Racial disparity in healthcare and clinical trial research is a recognized problem in oncology. Minorities have lower rates of participation in clinical trials, which can translate into trial results that are less generalizable to the population at large.1 Studies have demonstrated there are racially associated genetic variations affecting metabolism and biomarker prevalence which, in turn, can affect patient clinical outcomes and survival rates.1 The US Food and Drug Administration (FDA) and the National Institutes of Health have recognized this and taken steps to increase the representation of minorities in clinical research, but minority participation and race and race-subgroup analysis reporting remains low in landmark trials leading to FDA oncology drug approvals.1 The National Comprehensive Cancer Network Clinical Guidelines in Oncology recommend that all patients with advanced/metastatic non–small-cell lung cancer (NSCLC) have next-generation sequencing (NGS) performed to provide genetic and biomarker information to assist with diagnosis, prognosis, and treatment selection.2,3
At the 2021 American Society of Clinical Oncology annual meeting, the results of a study by Debra S. Bruno, MD, and colleagues were presented examining the differences in black versus white patients with NSCLC who underwent biomarker testing and clinical trial enrollment in the United States.2 The study was a retrospective analysis of patient data obtained from the Flatiron Health Electronic Health Record database. Eligible patients had advanced or metastatic NSCLC and had a record indicating evidence of receiving systemic therapy from January 2017 through October 2020.
A total of 14,768 patients (9793 white patients and 1288 black patients) proved to be eligible for enrollment in this study.2 At least 1 single molecular test or comprehensive genomic analysis was performed for 76.4% of white patients and 73.6% of black patients.2 NGS was performed on 50.1% of white patients and 39.8% of black patients.2 Clinical trial participation occurred among 3.9% of white patients and 1.9% of black patients.2 The researchers determined there was a statistically significant association between race, biomarker testing, and trial participation and differences in NGS testing, baseline biomarker testing, and race were retained as statistically significant (P <.01).2
First-line targeted therapy treatment was comparable between white and black patients (10.2% and 9.2%, respectively), but biomarker test results were not considered in this evaluation.2 Specific therapy given and percentage per race were single-agent pembrolizumab (white 14.8%, black 11.5%), pembrolizumab + carboplatin + pemetrexed (white 19.8%, black 22.6%), and carboplatin + paclitaxel (white 16.5%, black 18.6%).2
There was a 10-point difference in receipt of NGS testing between white patients and black patients, which may contribute to black patients having a lower rate of participation in clinical trials as clinical trials utilize molecular targets in determining participant eligibility.2
- Loree JM, Anand S, Dasari A, et al. Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol. 2019;5:e191870.
- Bruno DS, Hess LM, Li X, et al. Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC). J Clin Oncol. 2021;39(15_suppl):9005-9005.
- Conway JR, Warner JL, Rubinstein WS, Miller RS. Next-generation sequencing and the clinical oncology workflow: data challenges, proposed solutions, and a call to action. JCO Precis Oncol. 2019;3:PO.19.00232.