A phase 2 study of high-activity 186Re-HEDP with autologous peripheral blood stem cell transplant in progressive hormone-refractory prostate cancer metastatic to bone

Eur J Nucl Med Mol Imaging. 2006 Sep;33(9):1055-61. doi: 10.1007/s00259-005-0010-5. Epub 2006 Mar 30.

Abstract

Purpose: We investigated the potential for improvement in disease control by use of autologous peripheral blood stem cell transplant (PBSCT) to permit administration of high activities of (186)Re-hydroxyethylidene diphosphonate (HEDP) in patients with progressive hormone-refractory prostate cancer (HRPC).

Methods: Eligible patients had progressive HRPC metastatic to bone, good performance status and minimal soft tissue disease. Patients received 5,000 MBq of (186)Re-HEDP i.v., followed 14 days later by PBSCT. Response was assessed using PSA, survival, pain scores and quality of life.

Results: Thirty-eight patients with a median age of 67 years (range 50-77) and a median PSA of 57 ng/ml (range 4-3,628) received a median activity of 4,978 MBq (186)Re-HEDP (range 4,770-5,100 MBq). The most serious toxicity was short-lived grade 3 thrombocytopenia in 8 (21%) patients. The median survival of the group is 21 months (95%CI 18-24 months) with Kaplan-Meier estimated 1- and 2-year survival rates of 83% and 40% respectively. Thirty-one patients (81%, 95% CI 66-90%) had stable or reduced PSA levels 3 months post therapy while 11 (29%, 95% CI 15-49%) had PSA reductions of >50% lasting >4 weeks. Quality of life measures were stable or improved in 27 (66%) at 3 months.

Conclusion: We have shown that it is feasible and safe to deliver high-activity radioisotope therapy with PBSCT to men with metastatic HRPC. Response rates and survival data are encouraging; however, further research is needed to define optimal role of this treatment approach.

Publication types

  • Clinical Trial, Phase II
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Bone Neoplasms / drug therapy
  • Bone Neoplasms / radiotherapy
  • Bone Neoplasms / secondary
  • Bone Neoplasms / therapy
  • Combined Modality Therapy
  • Drug Resistance, Neoplasm
  • Etidronic Acid / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Organometallic Compounds / therapeutic use*
  • Peripheral Blood Stem Cell Transplantation*
  • Prostatic Neoplasms / drug therapy
  • Prostatic Neoplasms / radiotherapy*
  • Prostatic Neoplasms / therapy*
  • Radioisotopes / therapeutic use
  • Radiopharmaceuticals / therapeutic use*
  • Rhenium / therapeutic use
  • Transplantation, Autologous

Substances

  • Organometallic Compounds
  • Radioisotopes
  • Radiopharmaceuticals
  • rhenium-186 HEDP
  • Rhenium
  • Etidronic Acid