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Immunotherapy use outside clinical trial populations: never say never?
BACKGROUND: Based on favourable outcomes in clinical trials, immune checkpoint inhibitors (ICIs), most notably programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitors, are now widely used across multiple cancer types. However, due to their strict inclusion and...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Society for Medical Oncology. Published by Elsevier Ltd.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9246438/ https://www.ncbi.nlm.nih.gov/pubmed/33771665 http://dx.doi.org/10.1016/j.annonc.2021.03.199 |
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author | Rzeniewicz, K. Larkin, J. Menzies, A.M. Turajlic, S. |
author_facet | Rzeniewicz, K. Larkin, J. Menzies, A.M. Turajlic, S. |
author_sort | Rzeniewicz, K. |
collection | PubMed |
description | BACKGROUND: Based on favourable outcomes in clinical trials, immune checkpoint inhibitors (ICIs), most notably programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitors, are now widely used across multiple cancer types. However, due to their strict inclusion and exclusion criteria, clinical studies often do not address challenges presented by non-trial populations. DESIGN: This review summarises available data on the efficacy and safety of ICIs in trial-ineligible patients, including those with autoimmune disease, chronic viral infections, organ transplants, organ dysfunction, poor performance status, and brain metastases, as well as the elderly, children, and those who are pregnant. In addition, we review data concerning other real-world challenges with ICIs, including timing of therapy switch, relationships to radiotherapy or surgery, re-treatment after an immune-related toxicity, vaccinations in patients on ICIs, and current experience around ICI and coronavirus disease-19. Where possible, we provide recommendations to aid the often-difficult decision-making process in those settings. CONCLUSIONS: Data suggest that ICIs are often active and have an acceptable safety profile in the populations described above, with the exception of PD-1 inhibitors in solid organ transplant recipients. Decisions about whether to treat with ICIs should be personalised and require multidisciplinary input and careful counselling of patients with respect to potential risks and benefits. Clinical judgements need to be carefully weighed, considering factors such as underlying cancer type, feasibility of alternative treatment options, or activity in trial-eligible patients. |
format | Online Article Text |
id | pubmed-9246438 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | European Society for Medical Oncology. Published by Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92464382022-07-01 Immunotherapy use outside clinical trial populations: never say never? Rzeniewicz, K. Larkin, J. Menzies, A.M. Turajlic, S. Ann Oncol Review BACKGROUND: Based on favourable outcomes in clinical trials, immune checkpoint inhibitors (ICIs), most notably programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitors, are now widely used across multiple cancer types. However, due to their strict inclusion and exclusion criteria, clinical studies often do not address challenges presented by non-trial populations. DESIGN: This review summarises available data on the efficacy and safety of ICIs in trial-ineligible patients, including those with autoimmune disease, chronic viral infections, organ transplants, organ dysfunction, poor performance status, and brain metastases, as well as the elderly, children, and those who are pregnant. In addition, we review data concerning other real-world challenges with ICIs, including timing of therapy switch, relationships to radiotherapy or surgery, re-treatment after an immune-related toxicity, vaccinations in patients on ICIs, and current experience around ICI and coronavirus disease-19. Where possible, we provide recommendations to aid the often-difficult decision-making process in those settings. CONCLUSIONS: Data suggest that ICIs are often active and have an acceptable safety profile in the populations described above, with the exception of PD-1 inhibitors in solid organ transplant recipients. Decisions about whether to treat with ICIs should be personalised and require multidisciplinary input and careful counselling of patients with respect to potential risks and benefits. Clinical judgements need to be carefully weighed, considering factors such as underlying cancer type, feasibility of alternative treatment options, or activity in trial-eligible patients. European Society for Medical Oncology. Published by Elsevier Ltd. 2021-07 2021-03-24 /pmc/articles/PMC9246438/ /pubmed/33771665 http://dx.doi.org/10.1016/j.annonc.2021.03.199 Text en © 2021 European Society for Medical Oncology. Published by Elsevier Ltd. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Review Rzeniewicz, K. Larkin, J. Menzies, A.M. Turajlic, S. Immunotherapy use outside clinical trial populations: never say never? |
title | Immunotherapy use outside clinical trial populations: never say never? |
title_full | Immunotherapy use outside clinical trial populations: never say never? |
title_fullStr | Immunotherapy use outside clinical trial populations: never say never? |
title_full_unstemmed | Immunotherapy use outside clinical trial populations: never say never? |
title_short | Immunotherapy use outside clinical trial populations: never say never? |
title_sort | immunotherapy use outside clinical trial populations: never say never? |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9246438/ https://www.ncbi.nlm.nih.gov/pubmed/33771665 http://dx.doi.org/10.1016/j.annonc.2021.03.199 |
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