title: Assessment of cetuximab-induced infusion reactions and administration rechallenge at an academic medical center.
abstract: Cetuximab is approved for treatment of squamous cell carcinoma of the head and neck (SCCHN). Cetuximab is generally well tolerated, but does carry a black box warning for infusion reactions (IRs). Incidence of IR in clinical trials was 15-20% for all grades and 3-5% for grades III-IV. Retrospective studies reported a higher incidence of all grade IRs and grades III-IV IR in areas of the Southeastern United States. Information regarding rechallenge doses after an IR has not been well described. At our institution, we frequently rechallenge on the same day after an initial IR. The primary objective was to determine the incidence, timing, IR grade, and completion of a rechallenge dose in patients who experienced an initial IR. Secondary objectives included: (1) determining the incidence and grade of IR in patients who received a first dose of cetuximab and (2) identifying specific risk factors for cetuximab IR with the first dose. A single-center retrospective chart review was conducted in SCCHN patients treated with cetuximab between June 2008 and September 2015 at the University of Kansas Hospital Cancer Center and inpatient setting. The majority of patients (87.9%) were able to be quickly and successfully rechallenged after an initial IR. Minimal patients (27.6%) experienced a rechallenge IR, resulting in only 1 patient discontinuation. Rechallenge doses were most frequently (37.9%) administered between 30 and 59 min after initial dose discontinuation. This was a single-center retrospective study based on data collected from electronic medical records. Other limitations include interpretation of infusion reactions on a subjective basis by providers. These findings demonstrate the practice of same-day rechallenges in initial IR patients is feasible and safe.
authors.affiliation: Department of Pharmacy, University of Kansas Hospital, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA. Eburke2@kumc.edu.
authors.forename: Ellen
authors.identifier: http://orcid.org/0000-0001-7723-7784
authors.initials: E
authors.lastname: Burke
authors.affiliation: Department of Pharmacy, University of Kansas Hospital, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.|University of Kansas School of Pharmacy, 2010 Becker Drive, Lawrence, KS, 66047, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Rockey
authors.affiliation: University of Kansas School of Pharmacy, 2010 Becker Drive, Lawrence, KS, 66047, USA.
authors.forename: Dennis
authors.initials: D
authors.lastname: Grauer
authors.affiliation: University of Kansas School of Pharmacy, 2010 Becker Drive, Lawrence, KS, 66047, USA.
authors.forename: Dave
authors.initials: D
authors.lastname: Henry
authors.affiliation: University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.
authors.forename: Prakash
authors.initials: P
authors.lastname: Neupane
mesh_terms: D000046:Academic Medical Centers; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D000068818:Cetuximab / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D000970:Antineoplastic Agents; D000068818:Cetuximab
keywords: Cetuximab; Infusion reactions; Pre-medications; Rechallenge; Risk factors