Repeated bone-targeted therapy for hormone-refractory prostate carcinoma: tandomized phase II trial with the new, high-energy radiopharmaceutical rhenium-188 hydroxyethylidenediphosphonate.
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.
Palmedo
Holger
H
Department of Nuclear Medicine, University of Bonn, Bonn, Germany. holger.palmedo@ukb.uni-bonn.de.
Manka-Waluch
Agnieska
A
Albers
Peter
P
Schmidt-Wolf
Ingo G H
IG
Reinhardt
Michael
M
Ezziddin
Samer
S
Joe
Alexius
A
Roedel
Roland
R
Fimmers
Rolf
R
Knapp
F F
FF
Guhlke
Stefan
S
Biersack
Hans-Jurgen
HJ
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
D009942:Organometallic Compounds; C101598:rhenium-186 HEDP; D012211:Rhenium; D012968:Etidronic Acid