Checkpoint Inhibitor Monotherapy in Potentially Trial-Eligible or Trial-Ineligible Patients With Metastatic NSCLC in the German Prospective CRISP Registry Real-World Cohort (AIO-TRK-0315)

• DOI: 10.1016/j.jtocrr.2023.100626
• Publication Date: 2023-12-25T06:35:41Z
• Authors: Frank Griesinger; Wilfried E.E. Ebe...; Wolfgang M. Brueckl; Horst-Dieter Hummel; Bastian Jaeschke; Jens Kern; Claas Wesseler; Martina Jänicke; Annette Fleitz; Stefan Zacharias; Annette Hipper; Annika Groth; Wilko Weichert; Steffen Dörfel; Volker Petersen; Jan Schröder; Jochen Wilke; Martin Sebastian; Michael Thomas; Juliana Ababei; Jürgen Alt; Andreas Ammon; Jürgen Anhuf; Ivo Azeh; Stefan Bauer; Dirk Behringer; Winfried Berger; Christiane Bernhardt; Mathias Bertram; Michael Boesche; Sabine Bohnet; Harald-Robert Bruch; Wolfgang Brückl; Ulrike Burkhard-M...; Petros Christopoulos; Klaus-Ulrich Däßler; Maike de Wit; Tobias Dechow; Reinhard Depenbusch; Lutz Dietze; Markus Dommach; Steffen Dörfel; Wilfried Eberhardt; Corinna Elender; Wolfgang Elsel; Till-Oliver Emde; Martin Faehling; Thomas Fietz; Jürgen R. Fischer; Dimitri Flieger; Anke Freidt; Werner Freier; Christian Frenzel; Florian Fuchs; Roswitha Fuchs; Tobias Gaska; Wolfgang Gleiber; Christian Grah; Frank Griesinger; Christian Grohé; Matthias Groschek; Björn Güldenzoph; Andreas Günther; Siegfried Haas; Matthias Hackenthal; Volker Hagen; Lars Hahn; Verena Hannig Carla; Richard Hansen; Hanns-Detlev Harich; Monika Heilmann; Kathrin Heinrich; Christiane Hering...; Jörg Heßling; Petra Hoffknecht; Patricia Hortig; Gerdt Hübner; Horst-Dieter Hummel; Ulrich Hutzschenr...; Thomas Illmer; Georg Innig; Bastian Jaeschke; Christian Junghanß; Ulrich Kaiser; Haytham Kamal; Kato Kambartel; Jens Kern; Martin Kimmich; Dorothea Kingreen; Heinz Kirchen; Martine Klausmann; Ortwin Klein; Konrad Kokowski; Wolfgang Körber; Cornelius Kortsik; Dirk Koschel; Benoit Krämer; Beate Krammer-Ste...; Eckart Laack; Christof Lamberti; Rumo David Leistner; Christoph Losem; Andreas Lück; Christoph Maintz; Kerstin Martin; Dirk Medgenberg; Martin Metzenmacher; Christian Meyer z...; Philipp Meyn; Enno Moorahrend; Annette Müller; Lothar Müller; Michael Neise; Holger Nückel; Arnd Nusch; Tobias Overbeck; Henning Pelz; Volker Petersen; Bettina Peuser; Margarete Plath; Winfried J. Rande...; Jacqueline Rauh; Martin Reck; Dietmar Reichert; Niels Reinmuth; Marcel Reiser; Roland Repp; Daniel Reschke; Achim Rittmeyer; Yolanda Rodemer; Sandra Sackmann; Parvis Sadjadian; Reiner Sandner; Annette Sauer; Harald Schäfer; Christoph Schaudt; Rudolf Schlag; Burkhard Schmidt; Stephan Schmitz; Jan Schröder; Michael Schroeder; Mathias Schulze; Christian Schumann; Wolfgang Schütte; Martin Schwaiblmair; Florian Schwindt ...; Martin Sebastian; Bernd Seese; Gernot Seipelt; Thomas Sorgenfrei; Johannes Steiff; Heike Steiniger; Tanja Trarbach; Amanda Tufman; Jens Uhlig; Ursula Vehling-Ka...; Eyck von der Heyde; Ulla von Verschuer; Cornelius Waller; Thomas Wehler; Georg Weißenborn; Florian Weißinger; Martin Wermke; Claas Wesseler; Jörg Wiegand; Stefan Wilhelm; Jochen Wilke; Mark-Oliver Zahn; Matthias Zaiss; Matthias Zeth
• Keywords: Immune checkpoint inhibitors; 03 medical and health sciences; 0302 clinical medicine; Non–small cell lung carcinoma; Medizin; Neoplasms. Tumors. Oncology. Including cancer and carcinogens; Original Article; Prospective studies; Pembrolizumab; RC254-282

Introduction:Patients with metastatic non-small-cell lung cancer (mNSCLC) treated immune checkpoint inhibitors (CPIs) in clinical practice may often not meet the strict inclusion criteria of trials.Our aim was to assess trial eligibility patients mNSCLC pembrolizumab monotherapy real-world and compare outcome "trialineligible" "potentially trial-eligible" patients.Methods: Data from prospective, research platform CRISP were used patient characteristics, treatment programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% tumors who are deemed either or "trial-ineligible" according in-and exclusion registrational studies (KEYNOTE-024 042).Results: Of 746 included, 343 (46.0%) classified as had significantly worse outcomes compared (n= 403, 54.0%): median PFS: 6.2 (95% CI 5.2-8.4) vs. 10.3 8.4-13.8)months, hazard ratio (HR, trial-ineligible potentially trial-eligible) 1.43 1.19-1.72),p<0.001; OS: 15.9 11.4-20.3)vs. 25.3 19.8-30.4)months, HR 1.36 1.10-1.67),p=0.004. Conclusions:Our data show that a considerable eligible participate shown have than trial-eligible patients, whose comparable those obtained pivotal trials.This is substantial relevance for physicians discussing be expected their stresses need effectiveness analyses.