node dissection in patients with cutaneous melanoma without any clinical evidence of metastatic spread is still debated. Our aim was to evaluate the efficacy of immediate node dissection in patients with melanoma of the trunk and without clinical evidence of regional node and distant metastases.Methods An international multicentre randomised trial was carried out by the WHO Melanoma Programme from 1982 to 1989. The trial included only patients with a trunk melanoma 1.5 mm or more in thickness. After wide excision of primary melanoma, patients were randomised to either immediate regiona node dissection or a regional node dissection delayed until appearance of regional-node metastases.Findings Of the 252 patients entered, 240 (95%) were eligible and evaluable for analysis. 122 of these were randomised to immediate node dissection. 5-year survival observed in patients who had delayed node dissection was 51.3% (95% CI 41.7-60.1) compared with 61.7% (52.0-70.1) of patients who had immediate node dissection (p=0.09). 5-year survival rate in patients with occult regional node metastases was 48.2% (28.0-65.8) and 26.6% (13.4-41.8, p=0.04) in patients in whom the regional node dissection was delayed until the time of appearance of regional node metastases. Multivariate analysis showed that routine use of immediate node dissection had no impact on survival (hazard ratio 0.72, 95% CI 0.5-1.02), whilst the status of regional nodes affected survival significantly (p=0.007). The patients with regional nodes that became clinically and histologically positive during follow-up had the poorest prognosis.Interpretation Node dissection offers increased survival in patients with node metastases only. Sentinel node biopsy may become a tool to identify patients with occult node metastases, who could then undergo node dissection.