title: Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study.
abstract: OBJECTIVE
  Targeted monoclonal antibodies (MoAbs) have become a promising treatment option for patients with cancer. However, there is a risk of developing infusion reactions (IRs) with MoAbs. This study was conducted to evaluate the impact of IRs on staff time and costs among patients receiving an initial infusion of cetuximab (Erbitux) and rituximab (Rituxan).
  
  
  METHODS
  A prospective multicenter study involving time and motion and activity sampling methods was conducted among patients with cancer receiving their first outpatient infusion of cetuximab or rituximab. Patients were observed from initiation of MoAb infusion to the end of the clinic visit. IRs were classified as absent, mild/moderate, and severe/life threatening. Staff time and costs were estimated for preparation and administration of MoAb, other chemotherapy agents, and for management of IRs. Resource costs were compared across IR groups within each MoAb.
  
  
  RESULTS
  Among 161 patients enrolled, 32% of 71 patients on cetuximab and 39% of 90 patients on rituximab experienced IRs. Treatment of patients who experienced IRs required more staff time (31-80% more time) and resulted in higher human resource costs (increase of 17-65 US dollars) than patients who did not experience IRs.
  
  
  CONCLUSIONS
  IRs following cetuximab and rituximab administration are common and are associated with measurably increased costs of care. The frequency of IRs suggests the importance of identifying clinical guidelines for intervention and management.
authors.affiliation: Accelerated Community Oncology Research Network, 1770 Kirby Parkway, Suite 400, Memphis, TN, 38138, USA. lschwartzberg@westclinic.com
authors.forename: Lee S
authors.initials: LS
authors.lastname: Schwartzberg
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Stepanski
authors.forename: Mark S
authors.initials: MS
authors.lastname: Walker
authors.forename: Susan
authors.initials: S
authors.lastname: Mathias
authors.forename: Arthur C
authors.initials: AC
authors.lastname: Houts
authors.forename: Barry V
authors.initials: BV
authors.lastname: Fortner
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D017028:Caregivers; D000068818:Cetuximab; D016503:Drug Delivery Systems; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007262:Infusions, Intravenous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D000069283:Rituximab; D012720:Severity of Illness Index; D013996:Time and Motion Studies; D014481:United States / Q000453:epidemiology
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D000068818:Cetuximab