Outcomes of Patients With Solid Tumor Treated on Phase I Clinical Trials Within a Comprehensive Cancer Center's...

Despite a shift toward targeted therapies and immunotherapies, enrollment to phase I clinical trials for patients with solid tumor remains challenging. Historically, racial and ethnic minority populations are under-represented in clinical trial enrollment in the United States. Multiple barriers exist, including geographic distance from academic centers, restrictive eligibility criteria, and provider or patient factors. The University of Southern California (USC) Norris Comprehensive Cancer Center (USC Norris) clinical sites include both a private hospital and a safety-net hospital. In this report, we describe demographics and outcomes of patients enrolled to phase I clinical trials based on site of care.

Patients enrolled to early-phase clinical trials at USC Norris between January 1, 2015, and December 31, 2022, were included in this study. Patient demographics and outcomes were recorded in a database.

Between January 1, 2015, and December 31, 2022, there were 611 patients enrolled. In all, 43.2% of patients enrolled were non-Hispanic White, followed by 26.2% Hispanic White, 20.6% Asian, 4.9% unknown, 3.9% non-Hispanic Black, and <1% each of American Indian/Alaskan Native or Native Hawaiian/Pacific Islander. The median overall survival was 6.5 months. The median progression-free survival was 2.3 months. The best response was complete response in 1.0%, partial response in 6.4%, stable disease in 36.8%, progression of disease in 44.5%, and not evaluable in 11.3%. The overall response rate was 7.4%.

Enrollment of patients into early-phase clinical trials for solid tumors is challenging, but it is feasible to enroll patients both in a private hospital setting and in a safety-net hospital. Patient outcomes are similar regardless of enrollment site, and racial/ethnic diversity is increased compared with historic national averages in the United States.