Abstract 5532: Increasing racial and ethnic diversity of phase 1 solid tumor clinical trials through enrollment at a safety net hospital
Authors: Roy Varun , Lee Esther , Li Ming , Menendez Xiomara , Nieves Elena , Umayam Rebecca , Jensen Nicole , Martinez Lorraine , Hanna Diana , Nieva Jorge , El-Khoueiry Anthony , Thomas Jacob 
Published: April 2023

Background: Racial minorities are under-represented in oncology clinical trials. African Americans and Hispanic/Latinos account for 13% and 18% of the US population, respectively, but in 2018 these groups combined were only 8% of oncology trial subjects. Disproportionate enrollment can limit how generalizable trial outcomes may be and can perpetuate healthcare disparities. The majority of clinical trial enrollment occurs at large academic cancer centers that may not reflect the diverse general cancer patient population in the US. Los Angeles County/University of Southern California Medical Center (LAC+USC) is a large safety net hospital that serves a racially and ethnically diverse patient population.

Methods: We developed a database of all adult patients (pts) enrolled in phase I solid tumor trials at LAC+USC from 2015 - 2022. The data collected includes baseline demographics (age, gender, race, ethnicity, primary language, tumor histology), type of therapeutic intervention, radiologic response per RECIST 1.1, duration of treatment, and survival. Progression-free survival was defined as time from enrollment in the study until progression, discontinuation of treatment, or death. Disease control rate (DCR) was defined as pts with best response of CR, PR, or SD.

Results: 120 pts with solid tumors were enrolled in phase 1 trials at LAC+USC from 2015-2022. Median age was 58 (range 26-78); 58% female; ECOG 0-1 (99%), 2 (1%). 73 patients (61%) were Hispanic, 27 (23%) Asian/Pacific Islander, 9 (8%) non-Hispanic (NH) White, 5 (4%) were NH Black, and 6 (5%) were unknown. 70% of pts had a primary language other than English: 56% Spanish. The most common tumor types were colorectal (16%), hepatocellular (13%), non-small cell lung (12%), head and neck (11%), and ovarian (11%). Trial interventions included chemotherapy (19%), immunotherapy (35%), targeted therapy (54%), and 10% required biomarker selection. The disease control rate (DCR) was 58/120 (48%): 2 pts had CR, 9 pts had PR, and 47 pts had SD. 4-month progression-free survival (PFS) was 42/120 (35%), and 6-month PFS was 27/120 (23%). 90-day survival was confirmed in 101/120 (84%) of patients.

Discussion: A racially diverse population can be successfully enrolled in early phase oncology trials at a safety net hospital. Patient populations that are underrepresented nationally in clinical trials had robust enrollment and comprised the majority of participation (88%) in this setting. Almost half of patients derived clinical benefit (48% DCR) from trial participation. Creating an infrastructure to enroll patients to phase 1 clinical trials at a safety net hospital may be a successful strategy to improve racial and ethnic diversity.

Citation Format: Varun Roy, Esther Lee, Ming Li, Xiomara Menendez, Elena Nieves, Rebecca Umayam, Nicole Jensen, Lorraine Martinez, Diana Hanna, Jorge Nieva, Anthony El-Khoueiry, Jacob Thomas. Increasing racial and ethnic diversity of phase 1 solid tumor clinical trials through enrollment at a safety net hospital. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5532.