title: Repeated bone-targeted therapy for hormone-refractory prostate carcinoma: tandomized phase II trial with the new, high-energy radiopharmaceutical rhenium-188 hydroxyethylidenediphosphonate.
abstract: OBJECTIVE
  We investigated the effect of repeated bone-targeted therapy with rhenium-188 hydroxyethylidenediphosphonate (HEDP) in patients with progressive, hormone-resistant prostate carcinoma and bone pain. The aim of this study was to determine the pain palliation and the antitumor effect of rhenium-188 HEDP treatments.
  
  
  METHODS
  Sixty-four patients were randomly assigned to one of two groups for radionuclide therapy with rhenium-188 HEDP; patients of group A received a single injection, patients of group B received two injections (interval, 8 weeks). After therapy, patients were followed-up by assessment of pain palliation and clinical outcome until death.
  
  
  RESULTS
  In both groups, toxicity was low, with moderate thrombopenia and leukopenia (maximum common toxicity criteria grade of 2). The effectiveness of rhenium-188 HEDP for pain palliation was better in the repeated treatment group (group B), with a response rate and time of response of 92% and 5.66 months, respectively (P =.006 and P =.001). In group B, 11 (39%) of 28 patients had a prostate-specific antigen decrease of more than 50% for at least 8 weeks, compared with two (7%) of 30 patients in the single-injection group (group A). The median times to progression of group A and group B were 2.3 months (range, 0 to 12.2 months) and 7.0 months (range, 0 to 24.1 months), respectively (P =.0013), and the median overall survival times were 7.0 months (range, 1.3 to 36.7 months) and 12.7 months (range, 4.1 to 32.2 months), respectively (P =.043).
  
  
  CONCLUSIONS
  Compared with single-injection therapy, repeated bone-targeted therapy with rhenium-188 HEDP administered to patients with advanced progressive hormone-refractory prostate carcinoma enhanced pain palliation and improved progression-free and overall survival. Larger studies are justified to further evaluate the use of rhenium-188 HEDP.
authors.affiliation: Department of Nuclear Medicine, University of Bonn, Bonn, Germany. holger.palmedo@ukb.uni-bonn.de.
authors.forename: Holger
authors.initials: H
authors.lastname: Palmedo
authors.forename: Agnieska
authors.initials: A
authors.lastname: Manka-Waluch
authors.forename: Peter
authors.initials: P
authors.lastname: Albers
authors.forename: Ingo G H
authors.initials: IG
authors.lastname: Schmidt-Wolf
authors.forename: Michael
authors.initials: M
authors.lastname: Reinhardt
authors.forename: Samer
authors.initials: S
authors.lastname: Ezziddin
authors.forename: Alexius
authors.initials: A
authors.lastname: Joe
authors.forename: Roland
authors.initials: R
authors.lastname: Roedel
authors.forename: Rolf
authors.initials: R
authors.lastname: Fimmers
authors.forename: F F
authors.initials: FF
authors.lastname: Knapp
authors.forename: Stefan
authors.initials: S
authors.lastname: Guhlke
authors.forename: Hans-Jurgen
authors.initials: HJ
authors.lastname: Biersack
mesh_terms: D000368:Aged; D001859:Bone Neoplasms / Q000532:radiotherapy* / Q000556:secondary*; D018450:Disease Progression; D004307:Dose-Response Relationship, Radiation; D012968:Etidronic Acid / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009942:Organometallic Compounds; D010147:Pain Measurement; D010148:Intractable Pain / Q000532:radiotherapy; D010166:Palliative Care; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology*; D011879:Radiotherapy Dosage; D012211:Rhenium / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D009942:Organometallic Compounds; C101598:rhenium-186 HEDP; D012211:Rhenium; D012968:Etidronic Acid