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

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.

Figure 1

Flow chart of patients included in the analysis. CLIP², early-phase clinical trial centers certified by French National Cancer Institute; Cycle 1 day 1, administration of experimental treatment.

Figure 2

Patients’ referral in early-phase clinical trials in France. The different colors represent cities in which patients were referred to early-phase clinical trials. Orange = Paris, dark green = Dijon, light blue = Marseille, yellow = Toulouse, brown = Bordeaux, light green = Nantes, pink = Caen, dark blue = Lille. CLIP², early-phase clinical trial centers certified by French National Cancer Institute.

Figure 3

Forest plot of multivariate logistic regression of factors associated with administration of experimental treatment (n = 1099 patients). A logarithmic scale was used. CI, confidence interval; C1D1, administration of experimental treatment (cycle 1 day 1); OR, odds ratio; WMA, wealthy metropolitan areas.