Abstract B002: Clinical Trial Diversity: Outcomes for US patients with advanced cancer in Phase 1 clinical trials at a major cancer center
Authors: Davidson Tara M. , Roszik Jason , Kang Lei , Le Hung , Campbell Erick , Ozenne Cherri , Dumbrava Ecatarina Cathy , Fu Siquing , Hong David S. , Karp Daniel D. , Naing Aung , Piha-Paul Sarina A. , Rodon Jordi , Tsimberidou Apostolia M. , Yap Timothy A. , Meric-Bernstam Funda , Subbiah Vivek 
Published: December 2023

Background: Clinical trials should be equally accessible; however, multiple populations continue to be underrepresented in all phases of cancer clinical research due to interrelated economic, cultural, social, and medical barriers. Insight into how residing in rural areas, geographic distance to trial sites, race, and gender each affect patient enrollment and outcomes in early phase cancer trials will inform addressing these barriers. Methods:  Reviewed EMR data for all patients with advanced cancer (&gt; 18 years of age) who consented to at least one clinical trial at a single institution phase 1 unit from 4/1/2014 to 8/1/2022.  International patients and those without provided addresses were excluded. Bing geocode data for patient’s home zip codes was used with the haversine distance formula to determine geographic distance to the cancer center. Rural-Urban Commuting Area codes, which classify U.S. 2010 census tracts by zip codes were used to determine rural vs urban areas based on the Rural Health Research Center Categorization A and the Federal Office of Rural Health Policy definitions.  Overall survival (OS) was defined as the date of first phase 1 trial cycle 1 day 1 (C1D1) to last contact or death. Results:  8110 patients consented to ≥ 1 early phase clinical trial.  5264 patients had ≥ 1 C1D1 and were included for OS analysis. OS for the 4525 (85.9%) patients from urban areas vs. 740 (14.1%) from rural areas with a hazard ratio (HR) of 0.92 and confidence internal (CI) 0.83 to 1.01 (p: 0.07). In terms of patient travel, 2315 (44.0%) travelled ≥ 250miles for clinical trial participation. OS for patients who traveled ≥ 250miles to those that traveled &lt;250 was HR 0.99 (CI: 0.92, 1.05, p=0.67). Patient race demographics were: 4077 White/Caucasian (77.5%), 478 Black/African American (9.1%), 329 Other/Unknown (6.3%), 277 Asian (5.3%), 82 Hispanic/Latino (1.6%), 12 American Indian/Alaska Native (0.2%) and 9 Native Hawaiian/Pacific Islander (0.2%).  The OS HRs compared to Caucasian race patients were: American Indian/Alaskan Native American (HR 1.33 CI: 0.64,2.80 p=0.45), Asian (HR 1.01 CI: 0.86,1.16 p=0.99), Black/African American (HR 1.05 CI: 0.94,1.18 p=0.36), Hispanic/Latino (HR 0.68 CI: 0.53,0.88 p=0.004), Native Hawaiian/Pacific Islander (HR 0.73 CI: 0.30,1.75 p=0.48) and Other/Unknown (HR 0.90 CI: 0.77,1.05 p=0.17). For gender, OS was slightly worse for the 47.2% (2482) male patients with a HR of 1.08 (CI 1.01,1.15 p=0.022). Conclusion: The largest enrolled single institution Phase 1 oncology trial cohort of patients with advanced cancer reveals multiple insights. Disparities were clear for U.S. rural vs. urban and race enrollment without affecting clinical outcomes (except for significantly improved outcomes for Hispanic/Latino race). Similar OS outcomes for these historically marginalized phase 1 clinical trial populations supports pushing broader enrollment despite barriers. 

Citation Format: Tara M. Davidson, Jason Roszik, Lei Kang, Hung Le, Erick Campbell, Cherri Ozenne, Ecatarina Cathy Dumbrava, Siquing Fu, David S. Hong, Daniel D. Karp, Aung Naing, Sarina A. Piha-Paul, Jordi Rodon, Apostolia M. Tsimberidou, Timothy A. Yap, Funda Meric-Bernstam, Vivek Subbiah. Clinical Trial Diversity: Outcomes for US patients with advanced cancer in Phase 1 clinical trials at a major cancer center [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B002.