title: Phase 2 study of a high dose of 186Re-HEDP for bone pain palliation in patients with widespread skeletal metastases.
abstract: (186)Re-1-hydroxyethylidene-1,1-diphosphonate (HEDP) is an attractive radiopharmaceutical for the treatment of bone pain arising from skeletal metastatic lesions. Currently, (186)Re-HEDP is most commonly used in European countries. The aim of this study was to investigate the palliative efficacy and adverse effects of (186)Re-HEDP in patients with different types of cancers and skeletal bone pain.
  
  
  METHODS
  Nineteen (8 male, 11 female) patients with various cancers (breast, prostate, renal cell carcinoma, colon, and neuroendocrine tumors) and painful bone metastases were included in the study. A dose of 1,480-3,330 MBq (40-90 mCi) of (186)Re-HEDP was administered intravenously. The patients' level of pain relief was assessed by the Visual Analog Scale for 8 wk after treatment and by a weekly blood cell count to evaluate for hematologic toxicity.
  
  
  RESULTS
  The overall response rate was 89.5%, and the mean pain score assessed by the Visual Analog Scale was reduced from 9.1 to 5.3 after 1 wk (P = 0.003). No adverse effects were reported by patients during intravenous administration or for up to 24 h after administration. A flare reaction was seen in 63.2% of patients, mainly during days 1-3, and lasted for 2-4 d. There was no significant correlation between the response to therapy and the flare reactions (P > 0.05). The nadir of platelet reduction occurred at the fourth or fifth week and led to platelet infusion in only 4 patients with a low baseline platelet count and diffuse skeletal metastases. Bone marrow suppression occurred in patients receiving higher doses, but no clinical problems were seen except in 2 patients who required packed cell transfusion similar to their prior transfusions.
  
  
  CONCLUSIONS
  (186)Re-HEDP is an effective radiopharmaceutical for the palliative treatment of metastatic bone pain and has minimal adverse effects.
authors.affiliation: Department of Nuclear Medicine, Shohada-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Elahe
authors.initials: E
authors.lastname: Pirayesh
authors.forename: Mahasti
authors.initials: M
authors.lastname: Amoui
authors.forename: Hamid Reza
authors.initials: HR
authors.lastname: Mirzaee
authors.forename: Faraj
authors.initials: F
authors.lastname: Tabei
authors.forename: Afshin
authors.initials: A
authors.lastname: Rakhsha
authors.forename: Bagher Aziz
authors.initials: BA
authors.lastname: Kalantari
authors.forename: Babak
authors.initials: B
authors.lastname: Shafiei
authors.forename: Majid
authors.initials: M
authors.lastname: Assadi
authors.forename: Isa Neshandar
authors.initials: IN
authors.lastname: Asli
mesh_terms: D000328:Adult; D000368:Aged; D001859:Bone Neoplasms / Q000150:complications* / Q000556:secondary*; D012968:Etidronic Acid / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*; D010146:Pain / Q000150:complications*; D059408:Pain Management / Q000009:adverse effects / Q000379:methods*; D010166:Palliative Care / Q000379:methods*; D011829:Radiation Dosage
chemical_list: D009942:Organometallic Compounds; C101598:rhenium-186 HEDP; D012968:Etidronic Acid
keywords: bone metastasis; pain palliation; rhenium 186(tin) etidronate