Confirmatory mediastinoscopy not needed in resectable NSCLC

After a well performed, negative, systematic endosonography, confirmatory mediastinoscopy could be omitted in patients with resectable non-small cell lung cancer (NSCLC), the randomised-controlled MEDIASTrial demonstrated. Since mediastinoscopy is associated with morbidity and a delay in the treatment of patients with NSCLC, these findings are of clinical importance.

“The guidelines tell us to perform endosonography and confirmatory mediastinoscopy in advance of anatomical resection and lymph node dissection in patients with resectable NSCLC,” said Prof. Jouke Annema (Amsterdam UMC, the Netherlands) [1,2]. However, the role of confirmatory mediastinoscopy is under debate due to the upcoming experience and accuracy of endosonography as well as the negative impact that this surgical procedure may have on patients. Dr Annema and colleagues conducted the non-inferiority MEDIASTrial to assess whether confirmatory mediastinoscopy could be omitted after tumour-negative, systematic endosonography [2].

In total, 346 patients with resectable NSCLC were randomised 1:1 to immediate lung tumour resection or to mediastinoscopy. Unforeseen N2 disease after lymph node dissection was the primary outcome, with a non-inferiority margin of 8%.

In the intention-to-treat analysis, unforeseen N2 disease was observed in 8.8% of the participants in the immediate intervention group compared with 7.7% in the mediastinoscopy group (non-inferiority P=0.014). Likewise, in the per-protocol analysis, unforeseen N2 disease was identified in 9.0% of the participants in the immediate resection arm and in 8.2% of the participants in the mediastinoscopy arm (non-inferiority P=0.016). Major morbidity rates were comparable between the 2 groups, with 12% and 13% in the immediate resection and mediastinoscopy arm respectively. Finally, 30-day mortality data displayed that 2 deaths had occurred in the immediate resection arm and that 5 deaths had occurred in the mediastinoscopy arm (P=0.27).

The MEDIASTrial demonstrated that confirmatory mediastinoscopy could be omitted after negative systematic endosonograpy in patients with resectable NSCLC, concluded Prof. Annema.

1. Vilmann P, et al. Endoscopy. 2015;47(6):545–559.
2. Annema JT, et al. Endosonography with or without confirmatory mediastinoscopy for resectable lung cancer: A randomized clinical trial. ALERT 4, RCT4452, ERS International Congress 2022, Barcelona, Spain, 4–6 September.

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Posted on 30 October, 202230 October, 2022