title: Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim.
abstract: Bone pain is a common side effect of pegfilgrastim and can interfere with quality of life and treatment adherence. This study investigated the impact of antihistamine prophylaxis on pegfilgrastim-induced bone pain.
  
  
  
  This is a two-stage enrichment trial design. Patients receiving an initial dose of pegfilgrastim after chemotherapy were enrolled into the observation (OBS) stage. Those who developed significant back or leg bone pain (SP) were enrolled into the treatment (TRT) stage and randomized to daily loratadine 10 mg or placebo for 7 days. SP was defined by Brief Pain Inventory as back or leg pain score ≥5 and a 2-point increase after pegfilgrastim. The primary end point of TRT was reduction of worst back or leg bone pain with loratadine, defined as a 2-point decrease after treatment compared to OBS.
  
  
  
  Two hundred thirteen patients were included in the final analysis. Incidence of SP was 30.5 %. The SP subset had a worse overall Functional Assessment of Cancer Therapy-Bone Pain score (33.9 vs. 51.7, p < 0.001) and a higher mean white blood cell count (15.4 vs. 8.4 K/cm(3), p = 0.013) following pegfilgrastim than those without SP. Forty-six patients were randomized in the TRT. Benefit was 77.3 % with loratadine and 62.5 % with placebo (p = 0.35). Baseline NSAID use was documented in four patients (18.2 %) in loratadine arm and two patients (8.3 %) in placebo arm, with baseline non-NSAID use documented in five (22.7 %) and six (25 %) patients, respectively. Eight additional patients used NSAIDS by day 8 compared to day 1 (six in the loratadine and two in the placebo arm). A total of six additional patients used non-NSAIDS by day 8 compared to day 1 (four in the loratadine and two in the placebo arm).
  
  
  
  Administration of prophylactic loratadine does not decrease the incidence of severe bone pain or improve quality of life in a high-risk patient population. ClinicalTrials.gov identifier: NCT01311336.
authors.affiliation: Harold Alfond Center for Cancer Care, Maine General Health, Augusta, ME, USA.
authors.forename: J
authors.initials: J
authors.lastname: Moukharskaya
authors.affiliation: Hematology/Oncology, Harrison Health Partners, Poulsbo, WA, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Abrams
authors.affiliation: Medical Biostatistics, University of Vermont, Burlington, VT, USA.
authors.forename: T
authors.initials: T
authors.lastname: Ashikaga
authors.affiliation: University of Vermont Cancer Center, Burlington, VT, USA.
authors.forename: F
authors.initials: F
authors.lastname: Khan
authors.affiliation: Albany College of Pharmacy and Health Sciences, Vermont Campus, Colchester, VT, USA.
authors.forename: J
authors.initials: J
authors.lastname: Schwartz
authors.affiliation: University of Vermont Cancer Center, Burlington, VT, USA.
authors.forename: K
authors.initials: K
authors.lastname: Wilson
authors.affiliation: University of Vermont Cancer Center, Burlington, VT, USA.
authors.forename: C
authors.initials: C
authors.lastname: Verschraegen
authors.affiliation: Eastern Maine Medical Center Cancer Care of Maine, Bangor, ME, USA.
authors.forename: T
authors.initials: T
authors.lastname: Openshaw
authors.affiliation: Central Vermont Medical Center, Barre, VT, USA.
authors.forename: J
authors.initials: J
authors.lastname: Valentine
authors.affiliation: York Hospital Oncology and Infusion Center, York, ME, USA.
authors.forename: J
authors.initials: J
authors.lastname: Eneman
authors.affiliation: Champlain Valley Hematology Oncology, Colchester, VT, USA.
authors.forename: P
authors.initials: P
authors.lastname: Unger
authors.affiliation: University of Vermont Cancer Center, Burlington, VT, USA. steven.ades@uvm.edu.|Division of Hematology and Oncology, Department of Medicine, University of Vermont Cancer Center, Given Building, E214C, 89 Beaumont Ave, Burlington, VT, USA. steven.ades@uvm.edu.
authors.forename: S
authors.initials: S
authors.lastname: Ades
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001847:Bone Diseases / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects*; D039563:Histamine H1 Antagonists, Non-Sedating / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D011092:Polyethylene Glycols; D011788:Quality of Life; D011994:Recombinant Proteins / Q000009:adverse effects; D055815:Young Adult
chemical_list: D039563:Histamine H1 Antagonists, Non-Sedating; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D017336:Loratadine; D000069585:Filgrastim
keywords: Antihistamine; Bone pain; Loratadine; Pegfilgrastim; Prophylaxis; Taxane