Three-year follow-up of a phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer and bone metastases

Hirotsugu Uemura, Hiroji Uemura, Satsohi Nagamori, Yoshiaki Wakumoto, Go Kimura, Hiroaki Kikukawa, Akira Yokomizo, Atsushi Mizokami, Takeo Kosaka, Naoya Masumori, Yoshihide Kawasaki, Junji Yonese, Yasutomo Nasu, Satoshi Fukasawa, Takayuki Sugiyama, Seigo Kinuya, Makoto Hosono, Iku Yamaguchi, Takashi Akagawa, Nobuaki Matsubara

Research output: Contribution to journalArticle

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Abstract

Background: Radium-223 is a first-in-class targeted alpha therapy to prolong overall survival (OS) in castration-resistant prostate cancer with bone metastases (mCRPC). The aim of the present analysis was to assess the long-term safety with radium-223 in Japanese patients with mCRPC. Methods: Patients with symptomatic mCRPC, ≥ 2 bone metastases and no known visceral metastases received up to 6 injections of radium-223 (55 kBq/kg), one every 4 weeks. Adverse events (AEs) considered to be related to radium-223 were reported until 3 years after the first injection. Pre-specified conditions, such as acute myelogenous leukemia, myelodysplastic syndrome, aplastic anemia, primary bone cancer, or other primary malignancies, were reported regardless of causality. Results: Of the 49 patients enrolled in the study, 44 (89.8%) entered the survival follow-up period and 33 (67.3%) died. Throughout the entire study, there were no reports of second primary malignancy or other pre-specified conditions. Eight patients (16.3%) experienced post-treatment drug-related AEs, which were all hematological (anemia and decreased lymphocyte, platelet, and white blood cell counts). No serious post-treatment drug-related AEs were reported. Updated median OS was 19.3 months (95% CI: 14.2, 28.5). Conclusions: In Japanese patients with symptomatic mCRPC and bone metastases, radium-223 had a favorable long-term safety profile with no second primary malignancies reported. Taken together with median OS, which was comparable to that in the pivotal phase III ALSYMPCA study, these results support continued benefit from radium-223 in Japanese patients with mCRPC.

Original languageEnglish
JournalInternational Journal of Clinical Oncology
DOIs
Publication statusPublished - 2019 Jan 1

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Radium
Bone Neoplasms
Castration
Prostatic Neoplasms
Neoplasm Metastasis
Survival
Second Primary Neoplasms
Drug-Related Side Effects and Adverse Reactions
Safety
Bone and Bones
Injections
Aplastic Anemia
Myelodysplastic Syndromes
Leukocyte Count
Acute Myeloid Leukemia
Causality
Anemia
Therapeutics
Blood Platelets
Lymphocytes

Keywords

  • Bone metastases
  • Metastatic castration-resistant prostate cancer
  • Overall survival
  • Radium-223 dichloride
  • Safety

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

Cite this

Three-year follow-up of a phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer and bone metastases. / Uemura, Hirotsugu; Uemura, Hiroji; Nagamori, Satsohi; Wakumoto, Yoshiaki; Kimura, Go; Kikukawa, Hiroaki; Yokomizo, Akira; Mizokami, Atsushi; Kosaka, Takeo; Masumori, Naoya; Kawasaki, Yoshihide; Yonese, Junji; Nasu, Yasutomo; Fukasawa, Satoshi; Sugiyama, Takayuki; Kinuya, Seigo; Hosono, Makoto; Yamaguchi, Iku; Akagawa, Takashi; Matsubara, Nobuaki.

In: International Journal of Clinical Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Uemura, H, Uemura, H, Nagamori, S, Wakumoto, Y, Kimura, G, Kikukawa, H, Yokomizo, A, Mizokami, A, Kosaka, T, Masumori, N, Kawasaki, Y, Yonese, J, Nasu, Y, Fukasawa, S, Sugiyama, T, Kinuya, S, Hosono, M, Yamaguchi, I, Akagawa, T & Matsubara, N 2019, 'Three-year follow-up of a phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer and bone metastases', International Journal of Clinical Oncology. https://doi.org/10.1007/s10147-018-01389-4
Uemura, Hirotsugu ; Uemura, Hiroji ; Nagamori, Satsohi ; Wakumoto, Yoshiaki ; Kimura, Go ; Kikukawa, Hiroaki ; Yokomizo, Akira ; Mizokami, Atsushi ; Kosaka, Takeo ; Masumori, Naoya ; Kawasaki, Yoshihide ; Yonese, Junji ; Nasu, Yasutomo ; Fukasawa, Satoshi ; Sugiyama, Takayuki ; Kinuya, Seigo ; Hosono, Makoto ; Yamaguchi, Iku ; Akagawa, Takashi ; Matsubara, Nobuaki. / Three-year follow-up of a phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer and bone metastases. In: International Journal of Clinical Oncology. 2019.
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abstract = "Background: Radium-223 is a first-in-class targeted alpha therapy to prolong overall survival (OS) in castration-resistant prostate cancer with bone metastases (mCRPC). The aim of the present analysis was to assess the long-term safety with radium-223 in Japanese patients with mCRPC. Methods: Patients with symptomatic mCRPC, ≥ 2 bone metastases and no known visceral metastases received up to 6 injections of radium-223 (55 kBq/kg), one every 4 weeks. Adverse events (AEs) considered to be related to radium-223 were reported until 3 years after the first injection. Pre-specified conditions, such as acute myelogenous leukemia, myelodysplastic syndrome, aplastic anemia, primary bone cancer, or other primary malignancies, were reported regardless of causality. Results: Of the 49 patients enrolled in the study, 44 (89.8{\%}) entered the survival follow-up period and 33 (67.3{\%}) died. Throughout the entire study, there were no reports of second primary malignancy or other pre-specified conditions. Eight patients (16.3{\%}) experienced post-treatment drug-related AEs, which were all hematological (anemia and decreased lymphocyte, platelet, and white blood cell counts). No serious post-treatment drug-related AEs were reported. Updated median OS was 19.3 months (95{\%} CI: 14.2, 28.5). Conclusions: In Japanese patients with symptomatic mCRPC and bone metastases, radium-223 had a favorable long-term safety profile with no second primary malignancies reported. Taken together with median OS, which was comparable to that in the pivotal phase III ALSYMPCA study, these results support continued benefit from radium-223 in Japanese patients with mCRPC.",
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T1 - Three-year follow-up of a phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer and bone metastases

