Access to early-phase clinical trials in older patients with cancer in France: the EGALICAN-2 study

ESMO Open

article

C. Baldini¹  E. Charton³  E. Schultz⁴  L. Auroy⁶  A. Italiano⁷  M. Robert⁹  E. Coquan^1,10  N. Isambert^1,11  P. Moreau^1,12  S. Le Gouill^1,13  C. Le Tourneau^1,14  Z. Ghrieb^1,15  J.J. Kiladjian^1,16  J.P. Delord^1,16  C. Gomez Roca^1,16  N. Vey^1,17  F. Barlesi^1,18  T. Lesimple^2,20  N. Penel^2,21  J.C. Soria^1,19  C. Massard¹  S. Besle¹ 

[1] Gustave Roussy, Université Paris-Saclay, Drug Development Department;Laboratory for Immunomonitoring in Oncology ,(LIO), University Paris-Saclay, Gustave Roussy Cancer Campus;Human and Social Sciences Department, Centre Léon Bérard;CEPED ,(UMR 196), Université de Paris;SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l’Information Médicale, CANBIOS Team ,(Équipe Labellisée LIGUE 2019), Aix-Marseille University;Université Grenoble Alpes, CNRS, Sciences Po Grenoble;Institut Bergonié;University of Bordeaux;Institut de Cancérologie de l’Ouest, Medical Oncology Department;François Baclesse Cancer Center, Department of Oncology;Département d’Innovations Thérapeutiques/recherche Translationnelle en Oncologie et Hématologie;Centre GF Leclerc, Medical Oncology Department;Service d’Hématologie Clinique;Department of Drug Development and Innovation, Institut Curie, Paris-Saclay University;APHP, Hopital Saint-Louis, Centre d’Investigations Cliniques;Department of Medicine & Clinical Research Unit, Institut Claudius Regaud/Institut Universitaire du Cancer de Toulouse;Aix-Marseille University, CNRS, Inserm, Institut Paoli-Calmettes, Hematology Department;Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille Early Phases Cancer Center CLIP2;Gustave Roussy, Université Paris-Saclay;Clinical Research Department;CLIP2 Lille, Centre Oscar Lambret, Lille and Lille University;Lyon 1 University

关键词: early-phase clinical trials;    cancer;    older patients;    enrollment;    access;   

DOI  :  10.1016/j.esmoop.2022.100468

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background Access to clinical trials and especially early-phase trials (ECT) is an important issue in geriatric oncology. As cancer can be considered an age-related disease because the incidence of most cancers increases with age, new drugs should also be evaluated in older patients to assess their safety and efficacy. The EGALICAN-2 study was primarily designed to identify social and/or regional inequalities regarding access to ECT. We focused on the factors of inequalities in access to ECT in older patients.Patients and methods During a 1-year period (2015-2016), a survey was conducted in 11 early-phase units certified by the French National Cancer Institute.Results A total of 1319 patients were included in the analyses: 1086 patients (82.3%) were 70 years. The most common tumor types at referral in older patients were gastrointestinal (19.3%), hematological (19.3%), and thoracic tumors (18.0%). Most patients referred to the phase I unit had signed informed consent and the rate was similar across age (92.7% in younger patients versus 90.6% in older patients; P = 0.266). The rate of screening failure was also similar across age (28.5% in younger patients versus 24.3% in older patients; P = 0.219). Finally, in older patients, univariate analyses showed that initial care received in the hospital having a phase I unit was statistically associated with first study drug administration (odds ratio 0.49, 90% confidence interval 0.27-0.88; P = 0.045).Conclusions Older patients are underrepresented in early clinical trials with 17.7% of patients aged ≥70 years compared with the number of new cases of cancer in France (50%). However, when invited to participate, older patients were prone to sign informed consent.

【 授权许可】

CC BY|CC BY-NC-ND