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

被引：12

作者：

Charton, E. ^{[1
]}

Baldini, C. ^{[2
]}

Fayet, Y. ^{[1
,3
]}

Schultz, E. ^{[4
,5
]}

Auroy, L. ^{[6
]}

Vallier, E. ^{[1
,2
]}

Italiano, A. ^{[7
]}

Robert, M. ^{[8
]}

Coquan, E. ^{[9
]}

Isambert, N. ^{[10
]}

Moreau, P. ^{[11
]}

Touzeau, C. ^{[12
]}

Le Tourneau, C. ^{[13
]}

Ghrieb, Z. ^{[14
]}

Kiladjian, J. J. ^{[14
]}

Delord, J. -P. ^{[15
]}

Roca, C. Gomez ^{[15
]}

Vey, N. ^{[16
]}

Barlesi, F. ^{[17
,18
]}

Lesimple, T. ^{[19
]}

Penel, N. ^{[20
]}

Soria, J. -C. ^{[2
]}

Massard, C. ^{[2
]}

Besle, S. ^{[1
,2
,21
]}

机构：

[1] Ctr Leon Berard, Human & Social Sci Dept, 28 Rue Laennec, F-69008 Lyon, France

[2] Paris Saclay Univ, Drug Dev Dept DITEP, Gustave Roussy, Villejuif, France

[3] Res Healthcare Performance RESHAPE, INSERM U1290, Lyon, France

[4] Univ Paris, IRD, CEPED UMR 196, Paris, France

[5] Aix Marseille Univ, CANBIOS Team, SESSTIM, INSERM,IRD, Marseille, France

[6] Univ Grenoble Alpes, CNRS, Sci Po Grenoble, Grenoble, France

[7] Bergonie Inst, Bordeaux, France

[8] Inst Cancerol Ouest, Med Oncol Dept, St Herblain, France

[9] Ctr Francois Baclesse, Med Oncol Dept, Caen, France

[10] Univ Hosp Poitiers, Med Oncol Dept, Poitiers, France

[11] Ctr Georges Francois Leclerc, Med Oncol Dept, Dijon, France

[12] Univ Hosp Nantes, Dept Hematol, Nantes, France

[13] Inst Curie, Dept Drug Dev & Innovat, Paris, France

[14] Hop St Louis, AP HP, Serv Pharmacologie et Invest Clin, Paris, France

[15] IUCT Oncopole, Inst Claudius Regaud, Toulouse, France

[16] Inst Paoli Calmettes, Dept Hematol, Marseille, France

[17] Aix Marseille Univ, CRCM,APHM, INSERM, CNRS, Marseille, France

[18] Gustave Roussy, Villejuif, France

[19] Eugene Marquis Ctr, Dept Oncol, Rennes, France

[20] Lille Univ, Ctr Oscar Lambret, Lille, France

[21] Univ Claude Bernard Lyon 1, Inst Convergence PLAsCAN, Ctr Leon Berard,INSERM 1052, Ctr Rech cancerol Lyon,CNRS 5286, Lyon, France

来源：

ESMO OPEN | 2023年 / 8卷 / 04期

关键词：

early-phase clinical trial; cancer; social inequalities; access; SOCIOECONOMIC-STATUS; I TRIALS; CANCER; PARTICIPATION; GENDER; IMPACT;

D O I：

10.1016/j.esmoop.2023.101610

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页数：8

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