Division of Oncology, Department of Medicine, Stanford University Stanford, California, United States
Objective: Race and ethnicity are important factors in diagnostic and treatment outcomes in soft tissue sarcomas (STS). Previous research has shown that genetic variation associated with ancestry may play a role in etiology of sarcoma and prognosis.1 In 2022, the ASCO and Association of Community Cancer Centers presented specific recommendations and strategies to improve diversity in clinical trials for underrepresented populations. Despite the importance of race and ethnicity representation in clinical trials, limited data exist regarding enrollment trends in STS trials.
Methods: We identified all interventional studies in the United States for STS on ClinicalTrials.gov from conception to April 10, 2024. Data on race and ethnicity was manually extracted from the database and from published abstracts and papers. We analyzed the proportion of trials that reported race and ethnicity information and the proportion of each racial and ethnic group over time by linear regression.
Results: We identified 252 completed STS clinical trials with 137 trials (54.4%) including race and ethnicity information encompassing 12,359 patients. In total, 78.1% were White, 8.33% were Black, 3.72% were Asian, 0.22% were Native Hawaiian and Pacific Islander, 0.43% were American Indian or Alaskan Native, and 8.17% were Hispanic when averaging participants of specific race or ethnicity over total number of participants included in this study. Over time, there was an increase in the number of studies reporting race between 2005 to 2022 (p < 0.01, R2 = 0.68). There was no significant change in the proportion of White (p = 0.77), Black (p = 0.50), Asian (0.11), Native Hawaiian and Pacific Islander (p = 0.91), American Indian or Alaskan Native (p = 0.10), or Hispanic (p = 0.26) participants over time.
Conclusion: While the reporting of race and ethnicity has improved in STS trials over time, the relative participation of most ethnic and racial groups has not. Our studies show that throughout time, minorities remain underrepresented in STS trials. Analyzing the 2001-2015 Surveillance, Epidemiology and End Results program database, Diessner et al found that the STS population consisted of 64% White, 12% Black, 9% American Indian/Alaskan Native or Asian Pacific Islander (AIAN/API), and 16% Hispanic patients.1 From this study, we can see that White patients are well represented in clinical trials while Black, AIAN/API, and Hispanic patients were less represented compared to the prevalence of disease in respective race and ethnicity. Ultimately given the heterogenicity of STS and potential treatment response variability related to race/ethnicity, it is paramount to consider racial and ethnic disparities present in clinical trials.
Citations: 1. Diessner BJ, Weigel BJ, Murugan P, Zhang L, Poynter JN, Spector LG. Racial and ethnic differences in sarcoma incidence are independent of census-tract socioeconomic status. Cancer Epidemiol Biomarkers Prev. 2020;29(11):2141-2148. doi:10.1158/1055-9965.EPI-20-0520
