Chimeric Antigen Receptor T-Cell (CAR-T) Access Among Rural and Health Professional Shortage Area (HPSA) Populations in the Midwest

Carine Tabak, Aliya Rashid,Sam Pepper,William Wesson,Al-Ola Abdallah, Forat Lutfi, Muhammad Umair Mushtaq, Marc Hoffmann, Sarah Bromert, Allison Appenfeller, Erin Winters, Tara L Lin,Joaquina Celebre Baranda,Joseph P McGuirk,Dinesh Pal Mudaranthakam,Nausheen Ahmed

Transplantation and Cellular Therapy(2024)

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摘要
Introduction Chimeric antigen receptor T-cell (CAR-T) therapy has improved outcomes in non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). However, only a fraction of those who qualify for either a CAR-T trial or standard of care (SOC) can receive this therapy. Since CAR-T is delivered at authorized treatment centers (ATC), patients (pts) from rural and Health Professional Shortage Area (HPSA) backgrounds may have limited access to CAR-T. We currently lack the data to discern how these pts’ participation in immune effector cell (IEC) clinical trials compares to the use of approved CAR-T therapies within the same geographic catchment area. This retrospective database review conducted at the University of Kansas aimed to compare the impact of rural and Health Professional Shortage Area (HPSA) backgrounds on the IEC trial enrollment and standard of care (SOC) CAR-T treatments for NHL and MM. We additionally sought to identify whether clinical trial participants represented the same demographic as SOC patients to better understand if barriers to IEC trial enrollment and barriers to SOC CAR-T may be different. Methods Adult patients with NHL or MM diagnoses treated with IEC therapy on clinical trial between 1/1/2015 – 2/6/2023 and, SOC CAR-T recipients between May 2021 and May 2023 were included. Fisher's Exact Tests were conducted to identify significant differences (using P value). Rural-urban continuum codes (RUCC) were used to identify rural populations. Results The geographic catchment area is in Figure 1. There were 399 subjects, 261 (65.4%) CAR-T clinical trial participants, and 138 (34.6%) SOC CAR-T recipients. The majority in both groups were white (86.7%), male (58.4%), urban (79.7%), and non-HPSA areas (57.4%). 45.9% lived over 50 miles away. Of those over 50 miles, 41.53% were from rural compared to 2.3% rural within 50 miles (p<0.05). African Americans comprised 3.83% of individuals who lived over 50 miles compared to 9.72% of individuals living within 50 miles (p=0.066). When stratifying based on RUCC no significant difference was found between commercial and clinical trial patients. There was a significant relationship between rurality and race, as the trials had no African Americans (AA) from rural areas. Also, more subjects from rural areas were ≥65 yr old compared to urban areas, which were primarily 19 to 64 yrs. Conclusion Fewer pts from HPSA or rural regions received CAR-T, whether trial or SOC. Pts from rural and HPSA areas were mostly White, older, and lived further from the ATC. While the demographic composition may account for some of these findings, these results are the basis for further evaluating barriers and developing strategies to improve access in the rural and HPSA areas. In this analysis the SOC and clinical trial populations had similar demographic characteristics, suggesting an overlap between barriers to IEC trial enrollment and SOC CAR-T therapy.
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