Inequality factors in access to early-phase ...
Document type :
Article dans une revue scientifique: Article original
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Title :
Inequality factors in access to early-phase clinical trials in oncology in France: results of the EGALICAN-2 study.
Author(s) :
Charton, E. [Auteur]
Centre Léon Bérard [Lyon]
Baldini, C. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Fayet, Y. [Auteur]
Centre Léon Bérard [Lyon]
Schultz, E. [Auteur]
Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale [SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD]
Auroy, L. [Auteur]
Centre Hospitalier Universitaire [CHU Grenoble] [CHUGA]
Vallier, E. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Centre Léon Bérard [Lyon]
Italiano, A. [Auteur]
Institut Bergonié [Bordeaux]
Robert, M. [Auteur]
Institut de Cancérologie de l'Ouest [Angers/Nantes] [UNICANCER/ICO]
Coquan, E. [Auteur]
Centre Régional de Lutte contre le Cancer François Baclesse [Caen] [UNICANCER/CRLC]
Isambert, N. [Auteur]
Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] [UNICANCER/CRLCC-CGFL]
Moreau, P. [Auteur]
Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] [UNICANCER/CRLCC-CGFL]
Touzeau, C. [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Le Tourneau, C. [Auteur]
Institut Curie [Paris]
Ghrieb, Z. [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Kiladjian, J. J. [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Delord, J. P. [Auteur]
Institut Claudius Regaud
Gomez Roca, C. [Auteur]
Institut Claudius Regaud
Vey, N. [Auteur]
Institut Paoli-Calmettes [IPC]
Barlesi, F. [Auteur]
Aix Marseille Université [AMU]
Lesimple, T. [Auteur]
CRLCC Eugène Marquis [CRLCC]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Soria, J. C. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Massard, C. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Besle, S. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Moreau, P. [Auteur]
Centre Léon Bérard [Lyon]
Baldini, C. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Fayet, Y. [Auteur]
Centre Léon Bérard [Lyon]
Schultz, E. [Auteur]
Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale [SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD]
Auroy, L. [Auteur]
Centre Hospitalier Universitaire [CHU Grenoble] [CHUGA]
Vallier, E. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Centre Léon Bérard [Lyon]
Italiano, A. [Auteur]
Institut Bergonié [Bordeaux]
Robert, M. [Auteur]
Institut de Cancérologie de l'Ouest [Angers/Nantes] [UNICANCER/ICO]
Coquan, E. [Auteur]
Centre Régional de Lutte contre le Cancer François Baclesse [Caen] [UNICANCER/CRLC]
Isambert, N. [Auteur]
Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] [UNICANCER/CRLCC-CGFL]
Moreau, P. [Auteur]
Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] [UNICANCER/CRLCC-CGFL]
Touzeau, C. [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Le Tourneau, C. [Auteur]
Institut Curie [Paris]
Ghrieb, Z. [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Kiladjian, J. J. [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Delord, J. P. [Auteur]
Institut Claudius Regaud
Gomez Roca, C. [Auteur]
Institut Claudius Regaud
Vey, N. [Auteur]
Institut Paoli-Calmettes [IPC]
Barlesi, F. [Auteur]
Aix Marseille Université [AMU]
Lesimple, T. [Auteur]
CRLCC Eugène Marquis [CRLCC]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Soria, J. C. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Massard, C. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Besle, S. [Auteur]
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] [DITEP]
Moreau, P. [Auteur]
Journal title :
European Society for Medical Oncology
Abbreviated title :
ESMO Open
Volume number :
8
Pages :
101610
Publication date :
2023-08-05
ISSN :
2059-7029
English keyword(s) :
early-phase clinical trial
cancer
social inequalities
access
cancer
social inequalities
access
English abstract : [en]
Background
Investigation of the disparities in the access to experimental treatment in early-phase clinical trials is lacking. The objective of the EGALICAN-2 study was to identify the factors underpinning such ...
Show more >Background Investigation of the disparities in the access to experimental treatment in early-phase clinical trials is lacking. The objective of the EGALICAN-2 study was to identify the factors underpinning such inequalities. Methods A national prospective survey was conducted in 11 early-phase clinical trial centers (CLIP2) certified by the French National Cancer Institute. Sociodemographic, socioeconomic and medical data were collected. Univariate logistic regression models were carried out to estimate odds ratios and 90% confidence intervals associated with the effect of each study variable. A multivariate logistic regression model was built to explore the independent factors associated with the administration of the experimental treatment (C1D1). A post hoc analysis was carried out excluding female cancer patients. Results Between 2015 and 2016, 1355 patients referred from 11 CLIP2 centers in France were included in the study. Eight hundred and forty-eight patients received C1D1 (73%) and 320 patients (27%) were screening failure. Median age was 58 years (range 17-97 years) and 667 patients (54%) were female. Most patients had a metastatic disease (n = 751, 87%). In the multivariate logistic regression analysis, the significant independent factors associated with C1D1 were male sex, initial care received in a hospital with an early-phase unit and living in wealthy metropolitan areas (P values <0.05). In the post hoc analysis, the sex factor was no longer significant [odds ratio = 1.21 (95% confidence interval 0.86-1.70), P value = 0.271]. Conclusions This study investigated the factors producing social inequalities in the context of early-phase clinical trials in oncology. Our research highlights factors of sex, care pathway and geographic location. Gynecological cancer was found to impact C1D1 significantly, unlike breast cancer. The results of this study should contribute to improve patient access to early-phase clinical trials.Show less >
Show more >Background Investigation of the disparities in the access to experimental treatment in early-phase clinical trials is lacking. The objective of the EGALICAN-2 study was to identify the factors underpinning such inequalities. Methods A national prospective survey was conducted in 11 early-phase clinical trial centers (CLIP2) certified by the French National Cancer Institute. Sociodemographic, socioeconomic and medical data were collected. Univariate logistic regression models were carried out to estimate odds ratios and 90% confidence intervals associated with the effect of each study variable. A multivariate logistic regression model was built to explore the independent factors associated with the administration of the experimental treatment (C1D1). A post hoc analysis was carried out excluding female cancer patients. Results Between 2015 and 2016, 1355 patients referred from 11 CLIP2 centers in France were included in the study. Eight hundred and forty-eight patients received C1D1 (73%) and 320 patients (27%) were screening failure. Median age was 58 years (range 17-97 years) and 667 patients (54%) were female. Most patients had a metastatic disease (n = 751, 87%). In the multivariate logistic regression analysis, the significant independent factors associated with C1D1 were male sex, initial care received in a hospital with an early-phase unit and living in wealthy metropolitan areas (P values <0.05). In the post hoc analysis, the sex factor was no longer significant [odds ratio = 1.21 (95% confidence interval 0.86-1.70), P value = 0.271]. Conclusions This study investigated the factors producing social inequalities in the context of early-phase clinical trials in oncology. Our research highlights factors of sex, care pathway and geographic location. Gynecological cancer was found to impact C1D1 significantly, unlike breast cancer. The results of this study should contribute to improve patient access to early-phase clinical trials.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CHU Lille
CHU Lille
Submission date :
2024-01-20T22:10:38Z
2024-04-09T08:56:45Z
2024-04-09T08:56:45Z