Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm)
Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm)
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DOI：
10.1007/s10434-000-0087-9
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发表时间：
2000-03-01
影响因子：
3.7
通讯作者：
Harrison, R
中科院分区：
文献类型：
--
作者：
Balch, CM;Soong, SJ;Harrison, R
背景资料：10 - 15年生存率结果分析来自一项前瞻性多机构随机手术试验，该试验涉及740例I期和II期中厚黑色素瘤患者（1.0至4.0 mm），并与择期（立即）淋巴结清扫术（ELND），结合淋巴结的临床观察以及独立预测预后的预后因素。符合条件的患者根据肿瘤厚度、解剖部位和溃疡进行分层，然后预先随机分配至ELND或淋巴结观察组。采用考克斯逐步多元回归分析，肿瘤厚度是预后的独立预测因素（P < .001），肿瘤溃疡的存在（P < .001），躯干部位（P = .003），患者年龄超过60岁结果：接受ELND或淋巴结观察的患者的总体10年生存率无显著差异（77% vs. 73%; P = 0.12）。在前瞻性分层的患者亚组中，ELND患者的10年生存率更高，543例非溃疡性黑色素瘤患者的死亡率降低了30（84% vs. 77%; P = 0.03），446例肿瘤厚度为1.0至2.0 mm的患者的死亡率降低30%（86%对80%; P = 0.03），385例肢体黑色素瘤患者的死亡率降低27%（84%对78%; P = 0.05）。在这些亚组中，溃疡的存在或不存在应该是对中等厚度黑色素瘤患者进行ELND治疗建议的关键因素。这些来自77家机构治疗的患者的长期生存率表明，溃疡和肿瘤厚度是主要的预测因素，应用于I期和II期黑色素瘤的分期，并赋予这些前瞻性定义的黑色素瘤患者亚组生存优势。
Background: Ten- to 15-year survival results were analyzed from a prospective multi-institutional randomized surgical trial that involved 740 stages I and II melanoma patients with intermediate thickness melanomas (1.0 to 4.0 mm) and compared elective (immediate) lymph node dissection (ELND) with clinical observation of the lymph nodes as well as prognostic factors that independently predict outcomes.Methods: Eligible patients were stratified according to tumor thickness, anatomical site, and ulceration, and then prerandomized to either ELND or nodal observation. By using Cox stepwise multivariate regression analysis, the independent predictors of outcome were tumor thickness (P < .001), the presence of tumor ulceration (P < .001), trunk site (P = .003), and patient age more than 60 years (P = .01).Results: Overall 10-year survival was not significantly different for patients who received ELND or nodal observation (77% vs. 73%; P = .12). Among the prospectively stratified subgroups of patients, 10-year survival rates favored those patients with ELND, with a 30% reduction in mortality rate for the 543 patients with nonulcerated melanomas (84% vs. 77%; P = .03), a 30% reduction in mortality rate for the 446 patients with tumor thickness of 1.0 to 2.0 mm (86% vs. 80%; P = .03), and a 27% reduction in mortality rate for 385 patients with limb melanomas (84% vs. 78%; P = .05). Of these subgroups, the presence or absence of ulceration should be the key factor for making treatment recommendations with regard to ELND for patients with intermediate thickness melanomas.Conclusions: These long-term survival rates from patients treated at 77 institutions demonstrate that ulceration and tumor thickness are dominant predictive factors that should be used in the staging of stages I and II melanomas, and confer a survival advantage for these subgroups of prospectively defined melanoma patients.