title: Cetuximab infusion reactions: French pharmacovigilance database analysis.
abstract: OBJECTIVE
  To compare characteristics of patients exhibiting cetuximab infusion reactions or another adverse drug reaction related to cetuximab and to identify factors associated with the severity of cetuximab infusion reactions.
  
  
  METHODS
  All cases of adverse drug reaction reported with cetuximab from 1985 to 2010 were extracted from the French Pharmacovigilance database. The severity of infusion reactions was assessed according to the NCI-CTCAE criteria (v4.0). Multiple logistic regression analysis was performed to identify factors associated with the severity of infusion reactions.
  
  
  RESULTS
  Among the 602 adverse drug reaction reported with cetuximab during the study period, 374 infusion reactions were identified. Indication is more likely to be head and neck than colorectal cancer among patients experiencing an infusion reaction (p < 0.001). Among the seven deaths related to an infusion reaction, five patients were treated for head and neck cancer. Infusion reactions were more likely to be severe when they occurred during the first administration (OR = 7.40 95% CI [2.21-24.71]), adjusted for age, sex, region of France, quarter of the year, indication, year of occurrence, and premedication.
  
  
  CONCLUSIONS
  Our study found that reports of infusion reactions more often concerned patients treated for head and neck cancer, that in these patients the adverse drug reaction was more often fatal and severe infusion reactions were more likely during the first administration. In daily practice, the close monitoring of patients during the first infusion, especially patients with head and neck cancer, is recommended. Considering the possible immunoglobulin E-mediated mechanism, reliable tests for their detection need to be readily available.
authors.affiliation: Centre Régional de Pharmacovigilance de Bourgogne, CHU de Dijon, Dijon, France. aurelie.granvuillemin@chu-dijon.fr
authors.forename: Aurélie
authors.initials: A
authors.lastname: Grandvuillemin
authors.forename: Anne
authors.initials: A
authors.lastname: Disson-Dautriche
authors.forename: Ghada
authors.initials: G
authors.lastname: Miremont-Salamé
authors.forename: Annie
authors.initials: A
authors.lastname: Fourrier-Reglat
authors.forename: Catherine
authors.initials: C
authors.lastname: Sgro
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000068818:Cetuximab; D016208:Databases, Factual; D004342:Drug Hypersensitivity / Q000453:epidemiology / Q000209:etiology* / Q000503:physiopathology; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007262:Infusions, Intravenous; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D060735:Pharmacovigilance; D012307:Risk Factors; D012720:Severity of Illness Index
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab