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      Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim

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          Abstract

          Purpose

          Bone pain is a common side-effect of pegfilgrastim and can interfere with quality of life and treatment adherence. This study i nvestigated the impact of antihistamine prophylaxis on pegfilgrastim-induced bone pain.

          Methods

          This is a two stage enrichment trial design. Patients receiving an initial dose of pegfilgrastim after chemotherapy were enrolled into the observation stage (OBS). Those who developed significant back or leg bone pain (SP) were enrolled into the treatment stage (TRT) 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 2 point decrease after treatment compared to OBS.

          Results

          213 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. 46 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 4 patients (18.2%) in loratadine arm and 2 patients (8.3%) in placebo arm, with baseline non-NSAID use documented in 5 (22.7%) and 6 (25%) patients respectively. Eight additional patients used NSAIDS by day 8 compared to day 1 (6 in the loratadine and 2 in the placebo arm). A total of 6 additional patients used non-NSAIDS by day 8 compared to day 1 (4 in the loratadine and 2 in the placebo arm).

          Conclusions

          Administration of prophylactic loratadine does not decrease the incidence of severe bone pain or improve quality of life in a high-risk patient population.

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          Author and article information

          Journal
          9302957
          8479
          Support Care Cancer
          Support Care Cancer
          Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
          0941-4355
          1433-7339
          12 June 2016
          19 February 2016
          July 2016
          01 July 2017
          : 24
          : 7
          : 3085-3093
          Affiliations
          [1 ]Harold Alfond Center for Cancer Care, Maine General Health, Augusta, ME
          [2 ]Hematology/Oncology, Harrison Health Partners, Poulsbo, WA
          [3 ]Medical Biostatistics, University of Vermont, Burlington, VT
          [4 ]University of Vermont Cancer Center, Burlington, VT
          [5 ]Albany College of Pharmacy and Health Sciences, Vermont Campus, Colchester, VT
          [6 ]Eastern Maine Medical Center Cancer Care of Maine, Bangor, ME
          [7 ]Central Vermont Medical Center, Barre, VT
          [8 ]York Hospital Oncology and Infusion Center, York, ME
          [9 ]Champlain Valley Hematology Oncology, Colchester, VT
          Author notes
          Correspondence to: Steven Ades, MD MSc, University of Vermont Cancer Center, Division of Hematology and Oncology, Department of Medicine, Given Building, E214C, 89 Beaumont Ave, University of Vermont, Burlington, VT 05405 USA, Tel: 1-802-656-5487, steven.ades@ 123456uvm.edu
          Article
          PMC5266505 PMC5266505 5266505 nihpa782577
          10.1007/s00520-016-3119-0
          5266505
          26894485
          45e5059e-4a6c-44f3-880d-53e19eb50e8e
          History
          Categories
          Article

          taxane,loratadine,antihistamine,prophylaxis,bone pain,pegfilgrastim

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