Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials

Abstract Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency virus (PLWH), however this high-cancer-risk population has often been excluded from groundbreaking can...

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Autores principales:	Kruti B. Vora, Biagio Ricciuti, Mark M. Awad
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/aa00c730570744ea8ce5a8e2f7a79e54
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spelling	oai:doaj.org-article:aa00c730570744ea8ce5a8e2f7a79e542021-12-02T13:24:14ZExclusion of patients living with HIV from cancer immune checkpoint inhibitor trials10.1038/s41598-021-86081-w2045-2322https://doaj.org/article/aa00c730570744ea8ce5a8e2f7a79e542021-03-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-86081-whttps://doaj.org/toc/2045-2322Abstract Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency virus (PLWH), however this high-cancer-risk population has often been excluded from groundbreaking cancer ICI trials. Our study aimed to characterize the current rate of exclusion and conditional inclusion of PLWH in cancer ICI trials by tumor type, trial phase, and year. ClinicalTrials.gov cancer ICI trials with planned starts between 1/1/2019 and 10/20/2020 were identified. Based on trial eligibility criteria, trials were categorized as “excluded” if PLWH could not enroll, “conditionally included” if only PLWH with adequate immune function were allowed, or “included/not specified” if HIV was not mentioned in the eligibility criteria. Trials from 2014 were separately collected for comparison over time. The number of trials excluding PLWH were compared to the included/not specified group using Fisher’s exact test. Of 809 trials analyzed from 2019 to 2020, 74.4% excluded, 6.9% conditionally included, and 18.7% included/did not specify PLWH. Early phase trials excluded PLWH more frequently than late phase trials. The 2019–2020 trial cohort showed no significant change in exclusion of PLWH compared to 2014. Despite increasing evidence for safe and effective ICI use for PLWH, most cancer ICI trials exclude PLWH and few studies permit PLWH to participate, even if HIV is well-controlled.Kruti B. VoraBiagio RicciutiMark M. AwadNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-6 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Kruti B. Vora Biagio Ricciuti Mark M. Awad Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials
description	Abstract Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency virus (PLWH), however this high-cancer-risk population has often been excluded from groundbreaking cancer ICI trials. Our study aimed to characterize the current rate of exclusion and conditional inclusion of PLWH in cancer ICI trials by tumor type, trial phase, and year. ClinicalTrials.gov cancer ICI trials with planned starts between 1/1/2019 and 10/20/2020 were identified. Based on trial eligibility criteria, trials were categorized as “excluded” if PLWH could not enroll, “conditionally included” if only PLWH with adequate immune function were allowed, or “included/not specified” if HIV was not mentioned in the eligibility criteria. Trials from 2014 were separately collected for comparison over time. The number of trials excluding PLWH were compared to the included/not specified group using Fisher’s exact test. Of 809 trials analyzed from 2019 to 2020, 74.4% excluded, 6.9% conditionally included, and 18.7% included/did not specify PLWH. Early phase trials excluded PLWH more frequently than late phase trials. The 2019–2020 trial cohort showed no significant change in exclusion of PLWH compared to 2014. Despite increasing evidence for safe and effective ICI use for PLWH, most cancer ICI trials exclude PLWH and few studies permit PLWH to participate, even if HIV is well-controlled.
format	article
author	Kruti B. Vora Biagio Ricciuti Mark M. Awad
author_facet	Kruti B. Vora Biagio Ricciuti Mark M. Awad
author_sort	Kruti B. Vora
title	Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials
title_short	Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials
title_full	Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials
title_fullStr	Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials
title_full_unstemmed	Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials
title_sort	exclusion of patients living with hiv from cancer immune checkpoint inhibitor trials
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/aa00c730570744ea8ce5a8e2f7a79e54
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Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials

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