Two-year survival and disease recurrence after endosonography with or without confirmatory mediastinoscopy for resectable lung cancer (a short communication of the MEDIASTrial follow-up)

Abstract

Resectable non-small cell lung cancer (NSCLC) with increased risk of mediastinal nodal involvement requires invasive staging prior to surgical resection. The MEDIASTrial was a multicenter non-inferiority trial randomly assigning patients after negative endosonography to immediate lung tumor resection (n = 178) or to mediastinoscopy first (n = 182), only followed by tumor resection after negative mediastinoscopy. The omission of confirmatory mediastinoscopy after negative endosonography led to a clinically negligible and non-inferior increase in unforeseen N2. We report the two-year overall and disease-free survival (OS and DFS) and the health-related quality-of-life (HRQoL) gathered with the QLQ-C30 and QLQ-LC13 questionnaires. After randomization seven drop-outs were observed in both groups. Time to 80 % OS was 25 months in the immediate resection group versus 20 months in the mediastinoscopy group (adjusted HR 0.8, 95 % CI: 0.5-1.3). Time to 65 % DFS was 25 months in the immediate resection group versus 25 months in the mediastinoscopy group (adjusted HR 0.9, 95 % CI: 0.6-1.4). The HRQoL scores were comparable among the groups during the two-year follow-up. The loss in diagnostic yield by omitting confirmatory mediastinoscopy after negative systematic endosonography has no impact on two-year OS, DFS and HRQoL in patients with resectable NSCLC and an indication for invasive mediastinal nodal staging.