Utility of serum anti-cetuximab immunoglobulin E levels to identify patients at a high risk of severe hypersensitivity reaction to cetuximab.
Cetuximab is an anti-epidermal growth factor receptor antibody used for the treatment of metastatic colorectal cancer and head and neck cancer. Hypersensitivity reactions (HSRs) are associated with cetuximab use. The aim of the study was to evaluate the utility of anti-cetuximab immunoglobulin E (IgE) detection in order to identify patients at risk of HSR to cetuximab.



We included patients ready to receive a first cetuximab infusion in a prospective cohort carried out at nine French centres. Pretreatment anti-cetuximab IgE levels were measured. We compared the proportion of severe HSRs in the low anti-cetuximab IgE levels (≤29 IgE arbitrary units) subgroup with that in a historical cohort of 213 patients extracted from a previous study.



Of the 301 assessable patients (mean age: 60.9 ± 9.3 years, head-and-neck cancer: 77%), 66 patients (22%) had high anti-cetuximab IgE levels, and 247 patients received cetuximab (including 38 with high anti-cetuximab levels). Severe HSRs occurred in eight patients (five grade 3 and three grade 4). The proportion of severe HSRs was lower in the low anti-cetuximab IgE levels subgroup vs. the historical cohort (3/209 [1.4%] vs. 11/213 [5.2%], odds ratio, 0.27, 95% confidence interval, 0.07-0.97), and higher in high vs. low anti-cetuximab IgE levels subgroup (5/38 [13.2%] vs. 3/209 [1.4%]; odds ratio, 10.4, 95% confidence interval, 2.4-45.6). Patients with severe HSRs had higher anti-cetuximab IgE levels than patients without reaction (median, 45 vs. 2 IgE arbitrary units, P = 0.006).



Detection of pretreatment anti-cetuximab IgE is feasible and helpful to identify patients at risk of severe cetuximab-induced HSRs.
Department of Hepato-Gastroenterology and Nutrition, CHU de Caen, Caen, France.
Benoît
B
Dupont
Laboratory of Immunology and Immunopathology, CHU de Caen, Caen, France.
Delphine
D
Mariotte
Clinical Research Department, Centre François Baclesse, Caen, France.
Audrey E
AE
Dugué
Clinical Research Department, Centre François Baclesse, Caen, France.
Bénédicte
B
Clarisse
Clinical Research Department, Centre François Baclesse, Caen, France.
Jean-Michel
JM
Grellard
Department of Otolaryngology-Head and Neck Surgery, CHU de Caen, Caen, France.
Emmanuel
E
Babin
Medical Oncology Department, CHU d'Amiens, Amiens, France.
Bruno
B
Chauffert
Department of Maxillofacial Surgery and Stomatology, CHU d'Amiens, Amiens, France.
Stéphanie
S
Dakpé
Medical Oncology Department, Centre Henri Becquerel, Rouen, France.
Cristian
C
Moldovan
Department of Hepato-Gastroenterology and Nutrition, CHU de Caen, Caen, France.
Karine
K
Bouhier-Leporrier
Department of Hepato-Gastroenterology and Nutrition, CHU de Caen, Caen, France.|Department of Hepato-Gastroenterology and Nutritional Support, CHU de Strasbourg, Strasbourg, France.
Jean-Marie
JM
Reimund
Medical Oncology Department, Centre Henri Becquerel, Rouen, France.|Digestive Oncology Unit, Gastroenterology Department, CHU de Rouen, Rouen, France.
Frederic
F
Di Fiore
Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France.
Sylvie
S
Zanetta
Head and Neck Department, Centre Oscar Lambret, Lille, France.
Audrey
A
Mailliez
Medical Oncology Department, Centre François Baclesse, Caen, France.
Pascal
P
Do
Gastroenterology Department, Centre Hospitalier de Bayeux, Bayeux, France.
Annie
A
Peytier
Medical Oncology Department, Centre François Baclesse, Caen, France.
Marie-Pierre
MP
Galais
Medical Oncology Department, Centre François Baclesse, Caen, France.
Carmen
C
Florescu
Medical Oncology Department, Centre Paul Strauss, Strasbourg, France.
Roland
R
Schott
Laboratory of Immunology and Immunopathology, CHU de Caen, Caen, France.
Brigitte
B
Le Mauff
Medical Oncology Department, Centre François Baclesse, Caen, France.
Radj
R
Gervais
D000068818:Cetuximab / Q000276:immunology*; D004342:Drug Hypersensitivity / Q000097:blood / Q000453:epidemiology* / Q000276:immunology; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors
D007073:Immunoglobulin E; D000068818:Cetuximab
anaphylaxis; anti-immunoglobulin E antibodies; cetuximab; hypersensitivity
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