title: Stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction.
abstract: OBJECTIVE
  Paclitaxel-based chemotherapy continues to be an integral component of breast cancer treatment. Prolonged use of paclitaxel may result in repeated doses of premedications that can have unwanted side effects. Infusion hypersensitivity reactions occurring beyond the second dose of paclitaxel are infrequent and not well characterized. We previously published the results of a small, prospective pilot trial demonstrating the safety and feasibility of discontinuing premedications in patients who received the first two doses of paclitaxel-based chemotherapy without experiencing an infusion hypersensitivity reaction. In this study, we aimed to retrospectively characterize the incidence of rescue medication using this abbreviated premedication regimen in our institution following the publication of the pilot study.
  
  
  METHODS
  Patients with stages I-IV breast cancer who received paclitaxel from January 2011 through June 2013 were screened for eligibility. Patients who did not experience an infusion hypersensitivity reaction with their first or second dose of paclitaxel and discontinued paclitaxel premedication for subsequent doses were included in this analysis. The primary endpoint was to estimate the incidence of rescue medication use for the treatment of paclitaxel infusion hypersensitivity during doses three to six of paclitaxel in the study population.
  
  
  RESULTS
  In total, 449 patients received paclitaxel-based chemotherapy for the treatment of breast cancer during the interval time period. After receiving the first two doses of paclitaxel-based chemotherapy without experiencing an infusion hypersensitivity reaction, 234 breast cancer patients had their premedications discontinued for all remaining paclitaxel doses. These patients tolerated future paclitaxel doses without severe or life-threatening complications related to infusion hypersensitivity. The majority of patients did not have any symptoms of an infusion reaction, with only two of these patients requiring rescue medication to treat an infusion hypersensitivity reaction with subsequent paclitaxel doses (0.85; 95 % confidence interval (CI), 0.10-3.05 %).
  
  
  CONCLUSIONS
  Discontinuation of paclitaxel premedications in breast cancer patients who have not experienced an infusion hypersensitivity reaction with the first two doses of paclitaxel is not associated with increased rate of rescue medication use for infusion hypersensitivity.
authors.affiliation: Pharmacy Department, The Stefanie Spielman Comprehensive Breast Center, The James Cancer Hospital and Solove Research Institute at the Ohio State University, Columbus, USA, michael.berger@osumc.edu.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Berger
authors.forename: Craig
authors.initials: C
authors.lastname: Vargo
authors.forename: Mary
authors.initials: M
authors.lastname: Vincent
authors.forename: Katy
authors.initials: K
authors.lastname: Shaver
authors.forename: Gary
authors.initials: G
authors.lastname: Phillips
authors.forename: Rachel
authors.initials: R
authors.lastname: Layman
authors.forename: Erin
authors.initials: E
authors.lastname: Macrae
authors.forename: Ewa
authors.initials: E
authors.lastname: Mrozek
authors.forename: Bhuvaneswari
authors.initials: B
authors.lastname: Ramaswamy
authors.forename: Robert
authors.initials: R
authors.lastname: Wesolowski
authors.forename: Charles L
authors.initials: CL
authors.lastname: Shapiro
authors.forename: Maryam B
authors.initials: MB
authors.lastname: Lustberg
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003907:Dexamethasone / Q000008:administration & dosage; D004155:Diphenhydramine / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004342:Drug Hypersensitivity / Q000209:etiology* / Q000517:prevention & control*; D015738:Famotidine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects*; D011292:Premedication / Q000379:methods; D011446:Prospective Studies; D012189:Retrospective Studies
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D015738:Famotidine; D003907:Dexamethasone; D004155:Diphenhydramine; D017239:Paclitaxel