Abstract LB_A14: Factors associated with enrollment, participation, and survival of patients on early phase cancer clinical trials
Authors: Baldwin Elena , Van Hyfte Grace , Lucas Natalie , Wu Kathy , Shelton Gary , Aird Suzan , Chung Grace , Fazilov Gabriela , Fitzgerald Lisa , Hapanowicz Olivia , Holley Khadijah , King Paula , Lu Ashley , Melukkaran Nathasha , Lucas Miriam San , Urena Issamar , Wawrzyniak Aleksandra , Posner Marshall , Galsky Matthew D , Marron Thomas U , Doroshow Deborah B 
Published: December 2023

Abstract
Background: Enrollment and participation of a diverse patient (pt) population for early phase clinical trials is crucial for determining the safety and efficacy of new cancer therapies. However, strict eligibility criteria, co-occurring conditions, and socioeconomic barriers can limit pt participation. Improving methods of pt recruitment, enrollment, and support while on clinical trials has the potential to accelerate trial accrual and diversity within trial cohorts.
Methods: We conducted a retrospective chart review of oncology pts seen by the Early Phase Clinic Trials Unit (EPTU) at the Mount Sinai Hospital between July 2018 and October 2022. Pts had advanced solid tumors and had already received standard of care treatment. Data including demographics, cancer diagnosis, clinical trial enrollment, and overall survival (OS) were obtained from the electronic medical record. Demographic and clinical differences were compared between patients who enrolled on an early phase trial (T) and those who did not (NT). Univariable logistic regression was used to determine predictors of successful trial enrollment. Univariable Cox proportional hazards models were conducted to analyze factors associated with survival time on trial treating death of any cause as the outcome and censoring pts lost to follow-up or alive at trial termination.
Results: 261 referrals were evaluated representing 234 unique patients. Of these, 60 pts (25.64%) enrolled in a clinical trial. No significant differences were found between T and NT pts in gender, race, ethnicity, language, or insurance status. In univariable logistic regression, number of previous systemic therapies was inversely associated with likelihood of going on trial (OR 0.87 95% CI [0.75, 1.00] p= 0.045). Pts with skin cancer had a higher likelihood of going on trial compared to those with other tumor types (OR 4.57 95% CI [1.27, 18.4] p=0.021). Of T patients, 27 (45.00%) were White, 8 (13.33%) were Black, 9 (15.00%) were Asian, and 12 (20.00%) were Hispanic; 12 (20.00%) did not speak English. The median time between initial appointment and Day 1 on trial was 0.67 months. Median length of time on trial was 2.07 months, and median OS from enrollment was 4.16 months (IQR [2.21, 8.16]). In univariable Cox regression, an ECOG PS of 1 compared to 0 was associated with increased risk of death (HR 1.91 95% CI [1.01, 3.61] p=0.050). Both Spanish speaking and all non-English speaking T pts had an increased risk of death compared to English speaking T pts (HR 5.09 95% CI [2.00, 12.19]; HR 2.34 95% CI [1.04, 5.25]).
Conclusion: There were no significant demographic barriers to trial enrollment. However, times on trial and overall survival were modest, with the latter associated with poorer performance status. Given their increased risk of death, more support is needed for non-English speaking patients who participate on early phase trials.
Citation Format: Elena Baldwin, Grace Van Hyfte, Natalie Lucas, Kathy Wu, Gary Shelton, Suzan Aird, Grace Chung, Gabriela Fazilov, Lisa Fitzgerald, Olivia Hapanowicz, Khadijah Holley, Paula King, Ashley Lu, Nathasha Melukkaran, Miriam San Lucas, Issamar Urena, Aleksandra Wawrzyniak, Marshall Posner, Matthew D Galsky, Thomas U Marron, Deborah B Doroshow. Factors associated with enrollment, participation, and survival of patients on early phase cancer clinical trials [abstract]. In: Proceedings of the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics; 2023 Oct 11-15; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2023;22(12 Suppl):Abstract nr LB_A14.