Access to early-phase clinical trials in older patients with cancer in France: the EGALICAN-2 study
C. Baldini, Émilie Charton, Émilien Schultz, Lola Auroy, Antoîne Italiano, Marie Robert, Elodie Coquan, Nicolás Isambert, P. Moreau, Steven Le Gouill, Christophe Le Tourneau, Zineb Ghrieb, J.J. Kiladjian, Jean‐Pierre Delord, C. Gomez Roca, Norbert Vey, Fabrice Barlési, Thierry Lesimple, Nicolas Penel, Jean‐Charles Soria, Christophe Massard, Sylvain Besle
Abstract
•Older patients are underrepresented in early-phase clinical trials (17.7%) compared with the number of new cases (50%).•The rate of signed informed consent was similar across age groups (92.7% in younger patients versus 90.6% in older patients).•The rate of screening failure was consistent across all age groups (28.5% in younger patients versus 24.3% in older patients).•In older patients the initial care received in the center having a phase I unit was associated with study drug administration. BackgroundAccess 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 methodsDuring a 1-year period (2015-2016), a survey was conducted in 11 early-phase units certified by the French National Cancer Institute.ResultsA total of 1319 patients were included in the analyses: 1086 patients (82.3%) were <70 years and 233 patients (17.7%) 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).ConclusionsOlder 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. 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%) were <70 years and 233 patients (17.7%) 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). 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.