Clinical Trial Enrollment and Biomarker Testing in NSCLC: Racial Disparities

Within the healthcare system in the United States, racial disparities exist at many levels, including in cancer care screening, timely diagnosis, treatments received, and clinical trial enrollment. This study investigated differences in biomarker testing and enrollment in clinical trials in black versus white race among patients with non–small-cell lung cancer (NSCLC) in the United States.¹

Data from the Flatiron Health database were used for this retrospective observational study, which included longitudinal data of patients with advanced and metastatic NSCLC. Data were used if the patient had received systemic therapy. Descriptive analyses summarized differences by race in biomarker testing and trial enrollment, with multivariable regression utilized to examine the relationship between these factors.¹

Data for 14,768 patients were evaluated: 9793 (66.3%) white patients and 1288 (8.7%) black patients.¹ Most white patients (76.4%) and black patients (73.6%) underwent at least a single molecular test or comprehensive genomic analysis (P = .03), with next-generation sequencing (NGS) performed in 50.1% of white patients and 39.8% of black patients (P <.0001).¹ Clinical trial enrollment was lower for black versus white patients (odds ratio, 0.45; 95% confidence interval, 0.26-0.79).¹

Both biomarker testing before the start of first-line therapy (yes vs no) and trial participation (yes vs no) (both P <.001) were statistically significantly associated with race (white vs black).¹ In adjusted regression analyses, differences in NGS testing, baseline biomarker testing, and race remained statistically significant (P <.01).¹

White and black patients received comparable first-line targeted therapy (10.2% and 9.2%, respectively; P = .24).¹ First-line use of pembrolizumab plus carboplatin plus pemetrexed was observed among 19.8% of white patients and 22.6% of black patients; carboplatin plus paclitaxel was observed among 16.5% and 18.6%, and single-agent pembrolizumab was observed among 14.8% and 11.5%, respectively.¹

NGS-based testing, which is recommended by the National Comprehensive Cancer Network Clinical Guidelines in Oncology for patients with advanced or metastatic NSCLC, is the most notable racial disparity. There was a >10% difference in receipt of this testing by black patients versus white counterparts (39.8% vs 50.1%, P <.0001). NGS testing disparity may contribute to more than double the rate of participation in clinical trials observed among white patients, as trials use molecular targets as inclusion criteria for second-line and later-line therapies. Although multiple factors affect healthcare disparities, increasing access to, and receipt of, appropriate biomarker testing is an attainable goal to ensure equal access to quality care.¹

Reference

1. Bruno DS, Hess LM, Li X, et al. Racial disparities in biomarker testing and clinical trial enrollment in non-small-cell lung cancer (NSCLC). American Society of Clinical Oncology (ASCO), June 2021; Abstract 9005.