Evidence map›Paper›PMID 25296628›Full record

ArticleCancer medicine2015

A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions.

Sabine Maier, Christine H Chung, Michael Morse, Thomas Platts-Mills, Leigh Townes, Pralay Mukhopadhyay, Prabhu Bhagavatheeswaran, Jan Racenberg, Ovidiu C Trifan

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancer medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03485638 (Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 6% 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.

NCT03485638 unknown statusnot on this mapstarted 2016, after this paper: background citation

Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection

Typeobservational_patient_registrySponsorYonsei UniversityRan2016 to 2020Enrolled400ConditionsTumor Disease Including Colorectal Cancer, Head & Neck Squamous Cell Carcinoma
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Outpatient Emergencies: Anaphylaxis.The Medical clinics of North America · 2017
    Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Delayed anaphylaxis to alpha-gal, an oligosaccharide in mammalian meat.Allergology international : official journal of the Japanese Society of Allergology · 2016
    Review
  17. Anaphylaxis to the carbohydrate side chain alpha-gal.Immunology and allergy clinics of North America · 2015
    Review
  18. Article
  19. Review
  20. The alpha-gal story: lessons learned from connecting the dots.The Journal of allergy and clinical immunology · 2015
    Review
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

9 authors at 4 institutions in 1 country.

Sabine MaierBristol-Myers Squibb Company, Lawrenceville, New Jersey.
Christine H Chung
Michael Morse
Thomas Platts-Mills
Leigh Townes
Pralay Mukhopadhyay
Prabhu Bhagavatheeswaran
Jan Racenberg
Ovidiu C Trifan
Bristol-Myers Squibb (United States) · USDuke Medical Center · USJohns Hopkins University · USUniversity of Virginia · US

Funding

DUST MITE, COCKROACH AND CAT ALLERGENS IN HOUSES/ASTHMAR01AI020565 · NIAID · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI PLATTS-MILLS, THOMAS A. · 1985 to 2017
$7.1M
NIAID NIH HHS R01 AI020565
6 · The paper itself

Abstract

Severe infusion reactions (SIRs) at rates of 5% or less are known side effects of biological agents, including mAbs such as cetuximab. There are currently no prospectively validated risk factors to aid physicians in identifying patients who may be at risk of experiencing an SIR following administration of any of these drugs. A retrospective analysis of 545 banked serum or plasma samples from cancer patients participating in clinical trials of cetuximab was designed to evaluate whether the presence of pretreatment IgE antibodies against cetuximab, as determined by a commercially available assay system, is associated with SIRs during the initial cetuximab infusion. Patients with a positive test indicating the presence of pretreatment antibodies had a higher risk of experiencing an SIR; however, at the prespecified cutoff utilized in this analysis, the test has a relatively low-positive predictive value (0.577 [0.369-0.766]) and a negative predictive value of 0.961 (0.912-0.987) in an unselected patient population. Data collected in this large retrospective validation study support prior observations of an association between the presence of pretreatment IgE antibodies cross-reactive with cetuximab and SIRs. Further analysis of the test's ability to predict patients at risk of an SIR would be required before this assay could be used reliably in this patient population.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCase-Control StudiesCetuximabCross ReactionsDrug HypersensitivityHumansImmunoglobulin EInfusions, IntravenousOdds RatioRetrospective StudiesRisk FactorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCetuximabImmunoglobulin EBiomarkerscetuximabcolorectal neoplasmshead and neck neoplasmsimmunoglobulin Elung neoplasms

Identifiers

PMID25296628
PMCPMC4312116
OpenAlexW1988860477

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.