TY - JOUR
T1 - 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)
AU - CRISP Registry Group
AU - Griesinger, Frank
AU - Sebastian, Martin
AU - Brueckl, Wolfgang M.
AU - Hummel, Horst Dieter
AU - Jaeschke, Bastian
AU - Kern, Jens
AU - Wesseler, Claas
AU - Jänicke, Martina
AU - Fleitz, Annette
AU - Zacharias, Stefan
AU - Hipper, Annette
AU - Groth, Annika
AU - Weichert, Wilko
AU - Dörfel, Steffen
AU - Petersen, Volker
AU - Schröder, Jan
AU - Wilke, Jochen
AU - Eberhardt, Wilfried E.E.
AU - Thomas, Michael
AU - Ababei, Juliana
AU - Alt, Jürgen
AU - Ammon, Andreas
AU - Anhuf, Jürgen
AU - Azeh, Ivo
AU - Bauer, Stefan
AU - Behringer, Dirk
AU - Berger, Winfried
AU - Bernhardt, Christiane
AU - Bertram, Mathias
AU - Boesche, Michael
AU - Bohnet, Sabine
AU - Bruch, Harald Robert
AU - Brückl, Wolfgang
AU - Burkhard-Meier, Ulrike
AU - Christopoulos, Petros
AU - Däßler, Klaus Ulrich
AU - de Wit, Maike
AU - Dechow, Tobias
AU - Depenbusch, Reinhard
AU - Dietze, Lutz
AU - Dommach, Markus
AU - Eberhardt, Wilfried
AU - Elender, Corinna
AU - Elsel, Wolfgang
AU - Emde, Till Oliver
AU - Faehling, Martin
AU - Fietz, Thomas
AU - Fischer, Jürgen R.
AU - Flieger, Dimitri
AU - Freidt, Anke
N1 - Publisher Copyright:
© 2024
PY - 2024/4
Y1 - 2024/4
N2 - Introduction: Patients with metastatic NSCLC (mNSCLC) treated with immune checkpoint inhibitors 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 “trial-ineligible” 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 tumor proportion score greater than or equal to 50% tumors treated with pembrolizumab monotherapy who are deemed either “potentially trial-eligible” or “trial-ineligible” according to inclusion and exclusion criteria of the registrational studies (KEYNOTE-024 and -042). Results: Of 746 patients included, 343 patients (46.0%) were classified as “trial-ineligible” and had significantly worse outcomes compared with “potentially trial-eligible” patients (n = 403, 54.0%): median progression-free survival: 6.2 (95% confidence interval [CI]: 5.2–8.4) versus 10.3 (95% CI: 8.4–13.8) months, hazard ratio (trial-ineligible versus potentially trial-eligible) of 1.43 (95% CI: 1.19–1.72), p less than 0.001; median overall survival: 15.9 (95% CI: 11.4–20.3) versus 25.3 (95% CI: 19.8–30.4) months, hazard ratio of 1.36 (95% CI: 1.10–1.67), p equals 0.004. Conclusions: Our data reveal that a considerable proportion of patients with mNSCLC are not eligible to participate in a clinical trial and were found to have worse outcomes than potentially trial-eligible patients, whose outcomes were comparable with 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.
AB - Introduction: Patients with metastatic NSCLC (mNSCLC) treated with immune checkpoint inhibitors 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 “trial-ineligible” 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 tumor proportion score greater than or equal to 50% tumors treated with pembrolizumab monotherapy who are deemed either “potentially trial-eligible” or “trial-ineligible” according to inclusion and exclusion criteria of the registrational studies (KEYNOTE-024 and -042). Results: Of 746 patients included, 343 patients (46.0%) were classified as “trial-ineligible” and had significantly worse outcomes compared with “potentially trial-eligible” patients (n = 403, 54.0%): median progression-free survival: 6.2 (95% confidence interval [CI]: 5.2–8.4) versus 10.3 (95% CI: 8.4–13.8) months, hazard ratio (trial-ineligible versus potentially trial-eligible) of 1.43 (95% CI: 1.19–1.72), p less than 0.001; median overall survival: 15.9 (95% CI: 11.4–20.3) versus 25.3 (95% CI: 19.8–30.4) months, hazard ratio of 1.36 (95% CI: 1.10–1.67), p equals 0.004. Conclusions: Our data reveal that a considerable proportion of patients with mNSCLC are not eligible to participate in a clinical trial and were found to have worse outcomes than potentially trial-eligible patients, whose outcomes were comparable with 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.
KW - Immune checkpoint inhibitors
KW - Non–small cell lung carcinoma
KW - Pembrolizumab
KW - Prospective studies
UR - http://www.scopus.com/inward/record.url?scp=85189765411&partnerID=8YFLogxK
U2 - 10.1016/j.jtocrr.2023.100626
DO - 10.1016/j.jtocrr.2023.100626
M3 - Article
AN - SCOPUS:85189765411
SN - 2666-3643
VL - 5
JO - JTO Clinical and Research Reports
JF - JTO Clinical and Research Reports
IS - 4
M1 - 100626
ER -