Efficacy of an elective regional lymph node dissection of 1 to 4 mm thick melanomas for patients 60 years of age and younger
Efficacy of an elective regional lymph node dissection of 1 to 4 mm thick melanomas for patients 60 years of age and younger
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DOI：
10.1097/00000658-199609000-00002
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发表时间：
1996-09-01
影响因子：
9
通讯作者：
Wanebo, HJ
中科院分区：
文献类型：
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作者：
Balch, CM;Soong, SJ;Wanebo, HJ
目的采用跨组黑色素瘤外科计划，对740例I、II期黑色素瘤患者进行前瞻性、多机构随机手术试验，以确定与临床观察相比，选择性(即刻)淋巴清扫(ELND)治疗中厚度(1~4 mm)黑色素瘤是否能提高生存率。第二个目标是确定接受ELND治疗的黑色素瘤患者的亚组。方法根据肿瘤厚度、解剖位置和溃疡情况对符合条件的患者进行分层，然后预先随机进行ELND或结节观察。采用标准化的手术指南进行股骨、腋窝或改良颈清扫术。结果中位随访时间为7.4年。多因素(COX回归)分析显示，以下因素独立地影响患者的生存：肿瘤溃疡、躯干部位、肿瘤厚度和患者年龄。手术治疗结果首先基于随机意向进行比较。接受ELND或结节观察的患者总体5年生存率没有显著差异。然而，年龄在60岁或以下的552名ELND患者(占总数的75%)的5年生存率显著高于对照组。在这些患者中，335例肿瘤厚度为1~2 mm的患者、403例无肿瘤溃疡的患者和284例肿瘤厚度为1~2 mm且无溃疡的患者的5年生存率，ELND组优于结节观察组。相比之下，患有ELND的60岁以上的患者实际上比那些进行结节观察的患者的生存趋势更低。当根据实际接受的治疗(即包括交叉患者)比较生存率时，ELND术后5年生存率显著提高的患者包括肿瘤厚度为1~2 mm的患者、无溃疡的患者、60岁或以下肿瘤厚度为1~2 mm或无溃疡的患者。结论这是首次证实手术治疗临床隐匿性区域转移的价值的随机研究。60岁或以下患有中等厚度黑色素瘤的患者，特别是那些非溃疡性黑色素瘤和肿瘤厚度为1至2毫米的患者，可以受益于ELND。然而，由于一些患者仍在发展为远处疾病，这些结果应被视为中期分析。
ObjectiveA prospective multi-institutional randomized surgical trial involving 740 stage I and II melanoma patients was conducted by the Intergroup Melanoma Surgical Program to determine whether elective (immediate) lymph node dissection (ELND) for intermediate-thickness melanoma (1-4 mm) improves survival rates compared with clinical observation of the lymph nodes. A second objective was to define subgroups of melanoma patients who would have a higher survival with ELND.MethodsThe eligible patients were stratified according to tumor thickness, anatomic site, and ulceration, and then were prerandomized to either ELND or nodal observation. Femoral, axillary, or modified neck dissections were performed using standardized surgical guidelines.ResultsThe median follow-up was 7.4 years. A multifactorial (Cox regression) analysis showed that the following factors independently influenced survival: tumor ulceration, trunk site, tumor thickness, and patient age. Surgical treatment results were first compared based on randomized intent. Overall 5-year survival was not significantly different for patients who received ELND or nodal observation. However, the 552 patients 60 years of age or younger (75% of total group) with ELND had a significantly better 5-year survival. Among these patients, 5-year survival was better with ELND versus nodal observation for the 335 patients with tumors 1 to 2 mm thick, the 403 patients without tumor ulceration, and the 284 patients with tumors 1 to 2 mm thick and no ulceration. In contrast, patients cider than 60 years of age who had ELND actually had a lower survival trend than those who had nodal observation. When survival rates were compared based on treatment actually received (i.e., including crossover patients), the patients with significantly improved 5-year survival rates after ELND included those with tumors 1 to 2 mm thick, those without tumor ulceration, and those 60 years of age or younger with tumors 1 to 2 mm thick or without ulceration.ConclusionThis is the first randomized study to prove the value of surgical treatment for clinically occult regional metastases. Patients 60 years of age or younger with intermediate-thickness melanomas, especially those with nonulcerative melanoma and those with tumors 1 to 2 mm thick, may benefit from ELND. However, because some patients still are developing distant disease, these results should be considered an interim analysis.