In a trial (MEDIASTrial) reported in the Journal of Clinical Oncology, Bousema et al found that immediate lung tumor resection after negative systematic endosonography was noninferior to confirmatory mediastinoscopy in the detection of unforeseen N2 disease in patients with non–small cell lung cancer (NSCLC).
Study Details
In the trial, 346 patients from sites in the Netherlands and Belgium with suspected resectable NSCLC and an indication for mediastinal staging after negative systematic endosonography were randomly assigned between July 2017 and October 2020 to undergo immediate tumor resection with lymph node dissection (n = 171) or mediastinoscopy followed by resection and lymph node dissection (n = 175). The primary outcome measure was presence of unforeseen N2 disease in the immediate resection group vs the confirmatory mediastinoscopy group, with a noninferiority margin of 8% for the difference in upper limits of the 95% confidence intervals (CIs; P for noninferiority = .0250).
Key Findings
The study found that mediastinoscopy detected metastases in 14 (8.0%, 95% confidence interval [CI] = 4.8%–13.0%) of 175 patients.
In intention-to-treat analysis, unforeseen N2 disease was found in 15 (8.8%, 95% CI = 5.4%–14.0%) of 171 patients in the immediate resection group vs 12 (7.7%, 95% CI = 4.5%–13.0%) of 155 in the mediastinoscopy group (difference = 1.03%; difference in upper limit of 95% CI = 7.2%; P for noninferiority = .0144).
In per-protocol analysis, unforeseen N2 disease was found in 15 (9.0%, 95% CI = 5.6%–14.4%) of 166 patients in the immediate resection group vs 11 (8.2%, 95% CI = 4.7–14.1) of 134 patients in the mediastinoscopy group (difference = 0.83%; difference in upper limit of 95% CI = 7.3%; P for noninferiority = .0157).
Major morbidity or 30-day mortality occurred in 12.9% of the immediate resection group vs 15.4% of the mediastinoscopy group (P = .4940).
The investigators concluded: “On the basis of our chosen noninferiority margin in the rate of unforeseen N2, confirmatory mediastinoscopy after negative systematic endosonography can be omitted in patients with resectable NSCLC and an indication for mediastinal staging.”
Frank J.C. van den Broek, MD, PhD, Department of Surgery, Máxima MC, Veldhoven, the Netherlands, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The trial was funded by The Netherlands Organisation for Health Research and Development and Dutch Cancer Society. For full disclosures of the study authors, visit ascopubs.org.
