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

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posted on 2022-01-11, 09:40 authored by 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

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.

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.

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.

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.


The study was supported by the Danish Health Authority’s ‘Cancer Immunotherapy Research Grant’ [05-0400-44] and the Medical Fund of the Danish Regions. The funding sources were not involved in the study design or in the collection, analysis and interpretation of data. Furthermore, they were not involved in the writing of the report or in the decision to submit the article for publication.


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