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DISCREPANCIES IN ETHNIC DIVERSITY OF PATIENTS ENROLLED INTO UK MULTIPLE MYELOMA CLINICAL TRIALS
Author(s): ,
Samir Asher
Affiliations:
National Institute for Health Research Clinical Research Facility,University College London Hospitals NHS Trust,London,United Kingdom
,
Aikaterini Kazantzi
Affiliations:
National Institute for Health Research Clinical Research Facility,University College London Hospitals NHS Trust,London,United Kingdom
,
Fatjon Dekaj
Affiliations:
National Institute for Health Research Clinical Research Facility,University College London Hospitals NHS Trust,London,United Kingdom
,
Luke Steventon
Affiliations:
Cancer Clinical Trials Unit,University College London Hospitals NHS Trust,London,United Kingdom
,
Aisha Khatun
Affiliations:
Cancer Clinical Trials Unit,University College London Hospitals NHS Trust,London,United Kingdom
,
Neil Rabin
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Ashu Wechalekar
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Jonathan Sive
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Charalampia Kyriakou
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Xenofon Papanikolaou
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Ke Xu
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Shameem Mahmood
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Brendan Wisniowski
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Lydia Lee
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
,
Kwee Yong
Affiliations:
Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
Rakesh Popat
Affiliations:
National Institute for Health Research Clinical Research Facility,University College London Hospitals NHS Trust,London,United Kingdom;Department of Haematology,University College London Hospitals NHS Trust,London,United Kingdom
EHA Library. Asher S. 06/09/21; 324770; EP1047
Samir Asher
Samir Asher
Contributions
Abstract
Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP1047

Type: E-Poster Presentation

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background

The incidence of multiple myeloma (MM) varies with ethnicity with black patients (pts) approximately twice as likely to develop MM to white pts or Asians (males, black: white 2.9; females, black: white: 2.2 (median, source: CRUK)).  Despite this, a lower proportion of black pts have been reported to be enrolled into clinical trials.  In some countries, survival may be inferior and appear to be linked to access to treatments and other socio-economic factors.  If these are corrected, survival appears to be similar to white pts.  However, it is unknown if these discrepancies exist in a state funded health care system with intended equitable access to treatments.

Aims
The primary aim was to assess the proportions of ethnic groups enrolled into clinical trials in the UK National Health Service (NHS).  Secondary aims were to determine differences in patients enrolled into early phase vs late phase trials by ethnicity, sex and age; to assess the ethnic diversity of MM pts attending MM clinics and compare if the same diversity was observed in clinical trial enrolment, to assess the overall survival (OS) of patients enrolled into clinical trials by ethnic group.

Methods
Cross-sectional population-based analysis was assessed in participants enrolled into MM clinical trials from 2014 to 2021 in a large specialist MM centre receiving referrals from across the UK. Age, sex and ethnicity was determined by electronic health records.  Ethnicity was divided by White, Black, Asian and Mixed/Other. Statistical analysis was performed by one-way ANOVA, Fisher’s exact test and Chi-squared (GraphPad Prism version 9).

Results

182 pts (Phase I/II: 57; Phase II/III: 125) from 25 clinical trials were assessed.  The ethnicity was: white 143 (79%), black 23 (13%), Asian 8 (4%), mixed/ other 7 (4%).  The black: white ratio was 0.16 .  This discrepancy was more marked for Phase I/II trials: white 49 (86%), black 5 (9%), Asian 2 (4%), mixed/other 0 (0%); black: white 0.10 than Phase II/III trials: white 94 (75%), black 18 (14%), asian 6 (5%), mixed/ other 7 (6%); black: white 0.19.  Male: female ratio was 1.38 in keeping with incidence of MM by sex.  The median age of patients enrolled was 65 years (range 38-85) which is lower than expected for the population. 


Within the MM clinics (n=192 over a 4 week period), ethnicity was again skewed to white pts but less so than trial enrolment: white 124 (65%), black 32 (17%), Asian 15 (8%), mixed/ other 19 (10%); black: white 0.25.  Comparing ethnicity within clinics and clinical trial enrolment, there was a lower proportion of non-white pts enrolled into trials, p=0.0038 and this was particularly observed for Phase I/II trials, p=0.0014.  However, there was no significant difference in white: non-white pts between clinic and Phase II/III trial enrolment, p=0.0804.  There was also a lower proportion of mixed/ other pts enrolled into clinical trials, p= 0.0247.


