Sentinel-node biopsy or nodal observation in melanoma
Sentinel-node biopsy or nodal observation in melanoma
复制标题
DOI：
10.1056/nejmoa060992
复制
发表时间：
2006-09-28
影响因子：
158.5
通讯作者：
Wang, He-Jing
中科院分区：
文献类型：
--
作者：
Morton, Donald L.;Thompson, John F.;Wang, He-Jing
背景：我们评估了前哨淋巴结活检对新诊断的黑色素瘤患者预后的影响。方法：将原发性皮肤黑色素瘤患者随机分为两组，如果有淋巴结复发，则进行广泛切除并术后观察区域淋巴结；如果活检发现有微转移，则接受广泛切除并立即进行前哨淋巴结活检。结果：在1269例中厚原发黑色素瘤患者中，平均(+/-SE)估计人群的5年无病存活率，活检组为78.3+/-1.6%，观察组为73.1+/-2.1%(死亡风险比，0.74；95%可信区间[CI]，0.59~0.93；P=0.009)。两组黑色素瘤特异性5年生存率相似(分别为87.1+/-1.3%和86.6+/-1.6%)。在活检组中，前哨淋巴结转移是最重要的预后因素；肿瘤前哨淋巴结阳性患者的5年生存率为72.3%+/-4.6%，而肿瘤阴性前哨淋巴结患者的5年生存率为90.2%+/-1.3%(死亡风险比2.4895%可信区间1.543.98P<；0.001)。前哨淋巴结微转移发生率为16.0%(122/764例)，复发率为15.6%(78/500例)。相应的肿瘤受累结节的平均数目，活检组为1.4%，观察组为3.3%(P<；0.001)，表明观察期间疾病进展。在有淋巴结转移的患者中，立即清扫的患者的5年生存率高于延迟清扫的患者(72.3+/-4.6%vs.52.4+/-5.9%；死亡风险比0.51；95%可信区间0.32~0.81；P=0.004)。结论：根据前哨淋巴结活检结果对中等厚度(1.2~3.5 mm)的原发黑色素瘤的分期提供了重要的预后信息，并确定了可以通过立即清扫来延长生存期的淋巴结转移患者。(ClinicalTrials.gov编号，NCT00275496。)
Background: We evaluated the contribution of sentinel-node biopsy to outcomes in patients with newly diagnosed melanoma.Methods: Patients with a primary cutaneous melanoma were randomly assigned to wide excision and postoperative observation of regional lymph nodes with lymphadenectomy if nodal relapse occurred, or to wide excision and sentinel-node biopsy with immediate lymphadenectomy if nodal micrometastases were detected on biopsy.Results: Among 1269 patients with an intermediate-thickness primary melanoma, the mean (+/-SE) estimated 5-year disease-free survival rate for the population was 78.3+/-1.6% in the biopsy group and 73.1+/-2.1% in the observation group (hazard ratio for death, 0.74; 95% confidence interval [CI], 0.59 to 0.93; P=0.009). Five-year melanoma-specific survival rates were similar in the two groups (87.1+/-1.3% and 86.6+/-1.6%, respectively). In the biopsy group, the presence of metastases in the sentinel node was the most important prognostic factor; the 5-year survival rate was 72.3+/-4.6% among patients with tumor-positive sentinel nodes and 90.2+/-1.3% among those with tumor-negative sentinel nodes (hazard ratio for death, 2.48; 95% CI, 1.54 to 3.98; P < 0.001). The incidence of sentinel-node micrometastases was 16.0% (122 of 764 patients), and the rate of nodal relapse in the observation group was 15.6% (78 of 500 patients). The corresponding mean number of tumor-involved nodes was 1.4 in the biopsy group and 3.3 in the observation group (P < 0.001), indicating disease progression during observation. Among patients with nodal metastases, the 5-year survival rate was higher among those who underwent immediate lymphadenectomy than among those in whom lymphadenectomy was delayed (72.3+/-4.6% vs. 52.4+/-5.9%; hazard ratio for death, 0.51; 95% CI, 0.32 to 0.81; P=0.004).Conclusions: The staging of intermediate-thickness (1.2 to 3.5 mm) primary melanomas according to the results of sentinel-node biopsy provides important prognostic information and identifies patients with nodal metastases whose survival can be prolonged by immediate lymphadenectomy. (ClinicalTrials.gov number, NCT00275496.)