A Call to Action: Dismantling Racial Injustices in Preclinical Research and Clinical Care of Black Patients Living with Small Cell Lung Cancer

135 Background: Black patients have a disproportionately high incidence and mortality from lung cancer. Despite the importance of clinical trials, there continue to be significant racial disparities in recruitment for pivotal registration studies. In 2016, the FDA recommended reporting racial enrollment with a minimum of 5 categories (White, Black, Asian, American Indian or Alaskan Native [AIAN] and Native Hawaiian or Pacific Islander [NHPI]). The International Committee of Medical Journal Editors also recommend reporting race and ethnicity. We evaluated race reporting and representation in registration trials for thoracic cancers. Methods: We reviewed the FDA website and identified all new drug licensing indications in thoracic malignancies (small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and mesothelioma) from 2006 to 2020. NSCLC was further classified as EGFR+, ALK+, other mutation and NOS (no driver mutation). Clinical trials cited on the licensing label for market authorization were recorded and the corresponding registration trial publication was identified. If race was unreported or underreported (defined as ≤3 groups) in the licensing study, then additional information was obtained from clinicaltrials.gov. We calculated the proportion of registration trials meeting FDA criteria and the proportion of each racial group in trials. Results: From 2006-2020, we identified 55 new licensing indications, involving 26 unique drugs; 5 approvals in SCLC, 49 approvals in NSCLC and 1 in mesothelioma. Prior to the FDA race reporting guidelines, 33% (6/18) of registration studies did not meet FDA requirements. This improved to 27% (10/37) after the guideline introduction. Overall 29,545 patients participated in thoracic registration trials; 66% White, 22% Asian, 2% Black, <1% AIAN, <1% NHPI, 1% other or multiple races and 9% unknown. Table shows race distribution by cancer subtype. Conclusions: Although improving, a substantial number of registrational clinical trials in thoracic oncology still do not report race per FDA guidance. In addition, Black individuals are disproportionately under-represented in registration trials. Greater efforts are needed for the inclusion of Black patients and other minorities in clinical trials.[Table: see text]

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Racial Composition of Hospitals: Effects on Surgery for Early-Stage Non–Small-Cell Lung Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2007.15.5291 ◽

2008 ◽

Vol 26 (26) ◽

pp. 4347-4352 ◽

Cited By ~ 37

Author(s):

Christopher S. Lathan ◽

Bridget A. Neville ◽

Craig C. Earle

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Early Stage ◽

Small Cell ◽

Racial Composition ◽

Small Cell Lung ◽

Black Patients ◽

Study Results ◽

White Patients

PurposeBlack patients undergo potentially curative surgery for early-stage lung cancer at a lower rate when compared with white patients. Our study examines the relationship between the percentage of black patients treated at a hospital to determine whether it affects the likelihood of obtaining cancer-directed surgery for patients with non–small-cell lung cancer (NSCLC).Patients and MethodsWe examined claims data of Medicare-eligible patients with nonmetastatic NSCLC living in areas monitored by the Surveillance, Epidemiology, and End Results program between 1991 and 2001. Hospitals were categorized by the percentage of black patients seen: ≤ 8%, more than 8% to 29%, and ≥ 30%. Logistic regression with clustering analysis was used to calculate the odds of undergoing surgical resection.ResultsAmong 9,688 patients with NSCLC, 59% of white patients were seen at a hospital that had ≤ 8% black patients, whereas 60% of black patients were seen in hospitals that had ≥ 30% black patients. Regression analysis revealed that hospital racial composition of 30% or greater black patients had a significant negative effect on the likelihood of undergoing surgery for all patients (odds ratio [OR] = 0.71; 95% CI, 0.57 to 0.87), with black race (OR = 0.69; 95% CI, 0.56 to 0.85) and being seen at a low-volume hospital (OR = 0.64; 95% CI, 0.0.49 to 0.83) having a significant negative impact on likelihood of undergoing surgery.ConclusionOur study results indicate that patient and hospital characteristics are significant predictors of undergoing surgery for Medicare beneficiaries with localized lung cancer. Further examination of the role of the patient-, provider-, and hospital-level factors, in association with the decision to pursue surgical treatment of localized lung cancers, is needed.

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P1.06-012 Non-Small Cell Lung Cancer (NSCLC) Patient Characteristics and Clinical Care Insights in Sweden: The SCAN-LEAF Study

Journal of Thoracic Oncology ◽

10.1016/j.jtho.2017.09.906 ◽

2017 ◽

Vol 12 (11) ◽

pp. S1990 ◽

Cited By ~ 1

Author(s):

M. Sandelin ◽

M. Planck ◽

J.B. Sørensen ◽

O.T. Brustugun ◽

J. Rockberg ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Clinical Care ◽

Nsclc Patient ◽

Patient Characteristics ◽

Small Cell ◽

Small Cell Lung

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Comparison of Prognostic Factors and Survival Among Black Patients and White Patients Treated With Irradiation for Non-Small-Cell Lung Cancer

JNCI Journal of the National Cancer Institute ◽

10.1093/jnci/84.22.1731 ◽

1992 ◽

Vol 84 (22) ◽

pp. 1731-1735 ◽

Cited By ~ 20

Author(s):

M. V. Graham ◽

L. M. Geitz ◽

R. Byhardt ◽

S. Asbell ◽

M. Roach ◽

...

Keyword(s):

Lung Cancer ◽

Prognostic Factors ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Small Cell ◽

Small Cell Lung ◽

Black Patients ◽

White Patients

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The impact of race and insurance status on survival of patients with non-small cell lung cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18064 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18064-e18064

Author(s):

Vinay Nikhil Minocha ◽

Carmen Smotherman ◽

Jason Desmond Hew ◽

Dat C. Pham

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Small Cell ◽

Survival Outcomes ◽

Hazard Rates ◽

Insurance Status ◽

Small Cell Lung ◽

Black Patients ◽

White Patients

e18064 Background: Previous studies have demonstrated disparities in survival outcomes between black and white patients with lung cancer. Black patients are more likely than white patients to have no health insurance or insufficient coverage which may limit their access to treatment. The purpose of this study was to determine the impact of race and insurance status of patients with non-small cell lung cancer on survival outcomes at our institution. Methods: Our study included patients diagnosed and treated for non-small cell lung cancer from 2005 through 2015 at University of Florida hospital in Jacksonville. Cox proportional hazard models were used to study the effect of race (black vs white), insurance, age, tobacco use, family history of cancer and stage on hazard rates for mortality. Time to treatment was compared between blacks and whites using the non-parametric Wilcoxon rank sum test. Results: Of the 1301 patients in our study, 445 (34%) were black. More black patients had Medicaid (24% vs 18%, p = 0.01), and were diagnosed at stage III or IV (81% vs 75%, p = 0.01) compared to white patients. Black patients had higher death rates compared to white patients (80% vs. 71%, p < .0004). Adjusting for stage and insurance, black patients had higher hazard rates for mortality than white patients (HR = 1.18, 95%CI 1.03, 1.35, p = 0.02). Patients with Medicaid and Medicare without supplement had higher hazard rates for mortality compared to other insurance categories (Table). There was no significant difference in time to treatment amongst patients of different races (p = 0.38) and insurance types (p = 0.54). Conclusions: Our study reveals worse survival outcomes in black patients compared to white patients with non-small cell lung cancer, controlling for insurance status and stage at presentation. Future research is needed to determine whether other factors may explain these racial disparities. [Table: see text]

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