Real-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands

Abstract This study aims to assess how clinical outcomes of immunotherapy in real-world (effectiveness) correspond to outcomes in clinical trials (efficacy) and to look into factors that might explain an efficacy-effectiveness (EE) gap. All patients diagnosed with stage IV non-small cell lung cancer...

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Autores principales: Christine M. Cramer-van der Welle, Marjon V. Verschueren, Merel Tonn, Bas J. M. Peters, Franz M. N. H. Schramel, Olaf H. Klungel, Harry J. M. Groen, Ewoudt M. W. van de Garde, The Santeon NSCLC Study Group
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Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/7d32e5f6f02144ce9a5f775eb813f943
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spelling oai:doaj.org-article:7d32e5f6f02144ce9a5f775eb813f9432021-12-02T11:39:44ZReal-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands10.1038/s41598-021-85696-32045-2322https://doaj.org/article/7d32e5f6f02144ce9a5f775eb813f9432021-03-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-85696-3https://doaj.org/toc/2045-2322Abstract This study aims to assess how clinical outcomes of immunotherapy in real-world (effectiveness) correspond to outcomes in clinical trials (efficacy) and to look into factors that might explain an efficacy-effectiveness (EE) gap. All patients diagnosed with stage IV non-small cell lung cancer (NSCLC) in 2015–2018 in six Dutch large teaching hospitals (Santeon network) were identified and followed-up from date of diagnosis until death or end of data collection. Progression-free survival (PFS) and overall survival (OS) from first-line (1L) pembrolizumab and second-line (2L) nivolumab were compared with clinical trial data by calculating hazard ratios (HRs). From 1950 diagnosed patients, 1005 (52%) started with any 1L treatment, of which 83 received pembrolizumab. Nivolumab was started as 2L treatment in 141 patients. For both settings, PFS times were comparable between real-world and trials (HR 1.08 (95% CI 0.75–1.55), and HR 0.91 (95% CI 0.74–1.14), respectively). OS was significantly shorter in real-world for 1L pembrolizumab (HR 1.55; 95% CI 1.07–2.25). Receiving subsequent lines of treatment was less frequent in real-world compared to trials. There is no EE gap for PFS from immunotherapy in patients with stage IV NSCLC. However, there is a gap in OS for 1L pembrolizumab. Fewer patients proceeding to a subsequent line of treatment in real-world could partly explain this.Christine M. Cramer-van der WelleMarjon V. VerschuerenMerel TonnBas J. M. PetersFranz M. N. H. SchramelOlaf H. KlungelHarry J. M. GroenEwoudt M. W. van de GardeThe Santeon NSCLC Study GroupNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Christine M. Cramer-van der Welle
Marjon V. Verschueren
Merel Tonn
Bas J. M. Peters
Franz M. N. H. Schramel
Olaf H. Klungel
Harry J. M. Groen
Ewoudt M. W. van de Garde
The Santeon NSCLC Study Group
Real-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands
description Abstract This study aims to assess how clinical outcomes of immunotherapy in real-world (effectiveness) correspond to outcomes in clinical trials (efficacy) and to look into factors that might explain an efficacy-effectiveness (EE) gap. All patients diagnosed with stage IV non-small cell lung cancer (NSCLC) in 2015–2018 in six Dutch large teaching hospitals (Santeon network) were identified and followed-up from date of diagnosis until death or end of data collection. Progression-free survival (PFS) and overall survival (OS) from first-line (1L) pembrolizumab and second-line (2L) nivolumab were compared with clinical trial data by calculating hazard ratios (HRs). From 1950 diagnosed patients, 1005 (52%) started with any 1L treatment, of which 83 received pembrolizumab. Nivolumab was started as 2L treatment in 141 patients. For both settings, PFS times were comparable between real-world and trials (HR 1.08 (95% CI 0.75–1.55), and HR 0.91 (95% CI 0.74–1.14), respectively). OS was significantly shorter in real-world for 1L pembrolizumab (HR 1.55; 95% CI 1.07–2.25). Receiving subsequent lines of treatment was less frequent in real-world compared to trials. There is no EE gap for PFS from immunotherapy in patients with stage IV NSCLC. However, there is a gap in OS for 1L pembrolizumab. Fewer patients proceeding to a subsequent line of treatment in real-world could partly explain this.
format article
author Christine M. Cramer-van der Welle
Marjon V. Verschueren
Merel Tonn
Bas J. M. Peters
Franz M. N. H. Schramel
Olaf H. Klungel
Harry J. M. Groen
Ewoudt M. W. van de Garde
The Santeon NSCLC Study Group
author_facet Christine M. Cramer-van der Welle
Marjon V. Verschueren
Merel Tonn
Bas J. M. Peters
Franz M. N. H. Schramel
Olaf H. Klungel
Harry J. M. Groen
Ewoudt M. W. van de Garde
The Santeon NSCLC Study Group
author_sort Christine M. Cramer-van der Welle
title Real-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands
title_short Real-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands
title_full Real-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands
title_fullStr Real-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands
title_full_unstemmed Real-world outcomes versus clinical trial results of immunotherapy in stage IV non-small cell lung cancer (NSCLC) in the Netherlands
title_sort real-world outcomes versus clinical trial results of immunotherapy in stage iv non-small cell lung cancer (nsclc) in the netherlands
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/7d32e5f6f02144ce9a5f775eb813f943
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