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

• Published in: ESMO open Vol. 7; no. 3; p. 100468
• Main Authors: Baldini, C., Charton, E., Schultz, E., Auroy, L., Italiano, A., Robert, M., Coquan, E., Isambert, N., Moreau, P., Le Gouill, S., Le Tourneau, C., Ghrieb, Z., Kiladjian, J.J., Delord, J.P., Roca, C. Gomez, Vey, N., Barlesi, F., Lesimple, T., Penel, N., Soria, J.C., Massard, C., Besle, S.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01-06-2022; European Society for Medical Oncology; Elsevier
• Series: European Society for Medical Oncology
• Subjects: access; cancer; early-phase clinical trials; enrollment; Life Sciences; older patients; Original Research; older patients; cancer; access; early-phase clinical trials; enrollment; Older patients; Access; Early-phase clinical trials; Enrollment; Cancer
• ISSN: 2059-7029; 2059-7029
• DOI: 10.1016/j.esmoop.2022.100468

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.
•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.