title: Paclitaxel hypersensitivity reactions: assessment of the utility of a test-dose program.
abstract: Several studies have suggested the usefulness of a test dose of paclitaxel to reduce the incidence of hypersensitivity reactions and the resulting cost of drug wastage. The aim of this study was to assess the utility of implementing such a test dose.
  
  
  METHODS
  We retrospectively reviewed the medical charts of patients who had received one or two courses of single-agent paclitaxel or a combination chemotherapy regimen to calculate hypersensitivity reaction incidence and the cost of drug wastage. Thereafter, a paclitaxel test-dose program was routinely implemented during the first and second cycles of paclitaxel treatment for all patients. Hypersensitivity reaction incidence and drug wastage cost were again assessed.
  
  
  RESULTS
  Before the routine use of a test dose, 162 patients received one or two paclitaxel infusions alone or in combination therapy from January 1, 1997 to February 28, 2003. Ten (6.2%) patients experienced a hypersensitivity reaction; one of them was severe. After implementation of the test-dose program, 130 patients received 244 test doses (12 mg paclitaxel/10 mL normal saline) with an intensified premedication regimen at the first and second cycles of chemotherapy from June 28, 2003 to March 2, 2005. Three patients (2.3%) experienced a minor hypersensitivity reaction, one immediately after the test dose and two during infusion of the full dose despite a well-tolerated test dose. Thus, the negative predictive value of the test dose was 98.4%. The overall incidence of hypersensitivity reactions experienced during the first or second cycle of paclitaxel chemotherapy decreased about 63% compared with the incidence before implementation of the test dose (P < 0.20). The test-dose program resulted in a 29% increase in the cost of chemotherapy (approximately 6100 dollars for 130 patients).
  
  
  CONCLUSIONS
  To our knowledge, this is the largest study ever reported to test the potential cost-saving benefit of the implementation of a paclitaxel test-dose program to prevent hypersensitivity reactions. The results suggest that the routine use of a test dose is not a cost-effective measure.
authors.affiliation: Pharmacy Department, Croix-Rousse Hospital, Lyon, France. agnes.henry@chu-lyon.fr
authors.forename: Agnes
authors.initials: A
authors.lastname: Henry
authors.forename: Bruno
authors.initials: B
authors.lastname: Charpiat
authors.forename: Maurice
authors.initials: M
authors.lastname: Perol
authors.forename: Thierry
authors.initials: T
authors.lastname: Vial
authors.forename: Pierre Jousselin
authors.initials: PJ
authors.lastname: de Saint Hilaire
authors.forename: Jacques
authors.initials: J
authors.lastname: Descotes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D004342:Drug Hypersensitivity / Q000175:diagnosis*; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000191:economics; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D012189:Retrospective Studies
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel