Evidence map›Paper›PMID 30875000›Full record

Trial reportInternational journal of clinical oncology2019

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 and 10 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 17 institutions in 1 country.

Hirotsugu UemuraDepartment of Urology, Kindai University Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan. huemura@med.kindai.ac.jp.ORCID http://orcid.org/0000-0002-3665-9523
Hiroji UemuraDepartment of Urology and Renal Transplantation, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, Japan.
Satsohi NagamoriDepartment of Urology, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4 Jo, Shiroishi-ku, Sapporo, Japan.
Yoshiaki WakumotoDepartment of Urology, Juntendo University, 2-2-1 Hongo Bunkyo-ku, Tokyo, Japan.
Go KimuraDepartment of Urology, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
Hiroaki KikukawaDepartment of Urology, National Hospital Organization Kumamoto Medical Center, 1-5 Ninomaru, Chuo-ku, Kumamoto, Japan.
Akira YokomizoDepartment of Urology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan.
Atsushi MizokamiDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, 13-1 Takaramachi, Kanazawa, Ishikawa, Japan.
Takeo KosakaDepartment of Urology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.
Naoya MasumoriDepartment of Urology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Japan.
Yoshihide KawasakiDepartment of Urology, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan.
Junji YoneseDepartment of Urology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, Japan.
Yasutomo NasuDepartment of Urology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, 2-5-1, Shikata, Okayama, Japan.
Satoshi FukasawaProstate Center, Division of Urology, Chiba Cancer Center, 666-2, Nitona-cho, Chuo-ku, Chiba, Japan.
Takayuki SugiyamaDepartment of Urology, Hamamatsu University School of Medicine, 1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan.
Seigo KinuyaThe Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.
Makoto HosonoThe Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.
Iku YamaguchiClinical Statistics, Bayer Yakuhin, Ltd, 2-4-9, Umeda, Kita-ku, Osaka, Japan.
Takashi AkagawaOncology Clinical Development, Bayer Yakuhin, Ltd, 2-4-9, Umeda, Kita-ku, Osaka, Japan.
Nobuaki MatsubaraDivision of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan.
Bayer (Japan) · JPJapanese Society of Medical Oncology · JPYokohama City University Medical Center · JPChiba Cancer Center · JPHamamatsu University School of Medicine · JPJapanese Foundation For Cancer Research · JPJuntendo University · JPKanazawa University · JPKeio University Hospital · JPKumamoto Medical Center · JPKyushu University · JPNational Cancer Center Hospital East · JPNational Hospital Organization Hokkaido Medical Center · JPNippon Medical School · JPOkayama University · JPSapporo Medical University · JPTohoku University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadium-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.

methodsPatients 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.

resultsOf 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).

conclusionsIn 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.

Indexed as

Administration, IntravenousAgedAnemiaBone NeoplasmsFollow-Up StudiesHematologic DiseasesHumansMaleMiddle AgedProstatic Neoplasms, Castration-ResistantRadiation InjuriesRadioisotopesRadiumRadioisotopesRadiumradium Ra 223 dichlorideBone metastasesMetastatic castration-resistant prostate cancerOverall survivalRadium-223 dichlorideSafety

Identifiers

PMID30875000
PMCPMC6469691
OpenAlexW2921609221

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.