title: Clinical and economic impact of infusion reactions in patients with colorectal cancer treated with cetuximab.
abstract: BACKGROUND
  Systemic agents in cancer treatment were often associated with possible infusion reactions (IRs). This study estimated the incidence of IRs requiring medical intervention and assessed the clinical and economic impacts of IRs in patients with colorectal cancer (CRC) treated with cetuximab.
  
  
  METHODS
  Details on patients with CRC receiving cetuximab in 2004-2006 were extracted from a large USA administrative claims database. IRs were identified based on the occurrence of outpatient treatment, emergency room (ER) visit, and/or hospitalization for hypersensitivity and allergic reactions. Multivariate regressions were used to examine potential risk factors and quantify the economic impact of IRs.
  
  
  RESULTS
  A total of 1122 CRC patients receiving cetuximab were identified. The incidence of IRs requiring medical intervention was 8.4%. Sixty-eight percent of the patients had treatment disruptions and 34% discontinued cetuximab treatment. Mean adjusted costs were $13,863 for cetuximab administrations with an IR requiring ER visit or hospitalization and $6280 for those with an IR requiring outpatient treatment, compared with $4555 for those without an IR.
  
  
  CONCLUSIONS
  The incidence rate of cetuximab-related IRs requiring medical intervention in clinical practice was found to be higher than rates reported in the product label and clinical trials. The clinical and economic impacts of these IRs are substantial.
authors.affiliation: Jefferson School of Population Health, Health Economics and Outcomes Research, Thomas Jefferson University, Philadelphia, PA.
authors.forename: K A
authors.initials: KA
authors.lastname: Foley
authors.affiliation: Global Health Economics, Amgen, Inc., Thousand Oaks, CA.
authors.forename: P F
authors.initials: PF
authors.lastname: Wang
authors.affiliation: Global Health Economics, Amgen, Inc., Thousand Oaks, CA.
authors.forename: B L
authors.initials: BL
authors.lastname: Barber
authors.affiliation: Healthcare Division, Thomson Reuters, Cambridge, MA, USA.
authors.forename: S R
authors.initials: SR
authors.lastname: Long
authors.affiliation: Healthcare Division, Thomson Reuters, Cambridge, MA, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Bagalman
authors.affiliation: Global Health Economics, Amgen, Inc., Thousand Oaks, CA.
authors.forename: V
authors.initials: V
authors.lastname: Wagner
authors.affiliation: Healthcare Division, Thomson Reuters, Cambridge, MA, USA. Electronic address: xue.song@thomsonreuters.com.
authors.forename: X
authors.initials: X
authors.lastname: Song
authors.affiliation: Global Health Economics, Amgen, Inc., Thousand Oaks, CA.
authors.forename: Z
authors.initials: Z
authors.lastname: Zhao
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000191:economics*; D003362:Cost-Benefit Analysis; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000188:drug therapy / Q000191:economics*; D005260:Female; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab