Evidence map›Paper›PMID 33457089›Full record

Trial reportOncoimmunology2020

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

Fabrice Barlesi, Adrien Dixmier, Didier Debieuvre, Christophe Raspaud, Jean-Bernard Auliac, Nicolas Benoit, Pierre Bombaron, Denis Moro-Sibilot, Clarisse Audigier-Valette, Bernard Asselain and 15 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Oncoimmunology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03382496 (EVIDENS), which is not on this map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03382496 completednot on this map

EVIDENS: Lung Cancer Patients Treated With Nivolumab: A Longitudinal, Prospective, Observational, Multicentric Study

TypeobservationalSponsorBristol-Myers SquibbRan2016 to 2020Enrolled1,462ConditionsLung CancerArmsNon-Interventional
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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  7. Comparison of the efficacy and safety of domestically produced tislelizumab, camrelizumab, and imported pembrolizumab in the treatment of advanced NSCLC: a real-world retrospective study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 17 institutions in 5 countries.

Fabrice BarlesiCNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Hopital Nord, Pavillon Mistral, 6ème Étage A, Chemin des Bourrely, Aix Marseille University, Marseille, France.
Adrien DixmierDepartment of Pulmonology, Centre Hospitalier Régional d'Orléans, Orléans, France.
Didier DebieuvreRespiratory Medicine Department, Groupe Hospitalier De La Région Mulhouse Sud-Alsace, Hopital Emile Muller, Mulhouse, France.
Christophe RaspaudDepartment of Pulmonology, Clinique Pasteur, Toulouse, France.
Jean-Bernard AuliacDepartment of Pulmonology, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
Nicolas BenoitDepartment of Pulmonology, Clinique de l'Europe, Amiens, France.
Pierre BombaronDepartment of Pulmonology, Hôpital Privé Jean Mermoz, Lyon, France.
Denis Moro-SibilotThoracic Oncology Unit, SHUPP, Centre Hospitalier Universitaire Grenoble-Alpes, Grenoble Cedex, France.
Clarisse Audigier-ValetteDepartment of Pulmonology, Hôpital Sainte-Musse, Toulon, France.
Bernard AsselainDepartment of Biostatistics, Institut Curie, Paris, France.
Thomas EgenodDepartment of Cutaneous and Thoracic Oncology, Centre Hospitalier Universitaire Dupuytren, Limoges, France.
Audrey RabeauThoracic Oncology Department, Centre Hospitalier Universitaire de Toulouse, Hopital Rangueil, Toulouse, France.
Jérôme FayetteDepartment of Medicine, Centre Léon Bérard, Lyon, France.
Myriam Locatelli SanchezDepartment of Thoracic Oncology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Lyon, France.
Jean-Luc LaboureyDepartment of Oncology, Hôpital de Carcassonne, Carcasonne, France.
Virginie WesteelChest Disease Department, University Hospital, INSERM UMR 1098, University of Bourgogne Franche-Comté, Besançon, France.
Pauline LamoureuxBristol-Myers Squibb, Rueil-Malmaison, France.
François-Emery CotteBristol-Myers Squibb, Rueil-Malmaison, France.
Victoria AllanBristol-Myers Squibb, Uxbridge, UK.
Melinda DaumontBristol-Myers Squibb, Braine-l'alleud, Belgium.
Juliette DumanoirBristol-Myers Squibb, Rueil-Malmaison, France.
Dorothée ReynaudBristol-Myers Squibb, Rueil-Malmaison, France.
Christophe Yannick CalvetBristol-Myers Squibb, Rueil-Malmaison, France.
Nicolas OzanBristol-Myers Squibb, Rueil-Malmaison, France.
Maurice PérolDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.
Bristol-Myers Squibb (Germany) · DECentre Léon Bérard · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Toulouse · FRCentre hospitalier universitaire d'Orléans · FRCentre National de la Recherche Scientifique · FRClinique Pasteur · FRGroupe Hospitalier de la Région de Mulhouse et Sud Alsace · FRHôpital Européen · FRHôpital Intercommunal de Créteil · FRHôpital Privé Jean Mermo · FRHôpital régional · CHHôpital Sainte-Périne · FRHôpital Universitaire Dupuytren · FRHospices Civils de Lyon · FRInserm · FRInstitut Curie · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdultFranceHumansNivolumabProspective StudiesNivolumabEVIDENSfrancenivolumabnon-small cell lung cancerobservational study

Identifiers

PMID33457089
PMCPMC7790497
OpenAlexW3016265876

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.