Three-field vs two-field lymphadenectomy in thoracic ESCC patients: a multicenter randomized study (NST 1503)

IF 9.4 Q1 ONCOLOGY Journal of the National Cancer Center Pub Date : 2025-04-01 Epub Date: 2025-01-14 DOI:10.1016/j.jncc.2025.01.002

Yousheng Mao , Shuoyan Liu , Yongtao Han , Shiping Guo , Chun Chen , Shugeng Gao , Anlin Hao , Hongbing Duan , Wentao Fang , Renquan Zhang , Zhentao Yu , Xiangning Fu , Xiaofei Li , Qun Wang , Lijie Tan , Zhigang Li , Yin Li , Zhirong Zhang , Wenqiang Wei , Yan Fang , Jie He

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Abstract

Background

3-field lymph node dissection (3FL) frequently lead to much more perioperative complications than 2-field lymph node dissection (2FL). This study was designed as a non-inferiority trial to evaluate whether 3FL could be omitted without compromising overall survival (OS) and disease-free survival (DFS) in the patients with resectable thoracic esophageal squamous cell cancer (ESCC) and negative right recurrent laryngeal nerve lymph nodes (RRLN-LNs).

Methods

cT1b-3N0–1M0 thoracic ESCC patients were managed in 3 arms during open or minimally invasive McKeown esophagectomy according to the results of frozen section examination for RRLN-LNs: if positive, direct 3FL (RRLN[+]-3FL); if negative, 2FL (RRLN[-]-2FL) or 3FL (RRLN[-]-3FL) by randomization.

Results

Based on frozen section, of the 829 finally recruited patients, 121 (13.6 %) had positive RRLN-LNs and direct 3FL (RRLN[+]-3FL); 766 had negative RRLN-LNs and were randomized into the RRLN [-]-2FL (386 cases) or RRLN[-]-3FL (380 cases) group. The cervical LN metastasis rate in the RRLN[+]-3FL group (28.9 %) was significantly higher than that in the RRLN[-]-3FL group (8.3 %) (P<0.001). The 5-year OS and DFS were 72.2 % and 65.1 % in the RRLN[-]-3FL group and 68.8 % and 62.8 % in the RRLN[-]-2FL group (OS, P = 0.163; DFS, P = 0.378), versus 50.3 % and 41.2 % in the RRLN[+]-3FL group (both P<0.001), respectively.

Conclusions

Additional cervical lymphadenectomy can be avoided in the patients with middle or lower thoracic ESCC and negative RRLN-LNs by frozen section treated by upfront surgery.

Trial Registration: ClinicalTrials.gov Identifier NCT02448953.

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胸部 ESCC 患者的三野与两野淋巴结切除术：一项多中心随机研究（NST 1503）

背景：三野淋巴结清扫术（3FL）往往比二野淋巴结清扫术（2FL）导致更多的围手术期并发症。本研究设计为一项非劣效性试验，旨在评估可切除胸段食管鳞状细胞癌（ESCC）和右侧喉返神经淋巴结（RRLN-LNs）阴性患者是否可以在不影响总生存期（OS）和无病生存期（DFS）的情况下省略3FL。方法根据RRLN- lns冰冻切片检查结果，将sct1b - 3n0 - 1m0例胸段ESCC患者在开放式或微创McKeown食管切除术中分为3组进行处理：如果RRLN- lns阳性，直接3FL (RRLN[+]-3FL)；如果阴性，随机选择2FL （RRLN[-]-2FL）或3FL （RRLN[-]-3FL）。结果根据冷冻切片，最终招募的829例患者中，121例（13.6%）为RRLN- lns阳性和直接3FL (RRLN[+]-3FL)；766例RRLN- lns阴性，随机分为RRLN[-]- 2fl组（386例）和RRLN[-]- 3fl组（380例）。RRLN[+]- 3fl组颈淋巴转移率（28.9%）显著高于RRLN[-]- 3fl组（8.3%）（P<0.001）。RRLN[-]- 3fl组5年OS和DFS分别为72.2%和65.1%，RRLN[-]- 2fl组为68.8%和62.8% (OS, P = 0.163；DFS, P = 0.378)， RRLN[+]-3FL组分别为50.3%和41.2% （P = 0.001）。结论术前冷冻切片治疗中、下段ESCC及RRLN-LNs阴性患者可避免行额外的颈淋巴清扫手术。试验注册：ClinicalTrials.gov标识符NCT02448953。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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