TY - JOUR
T1 - Endosonography With or Without Confirmatory Mediastinoscopy for Resectable Lung Cancer
T2 - A Randomized Clinical Trial
AU - Bousema, Jelle E.
AU - Dijkgraaf, Marcel G. W.
AU - van der Heijden, Erik H. F. M.
AU - Verhagen, Ad F. T. M.
AU - Annema, Jouke T.
AU - van den Broek, Frank J. C.
AU - Papen-Botterhuis, Nicole E.
AU - Youssef-el Soud, Maggy
AU - van Boven, Wim J.
AU - Daniels, Johannes M. A.
AU - Heineman, David J.
AU - Zandbergen, Harmen R.
AU - Brocken, Pepijn
AU - Horn, Thirza
AU - Steup, Willem H.
AU - Braun, Jerry
AU - Ramai, Rajen S. R. S.
AU - Beck, Naomi
AU - Hoeijmakers, Fieke
AU - Barlo, Nicole P.
AU - van Dorp, Martijn
AU - Schreurs, W. Hermien
AU - Dingemans, Anne-Marie C.
AU - Sprooten, Roy T. M.
AU - Maessen, Jos G.
AU - Claessens, Niels J. M.
AU - Lardenoije, Jan-Willem H. P.
AU - Hiddinga, Birgitta I.
AU - van de Wauwer, Caroline
AU - van der Wekken, Anthonie J.
AU - Hanselaar, Wessel E.
AU - Thj Kortekaas, Robert
AU - Bard, Martin P.
AU - Rijna, Herman
AU - Bootsma, Gerben P.
AU - Vissers, Yvonne L. J.
AU - Veen, Eelco J.
AU - van der Leest, Cor H.
AU - Citgez, Emanuel
AU - van Duyn, Eino B.
AU - Marres, Geertruid M. H.
AU - van Thiel, Eric R.
AU - van Schil, Paul E.
AU - van Meerbeeck, Jan P.
AU - Wener, Reinier
AU - Smakman, Niels
AU - van der Meer, Femke
AU - Saboerali, Mohammed D.
AU - Bosch, Anne Marie
AU - de Jong, Wouter K.
AU - van Rossem, Charles C.
AU - Lie, W. Johan
AU - Kouwenhoven, Ewout A.
AU - Staal-van den Brekel, A. Jeske
AU - Hanneman, Nike M.
AU - Heller-Baan, Roxane
AU - Noyez, Valentin J. J. M.
N1 - 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.
PY - 2023/8/1
Y1 - 2023/8/1
N2 - PURPOSEResectable 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.METHODSPatients 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.RESULTSBetween 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).CONCLUSIONOn 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.
AB - PURPOSEResectable 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.METHODSPatients 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.RESULTSBetween 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).CONCLUSIONOn 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.
UR - http://www.scopus.com/inward/record.url?scp=85164908230&partnerID=8YFLogxK
U2 - https://doi.org/10.1200/JCO.22.01728
DO - https://doi.org/10.1200/JCO.22.01728
M3 - Article
C2 - 37018653
SN - 0732-183X
VL - 41
SP - 3805
EP - 3815
JO - Journal of clinical oncology
JF - Journal of clinical oncology
IS - 22
ER -