Cascinelli N, Morabito A, Santinami M, MacKie R M, Belli F
Department of General Surgery, Casa di Cura S Pio X, Milano, Italy.
Lancet. 1998 Mar 14;351(9105):793-6. doi: 10.1016/s0140-6736(97)08260-3.
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.
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 regional node dissection or a regional node dissection delayed until appearance of regional-node metastases.
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.
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.
对于无任何临床转移扩散证据的皮肤黑色素瘤患者，是否进行选择性区域淋巴结清扫仍存在争议。我们的目的是评估对躯干黑色素瘤且无区域淋巴结及远处转移临床证据的患者立即进行淋巴结清扫的疗效。
世界卫生组织黑色素瘤项目于1982年至1989年开展了一项国际多中心随机试验。该试验仅纳入厚度为1.5毫米或更厚的躯干黑色素瘤患者。在对原发性黑色素瘤进行广泛切除后，患者被随机分为立即进行区域淋巴结清扫或延迟至区域淋巴结转移出现时进行区域淋巴结清扫。
纳入的252例患者中，240例（95%）符合条件且可进行分析评估。其中122例被随机分配至立即进行淋巴结清扫组。延迟淋巴结清扫组患者的5年生存率为51.3%（95%可信区间41.7 - 60.1），而立即进行淋巴结清扫组患者为61.7%（52.0 - 70.1）（p = 0.09）。隐匿性区域淋巴结转移患者的5年生存率为48.2%（28.0 - 65.8），而区域淋巴结清扫延迟至区域淋巴结转移出现时的患者为26.6%（13.4 - 41.8，p = 0.04）。多变量分析显示，常规立即进行淋巴结清扫对生存率无影响（风险比为0.72，95%可信区间0.5 - 1.02），而区域淋巴结状态对生存率有显著影响（p = 0.007）。随访期间临床和组织学检查显示区域淋巴结呈阳性的患者预后最差。
淋巴结清扫仅能提高有淋巴结转移患者的生存率。前哨淋巴结活检可能成为识别隐匿性淋巴结转移患者的工具，这些患者随后可进行淋巴结清扫。
