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Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer t...

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Autores principales: Reynolds, Kerry L, Arora, Shaily, Elayavilli, Ravikumar Komandur, Louv, William C, Schaller, Teilo H, Khandelwal, Aakanksha, Rothenberg, Mace, Khozin, Sean, Guidon, Amanda C, Dougan, Michael, Zubiri, Leyre, Petrillo, Laura, Sise, Meghan E, Villani, Alexandra-Chloe, Johnson, Douglas B, Rahma, Osama, Sharon, Elad
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256840/
https://www.ncbi.nlm.nih.gov/pubmed/34215691
http://dx.doi.org/10.1136/jitc-2021-002896
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author Reynolds, Kerry L
Arora, Shaily
Elayavilli, Ravikumar Komandur
Louv, William C
Schaller, Teilo H
Khandelwal, Aakanksha
Rothenberg, Mace
Khozin, Sean
Guidon, Amanda C
Dougan, Michael
Zubiri, Leyre
Petrillo, Laura
Sise, Meghan E
Villani, Alexandra-Chloe
Johnson, Douglas B
Rahma, Osama
Sharon, Elad
author_facet Reynolds, Kerry L
Arora, Shaily
Elayavilli, Ravikumar Komandur
Louv, William C
Schaller, Teilo H
Khandelwal, Aakanksha
Rothenberg, Mace
Khozin, Sean
Guidon, Amanda C
Dougan, Michael
Zubiri, Leyre
Petrillo, Laura
Sise, Meghan E
Villani, Alexandra-Chloe
Johnson, Douglas B
Rahma, Osama
Sharon, Elad
author_sort Reynolds, Kerry L
collection PubMed
description Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk–benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs.
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spelling pubmed-82568402021-07-23 Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data Reynolds, Kerry L Arora, Shaily Elayavilli, Ravikumar Komandur Louv, William C Schaller, Teilo H Khandelwal, Aakanksha Rothenberg, Mace Khozin, Sean Guidon, Amanda C Dougan, Michael Zubiri, Leyre Petrillo, Laura Sise, Meghan E Villani, Alexandra-Chloe Johnson, Douglas B Rahma, Osama Sharon, Elad J Immunother Cancer Position Article and Guidelines Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk–benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs. BMJ Publishing Group 2021-07-02 /pmc/articles/PMC8256840/ /pubmed/34215691 http://dx.doi.org/10.1136/jitc-2021-002896 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Position Article and Guidelines
Reynolds, Kerry L
Arora, Shaily
Elayavilli, Ravikumar Komandur
Louv, William C
Schaller, Teilo H
Khandelwal, Aakanksha
Rothenberg, Mace
Khozin, Sean
Guidon, Amanda C
Dougan, Michael
Zubiri, Leyre
Petrillo, Laura
Sise, Meghan E
Villani, Alexandra-Chloe
Johnson, Douglas B
Rahma, Osama
Sharon, Elad
Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
title Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
title_full Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
title_fullStr Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
title_full_unstemmed Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
title_short Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
title_sort immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
topic Position Article and Guidelines
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256840/
https://www.ncbi.nlm.nih.gov/pubmed/34215691
http://dx.doi.org/10.1136/jitc-2021-002896
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