Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).

Abstract

9005 Background: Cancer racial disparities may exist at many levels in the health care system, from screening to timely diagnosis and treatments received, as well as clinical trial enrollment. This study investigated differences in black versus white race among patients with NSCLC undergoing biomarker testing and clinical trial enrollment in the US. Methods: This retrospective observational study utilized the Flatiron Health database, which includes longitudinal data of patients with advanced/metastatic NSCLC. Patients were eligible if they had evidence of systemic therapy in the database from 1/1/2017 through 10/30/2020. Descriptive analyses summarized differences by race in biomarker testing and trial enrollment. Multivariable regression examined the relationship between these factors. Results: A total of 14,768 patients were eligible: 9,793 (66.3%) were white and 1,288 (8.7%) were black. 76.4% of white patients and 73.6% of black patients underwent at least one single molecular test or comprehensive genomic analysis (p = 0.03). Next-generation sequencing (NGS) was performed among 50.1% of white patients and 39.8% of black patients (p < 0.0001. Trial participation was observed among 3.9% of white and 1.9% of black patients (p = 0.0002). There was a statistically significant association between race (white vs black) and both biomarker testing (ever vs never) and trial participation (yes vs no) (both p < 0.001, unadjusted chi square). Differences in NGS testing, baseline biomarker testing, and race were retained as statistically significant (p < 0.01) in adjusted regression analyses. The receipt of first-line targeted therapy was comparable between white and black patients (10.2% and 9.2%, respectively, p = 0.24); however, this summary did not consider biomarker test results. First line use of pembrolizumab+carboplatin+pemetrexed was observed among 19.8% of white and 22.6% of black patients; carboplatin+paclitaxel was observed among 16.5% and 18.6%, and single-agent pembrolizumab was observed among 14.8% and 11.5%, respectively. Conclusions: The use of NGS-based testing, which is recommended by the National Comprehensive Cancer Network Clinical Guidelines in Oncology for patients with advanced/metastatic NSCLC, is the most notable disparity among black patients, with more than a 10 percentage-point difference in receipt of this testing versus white counterparts. This may in part contribute to the more than double the rate of participation in clinical trials observed among white patients, as many second line and beyond trials utilize molecular targets as inclusion criteria. While multiple factors are known to impact health care disparities, access to and receipt of appropriate biomarker testing may be an attenable goal in order to ensure equal access to quality care.

Biomarker Testing for Patients With Advanced/Metastatic Nonsquamous NSCLC in the United States of America, 2015 to 2021

“…Early evidence suggests that race may continue to play a role in access to equal care, and additional work is needed to continue to reduce the health care disparities that persist in the health care system. 14 …”

“… 11 , 12 , 13 There is emerging work that has begun to explore diagnostic testing in real-world settings, but gaps remain in the knowledge of current practices in biomarker testing and its utilization across community and academic practice settings. 5 , 14 , 15 This study, therefore, was designed to evaluate the utilization of single-gene and panel-based biomarker testing (by NGS) among patients with nonsquamous advanced or metastatic NSCLC in community and academic practice settings across the United States to quantify the rates of testing in current practice to inform the development of guidelines or initiatives to address gaps in the receipt of biomarker testing.…”

Barries in precision medicine implementation among Advanced Nonsquamous Cell Lung Cancer-patients: A Real-World-Evidence Scenario

“…NGS testing may also improve clinical trial participation wich represents a very important pathway to access to innovative therapies. The same study previously cited showed that African American were also less likely to be treated in clinical trials (1.9% versus 3.9%) due to the lack of access to NGS testing 19 .…”

“…Our study did not assessed ethnic differences in terms of access to NGS testing. A recent study showed that African Americans were less likely to undergo NGS testing when compared to those who are Caucasian (39.8% versus 50.1%, p<0.0001) 19 .…”

Perspectives in Immunotherapy: meeting report from the Immunotherapy Bridge, December 1st–2nd, 2021

“…The clinical delivery of precision oncology is however still uneven, with evidence suggesting that currently less than half of the targeted therapy eligible patients are ever receiving a targeted therapy. Challenges are complex and importantly include a still limited use of comprehensive next generation sequencing (NGS) diagnostics, with the lack of comprehensive tumor biomarker diagnostics in the USA often associated with marked racial and socioeconomical patient disparities [ 90 ]. Clinical trial awareness and participation are also major issues.…”