Evidence map›Paper›PMID 35471602›Full record

SynthesisCancer immunology, immunotherapy : CII2022

Incidence of hepatotoxicity associated with addition of immune checkpoint blockade to systemic solid tumor therapy: a meta-analysis of phase 3 randomized controlled trials.

Yu Fujiwara, Nobuyuki Horita, Matthew Harrington, Ho Namkoong, Hirotaka Miyashita, Matthew D Galsky

Open access · greenAbstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Cancer immunology, immunotherapy : CII, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 14% of its field
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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

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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

6 authors at 4 institutions in 2 countries.

Yu FujiwaraDepartment of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, 281 First Avenue, New York, NY, 10003, USA. yu.fujiwara@mountsinai.org.ORCID http://orcid.org/0000-0003-1406-2352
Nobuyuki HoritaChemotherapy Center, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Matthew HarringtonDepartment of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, 281 First Avenue, New York, NY, 10003, USA.
Ho NamkoongDepartment of Infectious Diseases, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Hirotaka MiyashitaDepartment of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, 281 First Avenue, New York, NY, 10003, USA.
Matthew D GalskyThe Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, 1470 Madison Avenue, New York, NY, 10029-6542, USA.
Mount Sinai Beth Israel · USIcahn School of Medicine at Mount Sinai · USKeio University Hospital · JPYokohama City University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hepatotoxicity is a major immune-related adverse event that may become life-threatening. The impact of adding immune checkpoint blockade (ICB) to systemic therapy on the incidence of hepatotoxicity remains unknown. We performed a systematic review and meta-analysis to compare the incidence of hepatotoxicity among patients with cancer who received therapy with and without addition of ICB. PubMed, Embase, Web of Science, and Cochrane Library were searched to select phase 3 randomized controlled trials (RCTs) evaluating the effect of adding ICB to systemic therapy, placebo, or supportive care. The odds ratio (OR) of any grade and grade 3-5 hepatitis, elevations in aspartate aminotransferase (AST), and alanine aminotransferase (ALT) was pooled for meta-analysis. 43 RCTs with 28,905 participants were analyzed. Addition of ICB increased the incidence of hepatitis (any grade: OR, 2.13, 95% confidence interval [CI] 1.52-2.97, grade 3-5: OR, 2.66, 95% CI 1.72-4.11), elevated AST (any grade: OR, 2.16, 95% CI 1.73-2.70, grade 3-5: OR, 2.72, 95% CI 1.86-3.99), and elevated ALT (any grade: OR, 2.01, 95% CI 1.59-2.54, grade 3-5: OR, 2.40, 95% CI 1.62-3.55). Subgroup analysis based on the ICB mechanism revealed no significant heterogeneity among each mechanism for hepatitis (any Grade: I

Indexed as

Chemical and Drug Induced Liver InjuryHepatitisNeoplasmsAlanine TransaminaseAspartate AminotransferasesClinical Trials, Phase III as TopicHumansImmune Checkpoint InhibitorsIncidenceRandomized Controlled Trials as TopicAlanine TransaminaseAspartate AminotransferasesImmune Checkpoint InhibitorsHepatitisHepatotoxicityImmune checkpoint blockadeImmune checkpoint inhibitorImmune-related adverse eventImmuno-oncology

Identifiers

PMID35471602
PMCPMC10992785
OpenAlexW4224879711

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.