Disparities in clinical drug trial participation in endometrial cancer: a real-world analysis - 05/11/24

Doi : 10.1016/j.ajog.2024.09.103

Anna Jo Bodurtha Smith, MD, MPH ^a,^b,^c,^⁎ , Sebastian Spataro ^b,^d,^f, Jonathan Heintz, MS ^e, Fiona Simpkins, MD ^a, Emily M. Ko, MD, MSCR ^a,^b,^c
^a Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania Health Systems, Philadelphia, PA
^b Leonard Davis Institute of Health Economics, University of Pennsylvania Health Systems, Philadelphia, PA
^c Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania Health Systems, Philadelphia, PA
^d Rice University, Houston, TX
^e Biostatistics Analysis Center, Perelman School of Medicine, University of Pennsylvania Health Systems, Philadelphia, PA
^f Population Aging Research Center, Penn Arts and Sciences Populations Studies Center, University of Pennsylvania, Philadelphia, PA

^∗Corresponding author: Anna Jo Bodurtha Smith, MD, MPH, MSc.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Tuesday 05 November 2024

Abstract

Background

Racial disparities in clinical trial participation for uterine cancer have been reported.

Objective

We sought to examine disparities of endometrial cancer patient participation in clinical drug trials in a contemporary, real-world population in the United States.

Study Design

We conducted a retrospective cohort study of patients with advanced or recurrent patients with endometrial cancer diagnosed from 2013 to 2021 using a real-world electronic health record-derived database representing approximately 800 academic and community practice sites across the United States. We used multilevel Poisson regression modeling to analyze the association of clinical drug trial participation with patient, sociodemographic, health system, and cancer factors.

Results

Of 4423 patients with endometrial cancer, 2807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of patients with endometrial cancer ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (risk ratio (RR) 2.28, 95% confidence interval (CI) 1.12–4.62 and RR 2.59, 95% CI 1.26–5.3 respectively). By race, trial participants included 123 (72.4%) White, 18 (10.6%) Black, 1 (0.59%) Asian, and 28 (16.4%) some other race. While Black patients had the greatest proportion of high-risk histology, they were 50.0% less likely than white patients to participate in a clinical trial (RR 0.50, 95% CI 0.30–0.83).

Conclusion

Black patients with endometrial cancer were disproportionately underrepresented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.

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Key words : clinical drug trial participation, endometrial cancer, racial disparity, real-world analyses

Plan

Introduction

Materials and methods

Results

Comment

Principal findings

Results in the context of what is known

Clinical implications

Research implications

Strengths and limitations

Conclusions

CRediT authorship contribution statement

	A.J.B.S. and S.S. are the first co-authors of this study.
	The authors report no conflict of interest.
	Dr Smith's and Mr Heinz's work was funded by grants from the American College of Obstetrics and Gynecology and the University of Pennsylvania's Basser Center for BRCA. Mr Spataro's work was funded by a grant from the National Institute of Aging. Neither funder was involved in study design or manuscript submission.
	This study was presented at the 2022 American Society of Clinical Oncology Annual Meeting, e-publication abstract only: Ko EM, Alvarez R, Heintz J, Simpkins F, Smith AJ: Disparities in endometrial cancer clinical drug trial participation. Journal of Clinical Oncology 40(16_suppl): e18514-e18514. June 2022. This study was also presented at the 2023 Mid-Atlantic Gynecological Oncology Society conference, as a poster presentation: Anna Jo Bodurtha Smith, Sebastian Spataro, Jonathan Heintz, Fiona Simpkins, Stefanie Hinkle, Emily M. Ko: Disparities in Clinical Drug Trial Participation in Endometrial Cancer. October 2023.
	Cite this article as: Smith AJB, Spataro S, Heintz J, et al. Disparities in clinical drug trial participation in endometrial cancer: a real-world analysis. Am J Obstet Gynecol 2024;XXX:XX–XX.