Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.
Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.
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DOI：
10.1056/nejmoa1613210
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发表时间：
2017-06-08
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影响因子：
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通讯作者：
Elashoff RM
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作者：
Faries MB;Thompson JF;Cochran AJ;Andtbacka RH;Mozzillo N;Zager JS;Jahkola T;Bowles TL;Testori A;Beitsch PD;Hoekstra HJ;Moncrieff M;Ingvar C;Wouters MWJM;Sabel MS;Levine EA;Agnese D;Henderson M;Dummer R;Rossi CR;Neves RI;Trocha SD;Wright F;Byrd DR;Matter M;Hsueh E;MacKenzie-Ross A;Johnson DB;Terheyden P;Berger AC;Huston TL;Wayne JD;Smithers BM;Neuman HB;Schneebaum S;Gershenwald JE;Ariyan CE;Desai DC;Jacobs L;McMasters KM;Gesierich A;Hersey P;Bines SD;Kane JM;Barth RJ;McKinnon G;Farma JM;Schultz E;Vidal-Sicart S;Hoefer RA;Lewis JM;Scheri R;Kelley MC;Nieweg OE;Noyes RD;Hoon DSB;Wang HJ;Elashoff DA;Elashoff RM
前哨淋巴结活检与黑色素瘤特异性生存率增加相关（即，在淋巴结阳性的中厚黑色素瘤（1.2 - 3.5 mm）患者中，前哨淋巴结转移患者完成淋巴结清扫的价值尚不清楚。在一项国际试验中，我们将通过标准病理学评估或多标记分子检测检测发现前哨淋巴结转移的患者随机分配到立即完成淋巴结清扫（清扫组）或超声检查观察淋巴结（观察组）。主要终点是黑色素瘤特异性生存率。次要终点包括无病生存率和累积非前哨淋巴结转移率。在1934例患者中，立即完成淋巴结清扫与黑色素瘤特异性生存率的增加无关，这些患者的数据可以在意向治疗分析中进行评估，或者在符合方案分析的1755例患者中进行评估。在符合方案分析中，中位随访43个月时，夹层组和观察组的平均（±SE）3年黑色素瘤特异性生存率相似（分别为86±1.3%和86± 1.2%;对数秩检验P=0.42）。剥离组的无病生存率略高于观察组（分别为68±1.7%和63± 1.7%;对数秩检验P=0.05），基于3年时区域淋巴结疾病控制率的增加（92±1.0% vs. 77±1.5%;对数秩检验P<0.001）;必须谨慎解释这些结果。夹层组中11.5%的患者存在非前哨淋巴结转移，是复发的一个强有力的独立预后因素（风险比，1.78; P=0.005）。在夹层组中24.1%的患者和观察组中6.3%的患者中观察到淋巴水肿。立即完成淋巴结清扫可提高局部疾病控制率，并提供预后信息，但不能提高黑色素瘤和前哨淋巴结转移患者的黑色素瘤特异性生存率。（由国家癌症研究所和其他机构资助; MSLT-II ClinicalTrials.gov编号，NCT 00297895。
Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (±SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86±1.3% and 86±1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68±1.7% and 63±1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92±1.0% vs. 77±1.5%; P<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P=0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895.)