TY  - JOUR
A1  - Debieuvre, Didier
A1  - Juergens, Rosalyn A.
A1  - Asselain, Bernard
A1  - Audigier-Valette, Clarisse
A1  - Auliac, Jean-Bernard
A1  - Barlesi, Fabrice
A1  - Benoit, Nicolas
A1  - Bombaron, Pierre
A1  - Butts, Charles A.
A1  - Dixmier, Adrien
A1  - Gröschel, Andreas Günter
A1  - Gütz, Sylvia
A1  - Labbé, Catherine
A1  - Moro-Sibilot, Denis
A1  - Pérol, Maurice
A1  - Raspaud, Christophe
A1  - Schumann, Christian
A1  - Juarez-Garcia, Ariadna
A1  - Lakhdari, Khalid
A1  - Pettersson, Filippa
A1  - Penrod, John R.
A1  - Reynaud, Dorothee
A1  - Waldenberger, Daniela
A1  - Allan, Victoria
A1  - Sebastian, Martin
T1  - Two-year survival with nivolumab in previously treated advanced non–small-cell lung cancer: a real-world pooled analysis of patients from France, Germany, and Canada
T2  - Lung cancer
N2  - Objectives: Immune checkpoint inhibitors have become the standard of care for metastatic non–small-cell lung cancer (NSCLC) progressing during or after platinum-based chemotherapy. Real-world clinical practice tends to represent more diverse patient characteristics than randomized clinical trials. We sought to evaluate overall survival (OS) outcomes in the total study population and in key subsets of patients who received nivolumab for previously treated advanced NSCLC in real-world settings in France, Germany, or Canada.
Materials and methods: Data were pooled from two prospective observational cohort studies, EVIDENS and ENLARGE, and a retrospective registry in Canada. Patients included in this analysis were aged ≥18 years, had stage IIIB/IV NSCLC, and received nivolumab after at least one prior line of systemic therapy. OS was estimated in the pooled population and in various subgroups using the Kaplan-Meier method. Timing of data collection varied across cohorts (2015–2019).
Results: Of the 2585 patients included in this analyses, 1235 (47.8 %) were treated in France, 881 (34.1 %) in Germany, and 469 (18.1 %) in Canada. Median OS for the total study population was 11.3 months (95 % CI: 10.5–12.2); this was similar across France, Germany, and Canada. The OS rate was 49 % at 1 year and 28 % at 2 years for the total study population. In univariable Cox analyses, the presence of epidermal growth factor receptor mutations in nonsquamous disease, liver, or bone metastases were associated with significantly shorter OS, whereas tumor programmed death ligand 1 expression and Eastern Cooperative Oncology Group performance status 0–1 were associated with significantly prolonged OS. Similar OS was noted across subgroups of age and prior lines of therapy.
Conclusion: OS rates in patients receiving nivolumab for previously treated advanced NSCLC in real-world clinical practice closely mirrored those in phase 3 studies, suggesting similar effectiveness of nivolumab in clinical trials and clinical practice.
KW  - Nivolumab
KW  - Non–small-cell lung cancer
KW  - Observational study
KW  - Overall survival
KW  - Real-world data
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63095
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-630954
SN  - 1872-8332
N1  - This work was sponsored by Bristol Myers Squibb (Princeton, New Jersey).
VL  - 157
SP  - 40
EP  - 47
PB  - Elsevier
CY  - Amsterdam [u.a.]
ER  -