Disparities in Representation of Women, Older Adults, and Racial/Ethnic Minorities in Immune Checkpoint Inhibitor Trials - 29/07/22
, Mahnoor Islam, MD d, Ahsan Masood Khan, MD e, Syed Arsalan Ahmed Naqvi, MBBS a, Rabbia Siddiqi, MD d, Kaneez Zahra Rubab Khakwani, MBBS f, Noureen Asghar, MD f, Waleed Ikram, MD a, Syed A. Hussain, MBBS, MSc, MD g, Parminder Singh, MD a, Jeremy L. Warner, MD, MS b, Guru P. Sonpavde, MD h, Folakemi T. Odedina, PhD i, Kenneth L. Kehl h, Narjust Duma, MD h, Alan H. Bryce, MD aAbstract |
Purpose |
We aim to describe reporting and representation of minority patient populations in immune checkpoint inhibitor (ICI) clinical trials and assess predictors of enrollment disparity.
Methods |
Trial-level data were acquired from eligible phase II and III trials. Population-based estimates were acquired from the SEER 18 and Global Burden of Disease incidence databases. Trials reporting race, age, and sex were summarized using descriptive statistics. Enrollment-incidence ratio (EIR) was used to assess representation of subgroups. Average annual percentage change (AAPC) in EIR was calculated using Joinpoint Regression Analysis. Trial-level characteristics associated with EIR were assessed using multivariable linear regression.
Results |
A total of 107 trials with 48,095 patients were identified. Participation of Black, White, Asian, Native American, Pacific Islander, and Hispanic participants was reported in 65 (61%), 77 (72%), 68 (64%), 40 (37%,) and 24 trials (22%), respectively. Subgroup analyses of clinical outcomes by race, age, and sex were reported in 17 (22%), 62 (78%), and 57 (57%) trials, respectively. Women (trial proportion [TP]: 32%; EIR: 0.90 [95% confidence interval [CI]: 0.84-0.96]), patients aged ≥65 years (TP: 42%; EIR: 0.78 [95% CI: 0.72-0.84]), Black participants (TP: 1.9%; EIR: 0.17 [95% CI: 0.13-0.22]) and Hispanics (TP: 5.9%; EIR: 0.67 [95% CI: 0.53-0.82]) were underrepresented. Representation of Black patients decreased significantly from 2009 to 2020 (AAPC: −23.13). Black participants were significantly underrepresented in phase III trials (P < .001).
Conclusion |
The reporting of participation by racial or ethnic subgroup categories is inadequate. Women, older adults, as well as Black and Hispanic participants are significantly underrepresented in ICI clinical trials.
Le texte complet de cet article est disponible en PDF.Keywords : Clinical trial enrolment, Disparities, Immune checkpoint inhibitors, Older adults, Race, Women
Plan
| Funding: Irbaz bin Riaz was supported by National Institutes of Health under award number T15LM007092-30. |
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| Conflicts of Interest: IRB, MI, AMK, SAAN, RS, KZRK, NA, and WI report none. SAH reports consulting for Pierre Fabre, Bayer, Janssen Oncology, Roche, Merck, Bristol-Myers Squibb, AstraZeneca, Pfizer, Astellas, GSK; receiving grants from CR UK, MRC/NIHR, Boehringer Ingelheim, Roche, Janssen- Cilag, Pierre Fabre and support for attending meetings or travel from Janssen- Cilag, Bayer, Boehringer Ingelheim, Pierre Fabre, Pfizer, Roche, Bristol-Myers Squibb, AstraZeneca, MSD Oncology. PS reports Tivozanib RCC virtual advisory board meeting, Aveo Pharmaceuticals; advisory board invitation, Bayer Healthcare Pharmaceuticals; Bladder Cancer Workshop, Curio Science LLC; Avelumab in UC IS Feild Medical Advisory Board, EMD Serono Inc.; Emergent Treatment Landscape in Urothelial Cancer Advisory Board, Janssen Research & Development, LLC.; Bladder Cancer Decision Point, Medscape from WebMD. JL reports consulting for Westate, Roche, Melax Tech, and Flatiron Health; grants from NIH and AACR; and ownership in HemOnc.org LL; GPS reports serving on advisory board for BMS, Genentech, EMD Serono, Merck, Sanofi, Seattle Genetics/Astellas, Astrazeneca, Exelixis, Janssen, Bicycle Therapeutics, Pfizer/Immunomedics/Gilead, Scholar Rock, G1 Therapeutics, Eli Lilly/Loxo Oncology; research support to institution from Sanofi, Astrazeneca, Immunomedics/Gilead, QED, Predicine, BMS, Lucence, EMD Serono/Pfizer; servingon steering committee of studies for BMS, Bavarian Nordic, Seattle Genetics, QED, G1 Therapeutics (all unpaid), and Astrazeneca, EMD Serono, Debiopharm (paid); serving on data safety monitoring committee for Mereo; spouse employed by Myriad Genetics; receiving travel costs from BMS (2019) and Astrazeneca (2018); writing and editing fees from UpToDate, Editor of Elsevier Practice Update Bladder Cancer Center of Excellence; and speaking fees from Physicians Education Resource (PER), Onclive, Research to Practice, Medscape (all educational). FTO reports serving as an advisor to Pfizer and American Cancer Society. KLK reports serving as a consultant/advisor to Aetion, receiving funding from the American Association for Cancer Research, and receiving honoraria from Roche and IBM. ND reports serving as an advisory or consultant for Pfizer, AstraZeneca, Jansen, BMS, Neogenomics, Inivata and BI Oncology. AHB reports manuscript support from Research to Practice; serving as a consultant for Merck and Bayer; receiving speaking fees from Elsevier, Fallon Medica, Horizon CME, PRIME Education, MJH Life Sciences; receiving grants or contracts (funding to institution) from Janssen, Astra Zeneca, and Gilead; and holding patents Therapeutic Targeting of Cancer Patients with NRG1 Rearrangements15/735,289. |
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| Authorship: All authors had access to the data and a role in writing this manuscript. |
Vol 135 - N° 8
P. 984 - août 2022 Retour au numéro
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