Two-year survival and disease recurrence after endosonography with or without confirmatory mediastinoscopy for resectable lung cancer (MEDIASTrial)

Resectable non-small cell lung cancer (NSCLC) with increased risk of mediastinal nodal involvement requires invasive staging prior to surgical lung tumor resection. The MEDIASTrial demonstrated that the omission of confirmatory mediastinoscopy after negative systematic endosonography led to a clinically negligible and non-inferior increase in unforeseen N2 of 1.0%. We report the 2-year overall and disease-free survival (OS and DFS) and the health-related quality of life (HRQoL). The MEDIASTrial was a non-inferiority trial including patients with resectable NSCLC after negative endosonography. Patients were randomized to either immediate resection (n=178) or to mediastinoscopy first (n=182), only followed by resection in case of negative mediastinoscopy. OS is defined from randomisation until death from any cause; and DFS until cancer relapse or death from any cause. Two-year OS and DFS are reported as percentages with odds ratios (ORs) with 95%-confidence intervals (95-CI). The HRQoL was gathered with the QLQ-C30 (general) and QLQ-LC13 (lung cancer specific) questionnaires. After randomisation 7 drop-outs were observed in both groups. Two-year OS was 80% (136/171) in the immediate resection group versus 77% (134/175) in the mediastinoscopy group (OR 0.8, 95%-CI: 0.5-1.4), and 2-year DFS was 60% (102/171) versus 60% (105/175) respectively (OR 1.0, 95%-CI: 0.7-1.6). The HRQoL scores were comparable among the groups during the 2-year follow-up. The loss in diagnostic yield by omitting confirmatory mediastinoscopy after negative systematic endosonography has no impact on 2-year OS, DFS and HRQoL.