Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study
| Autor: | Pauline Lamoureux, Denis Moro-Sibilot, Thomas Egenod, P. Bombaron, Melinda Daumont, Audrey Rabeau, Adrien Dixmier, Christophe Raspaud, Nicolas Benoit, Didier Debieuvre, N. Ozan, Juliette Dumanoir, Bernard Asselain, Virginie Westeel, C. Calvet, Clarisse Audigier-Valette, Dorothee Reynaud, Victoria Allan, Fabrice Barlesi, François-Emery Cotté, Maurice Pérol, Jean-Bernard Auliac, Jérôme Fayette, Jean-Luc Labourey, Myriam Locatelli Sanchez |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Oncology Adult medicine.medical_specialty Lung Neoplasms Immunology Treatment of lung cancer EVIDENS 03 medical and health sciences 0302 clinical medicine Internal medicine Carcinoma Non-Small-Cell Lung medicine Immunology and Allergy Humans Prospective Studies Lung cancer RC254-282 non-small cell lung cancer nivolumab business.industry Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC581-607 medicine.disease 030104 developmental biology 030220 oncology & carcinogenesis Observational study observational study France Immunologic diseases. Allergy Nivolumab business Back Matter |
| Zdroj: | Oncoimmunology article-version (VoR) Version of Record OncoImmunology, Vol 9, Iss 1 (2020) |
| ISSN: | 2162-402X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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