AU - Uemura, Hirotsugu

AU - Uemura, Hiroji

AU - Nagamori, Satsohi

AU - Wakumoto, Yoshiaki

AU - Kimura, Go

AU - Kikukawa, Hiroaki

AU - Yokomizo, Akira

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 - Akagawa, Takashi

AU - Matsubara, Nobuaki

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Radium-223 is a first-in-class targeted alpha therapy to prolong overall survival (OS) in castration-resistant prostate cancer with bone metastases (mCRPC). The aim of the present analysis was to assess the long-term safety with radium-223 in Japanese patients with mCRPC. Methods: Patients with symptomatic mCRPC, ≥ 2 bone metastases and no known visceral metastases received up to 6 injections of radium-223 (55 kBq/kg), one every 4 weeks. Adverse events (AEs) considered to be related to radium-223 were reported until 3 years after the first injection. Pre-specified conditions, such as acute myelogenous leukemia, myelodysplastic syndrome, aplastic anemia, primary bone cancer, or other primary malignancies, were reported regardless of causality. Results: Of the 49 patients enrolled in the study, 44 (89.8%) entered the survival follow-up period and 33 (67.3%) died. Throughout the entire study, there were no reports of second primary malignancy or other pre-specified conditions. Eight patients (16.3%) experienced post-treatment drug-related AEs, which were all hematological (anemia and decreased lymphocyte, platelet, and white blood cell counts). No serious post-treatment drug-related AEs were reported. Updated median OS was 19.3 months (95% CI: 14.2, 28.5). Conclusions: In Japanese patients with symptomatic mCRPC and bone metastases, radium-223 had a favorable long-term safety profile with no second primary malignancies reported. Taken together with median OS, which was comparable to that in the pivotal phase III ALSYMPCA study, these results support continued benefit from radium-223 in Japanese patients with mCRPC.

AB - Background: Radium-223 is a first-in-class targeted alpha therapy to prolong overall survival (OS) in castration-resistant prostate cancer with bone metastases (mCRPC). The aim of the present analysis was to assess the long-term safety with radium-223 in Japanese patients with mCRPC. Methods: Patients with symptomatic mCRPC, ≥ 2 bone metastases and no known visceral metastases received up to 6 injections of radium-223 (55 kBq/kg), one every 4 weeks. Adverse events (AEs) considered to be related to radium-223 were reported until 3 years after the first injection. Pre-specified conditions, such as acute myelogenous leukemia, myelodysplastic syndrome, aplastic anemia, primary bone cancer, or other primary malignancies, were reported regardless of causality. Results: Of the 49 patients enrolled in the study, 44 (89.8%) entered the survival follow-up period and 33 (67.3%) died. Throughout the entire study, there were no reports of second primary malignancy or other pre-specified conditions. Eight patients (16.3%) experienced post-treatment drug-related AEs, which were all hematological (anemia and decreased lymphocyte, platelet, and white blood cell counts). No serious post-treatment drug-related AEs were reported. Updated median OS was 19.3 months (95% CI: 14.2, 28.5). Conclusions: In Japanese patients with symptomatic mCRPC and bone metastases, radium-223 had a favorable long-term safety profile with no second primary malignancies reported. Taken together with median OS, which was comparable to that in the pivotal phase III ALSYMPCA study, these results support continued benefit from radium-223 in Japanese patients with mCRPC.

KW - Bone metastases

KW - Metastatic castration-resistant prostate cancer

KW - Overall survival

KW - Radium-223 dichloride

KW - Safety

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DO - 10.1007/s10147-018-01389-4

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