IFCT-1502 CLINIVO: real-world evidence of long-term survival with nivolumab in a nationwide cohort of patients with advanced non-small-cell lung cancer ☆

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J. Mazières¹  J. Cadranel²  J. Hureaux⁴  W. Hilgers⁵  E. Quoix⁶  B. Coudert⁷  D. Moro-Sibilot⁸  E. Fauchon⁹  V. Westeel^1,10  P. Brun⁹  A. Langlais^1,11  F. Morin^1,12  P.J. Souquet^1,13  N. Girard^1,14  O. Molinier^1,16  B. Besse^1,17  F. Barlesi^1,18  C. Audigier-Valette^2,20  S. Friard^2,21  I. Monnet⁹  G. Jeannin⁹ 

[1] Pneumology Service, Centre Hospitalier Universitaire de Toulouse, Hôpital Larrey;Pneumology Service, Assistance Publique Hôpitaux de Paris, Hôpital Tenon;Sorbonne Universités;Pôle Hippocrate;Medical Oncology, Sainte Catherine Cancer Institute;Pneumology Service, Hôpitaux Universitaires de Strasbourg-Unistra;Medical Oncology Department, Centre Georges-François Leclerc;Pneumology and Thoracic Oncology Department;Pneumology Service;Pneumology Service, Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz;Biostatistic Department, French Cooperative Thoracic Intergroup;Clinical Research Unit, French Cooperative Thoracic Intergroup;Pneumology Service, Centre hospitalier Lyon-Sud;Paris-Saclay University;Institut du Thorax Curie-Montsouris, Institut Curie;Pneumology, Centre Hospitalier Du Mans;Cancer Medicine Department;Aix Marseille University;Gustave Roussy Cancer Campus;Pneumology Department, Centre Hospitalier Toulon Sainte-Musse;Hopital Foch, Chest Department

关键词: non-small-cell lung cancer;    immunotherapy;    sequence;    real-life evidence;    chemotherapy;    lung cancer;   

DOI  :  10.1016/j.esmoop.2021.100353

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background Immunotherapy using inhibitors targeting immune checkpoint programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) is currently the standard of care in patients with advanced non-small-cell lung cancer (NSCLC).Materials and methods We carried out a nationwide cohort retrospective study of consecutive patients with advanced, refractory NSCLC who received nivolumab as second to later lines of treatment as part of the expanded access program. Key objectives were to assess the efficacy and safety of nivolumab and the efficacy of first post-nivolumab treatment.Results Nine hundred and two patients were enrolled: 317 (35%) with squamous cell carcinoma and 585 (65%) with non-squamous cell carcinoma. Median age was 64 years; there were 630 (70%) men, 795 (88%) smokers, 723 (81%) patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0/1, 197 (22%) patients with brain metastases, and 212 (27%) with liver metastases. Best response was partial response for 16.2% and stable disease (SD) for 30.5%. Progression-free survival and overall survival (OS) rates at 2, 3, and 5 years were 8% and 25%, 6% and 16%, and 4% and 10%, respectively. At multivariate analysis, ECOG PS ≥2 [hazard ratio (HR) = 2.13, 95% confidence interval (95% CI) 1.78-2.55, P < 0.001], squamous histology (HR = 1.17, 95% CI 1.01-1.36, P = 0.04), and presence of central nervous system metastases (HR = 1.29, 95% CI 1.08-1.54, P = 0.005) were significantly associated with lower OS. Four hundred and ninety-two patients received at least one treatment after discontinuation of nivolumab, consisting of systemic therapies in 450 (91%). Radiation therapy was delivered to 118 (24%) patients.Conclusion The CLINIVO cohort represents the largest real-world evidence cohort with the use of immune checkpoint inhibitor in advanced, metastatic NSCLC after failure of first-line chemotherapy, with long-term follow-up and analysis of subsequent therapies. Our data confirm the efficacy of nivolumab in a cohort larger than that reported in landmark clinical trials and identify prognostic factors, which reinforces the need for accurate selection of patients for treatment with immune checkpoint inhibitors. Our data indicate that oligoprogression is frequent after nivolumab exposure and provide a unique insight into the long-term survival.

【 授权许可】

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