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Randomized Controlled Trial
. 2020 Apr 12;9(1):1744898.
doi: 10.1080/2162402X.2020.1744898.

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

Fabrice Barlesi  1 , Adrien Dixmier  2 , Didier Debieuvre  3 , Christophe Raspaud  4 , Jean-Bernard Auliac  5 , Nicolas Benoit  6 , Pierre Bombaron  7 , Denis Moro-Sibilot  8 , Clarisse Audigier-Valette  9 , Bernard Asselain  10 , Thomas Egenod  11 , Audrey Rabeau  12 , Jérôme Fayette  13 , Myriam Locatelli Sanchez  14 , Jean-Luc Labourey  15 , Virginie Westeel  16 , Pauline Lamoureux  17 , François-Emery Cotte  17 , Victoria Allan  18 , Melinda Daumont  19 , Juliette Dumanoir  17 , Dorothée Reynaud  17 , Christophe Yannick Calvet  17 , Nicolas Ozan  17 , Maurice Pérol  20
Affiliations
Randomized Controlled Trial

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

Fabrice Barlesi et al. Oncoimmunology. .

Abstract

EVIDENS is an ongoing, prospective, non-interventional study evaluating the effectiveness and safety of nivolumab in lung cancer patients in France (ClinicalTrials.gov NCT03382496). Adults with a pathologically confirmed diagnosis of lung cancer and initiating treatment with nivolumab were recruited from 146 sites in France. This analysis included only patients with non-small cell lung cancer (NSCLC) who received ≥1 nivolumab infusion, and evaluated patient characteristics at the time of nivolumab initiation and its effectiveness and safety after a median follow-up of 18 months. A total of 1,420 patients with NSCLC were included, most of whom had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (82.9%), non-squamous histology (69.2%) and stage IV disease (91.4%). Brain metastases were present in 19.9% of patients. Nivolumab was a second-line or ≥third-line regimen in 73.6% and 26.1% of patients, respectively. Almost all patients had prior chemotherapy (99.7%). Median overall survival was 11.2 months (95% confidence interval [CI]: 10.0-12.4). ECOG PS, smoking status, corticosteroids at baseline, epidermal growth factor receptor mutation status, presence of symptomatic brain metastases and treatment-related adverse events (TRAEs) were independent predictors of survival. Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported. Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population.

Keywords: EVIDENS; france; nivolumab; non-small cell lung cancer; observational study.

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Figures

Figure 1.
Figure 1.
Overall survival. CI, confidence interval; OS, overall survival
Figure 2.
Figure 2.
Progression-free survival. CI, confidence interval; PFS, progression-free survival
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