Despite these differences, the OS for those pts enrolled into clinical trials by ethnicity was not significantly different (p=0.4352). OS (years): white: 10.9, black: 11.8, Asian 15.1, mixed/ other 13.5.

Conclusion
The proportion of ethnic minorities enrolled into MM clinical trials was lower than expected compared to the incidence of MM in the UK.  This was particularly apparent in Phase I/II clinical trials where patients are referred from a wider geographical area. Further research is required to understand and improve ethnic diversity into MM trials in state funded health care systems.

Keyword(s): Clinical trial, Ethnicity, Myeloma

Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP1047

Type: E-Poster Presentation

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background

The incidence of multiple myeloma (MM) varies with ethnicity with black patients (pts) approximately twice as likely to develop MM to white pts or Asians (males, black: white 2.9; females, black: white: 2.2 (median, source: CRUK)).  Despite this, a lower proportion of black pts have been reported to be enrolled into clinical trials.  In some countries, survival may be inferior and appear to be linked to access to treatments and other socio-economic factors.  If these are corrected, survival appears to be similar to white pts.  However, it is unknown if these discrepancies exist in a state funded health care system with intended equitable access to treatments.

Aims
The primary aim was to assess the proportions of ethnic groups enrolled into clinical trials in the UK National Health Service (NHS).  Secondary aims were to determine differences in patients enrolled into early phase vs late phase trials by ethnicity, sex and age; to assess the ethnic diversity of MM pts attending MM clinics and compare if the same diversity was observed in clinical trial enrolment, to assess the overall survival (OS) of patients enrolled into clinical trials by ethnic group.

Methods
Cross-sectional population-based analysis was assessed in participants enrolled into MM clinical trials from 2014 to 2021 in a large specialist MM centre receiving referrals from across the UK. Age, sex and ethnicity was determined by electronic health records.  Ethnicity was divided by White, Black, Asian and Mixed/Other. Statistical analysis was performed by one-way ANOVA, Fisher’s exact test and Chi-squared (GraphPad Prism version 9).

Results

182 pts (Phase I/II: 57; Phase II/III: 125) from 25 clinical trials were assessed.  The ethnicity was: white 143 (79%), black 23 (13%), Asian 8 (4%), mixed/ other 7 (4%).  The black: white ratio was 0.16 .  This discrepancy was more marked for Phase I/II trials: white 49 (86%), black 5 (9%), Asian 2 (4%), mixed/other 0 (0%); black: white 0.10 than Phase II/III trials: white 94 (75%), black 18 (14%), asian 6 (5%), mixed/ other 7 (6%); black: white 0.19.  Male: female ratio was 1.38 in keeping with incidence of MM by sex.  The median age of patients enrolled was 65 years (range 38-85) which is lower than expected for the population. 


Within the MM clinics (n=192 over a 4 week period), ethnicity was again skewed to white pts but less so than trial enrolment: white 124 (65%), black 32 (17%), Asian 15 (8%), mixed/ other 19 (10%); black: white 0.25.  Comparing ethnicity within clinics and clinical trial enrolment, there was a lower proportion of non-white pts enrolled into trials, p=0.0038 and this was particularly observed for Phase I/II trials, p=0.0014.  However, there was no significant difference in white: non-white pts between clinic and Phase II/III trial enrolment, p=0.0804.  There was also a lower proportion of mixed/ other pts enrolled into clinical trials, p= 0.0247.


Despite these differences, the OS for those pts enrolled into clinical trials by ethnicity was not significantly different (p=0.4352). OS (years): white: 10.9, black: 11.8, Asian 15.1, mixed/ other 13.5.

Conclusion
The proportion of ethnic minorities enrolled into MM clinical trials was lower than expected compared to the incidence of MM in the UK.  This was particularly apparent in Phase I/II clinical trials where patients are referred from a wider geographical area. Further research is required to understand and improve ethnic diversity into MM trials in state funded health care systems.

Keyword(s): Clinical trial, Ethnicity, Myeloma

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