Phase III Study of Mediastinal Lymph Node Dissection for Ground Glass Opacity-Dominant Lung Adenocarcinoma.

We aimed to investigate whether no mediastinal LND was noninferior to systematic LND in patients with ground glass opacity (GGO)-dominant invasive lung adenocarcinoma.

我们旨在研究在以磨玻璃影（GGO）为主的侵袭性肺腺癌患者中，不行纵隔淋巴结清扫是否不劣于系统性淋巴结清扫。

Methods

We conducted a multicenter, open-label, phase III, noninferiority randomized controlled trialcomparing systematic mediastinal LND versus no mediastinal LND in patients with GGO-dominant invasive lung adenocarcinoma, who were predicted to have no lymph node metastasis on the basis of criteria established in our previous trial. The primary end point was 3-year disease-free survival. An interim analysis was planned upon enrollment of 300 patients, with predefined termination criteria if no mediastinal lymph node metastasis is detected and life-threatening complications occur in the systematic LND arm.

我们开展了一项多中心、开放标签、III期、非劣效性随机对照试验，比较了系统性纵隔淋巴结清扫（LND）与不进行纵隔LND在预测无淋巴结转移的磨玻璃样变性为主的浸润性肺腺癌患者中的效果。主要终点是3年无病生存率。计划在招募300名患者后进行中期分析，如果在系统性LND组中未检测到纵隔淋巴结转移并且出现危及生命的并发症，则有预定的终止标准。

This trial is registered on ClinicalTrials.gov (ECTOP-1009, identifier: NCT04527419).

该试验已在ClinicalTrials.gov上注册（ECTOP-1009，注册号：NCT04527419）。

Results

Interim analysis of 302 patients revealed no lymph node metastasis in either study arm.

对302名患者的中期分析显示，两个研究组中均未发现淋巴结转移。

The no LND arm had significantly reduced surgery duration (mean, 74 minutes v 109 minutes; P < .001), blood loss (mean, 44 mL v 82 mL; P = .033), and postoperative hospital stay (mean, 3.9 days v 4.5 days; P = .002).

无淋巴结清扫（LND）组的手术时间显著缩短（平均74分钟对比109分钟；P < .001），术中出血量减少（平均44毫升对比82毫升；P = .033），以及术后住院时间缩短（平均3.9天对比4.5天；P = .002）。

Complications observed in the systematic LND arm included chylothorax in one patient (0.7%) and intraoperative massive bleeding because of superior vena cava injury in one patient (0.7%).

系统性淋巴结清扫组观察到的并发症包括一名患者（0.7%）出现乳糜胸和一名患者（0.7%）因上腔静脉损伤导致术中大出血。

No lymphadenectomy-related complications occurred in the no LND arm.

在未进行淋巴结清扫的组别中，没有出现与淋巴结清扫相关的并发症。

Conclusions

On the basis of interim findings and the principle of nonmaleficence, the trial should be terminated.

基于中期发现和不造成伤害的原则，应终止该试验。

Systematic mediastinal LND should no longer be recommended for patients with GGO-dominant lung adenocarcinoma.

对于以磨玻璃影为主的肺腺癌患者，不应再推荐系统性纵隔淋巴结清扫术。