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Multicenter Study
. 2025 Apr:202:108462.
doi: 10.1016/j.lungcan.2025.108462. Epub 2025 Mar 22.

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)

Jelle E Bousema  1 , Louisa N Spaans  1 , Marcel G W Dijkgraaf  2 , Erik H F M van der Heijden  3 , Ad F T M Verhagen  4 , Jouke T Annema  5 , Frank J C van den Broek  6 ; MEDIASTrial study group
Collaborators, Affiliations
Free article
Multicenter Study

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)

Jelle E Bousema et al. Lung Cancer. 2025 Apr.
Free article

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.

Keywords: Disease recurrence; Endosonography; Lymph node dissection; Mediastinal nodal staging; Mediastinoscopy; Non-small cell lung cancer; Overall survival; Quality of life; Thoracic surgery.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Bousema and Van Den Broek report grants from ZonMw and the Dutch Cancer Society, during the conduct of this study. Van Der Heijden reports unrestricted research grants from Astra Zeneca Oncology, Pentax Medical, Philips Medical, Intuitive and Johnson & Johnson; consultancy for Philips Medical and Johnson & Johnson, and speakers’ fees from AstraZeneca, Pentax Medical, Siemens, Janssen-Cilag, Ethicon and Intuitive, all unrelated to the content of this study and paid to his department. Annema reports educational course support from Hitachi Medical systems, Pentax Medical, COOK Medical, Olympus, Boston Scientific, Fujinon, scientific investigator initiated grants from Cook medical, Mauna Kea Technologies, Boston Scientific outside the submitted work. Dijkgraaf, Spaans and Verhagen have nothing to disclose.

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