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Safety and efficacy of radium-223 dichloride in Japanese patients with castration-resistant prostate cancer and bone metastases.
- Source :
-
International Journal of Clinical Oncology . Oct2017, Vol. 22 Issue 5, p954-963. 10p. - Publication Year :
- 2017
-
Abstract
- Background: Radiation therapy with radium-223 dichloride improves overall survival, reduces symptomatic skeletal events in Caucasian patients with castration-resistant prostate cancer (CRPC) and bone metastases, and is well tolerated. We report here the results of the first efficacy and safety study of radium-223 dichloride in a Japanese population. Methods: In this open-label, uncontrolled, non-randomized, phase I trial, radium-223 dichloride was given to Japanese patients with CRPC and ≥2 bone metastases in 4-week cycles. The patients were divided into three cohorts, with cohort 1 and the expansion cohort receiving injections of radium-223 dichloride [55 kBq/kg body weight (BW)] every 4 weeks (Q4W) for up to six injections, and cohort 2 receiving an initial single radium-223 dichloride injection of 110 kBq/kg BW followed by up to five injections of 55 kBq/kg BW Q4W. Safety was determined via adverse event (AE) reporting, and biochemical bone markers were assessed for treatment efficacy. Results: In total 19 patients received at least one dose of radium-223 dichloride and 18 patients experienced at least one treatment-emergent AE (TEAE) of which the most common were anemia, thrombocytopenia, and lymphocytopenia. Serious AEs were reported in three patients but none were drug-related. In the patients of cohort 1 + expansion cohort (55 kBq/kg BW Q4W treatment; n = 16), prostate-specific antigen levels remained stable or slightly increased while the bone alkaline phosphatase (ALP) level significantly decreased. The response rates of bone ALP (≥30 and ≥50% reductions) were 81.8 and 36.4% at week 12, and 81.3 and 50.0% at the end of treatment. Conclusions: Radium-223 dichloride was well tolerated in these Japanese patients and, at a dose of 55 kBq/kg BW, efficacy on biomarkers was as expected. The outcomes in Japanese patients were consistent with those reported in other non-Japanese populations. Trial registration: ClinicalTrials.gov record NCT01565746. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 13419625
- Volume :
- 22
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- International Journal of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 125256752
- Full Text :
- https://doi.org/10.1007/s10147-017-1130-1