Radium-223 international early access program: results from the Spanish subset

Future Oncol. 2018 Jan;14(1):41-50. doi: 10.2217/fon-2017-0297. Epub 2017 Dec 13.

Abstract

Aim: To report results from the Spanish subset included in the radium-223 international early access program (iEAP).

Patients & methods: Ninety patients with castration-resistant prostate cancer and bone metastases received radium-223 55 kBq/kg every 4 weeks for six cycles.

Results: The median time to disease progression was 8 months and to prostate-specific antigen progression was 4 months. The percentage of patients with ≥50% confirmed declines in prostate-specific antigen was 9%. The median overall survival was 14 months. Grade 3 or 4 treatment emergent adverse events (TEAEs) occurred in 34% of patients (serious TEAEs 28%, TEAEs leading to discontinuation 27%).

Conclusion: Outcomes of the Spanish subset are consistent with the iEAP. Radium-223 was generally well tolerated with no safety concerns.

Keywords: bone metastasis; castration-resistant prostate cancer; radium-223; safety; survival.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Bone Neoplasms / pathology
  • Bone Neoplasms / radiotherapy*
  • Bone Neoplasms / secondary
  • Disease Progression
  • Disease-Free Survival
  • Humans
  • Male
  • Middle Aged
  • Prostate-Specific Antigen / blood
  • Prostatic Neoplasms, Castration-Resistant / blood
  • Prostatic Neoplasms, Castration-Resistant / pathology
  • Prostatic Neoplasms, Castration-Resistant / radiotherapy*
  • Radioisotopes / administration & dosage*
  • Radioisotopes / adverse effects
  • Radium / administration & dosage*
  • Radium / adverse effects
  • Spain / epidemiology

Substances

  • Radioisotopes
  • Radium-223
  • Prostate-Specific Antigen
  • Radium