Addressing Racial Disparities in Breast Cancer Clinical Trial Enrollment

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.

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Racial disparities in comprehensive biomarker testing and clinical trial enrollment among patients with metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.125 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 125-125

Author(s):

Lisa M. Hess ◽

Debora S. Bruno ◽

Xiaohong Li ◽

Eric Wen Su ◽

Monaliben Patel

Keyword(s):

Clinical Trial ◽

Racial Disparities ◽

Racial Differences ◽

Significant Relationship ◽

Trial Participation ◽

Regression Analyses ◽

Significant Difference ◽

The Us ◽

Biomarker Testing ◽

Clinical Trial Enrollment

125 Background: Racial disparities may exist at many levels in the health care system; in oncology, yet little is known about racial disparities in biomarker testing and clinical trial enrollment among patients with mCRC. This study was designed to explore racial differences in comprehensive biomarker testing and clinical trial enrollment in the US using a large real-world database. Methods: This retrospective observational study utilized the Flatiron Health electronic health records database, which includes longitudinal data from patients diagnosed with mCRC. Patients with mCRC were eligible for this study if they had evidence of systemic therapy from 1/1/2017 through 10/30/2020 and were alive for at least 120 days after metastatic diagnosis. Unadjusted analyses summarized differences in biomarker testing and clinical trial enrollment between White and Black race, adjusted regression analyses were conducted using all baseline variables as covariates. These data are de-identified and are not considered human subjects research in accordance with the US Code of Federal Regulations (45 CFR Part 46). Results: A total of 7,879 patients were eligible: 4,803 (61.0%) were White and 838 (10.6%) were Black. Comprehensive testing by next-generation sequencing (NGS) was received by 51.6% and 41.8% of patients who were White and Black, respectively (p < 0.0001). There was no significant difference in clinical trial participation across all lines of therapy (2.9%, White and 2.9% Black). There was a statistically significant relationship between NGS-based testing and clinical trial enrollment (p < 0.0001), however, race was not identified a moderating factor in this relationship in adjusted regression analyses. The receipt of molecularly-targeted therapy was comparable between both races (11.9% and 9.7% for White and Black, respectively; p = 0.06). Patients received FOLFOX+bevacizumab most commonly in the first line (34.3% White; 40.5% Black), all other regimens were within 2 percentage points between racial groups. Targeted agents were each used by less than 7.4% of the study population. Conclusions: The use of NGS-based testing is significantly different by race in this database. The significant relationship between NGS testing and clinical trial enrollment at any time in the database did not appear to be moderated by race; however, descriptive analyses suggest that the ongoing analyses by line of therapy and considering timing of testing may better quantify these relationships. These data may not be generalizable to the entire US population as they are obtained from a single database that is limited to practices using this EHR system.

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Abstract A083: Diversifying breast cancer clinical trial accrual: An approach to recruitment at a Comprehensive Cancer Center

10.1158/1538-7755.disp18-a083 ◽

2020 ◽

Author(s):

Tanya A. Chavez ◽

Christine Thai ◽

Angelica Sanchez ◽

Laura L. Kruper ◽

Veronica C. Jones ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Cancer Clinical Trial ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Clinical Trial Accrual

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Prospective testing of circulating tumour DNA in metastatic breast cancer facilitates clinical trial enrollment and precision oncology

Annals of Oncology ◽

10.1093/annonc/mdz239.016 ◽

2019 ◽

Vol 30 ◽

pp. v30 ◽

Cited By ~ 1

Author(s):

A.Z. Bujak ◽

C.-F. Weng ◽

M.-J. Silva ◽

M. Yeung ◽

L. Lo ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Metastatic Breast Cancer ◽

Metastatic Breast ◽

Precision Oncology ◽

Clinical Trial Enrollment ◽

Circulating Tumour Dna

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Implementation of a prospective screening tool for breast cancer clinical trial eligibility at an NCI designated cancer center.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.6052 ◽

2011 ◽

Vol 29 (15_suppl) ◽

pp. 6052-6052 ◽

Cited By ~ 1

Author(s):

K. H. Lethert ◽

S. K. Cheng ◽

D. J. Nauman ◽

D. M. Dilts ◽

A. Sandler ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Screening Tool ◽

Cancer Clinical Trial ◽

Cancer Center

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Comparison of attitudes and beliefs about cancer clinical trial enrollment between physicians, research staff, and cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.27_suppl.170 ◽

2019 ◽

Vol 37 (27_suppl) ◽

pp. 170-170

Author(s):

Grace Hillyer ◽

Melissa Beauchemin ◽

Dawn L. Hershman ◽

Moshe A. Kelsen ◽

Frances L Brogan ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cancer Patients ◽

Online Survey ◽

Cancer Clinical Trial ◽

Cultural Barriers ◽

Attitudes And Beliefs ◽

Research Staff ◽

Hispanic Patients ◽

Clinical Trial Enrollment

170 Background: Essential to bringing innovative cancer treatments to patients is voluntary participation in clinical trials but fewer than 10% of cancer patients are enrolled onto a trial. We used a domain-oriented framework to assess barriers to cancer clinical trial enrollment (CTE). Methods: Physicians and research staff completed an online survey in 2017; adult cancer patients not currently enrolled in a trial were interviewed in 2018. Perceived structural, provider- and patient-level barriers to CTE were assessed. Differences in perceptions, attitudes and beliefs toward CTE between physicians and staff, patients by ethnicity, and physicians/staff and patients were examined. Results: In total, 120 physician/staff (64.4% response rate) and 150 cancer patient completed surveys. Interacting with the patients’ family was seen as a CTE barrier by nearly one-third of physicians/staff overall, however, staff much more often stated this barrier than did physicians (44.0% vs. 18.2%, p= 0.007). Hispanic patients more often stated they would join a trial, even if standard therapy was an option compared to non-Hispanic patients ( p= 0.004). Overall, patients, more often than physicians/staff, believed that clinical trials are only offered to people whose disease is hopeless (27.3% vs. 8.7%, p < 0.001) and that CTE does not help patients personally (32.9% vs. 1.8%, p < 0.001). More often physicians/staff believed that patients decline CTE due to language or cultural barriers (57.5% vs. 27.3%, p < 0.001), lack of understanding about clinical trials (63.3% vs. 9.1%, p = 0.001), and mistrust of the medical system (69.2% vs. 36.4%, p= 0.043) than was reported by patients. Patients less often reported declining CTE because of concerns about invasive procedures (9.1% vs. 41.7%, p = 0.02), toxicity (18.2% vs. 60.0%, p= 0.006) or reluctance to be randomized/receive a placebo (27.3% vs. 70.8%, p= 0.005). Conclusions: Our findings indicate a wide gap between provider and patient attitudes and beliefs about CTE. Reconciling these differences will require tailored education to dispel misperceptions and strategies to improve the quality of patient-provider communication.

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