Final trial report of sentinel-node biopsy versus nodal observation in melanoma.
Final trial report of sentinel-node biopsy versus nodal observation in melanoma.
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DOI：
10.1056/nejmoa1310460
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发表时间：
2014-02-13
期刊：
影响因子：
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通讯作者：
MSLT Group
中科院分区：
文献类型：
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作者：
Morton DL;Thompson JF;Cochran AJ;Mozzillo N;Nieweg OE;Roses DF;Hoekstra HJ;Karakousis CP;Puleo CA;Coventry BJ;Kashani-Sabet M;Smithers BM;Paul E;Kraybill WG;McKinnon JG;Wang HJ;Elashoff R;Faries MB;MSLT Group
前哨淋巴结活检是一种微创的区域性黑色素瘤分期方法，在3期试验中进行了评估。我们评估了2001例原发性皮肤黑色素瘤患者的结果，这些患者被随机分配到接受广泛切除和结节观察的患者中(观察组)，或广泛切除和前哨淋巴结活检的患者(观察组)，对于活检发现的淋巴结转移立即进行淋巴清扫(活检组)。在总体研究人群中，与治疗相关的10年特定黑色素瘤存活率没有显著差异(有淋巴结转移的20.8%和没有淋巴结转移的79.2%)。活检组与观察组相比，中层黑色素瘤定义为1.20~3.50 mm的患者(71.3±1.8%比64.7±2.3%；复发转移风险比0.76；P=0.01)和厚黑色素瘤定义为3.50 mm的患者(50.7±4.0%比40.5±4.7%；风险比0.70；P=0.03)的10年无瘤生存率显著提高。在中等厚度黑色素瘤患者中，有转移者的10年生存率为62.1±4.8%，无转移者为85.1±1.5%(黑色素瘤死亡风险比为3.0 9；P=0.001)，在厚层黑色素瘤患者中分别为48.0±7.0%和64.6±4.9%(风险比为1.75；P=0.0 3)。对于患有中等厚度黑色素瘤和结节转移的患者，基于活检的治疗提高了10年无远地疾病存活率(远处转移风险比为0.62；P=0.02)和10年特定黑色素瘤存活率(黑色素瘤死亡风险比为0.56；P=0.006)。进行加速失效潜伏期亚组分析，以说明这样一个事实，即最初只在活检组中知道结节状态，并且持续有显著的治疗益处。以活检为基础的中等厚度或厚的原发黑色素瘤的分期提供了重要的预后信息，并确定了可能从立即彻底淋巴清扫中受益的淋巴结转移患者。基于活检的治疗延长了所有患者的无病生存期，延长了中等厚度黑色素瘤结节转移患者的远处无病生存期和黑色素瘤特异性生存期。(由国家癌症研究所、国家卫生研究院以及澳大利亚和新西兰黑色素瘤试验小组资助；ClinicalTrials.gov编号，NCT00275496。)
Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial. We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (observation group), or wide excision and sentinel-node biopsy, with immediate lymphadenectomy for nodal metastases detected on biopsy (biopsy group). No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population (20.8% with and 79.2% without nodal metastases). Mean (±SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3±1.8% vs. 64.7±2.3%; hazard ratio for recurrence or metastasis, 0.76; P = 0.01), and those with thick melanomas, defined as >3.50 mm (50.7±4.0% vs. 40.5±4.7%; hazard ratio, 0.70; P = 0.03). Among patients with intermediate-thickness melanomas, the 10-year melanoma-specific survival rate was 62.1±4.8% among those with metastasis versus 85.1±1.5% for those without metastasis (hazard ratio for death from melanoma, 3.09; P<0.001); among patients with thick melanomas, the respective rates were 48.0±7.0% and 64.6±4.9% (hazard ratio, 1.75; P = 0.03). Biopsy-based management improved the 10-year rate of distant disease–free survival (hazard ratio for distant metastasis, 0.62; P = 0.02) and the 10-year rate of melanoma-specific survival (hazard ratio for death from melanoma, 0.56; P = 0.006) for patients with intermediate-thickness melanomas and nodal metastases. Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group, and a significant treatment benefit persisted. Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy. Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease–free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas. (Funded by the National Cancer Institute, National Institutes of Health, and the Australia and New Zealand Melanoma Trials Group; ClinicalTrials.gov number, NCT00275496.)