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Mouritzen MT, Junker KF, Carus A, et al. Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study. Acta Oncol. 2022;1-8doi: 10.1080/0284186X.2021.2023213.
Mouritzen, M. T., Junker, K. F., Carus, A., Ladekarl, M., Meldgaard, P., Nielsen, A. W. M., Livbjerg, A., Larsen, J. W., Skuladottir, H., Kristiansen, C., Wedervang, K., Schytte, T., Hansen, K. H., Østby, A. C., Frank, M. S., Lauritsen, J., Sørensen, J. B., Langer, S. W., Persson, G. F., Andersen, J. L., Homann, P. H., Kristensen, E. B., Drivsholm, L. B., Bøgsted, M., Christensen, H. S., Pøhl, M., & Bjørnhart, B. (2022). Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study. Acta oncologica (Stockholm, Sweden), 1-8. https://doi.org/10.1080/0284186X.2021.2023213
Mouritzen, Mette T, et al. "Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study." Acta oncologica (Stockholm, Sweden) vol. (2022): 1-8. doi: https://doi.org/10.1080/0284186X.2021.2023213
Mouritzen MT, Junker KF, Carus A, Ladekarl M, Meldgaard P, Nielsen AWM, Livbjerg A, Larsen JW, Skuladottir H, Kristiansen C, Wedervang K, Schytte T, Hansen KH, Østby AC, Frank MS, Lauritsen J, Sørensen JB, Langer SW, Persson GF, Andersen JL, Homann PH, Kristensen EB, Drivsholm LB, Bøgsted M, Christensen HS, Pøhl M, Bjørnhart B. Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study. Acta Oncol. 2022 Jan 11;1-8. doi: 10.1080/0284186X.2021.2023213. Epub 2022 Jan 11. PMID: 35012430.
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Acta Oncol. 2022 Jan 11;1-8. doi: 10.1080/0284186X.2021.2023213. Epub 2022 Jan 11.

Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study.

Acta oncologica (Stockholm, Sweden)

Mette T Mouritzen, Karen F Junker, Andreas Carus, Morten Ladekarl, Peter Meldgaard, Anders W M Nielsen, Anna Livbjerg, Jacob W Larsen, Halla Skuladottir, Charlotte Kristiansen, Kim Wedervang, Tine Schytte, Karin H Hansen, Anne-Cathrine Østby, Malene S Frank, Jakob Lauritsen, Jens B Sørensen, Seppo W Langer, Gitte F Persson, Jon L Andersen, Pernille H Homann, Emilie B Kristensen, Lars B Drivsholm, Martin Bøgsted, Heidi S Christensen, Mette Pøhl, Birgitte Bjørnhart

Affiliations

  1. Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.
  2. Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark.
  3. Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
  4. Department of Oncology, Copenhagen E, Denmark.
  5. Department of Oncology, Aarhus University Hospital, Aarhus N, Denmark.
  6. Department of Oncology, Region Hospital West Jutland, Herning, Denmark.
  7. Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
  8. Department of Oncology, Hospital Sønderjylland, Sønderborg, Denmark.
  9. Department of Oncology, Odense University Hospital, Odense, Denmark.
  10. Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
  11. Odense Patient data Explorative Network (OPEN), Odense, Denmark.
  12. Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Roskilde, Denmark.
  13. Department of Clinical Medicine, University of Copenhagen, Copenhagen N, Denmark.
  14. Department of Oncology, Copenhagen University Hospital, Herlev, Denmark.
  15. Department of Oncology, North Zealand Hospital, Hillerød, Denmark.
  16. Department of Hematology, Aalborg University Hospital, Aalborg, Denmark.

PMID: 35012430 DOI: 10.1080/0284186X.2021.2023213

Abstract

BACKGROUND: Immune checkpoint inhibitors (ICIs) are implemented as standard treatment for patients with advanced non-small cell lung cancer (NSCLC) in first-line and subsequent-line treatment. However, certain subgroups such as patients with older age, poor performance status (PS), and severe comorbidity are underrepresented in the randomized controlled trials (RCTs). This study aimed to assess overall survival (OS), treatment data, and clinical features affecting second- or subsequent-line ICI efficacy in an unselected, Danish, nationwide NSCLC population.

METHODS: Patients with advanced NSCLC who started nivolumab or pembrolizumab as second-line or subsequent-line treatment between 1 September 2015, and 1 October 2018, were identified from institutional records of all Danish oncology departments. Clinical and treatment data were retrospectively collected. Descriptive statistics and survival analyses were performed.

RESULTS: Data were available for 840 patients; 49% females. The median age was 68 years (19% were ≥75 years), 19% had PS ≥2, and 36% had moderate to severe comorbidity. The median OS (mOS) was 12.2 months; 15.1 months and 10.0 months in females and males, respectively. The median time-to-treatment discontinuation (mTTD) and median progression-free survival (mPFS) was 3.2 and 5.2 months, respectively. Patients with PS ≥2 had a mOS of 4.5 months, mTTD of 1.1 month, and mPFS of 2.0 months. In multivariable Cox regression analysis, male sex (HR = 1.35, 95% CI 1.11-1.62), PS >0 (PS 1, HR = 1.88, 95% CI 1.52-2.33; PS ≥2, HR = 4.15, 95% CI 3.13-5.5), liver metastases (HR = 1.72, 95% CI 1.34-2.22), and bone metastases (HR = 1.27, 95% CI 1.03-1.58) were significant poor prognostic OS factors.

CONCLUSIONS: Danish real-world patients with advanced NSCLC treated with second- or subsequent-line ICI had an OS comparable to results from RCTs. Women, frail and older patients constituted a higher proportion than in previous RCTs. Clinical features associated with poor OS were male sex, PS ≥1 (in particular PS ≥2), bone-, and liver metastases.

Keywords: Cancer immunotherapy; clinical prognostic factors; immune-checkpoint inhibitors; non-small cell lung cancer; real-world evidence

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