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肺叶或肺段切除术后淋巴结清扫范围与无病生存期无关:CALGB 140503(联盟)研究结果

The extent of lymph node dissection is not associated with disease-free survival following lobar or sublobar resection: results from CALGB 140503 (Alliance).

作者信息

Altorki Nasser, Damman Bryce, Wang Xiaofei, Liberman Moishe, Wigle Dennis, Ashrafi Ahmad, Conti Massimo, Yasufuku Kazuhiro, Schuchert Matthew J, Stinchcombe Thomas E

机构信息

Weill Cornell Medicine - New York-Presbyterian Hospital, New York, NY, USA.

Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.

出版信息

J Thorac Cardiovasc Surg. 2025 Jun 16. doi: 10.1016/j.jtcvs.2025.06.007.

DOI:10.1016/j.jtcvs.2025.06.007
PMID:40532782
Abstract

OBJECTIVE

The extent of lymphadenectomy (LAD) in patients with c-stage I non-small cell lung cancer (NSCLC) is controversial. CALGB 140503 (Alliance; NCT00499330) randomized patients with peripheral clinical stage 1A NSCLC ≤ 2 cm to lobar (LR) or sublobar resection (SLR) after frozen section examination of 2 mediastinal and one major hilar node (simple sampling) confirmed the absence of nodal metastases. Additional node dissection was performed at the surgeon's discretion and included simple sampling (S), systematic sampling (SS), or complete lymph node dissection (CLND). Here, we report the impact of the extent of LAD on disease- and recurrence-free survival (DFS and RFS) in this trial.

METHODS

Between 6/2007 and 3/2017, 697 patients were randomized to LR (357) or SLR (340). Data on the extent of lymphadenectomy was available on 689 patients: 182 had CLND, 349 had SS, and 158 had S. DFS was defined as the time to lung cancer (LC) recurrence or all-cause mortality. RFS was defined as the time to LC recurrence or death from LC. Survival endpoints were estimated using the Kaplan-Meier method. Stratified Cox proportional hazards (PH) models estimated hazard ratios and their confidence intervals (CI).

RESULTS

Baseline characteristics were generally similar between groups. Five-year DFS was 62.3% (95%CI: 55.2 - 70.4%) after CLND, 65.7% (95%CI: 60.7 - 71.2%) after SS, and 61.2% (95%CI: 53.7 - 69.7%) after S. DFS was not statistically significantly different between LR and SLR based on the extent of node dissection. Five-year DFS among patients who had CLND was 65.7% (95%CI: 56.4 - 76.6%) after LR and 58.5% (95%CI: 48.2 - 71.1%) after SLR (p=0.530). Five-year DFS in patients who had S/SS was 63.5% (95%CI: 57.6 - 70.0%) after LR and 65.1% (95%CI: 59.2 - 71.6%) after SLR). Five-year RFS for patients who had CLND was 72.5% (95% CI: 63.5 - 82.9%) after LR and 68.9% (95%CI: 59.0 - 80.5%) after SLR (p=0.526). Five-year RFS in pts who had S/SS was 70.8% (95%CI: 65.0 - 77.0%) after LR and 70.2% (95%CI: 64.4 - 76.5%) after SLR (p=0.604). There was no difference between groups in the incidence of systemic recurrence or isolated hilar, mediastinal, or supraclavicular nodal recurrence.

CONCLUSIONS

In patients with peripheral c-stage IA NSCLC ≤ 2 cm in size who have no nodal metastases to at least two mediastinal and one major hilar lymph nodes, there is no difference in DFS or RFS based on the extent of lymph node dissection, regardless of the magnitude of parenchymal resection. Our findings apply to a highly selected cohort of patients deemed node negative by meticulous radiographic and intraoperative nodal staging.

摘要

目的

c期I非小细胞肺癌(NSCLC)患者的淋巴结清扫范围存在争议。CALGB 140503试验(联盟;NCT00499330)将外周临床分期为1A期且肿瘤直径≤2 cm的NSCLC患者随机分为肺叶切除组(LR)或亚肺叶切除组(SLR),在对2个纵隔淋巴结和1个主要肺门淋巴结进行冰冻切片检查(简单采样)确认无淋巴结转移后进行手术。额外的淋巴结清扫由外科医生自行决定,包括简单采样(S)、系统采样(SS)或完全淋巴结清扫(CLND)。在此,我们报告本试验中淋巴结清扫范围对无病生存期和无复发生存期(DFS和RFS)的影响。

方法

2007年6月至2017年3月期间,697例患者被随机分为LR组(357例)或SLR组(340例)。689例患者有淋巴结清扫范围的数据:182例进行了CLND,349例进行了SS,158例进行了S。DFS定义为肺癌(LC)复发或全因死亡的时间。RFS定义为LC复发或死于LC的时间。生存终点采用Kaplan-Meier方法估计。分层Cox比例风险(PH)模型估计风险比及其置信区间(CI)。

结果

两组的基线特征总体相似。CLND术后5年DFS为62.3%(95%CI:55.2 - 70.4%),SS术后为65.7%(95%CI:60.7 - 71.2%),S术后为61.2%(95%CI:53.7 - 69.7%)。基于淋巴结清扫范围,LR组和SLR组的DFS无统计学显著差异。CLND患者中,LR术后5年DFS为65.7%(95%CI:56.4 - 76.6%),SLR术后为58.5%(95%CI:48.2 - 71.1%)(p = 0.530)。S/SS患者中,LR术后5年DFS为63.5%(95%CI:57.6 - 70.0%),SLR术后为65.1%(95%CI:59.2 - 71.6%)。CLND患者中,LR术后5年RFS为72.5%(95%CI:63.5 - 82.9%),SLR术后为68.9%(95%CI:59.0 - 80.5%)(p = 0.526)。S/SS患者中LR术后5年RFS为70.8%(95%CI:65.0 - 77.0%),SLR术后为70.2%(95%CI:64.4 - 76.5%)(p = 0.604)。全身复发或孤立性肺门、纵隔或锁骨上淋巴结复发的发生率在两组之间无差异。

结论

对于外周c期IA期、肿瘤大小≤2 cm且至少2个纵隔淋巴结和1个主要肺门淋巴结无转移的NSCLC患者,无论实质切除范围如何,基于淋巴结清扫范围的DFS或RFS无差异。我们的研究结果适用于通过细致的影像学和术中淋巴结分期被认为淋巴结阴性的高度选择的患者队列。

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Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial.右侧结肠癌手术治疗的淋巴结清扫范围:随机 III 期 RELARC 试验。
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Which extent of surgical resection thoracic surgeons would choose if they were diagnosed with an early-stage lung cancer: a European survey.如果胸外科医生被诊断为早期肺癌,他们会选择何种程度的手术切除:一项欧洲调查。
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早期胃癌患者腹腔镜前哨淋巴结导航保胃手术的临床疗效:SENORITA试验的5年结果
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Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial.前哨淋巴结活检与阴性超声腋窝淋巴结结果的小乳腺癌患者不进行腋窝手术的比较:SOUND 随机临床试验。
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