Evidence map›Paper›PMID 38728613›Full record

ArticleJCO clinical cancer informatics2024

Phenotyping Hepatic Immune-Related Adverse Events in the Setting of Immune Checkpoint Inhibitor Therapy.

Theodore C Feldman, David E Kaplan, Albert Lin, Jennifer La, Jerry S H Lee, Mayada Aljehani, David P Tuck, Mary T Brophy, Nathanael R Fillmore, Nhan V Do

Erratum issuedAbstract read
In one paragraph

Article in JCO clinical cancer informatics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Theodore C FeldmanVA Boston Healthcare System, Boston, MA.ORCID 0009-0009-9592-8998
David E KaplanCorporal Michael J. Crescenz Department of Veterans Affairs Medical Center, Philadelphia, PA.ORCID 0000-0002-3839-336X
Albert LinVA Palo Alto Healthcare System, Palo Alto, CA.
Jennifer LaVA Boston Healthcare System, Boston, MA.ORCID 0000-0003-2266-0221
Jerry S H LeeEllison Institute of Technology, Los Angeles, CA.ORCID 0000-0003-1515-0952
Mayada AljehaniEllison Institute of Technology, Los Angeles, CA.ORCID 0000-0002-0090-2691
David P TuckVA Boston Healthcare System, Boston, MA.ORCID 0000-0001-7313-5158
Mary T BrophyVA Boston Healthcare System, Boston, MA.ORCID 0000-0003-2314-4368
Nathanael R FillmoreVA Boston Healthcare System, Boston, MA.ORCID 0000-0002-8058-3423
Nhan V DoVA Boston Healthcare System, Boston, MA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe present and validate a rule-based algorithm for the detection of moderate to severe liver-related immune-related adverse events (irAEs) in a real-world patient cohort. The algorithm can be applied to studies of irAEs in large data sets.

methodsWe developed a set of criteria to define hepatic irAEs. The criteria include: the temporality of elevated laboratory measurements in the first 2-14 weeks of immune checkpoint inhibitor (ICI) treatment, steroid intervention within 2 weeks of the onset of elevated laboratory measurements, and intervention with a duration of at least 2 weeks. These criteria are based on the kinetics of patients who experienced moderate to severe hepatotoxicity (Common Terminology Criteria for Adverse Events grades 2-4). We applied these criteria to a retrospective cohort of 682 patients diagnosed with hepatocellular carcinoma and treated with ICI. All patients were required to have baseline laboratory measurements before and after the initiation of ICI.

resultsA set of 63 equally sampled patients were reviewed by two blinded, clinical adjudicators. Disagreements were reviewed and consensus was taken to be the ground truth. Of these, 25 patients with irAEs were identified, 16 were determined to be hepatic irAEs, 36 patients were nonadverse events, and two patients were of indeterminant status. Reviewers agreed in 44 of 63 patients, including 19 patients with irAEs (0.70 concordance, Fleiss' kappa: 0.43). By comparison, the algorithm achieved a sensitivity and specificity of identifying hepatic irAEs of 0.63 and 0.81, respectively, with a test efficiency (percent correctly classified) of 0.78 and outcome-weighted F1 score of 0.74.

conclusionThe algorithm achieves greater concordance with the ground truth than either individual clinical adjudicator for the detection of irAEs.

Indexed as

AlgorithmsImmune Checkpoint InhibitorsLiver NeoplasmsAgedCarcinoma, HepatocellularChemical and Drug Induced Liver InjuryDrug-Related Side Effects and Adverse ReactionsFemaleHumansLiverMaleMiddle AgedPhenotypeRetrospective StudiesImmune Checkpoint Inhibitors

Identifiers

PMID38728613
PMCPMC11161238

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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.