Abstract Details

Title Underrepresentation of Women and Older Patients in U.S. Glioblastoma Clinical Trials

Topic Neuro-oncology

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 13-003

Objective To determine if enrollment on glioblastoma (GBM) interventional clinical trials (ICT) in the U.S. is representative of the population, to identify disparities and describe their evolution over time.

Background Age, gender and racial representation in GBM ICT are not well described.

Design/Methods We queried ClinicalTrials.gov for all adult ICT in GBM from 1995 to 2019. Intervention type was assigned based on definitions in the NCI drug dictionary. Demographics were obtained from ClinicalTrials.gov or the trial publication and compared to corresponding population data from CBTRUS. Mann-Whitney U-test, Kruskal-Walls, one-sample t-test and Wilcoxon signed rank test were used for data analysis.

Results 10617 GBM patients enrolled on 118 adult ICT: experimental agents in 99 ICT were systemic therapy (cytotoxic (24), immunotherapy/vaccine (11) and targeted therapy (64)); 19 ICT involved other modalities. Median age was 54.0 (10.05 years younger than CBTRUS, p < 0.001). Age was most discrepant in recurrent vs newly diagnosed (11.29 years younger vs. 7.57, p < 0.001), non-randomized vs randomized, (10.54 years younger vs 7.65, p = 0.004) and NCI consortium vs. other (10.61 years younger vs. 7.83, p = 0.005). Median age improved from 52.0 (1995 - 2002) to 59.5 (2011 - 2019). Women represented only 37.5% of subjects, 1.23% less than expected from population data (p < 0.018). Sex disparities were not significantly associated with disease setting or ICT type and changed minimally over time. Data on race was unavailable for most ICT from any source.

Conclusions

Despite improvement over time, GBM ICT underrepresent older patients, particularly in earlier phase trials and at recurrence. Fewer women enroll on GBM ICT than men. Racial demographics were not available precluding identification of potential disparities. ICTs need to be designed and implemented to better represent the population. Reporting of race and ethnicity should be encouraged.

Authors/Disclosures
PRESENTER	No disclosure on file
Andrea C. Wasilewski, MD (Givens Brain Tumor Center)	Dr. Wasilewski has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novocure. Dr. Wasilewski has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Servier Pharmaceuticals .
Nimish A. Mohile, MD, FAAN	The institution of Dr. Mohile has received research support from Novocure.