Determining demographic barriers for cervical and endometrial cancer trial inclusion among women in the Louisiana tumor registry over one year (284)

Abstract

<b>Objectives:</b> To determine cohorts of women diagnosed with cervical and endometrial cancers in Louisiana, meeting national NCORP clinical trial eligibility criteria based on cancer histology and stage. Then, to determine if there is a disparate rate of disqualification among these cohorts for potential trial participation based on comorbid conditions according to age, race, and socioeconomic markers. <b>Methods:</b> The baseline population for this study was all women with either endometrial or cervical malignancies from the Louisiana Tumor Registry (LTR) between January-December 2019. Based on the eligibility criteria of cooperative group clinical trials open at NCORP sites in Louisiana, a cohort of ‘potentially eligible' trial patients was defined based on cancer stage and histology. This cohort was then further filtered according to registry reported, potentially excluding comorbid conditions (renal and/or hepatic disease, Charlson comorbidity index >6, HIV/AIDs and secondary malignancy) to define those who were ‘eligible and included' versus those who were ‘eligible but excluded.' Summary and comparative statistical analyses were used to determine differences between these groups based on demographic and socioeconomic factors. <b>Results:</b> From the baseline population, 152 (68%) patients were defined as potentially eligible for cervix clinical trials. Comparing women who did and did not meet inclusion criteria, women who were excluded were older (p=0.008) and of lower socioeconomic status (<i>n</i>=8, 38%) (p=0.038). Among those with endometrial cancer, 326 (55%) patients were potentially eligible for endometrial cancer trials. Patients eligible and included were more likely to be younger (p=0.028), of the White race (86%) than Black race (55%) (p=0.002) and privately insured (43%) than publicly insured (54%) (p=0.001). Those eligible and included were more likely to be alive at the time of reporting than those eligible but excluded. <b>Conclusions:</b> Age, race, underinsurance, and lower SES are associated with the exclusion of eligible patients from endometrial and cervical cancer trial enrollment. Critical efforts to address barriers to enrollment into clinical cancer trials, especially for underrepre-sented groups, are required in order to reconsider and tailor eligibility criteria to be more equitable and inclusive.