Cargando…

Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S.

INTRODUCTION: Patients with hematologic malignancies (HM) who are eligible for allogeneic hematopoietic cell transplant (allo-HCT) often lack an HLA-matched related donor (MRD) and rely on unrelated donors for a matched or mismatched unrelated donor (MUD or MMUD) or on umbilical cord blood (UCB). It...

Descripción completa

Detalles Bibliográficos
Autores principales: Gergis, Usama, Khera, Nandita, Edwards, Marie Louise, Song, Yan, Sun, Rochelle, Simantov, Ronit, Sivaraman, Smitha, Manghani, Rocio, Signorovitch, James
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9446946/
http://dx.doi.org/10.1093/stcltm/szac057.006
_version_ 1784783752537309184
author Gergis, Usama
Khera, Nandita
Edwards, Marie Louise
Song, Yan
Sun, Rochelle
Simantov, Ronit
Sivaraman, Smitha
Manghani, Rocio
Signorovitch, James
author_facet Gergis, Usama
Khera, Nandita
Edwards, Marie Louise
Song, Yan
Sun, Rochelle
Simantov, Ronit
Sivaraman, Smitha
Manghani, Rocio
Signorovitch, James
author_sort Gergis, Usama
collection PubMed
description INTRODUCTION: Patients with hematologic malignancies (HM) who are eligible for allogeneic hematopoietic cell transplant (allo-HCT) often lack an HLA-matched related donor (MRD) and rely on unrelated donors for a matched or mismatched unrelated donor (MUD or MMUD) or on umbilical cord blood (UCB). It is well known that racial minorities are underrepresented in donor registries. OBJECTIVE: Omidubicel, an advanced cell therapy for allo-HCT, demonstrated superior hematopoietic recovery and clinical outcomes compared with standard UCB (NCT02730299). We hypothesized the impact of omidubicel access on racial and ethnic health disparities in a projection model. METHODS: A model was developed to project allo-HCT access and clinical outcomes in a hypothetical population of 10,000 allo-HCT-eligible US patients with HM lacking an HLA-MRD. Outcomes associated with omidubicel, MUD, MMUD, haploidentical or UCB HCT, or no transplant were assessed by race/ethnic group. Model inputs, including clinical outcomes for each HCT type, were drawn from clinical trials, public CIBMTR and US Department of Health and Human Services data, and published studies. Increasing omidubicel use was modeled, with proportional reductions in other allo-HCT types or no transplant. RESULTS: In a modeled population of 10,000 patients, 5,956 (60%) received allo-HCT utilizing current donor sources (MUD, MMUD, haploidentical, UCB) with no omidubicel (status quo). While 80% of white patients underwent allo-HCT, only 40% of Hispanic, 32% of Asian, and 22% of Black patients underwent allo-HCT. Mean time from selecting graft to HCT was 11.5 weeks. Including those not transplanted, 1-year OS was 62% overall, ranging from 56% (Black) to 65% (White). Modeled increases in omidubicel use in eligible patients were associated with higher proportions of patients undergoing allo-HCT, decreased time to HCT, and increased 1-year OS. Improvements were greatest among racial minorities. Assuming 20% omidubicel use, the proportion of patients receiving allo-HCT increased by 71% in Black, 43% in Asian, 30% in Hispanic, and 5% in White patients. Modeled time to allo-HCT improved as well. DISCUSSION: Access to omidubicel is projected to decrease time to allo-HCT, improve outcomes overall, with greatest improvements among racial and ethnic groups underserved by the status quo, thus helping to reduce racial disparities and improving health equity in allo-HCT.
format Online
Article
Text
id pubmed-9446946
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-94469462022-09-06 Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S. Gergis, Usama Khera, Nandita Edwards, Marie Louise Song, Yan Sun, Rochelle Simantov, Ronit Sivaraman, Smitha Manghani, Rocio Signorovitch, James Stem Cells Transl Med Clinical Trials – Hematopoietic Stem Cell Therapy INTRODUCTION: Patients with hematologic malignancies (HM) who are eligible for allogeneic hematopoietic cell transplant (allo-HCT) often lack an HLA-matched related donor (MRD) and rely on unrelated donors for a matched or mismatched unrelated donor (MUD or MMUD) or on umbilical cord blood (UCB). It is well known that racial minorities are underrepresented in donor registries. OBJECTIVE: Omidubicel, an advanced cell therapy for allo-HCT, demonstrated superior hematopoietic recovery and clinical outcomes compared with standard UCB (NCT02730299). We hypothesized the impact of omidubicel access on racial and ethnic health disparities in a projection model. METHODS: A model was developed to project allo-HCT access and clinical outcomes in a hypothetical population of 10,000 allo-HCT-eligible US patients with HM lacking an HLA-MRD. Outcomes associated with omidubicel, MUD, MMUD, haploidentical or UCB HCT, or no transplant were assessed by race/ethnic group. Model inputs, including clinical outcomes for each HCT type, were drawn from clinical trials, public CIBMTR and US Department of Health and Human Services data, and published studies. Increasing omidubicel use was modeled, with proportional reductions in other allo-HCT types or no transplant. RESULTS: In a modeled population of 10,000 patients, 5,956 (60%) received allo-HCT utilizing current donor sources (MUD, MMUD, haploidentical, UCB) with no omidubicel (status quo). While 80% of white patients underwent allo-HCT, only 40% of Hispanic, 32% of Asian, and 22% of Black patients underwent allo-HCT. Mean time from selecting graft to HCT was 11.5 weeks. Including those not transplanted, 1-year OS was 62% overall, ranging from 56% (Black) to 65% (White). Modeled increases in omidubicel use in eligible patients were associated with higher proportions of patients undergoing allo-HCT, decreased time to HCT, and increased 1-year OS. Improvements were greatest among racial minorities. Assuming 20% omidubicel use, the proportion of patients receiving allo-HCT increased by 71% in Black, 43% in Asian, 30% in Hispanic, and 5% in White patients. Modeled time to allo-HCT improved as well. DISCUSSION: Access to omidubicel is projected to decrease time to allo-HCT, improve outcomes overall, with greatest improvements among racial and ethnic groups underserved by the status quo, thus helping to reduce racial disparities and improving health equity in allo-HCT. Oxford University Press 2022-09-06 /pmc/articles/PMC9446946/ http://dx.doi.org/10.1093/stcltm/szac057.006 Text en © The Author(s) 2022. Published by Oxford University Press. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Clinical Trials – Hematopoietic Stem Cell Therapy
Gergis, Usama
Khera, Nandita
Edwards, Marie Louise
Song, Yan
Sun, Rochelle
Simantov, Ronit
Sivaraman, Smitha
Manghani, Rocio
Signorovitch, James
Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S.
title Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S.
title_full Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S.
title_fullStr Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S.
title_full_unstemmed Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S.
title_short Abstract 6 Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the U.S.
title_sort abstract 6 projected impact of omidubicel on racial and ethnic disparities in allogeneic hematopoietic cell transplant access and outcomes for patients with hematologic malignancies in the u.s.
topic Clinical Trials – Hematopoietic Stem Cell Therapy
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9446946/
http://dx.doi.org/10.1093/stcltm/szac057.006
work_keys_str_mv AT gergisusama abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT kheranandita abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT edwardsmarielouise abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT songyan abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT sunrochelle abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT simantovronit abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT sivaramansmitha abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT manghanirocio abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus
AT signorovitchjames abstract6projectedimpactofomidubicelonracialandethnicdisparitiesinallogeneichematopoieticcelltransplantaccessandoutcomesforpatientswithhematologicmalignanciesintheus