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- Title
Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer.
- Authors
Nobuaki Matsubara; Satsohi Nagamori; Yoshiaki Wakumoto; Hirotsugu Uemura; Go Kimura; Akira Yokomizo; Hiroaki Kikukawa; Atsushi Mizokami; Takeo Kosaka; Naoya Masumori; Yoshihide Kawasaki; Junji Yonese; Yasutomo Nasu; Satoshi Fukasawa; Takayuki Sugiyama; Seigo Kinuya; Makoto Hosono; Iku Yamaguchi; Hirokazu Tsutsui; Hiroji Uemura
- Abstract
Background Radium-223 dichloride (radium-223) is the first targeted alpha therapy approved for the treatment of castration-resistant prostate cancer (CRPC) with bone metastases. This study investigated the efficacy and safety of radium-223 in Japanese patients with symptomatic CRPC and bone metastases. Methods In this open-label, multicenter, phase II study, patients with progressive, symptomatic CRPC and bone metastases were treated with radium-223 (55 kBq/kg, intravenously) in a 4-week cycle for six cycles. The primary endpoint was the percent change in total alkaline phosphatase (ALP) from baseline at 12 weeks. Secondary endpoints included the percent ALP change from baseline to end of treatment (EOT), ALP response rates, percent change in prostate-specific antigen (PSA) from baseline to 12 weeks and EOT, PSA response rates, overall survival (OS), and time to symptomatic skeletal events (SSEs). Adverse events were monitored throughout the study period. Results Of the 49 Japanese patients (median age 74 years), 28 completed all infusions. Mean percent change in total ALP and PSA from baseline to 12 weeks was -19.3 and +97.4%, respectively. One-year OS and SSE-free rate at the end of active follow-up were 78 and 89%, respectively. The ALP response rate was 31%, while the PSA response rate was 6%. Grade 3/4 treatment-emergent adverse events observed in ≥10% of patients included decreased lymphocyte count (14%), anemia (14%), anorexia (10%), and bone pain (10%). Conclusions Radium-223 is effective and well tolerated in Japanese patients with CRPC and bone metastases. Results were comparable with the Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. Clinical trial registration ClinicalTrials.gov NCT01929655.
- Subjects
RADIUMTHERAPY; CASTRATION-resistant prostate cancer; PROSTATE cancer patients; ALKALINE phosphatase; PROSTATE-specific antigen; CLINICAL trials; CANCER treatment
- Publication
International Journal of Clinical Oncology, 2018, Vol 23, Issue 1, p173
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-017-1176-0