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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.
Afiliación
  • Uemura H; Department of Urology, Kindai University Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan. huemura@med.kindai.ac.jp.
  • Uemura H; Department of Urology and Renal Transplantation, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, Japan.
  • Nagamori S; Department of Urology, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4 Jo, Shiroishi-ku, Sapporo, Japan.
  • Wakumoto Y; Department of Urology, Juntendo University, 2-2-1 Hongo Bunkyo-ku, Tokyo, Japan.
  • Kimura G; Department of Urology, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
  • Kikukawa H; Department of Urology, National Hospital Organization Kumamoto Medical Center, 1-5 Ninomaru, Chuo-ku, Kumamoto, Japan.
  • Yokomizo A; Department of Urology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan.
  • Mizokami A; Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, 13-1 Takaramachi, Kanazawa, Ishikawa, Japan.
  • Kosaka T; Department of Urology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.
  • Masumori N; Department of Urology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Japan.
  • Kawasaki Y; Department of Urology, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan.
  • Yonese J; Department of Urology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, Japan.
  • Nasu Y; Department of Urology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, 2-5-1, Shikata, Okayama, Japan.
  • Fukasawa S; Prostate Center, Division of Urology, Chiba Cancer Center, 666-2, Nitona-cho, Chuo-ku, Chiba, Japan.
  • Sugiyama T; Department of Urology, Hamamatsu University School of Medicine, 1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan.
  • Kinuya S; The Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.
  • Hosono M; The Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.
  • Yamaguchi I; Clinical Statistics, Bayer Yakuhin, Ltd, 2-4-9, Umeda, Kita-ku, Osaka, Japan.
  • Akagawa T; Oncology Clinical Development, Bayer Yakuhin, Ltd, 2-4-9, Umeda, Kita-ku, Osaka, Japan.
  • Matsubara N; Division of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan.
Int J Clin Oncol ; 24(5): 557-566, 2019 May.
Article en En | MEDLINE | ID: mdl-30875000
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Óseas / Radio (Elemento) / Neoplasias de la Próstata Resistentes a la Castración Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies Límite: Aged / Humans / Male / Middle aged Idioma: En Revista: Int J Clin Oncol Asunto de la revista: NEOPLASIAS Año: 2019 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Óseas / Radio (Elemento) / Neoplasias de la Próstata Resistentes a la Castración Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies Límite: Aged / Humans / Male / Middle aged Idioma: En Revista: Int J Clin Oncol Asunto de la revista: NEOPLASIAS Año: 2019 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón