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

Capucine Baldini (1) , E. Charton (2) , E. Schultz (3, 4) , L. Auroy (5) , A. Italiano (6) , M. Robert (7) , E. Coquan (8) , Nicolas Isambert (9, 10) , P. Moreau (11) , S. Le Gouill (12) , C. Le Tourneau (13) , Z. Ghrieb (14) , J. J. Kiladjian (15) , J. P. Delord (16) , C. G. Roca (15) , N. Vey (17) , F. Barlesi (18) , T. Lesimple (19) , Nicolas Penel (20) , J. C. Soria (1) , C. Massard (1) , S. Besle (1)

1 DITEP - Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy]
2 Centre Léon Bérard [Lyon]
3 SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
4 CEPED - UMR_D 196 - Centre population et développement
5 IEPG - Sciences Po Grenoble - Institut d'études politiques de Grenoble
6 Institut Bergonié [Bordeaux]
7 UNICANCER/ICO - Institut de Cancérologie de l'Ouest [Angers/Nantes]
8 UNICANCER/CRLC - Centre Régional de Lutte contre le Cancer François Baclesse [Caen]
9 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
10 LNEC [Poitiers] - Laboratoire de neurosciences expérimentales et cliniques
11 UNICANCER/CRLCC-CGFL - Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon]
12 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
13 Institut Curie [Paris]
14 AP-HP - Hopital Saint-Louis [AP-HP]
15 Institut Claudius Regaud
16 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
17 IPC - Institut Paoli-Calmettes
18 CRCM - Centre de Recherche en Cancérologie de Marseille
19 CRLCC - CRLCC Eugène Marquis
20 METRICS - Evaluation des technologies de santé et des pratiques médicales - ULR 2694

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.

Mots clés: Early-phase clinical trials; Cancer; Older patients; Enrollment; Access

Domaines: Sciences du Vivant [q-bio]

Capucine Baldini, E. Charton, E. Schultz, L. Auroy, A. Italiano, et al.. Access to early-phase clinical trials in older patients with cancer in France: the EGALICAN-2 study. ESMO Open, 2022, European Society for Medical Oncology, 7, pp.100468. ⟨10.1016/j.esmoop.2022.100468⟩. ⟨hal-04567217⟩