Advancing therapeutic clinical trial equity: drivers of enrollment for diverse patients with low- and high-grade glioma

Saturday, May 4, 2024

2:33 PM – 2:35 PM CT

Location: Booth 745 Neuro Spotlight

Presenting Author(s)

Mulki Mehari, BA (she/her/hers)

Medical Student
Department of Neurological Surgery, University of California, San Francisco

Co-Author(s)

UC

Ugonma Chukwueke, MD

Neuro-oncologist
Center for Neuro-Oncology, Dana-Farber Cancer Institute, Department of Neurology, Harvard Medical School, Boston, Massachusetts, USA, United States
Abraham Dada, BA (he/him/his)

Medical Student
Department of Neurological Surgery, University of California, San Francisco
Shawn Hervey-Jumper, MD

Associate Professor
Department of Neurological Surgery, University of California, San Francisco
San Francisco, California, United States
AK

Aymen Kabir, BA

Medical Student
Department of Neurological Surgery, University of California, San Francisco, United States
Cesar Nava, BS (he/him/his)

Medical Student
Department of Neurological Surgery, University of California, San Francisco
Mikias Negussie, BS (he/him/his)

Medical Student
Department of Neurological Surgery, University of California, San Francisco
San Francisco, California, United States
AP

Alyx Porter, MD

Neuro-oncologist
Mayo Clinic, Division of Neuro-Oncology, Department of Neurology, Phoenix, Arizona, United States
SR

Sheantel Reihl, MD

Neurosurgery Resident
University of California, Los Angeles, Department of Neurosurgery
Los Angeles, California, United States
GW

Gayathri Warrier, MS

Associate Specialist
Department of Neurological Surgery, University of California, San Francisco, United States

Disclosure(s):

Abraham Dada, BA: No financial relationships to disclose

Shawn Hervey-Jumper, MD: No financial relationships to disclose

Mulki Mehari, BA: No financial relationships to disclose

Cesar Nava, BS: No financial relationships to disclose

Introduction: Despite widespread recognition of disparities in clinical trial enrollment and subsequent national policy improvements over the past 3 decades, therapeutic clinical trials enroll predominantly White and male participants. This study aims to (1) uncover primary drivers of therapeutic clinical trial enrollment and (2) determine the association between trial enrollment and overall survival for vulnerable patient populations with low- and high-grade glioma.

Methods: Adult glioma patients who received care from the UCSF Brain Tumor Center between 1997-2017 were identified in a prospective registry. Factors associated with therapeutic clinical trial enrollment on univariate logistic regression (p < 0.2) were selected for multivariate logistic regression, our primary analysis. A Cox proportional hazard model was used for survival analysis by clinical trial enrollment, adjusting for known covariates.

Results: There were 351 trial participants (12% minority, 41% women) and 627 non-trial participants (17% minority, 44% women). Higher median neighborhood household income (OR 1.07 per $10,000 increase, p=0.002), WHO tumor grade (4 vs 2-3, OR 1.60, p=0.039), seizure at presentation (OR 1.73, p=0.001), lower extent of tumor resection (80-89% vs 100%, OR 2.36, p=0.013) and higher KPS score (>=80 vs < 80, OR 3.08, p< 0.0001) were associated with increased odds of clinical trial enrollment. Non-English preferred language (OR 0.020, p=0.007), lack of interpreter use (OR 0.05, p=0.035), and no chemotherapy treatment (OR 0.27, p< 0.0001) were associated with decreased odds of clinical trial enrollment. Clinical trial enrollment was associated with improved overall survival (enrolled vs unenrolled, HR 0.84, p=0.015).

Conclusion : Clinical trial enrollment is associated with a survival benefit for patients. We identified primary drivers of enrollment, which will inform equity efforts to increase trial accrual.