ArticlemAbs
Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis.
Article in mAbs. 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.
What it found
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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.
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.
Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.
- The role of IgE specific for galactose-α-1,3-galactose in predicting cetuximab induced hypersensitivity reaction: a systematic review and a diagnostic meta-analysis.Scientific reports · 2020Pooled it
- Chemically Defined Non-human Glycans Comprising Galactose-α1-3-Galactose (α-Gal) Epitopes Glycoengineered into the Fragment Antigen-Binding (Fab) Domain of Cetuximab Differentially Affect Human Anti-α-Gal Immunoglobulin E (IgE) Binding.ACS pharmacology & translational science · 2026Article
- Clinical usefulness of anti-α3Gal immunoglobulin E assays for cetuximab-mediated anaphylaxis in head and neck cancer.Immuno-oncology technology · 2025Article
- Basophil Activation Test Predicts Cetuximab Anaphylaxis Severity in Alpha-Gal IgE-Positive Patients.Diagnostics (Basel, Switzerland) · 2024Article
- Validation of an anti-α-Gal IgE fluoroenzyme-immunoassay for the screening of patients at risk of severe anaphylaxis to cetuximab.BMC cancer · 2023Article
- Nationwide pharmacovigilance data for cetuximab-induced anaphylaxis and predictive model validation using prospective specific IgE detection.The World Allergy Organization journal · 2021Article
- Allergo Journal : interdisziplinare Zeitschrift fur Allergologie und Umweltmedizin : Organ der Deutschen Gesellschaft fur Allergie- und Immunitatsforschung · 2020Article
- Glycosylation engineering of therapeutic IgG antibodies: challenges for the safety, functionality and efficacy.Protein & cell · 2018Review
- Retrospective evaluation of concomitant cetuximab and radiotherapy tolerance for locoregional advanced head and neck squamous cell carcinoma treatment in patients unfit for platinum-based chemotherapy.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2017Article
- The Value of In Vitro Tests to DiminishDrug Challenges.International journal of molecular sciences · 2017Review
- Utility of serum anti-cetuximab immunoglobulin E levels to identify patients at a high risk of severe hypersensitivity reaction to cetuximab.British journal of clinical pharmacology · 2017Article
- Approach to the diagnosis of drug hypersensitivity reactions: similarities and differences between Europe and North America.Clinical and translational allergy · 2017Review
- A novel approach to predict cetuximab-induced hypersensitivity reaction: detection of drug-specific IgE on basophils.Cancer medicine · 2016Article
- Balancing Safety and Efficacy of Epidermal Growth Factor Receptor Inhibitors in Patients With Squamous Cell Carcinoma of the Head and Neck.The oncologist · 2015Review
- Clinical development methodology for infusion-related reactions with monoclonal antibodies.Clinical & translational immunology · 2015Review
- A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions.Cancer medicine · 2015Article
- Case Report About Fatal or Near-Fatal Hypersensitivity Reactions to Cetuximab: Anticetuximab IgE as a Valuable Screening Test.Clinical Medicine Insights. Oncology · 2014Article
- IgE and chemotherapy.Cancer immunology, immunotherapy : CII · 2012Review
- Fatal infusion reactions to cetuximab: role of immunoglobulin e-mediated anaphylaxis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012Article
- Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Cetuximab, a chimeric mouse-human IgG1 monoclonal antibody against the epidermal growth factor receptor, has proven effective in the treatment of metastatic colorectal cancer and squamous cell carcinoma of the head and neck. However, a high incidence of immediate hypersensitivity reactions (HSR) to cetuximab after the first infusion has been observed. We have developed a test for identification of patients likely to show treatment-related HSR to cetuximab. An enzyme-linked immunosorbent assay (ELISA) for detecting anti-cetuximab IgEs was developed and tested on serum samples collected from cancer patients before start of cetuximab treatment, and from healthy blood donors. Similar levels of anti-cetuximab IgE were detected in pre-treatment patient sera (24/92, 26.1%) and sera from healthy blood donors (33/117, 28.2%). HSR were observed in 14 out of the 92 patients (15.2%), and 8 of these (57.1%) were grade 3-4. Anti-cetuximab IgEs were detected in 7/8 of the patients (87.5%) with severe HSRs as compared with 14/78 patients (17.9%) with no HSR (p=0.0002). Predictive value of the anti-cetuximab IgE test for HSR events of grades 3-4 was calculated using Receiver Operating Characteristics analysis. With a cut-off value of 29 arbitrary units for the anti-cetuximab IgE, the ELISA test showed a sensitivity of 87.5%, specificity of 82.1%, positive predictive value of 33.3% and negative predictive value of 98.5%. Anti-cetuximab IgE ELISA detection could be a valuable tool to help the physician anticipate an anaphylaxis episode following cetuximab infusion and opt for a suitable alternative treatment.
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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.