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

Autor: C, Baldini, E, Charton, E, Schultz, L, Auroy, A, Italiano, M, Robert, E, Coquan, N, Isambert, P, Moreau, S, Le Gouill, C, Le Tourneau, Z, Ghrieb, J J, Kiladjian, J P, Delord, C Gomez, Roca, N, Vey, F, Barlesi, T, Lesimple, N, Penel, J C, Soria, C, Massard, S, Besle
Rok vydání: 2022
Předmět:
Zdroj: ESMO Open. 7:100468
ISSN: 2059-7029
Popis: 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.During a 1-year period (2015-2016), a survey was conducted in 11 early-phase units certified by the French National Cancer Institute.A total of 1319 patients were included in the analyses: 1086 patients (82.3%) were70 years and 233 patients (17.7%) were70 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).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.
Databáze: OpenAIRE