title: Using the galactose-α-1,3-galactose enzyme-linked immunosorbent assay to predict anaphylaxis in response to cetuximab.
abstract: Cetuximab is a monoclonal antibody against epidermal growth factor receptor with activity against head and neck cancer and colorectal cancer. Anaphylaxis in response to cetuximab is a significant clinical problem in the Southeastern United States with a grade 3/4 infusion reaction rate of 14%. Previous retrospective data have suggested that the presence of preformed immunoglobulin E antibodies against galactose-α-1,3-galactose in serum can predict anaphylaxis in response to cetuximab.
  
  
  
  Sixty patients were prospectively screened as part of the entry criteria for a phase 2 study of neoadjuvant carboplatin, nab-paclitaxel, and cetuximab. Patients were recruited at 2 academic medical centers known to have high anaphylaxis rates: the University of North Carolina and Vanderbilt. Only patients with a negative laboratory result were treated on the clinical protocol.
  
  
  
  No patient experienced anaphylaxis; the negative predictive value was thus 100%. Other than smoking history, the demographics were similar for assay-positive subjects and assay-negative subjects.
  
  
  
  Subjects with a negative test result can be safely treated with cetuximab. Further research is required regarding the optimal cutoff for positivity and the positive predictive value. Cancer 2016;122:1697-701. © 2016 American Cancer Society.
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Jared
authors.initials: J
authors.lastname: Weiss
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Juneko
authors.initials: J
authors.lastname: Grilley Olson
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Allison Mary
authors.initials: AM
authors.lastname: Deal
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Bhishamjit
authors.initials: B
authors.lastname: Chera
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Mark
authors.initials: M
authors.lastname: Weissler
authors.affiliation: Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Murphy
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: David Neil
authors.initials: DN
authors.lastname: Hayes
authors.affiliation: Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.
authors.forename: Jill
authors.initials: J
authors.lastname: Gilbert
mesh_terms: D000418:Albumins / Q000008:administration & dosage; D000707:Anaphylaxis / Q000175:diagnosis / Q000276:immunology*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage; D000068818:Cetuximab / Q000008:administration & dosage / Q000009:adverse effects*; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000276:immunology*; D004187:Disaccharides / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000276:immunology*; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood*; D017239:Paclitaxel / Q000008:administration & dosage; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012907:Smoking / Q000276:immunology; D015144:Southeastern United States
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000970:Antineoplastic Agents; D004187:Disaccharides; C055075:galactosyl-(1-3)galactose; D007073:Immunoglobulin E; D016190:Carboplatin; D017239:Paclitaxel; D000068818:Cetuximab
keywords: Southeastern United States; anaphylaxis; cetuximab; colorectal neoplasms; head and neck neoplasms