当前位置： SCI文献检索 > International Journal of Clinical Oncology期刊下所有文献 > 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.

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.

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.

journal_name

Int J Clin Oncol

journal_title

International journal of clinical oncology

authors

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

doi

10.1007/s10147-018-01389-4

subject

Has Abstract

pub_date

2019-05-01 00:00:00

pages

557-566

issue

eissn

1341-9625

issn

1437-7772

pii

10.1007/s10147-018-01389-4

journal_volume

pub_type

杂志文章,多中心研究

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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.