Clinicodemographic predictors of enrollment and outcomes in early phase oncology clinical trials in a diverse urban population.

Abstract

e13514 Background: Early phase clinical trials (EPCTs) evaluate the safety, toxicity, pharmacokinetics, and preliminary efficacy of novel anticancer agents. However, the underrepresentation of minoritized racial and ethnic groups hinders the generalizability of EPCTs and reflects limited access to potentially effective novel therapies. This study aims to evaluate the clinical and sociodemographic factors associated with EPCT enrollment in a diverse, urban population to inform data-driven interventions that promote equitable trial access. Methods: A retrospective chart review of solid tumor patient (pt) referrals to the Mt. Sinai Early Phase Trials Unit between July 2018 and October 2023 was conducted. Data collected included socio-clinicodemographic factors and outcomes of referred pts who either enrolled onto a trial (T) or did not (NT). Logistic regression was used to determine predictors of T enrollment. Univariable Cox proportional hazards models were conducted to analyze factors associated with overall survival (OS) and time on T. Results: Of 499 referrals, 27.1% (n = 135) enrolled in a trial, with a median time on T of 2.14 months (95% CI: 2.07–2.79) and median OS from first dose of study therapy of 10.5 months (95% CI: 8.28-14.3). T patients had a median age of 61 and a median of 3 lines of prior therapy (range: 0-10). Histologies most frequently represented were colorectal (24.4%), gynecological (18.5%) and breast cancers (10.4%). The racial composition of T pts was 53.0% white, 14.9% Black, and 12.7% Asian. 18.6% identified as Hispanic and 14.1% did not speak English. On univariate analysis, non-white race (p = 0.027), hepatopancreaticobiliary cancer (p = 0.009), and ECOG performance status (PS) (p < 0.001) were associated with decreased likelihood of enrolling on trial among all pts referred. In multivariate analysis, only ECOG PS remained significant (p < 0.001). Ethnicity, non-English language, insurance type, median family income, and distance to treatment center were not associated with T enrollment, time on T, or OS. Conclusions: This study demonstrates that it is feasible to enroll a diverse urban pt population onto EPCTs despite well-documented barriers to participation associated with social determinants of health. Moreover, earlier exploration of EPCTs as therapeutic options before PS deterioration affects eligibility is crucial for improving T access and expanding opportunities for underrepresented populations.