Evidence map›Paper›PMID 34215691›Full record

ArticleJournal for immunotherapy of cancer2021

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

Kerry L Reynolds, Shaily Arora, Ravikumar Komandur Elayavilli, William C Louv, Teilo H Schaller, Aakanksha Khandelwal, Mace Rothenberg, Sean Khozin, Amanda C Guidon, Michael Dougan and 7 more

Abstract read
In one paragraph

Article in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed.

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  11. Role for Artificial Intelligence in the Detection of Immune-Related Adverse Events.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Kerry L ReynoldsDivision of Hematology and Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA kreynolds7@partners.org.
Shaily AroraOffice of Oncologic Diseases, US Food and Drug Administration, Silver Spring, Florida, USA.
Ravikumar Komandur ElayavilliProgram Director, Project Data Sphere, Cary, North Carolina, USA.
William C LouvPresident, Project Data Sphere, Cary, North Carolina, USA.
Teilo H SchallerProgram Director, Project Data Sphere, Cary, North Carolina, USA.
Aakanksha KhandelwalGlobal Head of Portfolio Strategy & Innovation, Merck KGaA, Darmstadt, Germany.
Mace RothenbergFormer Chief Medical Officer, Pfizer Inc, New York, New York, USA.
Sean KhozinChief Executive Officer, ASCO CancerLinQ LLC, Alexandria, Virginia, USA.
Amanda C GuidonDivision of Neuromuscular Disorders, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0003-0843-2935
Michael DouganDivision of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-9266-2009
Leyre ZubiriDivision of Hematology and Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Laura PetrilloDivision of Palliative Care, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Meghan E SiseDivision of Nephrology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Alexandra-Chloe VillaniCenter for Immunology and Inflammatory Diseases and Center for Cancer Research, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Douglas B JohnsonDivision of Hematology/Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Osama RahmaCenter for Immuno-Oncology and Gastroenterology Cancer Center, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Elad SharonCancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA.ORCID 0000-0002-0044-9719

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Biomarkers, TumorDrug-Related Side Effects and Adverse ReactionsHumansImmune Checkpoint InhibitorsNeoplasmsBiomarkers, TumorImmune Checkpoint Inhibitorsguidelines as topicimmune toleranceimmunotherapytranslational medical researchtumor biomarkers

Identifiers

PMID34215691
PMCPMC8256840

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.