Inequality factors in access to early-phase clinical trials in oncology in France: results of the EGALICAN-2 study

E Charton; C Baldini; Y Fayet; E Schultz; L Auroy; E Vallier; A Italiano; M Robert; E Coquan; N Isambert; P Moreau; C Touzeau; 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

doi:10.1016/j.esmoop.2023.101610

Inequality factors in access to early-phase clinical trials in oncology in France: results of the EGALICAN-2 study

ESMO Open. 2023 Aug;8(4):101610. doi: 10.1016/j.esmoop.2023.101610. Epub 2023 Aug 1.

Authors

E Charton¹, C Baldini², Y Fayet³, E Schultz⁴, L Auroy⁵, E Vallier⁶, A Italiano⁷, M Robert⁸, E Coquan⁹, N Isambert¹⁰, P Moreau¹¹, C Touzeau¹², C Le Tourneau¹³, Z Ghrieb¹⁴, J-J Kiladjian¹⁴, J-P Delord¹⁵, C Gomez Roca¹⁵, N Vey¹⁶, F Barlesi¹⁷, T Lesimple¹⁸, N Penel¹⁹, J-C Soria², C Massard², S Besle²⁰

Affiliations

¹ Human and Social Sciences Department, Centre Léon Bérard, Lyon. Electronic address: emilie.charton@lyon.unicancer.fr.
² Drug Development Department (DITEP), Gustave Roussy, Paris-Saclay University, Villejuif.
³ Human and Social Sciences Department, Centre Léon Bérard, Lyon; Research on Healthcare Performance (RESHAPE), INSERM U1290, Lyon.
⁴ CEPED (UMR 196), University of Paris, IRD, Paris; SESSTIM, CANBIOS Team, Aix-Marseille University, INSERM, IRD, Marseille.
⁵ University of Grenoble Alpes, CNRS, Sciences Po Grenoble, Grenoble.
⁶ Human and Social Sciences Department, Centre Léon Bérard, Lyon; Drug Development Department (DITEP), Gustave Roussy, Paris-Saclay University, Villejuif.
⁷ Bergonié Institute, Bordeaux.
⁸ Medical Oncology Department, Institut de Cancérologie de l'Ouest, Saint-Herblain.
⁹ Medical Oncology Department, Centre François Baclesse, Caen.
¹⁰ Medical Oncology Department, University Hospital of Poitiers, Poitiers.
¹¹ Medical Oncology Department, Centre Georges-François Leclerc, Dijon.
¹² Department of Hematology, University Hospital of Nantes, Nantes.
¹³ Department of Drug Development and Innovation, Institut Curie, Paris.
¹⁴ Service de Pharmacologie et Investigations Cliniques, Hôpital Saint-Louis, AP-HP, Paris.
¹⁵ Institut Claudius Regaud, IUCT-Oncopole, Toulouse.
¹⁶ Department of Hematology, Institut Paoli-Calmettes, Marseille.
¹⁷ CRCM, INSERM, CNRS, APHM, Aix-Marseille University, Marseille; Gustave Roussy, Villejuif.
¹⁸ Department of Oncology, Eugene Marquis Center, Rennes.
¹⁹ Centre Oscar Lambret, Lille University, Lille.
²⁰ Human and Social Sciences Department, Centre Léon Bérard, Lyon; Drug Development Department (DITEP), Gustave Roussy, Paris-Saclay University, Villejuif; Université Claude Bernard Lyon 1, INSERM 1052, CNRS 5286, Centre Léon Bérard, Centre de recherche en cancérologie de Lyon, Institut Convergence PLAsCAN, Lyon, France.

Abstract

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.

Keywords: access; cancer; early-phase clinical trial; social inequalities.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Aged
Aged, 80 and over
Breast Neoplasms* / diagnosis
Female
France / epidemiology
Humans
Male
Middle Aged
Prospective Studies
Young Adult