title: Risk factors for and pre-medications to prevent cetuximab-induced infusion reactions in patients with squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  Cetuximab, a chimeric monoclonal antibody, is the only targeted therapy approved for squamous cell carcinoma of the head and neck (SCCHN). Infusion reactions (IRs) occur in 6-18% of patients pre-medicated with diphenhydramine. Evidence for clinical risk factors for IRs is limited and the benefit of additional pre-medication to prevent IRs is unclear.
  
  
  METHODS
  A retrospective, single institution study of 243 SCCHN patients treated with cetuximab to evaluate potential risk factors for IRs and to assess the efficacy of additional pre-medications (nebulized albuterol and intravenous (IV) corticosteroids and/or H2-blockers) to decrease the risk of IR.
  
  
  RESULTS
  IR (grades 1-4) and high grade (grades 3-4 only) IR occurred in 47 (19.3%) and 16 (6.6%) patients, respectively. Multivariate analysis identified Caucasian race (OR7.11, p=0.003), medication allergy (OR3.74, p=0.002), and blood eosinophils >3% (OR2.75, p=0.01) independently increased the risk of IR; Caucasian race (OR5.57, p=0.007) and medication allergy (OR4.10, p=0.0007) increased the risk of high grade IR. IR (grades 1-4) and high grade IR occurred in 31.8% and 22.7% pre-medicated with diphenhydramine alone. Univariate analysis identified albuterol, famotidine, and corticosteroids decreased the risk of high grade IR. Furthermore, there was a significant difference between the possible combinations of the pre-medications and the risk of high grade IR by Fisher Exact test (p=0.003) whereby the combination of albuterol, famotidine and corticosteroids was effective in preventing high grade IR. Thirty (64%) of the 47 patients who developed an IR were re-challenged and did not experience a recurrence of an IR.
  
  
  CONCLUSIONS
  These data may be used to identify patients at higher risk for cetuximab-induced IR who may be advised to not receive cetuximab or who may benefit from additional pre-medications to decrease the risk of a high grade IR.
authors.affiliation: Division of Hospital Medicine, Department of Internal Medicine, St. Louis, MO, United States.
authors.forename: Waseem
authors.initials: W
authors.lastname: Touma
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States.
authors.forename: Sami S
authors.initials: SS
authors.lastname: Koro
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States.
authors.forename: Jessica
authors.initials: J
authors.lastname: Ley
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States; Alvin J. Siteman Cancer Center, St. Louis, MO, United States.
authors.forename: Tanya M
authors.initials: TM
authors.lastname: Wildes
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States; Alvin J. Siteman Cancer Center, St. Louis, MO, United States.
authors.forename: Loren
authors.initials: L
authors.lastname: Michel
authors.affiliation: Division of Biostatistics, St. Louis, MO, United States.
authors.forename: Yu
authors.initials: Y
authors.lastname: Tao
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, St. Louis, MO, United States; Alvin J. Siteman Cancer Center, St. Louis, MO, United States. Electronic address: dadkins@dom.wustl.edu.
authors.forename: Douglas
authors.initials: D
authors.lastname: Adkins
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D000068818:Cetuximab; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab
keywords: Cetuximab; Infusion reaction; Pre-medication; Risk factors