TY - JOUR
T1 - Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer
AU - Matsubara, Nobuaki
AU - Nagamori, Satsohi
AU - Wakumoto, Yoshiaki
AU - Uemura, Hirotsugu
AU - Kimura, Go
AU - Yokomizo, Akira
AU - Kikukawa, Hiroaki
AU - Mizokami, Atsushi
AU - Kosaka, Takeo
AU - Masumori, Naoya
AU - Kawasaki, Yoshihide
AU - Yonese, Junji
AU - Nasu, Yasutomo
AU - Fukasawa, Satoshi
AU - Sugiyama, Takayuki
AU - Kinuya, Seigo
AU - Hosono, Makoto
AU - Yamaguchi, Iku
AU - Tsutsui, Hirokazu
AU - Uemura, Hiroji
N1 - Funding Information:
Funding This study was sponsored by Bayer HealthCare Pharmaceuticals, Inc.
Funding Information:
The authors would like to thank Andrea Bothwell and Nishad Parkar, PhD, of Springer Healthcare Communications for their support with the writing of the manuscript. This assistance was funded by Bayer, Japan. This study was sponsored by Bayer HealthCare Pharmaceuticals, Inc. The authors have the following conflicts of interest to disclose: SN, Speaker’s bureau (Bayer, Sanofi, Daiichi-Sankyo, Kirin), Research funding (Takeda, Astellas, Taiho, Nihon-Kayaku), Travel, accommodations, expenses (Bayer); Hirotsugu U, Honoraria (AstraZeneca, Pfizer, Novartis, Jansen, Sanofi, Bayer, Astellas, Takeda, Daiichi-Sankyo, Nippon Shinyaku), Consulting or Advisory role (AstraZeneca, Jansen, Ono, Bayer, MSD), Speaker’s bureau (AstraZeneca, Jansen, Ono, Bristol-Myers Squibb, Pfizer, Sanofi, Astellas, Takeda), Research funding (AstraZeneca, Jansen, Ono, Novartis, Sanofi, Takeda, Astellas, Pfizer, Daiichi-Sankyo, Chugai); AY, Honoraria (Bayer); N Masumori, Speaker’s bureau (Astellas, Nippon Shinyaku, Asahi Kasei Pharma, AstraZeneca, Kissei), Research funding (Takeda, Astellas); YN, Stock or other ownership (Momotaro-Gene Inc.); MH, Speaker’s bureau (Bayer); SK, Speaker’s bureau (Bayer); IY, Employment (Bayer); HT, Employment (Bayer); Hiroji U, Honoraria (Bayer, Takeda, Astellas, Jansen, AstraZeneca, Fuji Film RI Pharma, Sanofi), Consulting or Advisory Role (Bayer, Sanofi, Jansen, Takeda), Speaker’s bureau (Bayer, Fuji Film RI Pharma, Sanofi, Kissei, Jansen, AstraZeneca, Takeda, Astellas), Research Funding (Astellas), Travel, accommodations, expenses (Bayer, Fuji Film RI Pharma, Sanofi, Jansen, AstraZeneca, Takeda, Astellas). All remaining authors declared no conflict of interest.
Funding Information:
Acknowledgements The authors would like to thank Andrea Both-well and Nishad Parkar, PhD, of Springer Healthcare Communications for their support with the writing of the manuscript. This assistance was funded by Bayer, Japan.
Publisher Copyright:
© 2017, The Author(s).
PY - 2018/2/1
Y1 - 2018/2/1
N2 - 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.
AB - 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.
KW - Alkaline phosphatase
KW - Bone metastasis
KW - Castration-resistant prostate cancer
KW - Prostate-specific antigen
KW - Radium-223 dichloride
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UR - http://www.scopus.com/inward/citedby.url?scp=85026734241&partnerID=8YFLogxK
U2 - 10.1007/s10147-017-1176-0
DO - 10.1007/s10147-017-1176-0
M3 - Article
C2 - 28770408
AN - SCOPUS:85026734241
SN - 1341-9625
VL - 23
SP - 173
EP - 180
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 1
ER -
