Benoît Dupont1, Delphine Mariotte2, Audrey E Dugué3, Bénédicte Clarisse3, Jean-Michel Grellard3, Emmanuel Babin4, Bruno Chauffert5, Stéphanie Dakpé6, Cristian Moldovan7, Karine Bouhier-Leporrier1, Jean-Marie Reimund1,8, Frederic Di Fiore7,9, Sylvie Zanetta10, Audrey Mailliez11, Pascal Do12, Annie Peytier13, Marie-Pierre Galais12, Carmen Florescu12, Roland Schott14, Brigitte Le Mauff2, Radj Gervais12. 1. Department of Hepato-Gastroenterology and Nutrition, CHU de Caen, Caen, France. 2. Laboratory of Immunology and Immunopathology, CHU de Caen, Caen, France. 3. Clinical Research Department, Centre François Baclesse, Caen, France. 4. Department of Otolaryngology-Head and Neck Surgery, CHU de Caen, Caen, France. 5. Medical Oncology Department, CHU d'Amiens, Amiens, France. 6. Department of Maxillofacial Surgery and Stomatology, CHU d'Amiens, Amiens, France. 7. Medical Oncology Department, Centre Henri Becquerel, Rouen, France. 8. Department of Hepato-Gastroenterology and Nutritional Support, CHU de Strasbourg, Strasbourg, France. 9. Digestive Oncology Unit, Gastroenterology Department, CHU de Rouen, Rouen, France. 10. Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France. 11. Head and Neck Department, Centre Oscar Lambret, Lille, France. 12. Medical Oncology Department, Centre François Baclesse, Caen, France. 13. Gastroenterology Department, Centre Hospitalier de Bayeux, Bayeux, France. 14. Medical Oncology Department, Centre Paul Strauss, Strasbourg, France.
Abstract
AIM: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: Detection of pretreatment anti-cetuximab IgE is feasible and helpful to identify patients at risk of severe cetuximab-induced HSRs.
AIM: 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-cetuximabimmunoglobulin E (IgE) detection in order to identify patients at risk of HSR to cetuximab. METHODS: We included patients ready to receive a first cetuximab infusion in a prospective cohort carried out at nine French centres. Pretreatment anti-cetuximabIgE levels were measured. We compared the proportion of severe HSRs in the low anti-cetuximabIgE levels (≤29 IgE arbitrary units) subgroup with that in a historical cohort of 213 patients extracted from a previous study. RESULTS: Of the 301 assessable patients (mean age: 60.9 ± 9.3 years, head-and-neck cancer: 77%), 66 patients (22%) had high anti-cetuximabIgE 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-cetuximabIgE 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-cetuximabIgE 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-cetuximabIgE levels than patients without reaction (median, 45 vs. 2 IgE arbitrary units, P = 0.006). CONCLUSIONS: Detection of pretreatment anti-cetuximabIgE is feasible and helpful to identify patients at risk of severe cetuximab-induced HSRs.
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