Endosonography With or Without Confirmatory Mediastinoscopy for Resectable Lung Cancer: A Randomized Clinical Trial

Jelle E. Bousema, Marcel G.W. Dijkgraaf, Erik H.F.M. Van Der Heijden, Ad F.T.M. Verhagen, Jouke T. Annema, Frank J.C. Van Den Broek*, Nicole E. Papen-Botterhuis, Maggy Youssef-El Soud, Wim J. Van Boven, Johannes M.A. Daniels, David J. Heineman, Harmen R. Zandbergen, Pepijn Brocken, Thirza Horn, Willem H. Steup, Jerry Braun, Rajen S.R.S. Ramai, Naomi Beck, Fieke Hoeijmakers, Nicole P. BarloMartijn Van Dorp, W. Hermien Schreurs, Anne Marie C. Dingemans, Roy T.M. Sprooten, Jos G. Maessen, Niels J.M. Claessens, Jan Willem H.P. Lardenoije, Birgitta I. Hiddinga, Caroline Van De Wauwer, Anthonie J. Van Der Wekken, Wessel E. Hanselaar, Robert Thj Kortekaas, Martin P. Bard, Herman Rijna, Gerben P. Bootsma, Yvonne L.J. Vissers, Eelco J. Veen, Cor H. Van Der Leest, Emanuel Citgez, Eino B. Van Duyn, Geertruid M.H. Marres, Eric R. Van Thiel, Paul E. Van Schil, Jan P. Van Meerbeeck, Reinier Wener, Niels Smakman, Femke Van Der Meer, Mohammed D. Saboerali, Anne Marie Bosch, Wouter K. De Jong

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

PURPOSE:

Resectable non-small-cell lung cancer (NSCLC) with a high probability of mediastinal nodal involvement requires mediastinal staging by endosonography and, in the absence of nodal metastases, confirmatory mediastinoscopy according to current guidelines. However, randomized data regarding immediate lung tumor resection after systematic endosonography versus additional confirmatory mediastinoscopy before resection are lacking.

METHODS:

Patients with (suspected) resectable NSCLC and an indication for mediastinal staging after negative systematic endosonography were randomly assigned to immediate lung tumor resection or confirmatory mediastinoscopy followed by tumor resection. The primary outcome in this noninferiority trial (noninferiority margin of 8% that previously showed to not compromise survival, Pnoninferior <.0250) was the presence of unforeseen N2 disease after tumor resection with lymph node dissection. Secondary outcomes were 30-day major morbidity and mortality.

RESULTS:

Between July 17, 2017, and October 5, 2020, 360 patients were randomly assigned, 178 to immediate lung tumor resection (seven dropouts) and 182 to confirmatory mediastinoscopy first (seven dropouts before and six after mediastinoscopy). Mediastinoscopy detected metastases in 8.0% (14/175; 95% CI, 4.8 to 13.0) of patients. Unforeseen N2 rate after immediate resection (8.8%) was noninferior compared with mediastinoscopy first (7.7%) in both intention-to-treat (Δ, 1.03%; UL 95% CIΔ, 7.2%; Pnoninferior =.0144) and per-protocol analyses (Δ, 0.83%; UL 95% CIΔ, 7.3%; Pnoninferior =.0157). Major morbidity and 30-day mortality was 12.9% after immediate resection versus 15.4% after mediastinoscopy first (P =.4940).

CONCLUSION:

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.

Original languageEnglish
Pages (from-to)3805-3815
Number of pages11
JournalJournal of Clinical Oncology
Volume41
Issue number22
DOIs
Publication statusPublished - 1 Aug 2023

Bibliographical note

Funding Information:
The MEDIASTrial was funded by The Netherlands Organisation for Health Research and Development (ZonMw; project number 843004109) and The Dutch Cancer Society (KWF; project number 11313). The funding sources had no involvement in the study design, data analysis, data interpretation and the decision to submit the article for publication.

Publisher Copyright:
© American Society of Clinical Oncology.

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