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

Author(s): Yang Zhang, MD^1,2,3; Bin Qian, MD⁴; Qingping Song, MD⁵; Junjie Ma, MD⁶; Hang Cao, MD^1,2,3; Chaoqiang Deng, MD^1,2,3; Shengping Wang, MD^3,7; Ting Ye, MD^1,2,3; Jiaqing Xiang, MD^1,2,3; Yawei Zhang, MD^1,2,3; Yihua Sun, MD^1,2,3; Yueren Yan, MD^1,2,3; Shanbo Zheng, MD^1,2,3; Haoxuan Wu, MD^1,2,3; Qingyuan Huang, MD^1,2,3; Hong Hu, MD^1,2,3; Yuan Li, MD, PhD^3,8; Fangqiu Fu, MD^1,2,3; Haiquan Chen, MD, PhD^1,2,3;

Source: DOI: 10.1200/JCO-25-00610

Dr. Maen Hussein's Thoughts

Interim analysis of 302 patients revealed no lymph node metastases in either study arm. No lymphadenectomy-related complications occurred in the no-LND arm.

PURPOSE

Systematic mediastinal lymph node dissection (LND) or sampling is currently recommended for patients with early-stage non–small cell lung cancer. We aimed to investigate whether no mediastinal LND was noninferior to systematic LND in patients with ground glass opacity (GGO)–dominant invasive lung adenocarcinoma.

METHODS

We conducted a multicenter, open-label, phase III, noninferiority randomized controlled trial comparing 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. This trial is registered on ClinicalTrials.gov (ECTOP-1009, identifier: NCT04527419).

RESULTS

Interim analysis of 302 patients revealed no lymph node metastasis in either study arm. 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). 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%). No lymphadenectomy-related complications occurred in the no LND arm.

CONCLUSION

On the basis of interim findings and the principle of nonmaleficence, the trial should be terminated. Systematic mediastinal LND should no longer be recommended for patients with GGO-dominant lung adenocarcinoma.

Author Affiliations

¹Department of Thoracic Surgery and State Key Laboratory of Genetics and Development of Complex Phenotypes, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China; ²Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China; ³Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China; ⁴Department of Thoracic Surgery, Jiangdu People's Hospital Affiliated to Medical College of Yangzhou University, Jiangsu, People's Republic of China; ⁵Department of Thoracic Surgery, Liaocheng Cancer Hospital, Shandong, People's Republic of China; ⁶Department of Thoracic Surgery, Liaocheng Second People's Hospital, Shandong, People's Republic of China; ⁷Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China; ⁸Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China

Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules

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Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non–Small-Cell Lung Cancer: The Phase III POSEIDON Study

Suddenly met-NSCLC is a crowded space. This study did not conclude that T+D+CT was better than D+CT, the findings showed that D+CT was better than CT alone. The addition of T to D+CT improved the PFS and OS trend but I don’t think this was a homerun result. There was not a significant OS benefit and further follow-up will declare these results. Also an improved outcomes were not seen in the non-squamous population. The pembrolizumab studies have 5+ years of follow-up and an improvement in PFS and OS across NSCLC subtypes.