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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Series: | Journal for ImmunoTherapy of Cancer |
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doaj-97dca91fdbdd49169c5aa2a5752588002021-08-04T16:30:13ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262021-07-019710.1136/jitc-2021-002896Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world dataSean Khozin0Osama Rahma1Meghan E Sise2Shaily Arora3Ravikumar Komandur Elayavilli4Aakanksha Khandelwal5Mace Rothenberg6Laura Petrillo7Alexandra-Chloe Villani8Chief Executive Officer, ASCO CancerLinQ LLC, Alexandria, Virginia, USACenter for Immuno-Oncology and Gastroenterology Cancer Center, Dana-Farber Cancer Institute, Boston, Massachusetts, USADivision of Nephrology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USAOffice of Oncologic Diseases, US Food and Drug Administration, Silver Spring, Florida, USAProgram Director, Project Data Sphere, Cary, North Carolina, USAGlobal Head of Portfolio Strategy & Innovation, Merck KGaA, Darmstadt, GermanyFormer Chief Medical Officer, Pfizer Inc, New York, New York, USADivision of Palliative Care, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USACenter for Immunology and Inflammatory Diseases and Center for Cancer Research, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USAImmune 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.https://jitc.bmj.com/content/9/7/e002896.full |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Sean Khozin Osama Rahma Meghan E Sise Shaily Arora Ravikumar Komandur Elayavilli Aakanksha Khandelwal Mace Rothenberg Laura Petrillo Alexandra-Chloe Villani |
spellingShingle |
Sean Khozin Osama Rahma Meghan E Sise Shaily Arora Ravikumar Komandur Elayavilli Aakanksha Khandelwal Mace Rothenberg Laura Petrillo Alexandra-Chloe Villani Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data Journal for ImmunoTherapy of Cancer |
author_facet |
Sean Khozin Osama Rahma Meghan E Sise Shaily Arora Ravikumar Komandur Elayavilli Aakanksha Khandelwal Mace Rothenberg Laura Petrillo Alexandra-Chloe Villani |
author_sort |
Sean Khozin |
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_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_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_sort |
immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data |
publisher |
BMJ Publishing Group |
series |
Journal for ImmunoTherapy of Cancer |
issn |
2051-1426 |
publishDate |
2021-07-01 |
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. |
url |
https://jitc.bmj.com/content/9/7/e002896.full |
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