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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)

2023; Elsevier BV; Volume: 5; Issue: 4 Linguagem: Inglês

10.1016/j.jtocrr.2023.100626

2666-3643

Frank Griesinger, Wilfried Eberhardt, Wolfgang M. Brueckl, Horst-Dieter Hummel, Bastian Jaeschke, Jens Kern, Claas Wesseler, Martina Jänicke, A. Fleitz, Stefan Zacharias, A. Hipper, Annika Groth, Wilko Weichert, Steffen Dörfel, Volker Petersen, Jan Schröder, Jochen Wilke, Martin Sebastian, Michael Thomas, Juliana Ababei, Jürgen Alt, A. Ammon, Jürgen Anhuf, Ivo Azeh, Stefan Bauer, Dirk Behringer, W. Berger, Christiane Bernhardt, Mathias Bertram, M Boesche, Sabine Bohnet, Harald-Robert Bruch, W. Brückl, Ulrike Burkhard‐Meier, Petros Christopoulos, Klaus‐Ulrich Däßler, Maike de Wit, Tobias Dechow, Reinhard Depenbusch, Lutz Dietze, Markus Dommach, Steffen Dörfel, Wilfried Eberhardt, Corinna Elender, W. Elsel, Till‐Oliver Emde, Martin Faehling, Thomas Fietz, Jürgen R. Fischer, Dimitri Flieger, Anke Freidt, W. Freier, Christian Frenzel, Florian Fuchs, Roswitha Fuchs, Tobias Gaska, Wolfgang Gleiber, Christian Grah, Frank Griesinger, Christian Grohé, Matthias Groschek, B. Güldenzoph, Andreas Günther, Siegfried Haas, M. Hackenthal, Volker Hagen, Lars Hahn, V. Carla�, Richard M. Hansen, Hanns‐Detlev Harich, Monika Heilmann, Kathrin Heinrich, Christiane Hering-Schubert, Jörg Heßling, Petra Hoffknecht, P. Hortig, G Hübner, Horst-Dieter Hummel, Ulrich Hutzschenreuter, Thomas Illmer, G. Innig, Bastian Jaeschke, Christian Junghanß, Ulrich Kaiser, Haytham Kamal, Kato Kambartel, Jens Kern, Martin Kimmich, D. Kingreen, Heinz Kirchen, Martine Klausmann, O. Klein, Konrad Kokowski, W Körber, C. Kortsik, Dirk Koschel, Benoit Krämer, Beate Krammer‐Steiner, Eckart Laack, Christof Lamberti, Rumo Leistner, Christoph Losem, Andreas Lück, Christoph Maintz, Kerstin Martin, Dirk Medgenberg, Martin Metzenmacher, Christian Meyer zum Büschenfelde, Philipp Meyn, Enno Moorahrend, Annette Müller, Lothar Müller, Michael Neise, Holger Nückel, Arnd Nusch, Tobias R. Overbeck, Henning Pelz, Volker Petersen, Bettina Peuser, Margarete Plath, Winfried Randerath, Jacqueline Rauh, Martin Reck, Dietmar Reichert, Niels Reinmuth, Marcel Reiser, Roland Repp, Daniel Reschke, Achim Rittmeyer, Yolanda Rodemer, S Sackmann, Parvis Sadjadian, Reiner Sandner, Annette Sauer, H Schäfer, Christoph Schaudt, Rudolf Schlag, B. Schmidt, Stephan Schmitz, Jan Schröder, Michael J. Schroeder, Mathias Schulze, Christian Schumann, Wolfgang Schütte, Martin Schwaiblmair, Florian Schwindt Peter, Martin Sebastian, Bernd Seese, G. Seipelt, Thomas Sorgenfrei, J Steiff, Heike Steiniger, Tanja Trarbach, Amanda Tufman, Jens Uhlig, Ursula Vehling‐Kaiser, Eyck von der Heyde, Ulla von Verschuer, Cornelius F. Waller, Thomas Wehler, Georg Weißenborn, Florian Weißinger, Martin Wermke, Claas Wesseler, Jörg Wiegand, Stefan Wilhelm, Jochen Wilke, Mark‐Oliver Zahn, Matthias Zaiß, Matthias Zeth,

Cancer Genomics and Diagnostics

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