Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age
Objective: To perform an exploratory analysis on the safety and effectiveness of radium-223 (Ra-223) by patient baseline age, using the results of a post-marketing surveillance study of Ra-223 in castration-resistant prostate cancer patients with bone metastasis in Japan. Method: The safety analysis...
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| Veröffentlicht in: | KAKUIGAKU 2021, Vol.58(1), pp.91-101 |
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| creator | HOSONO, Makoto UEMURA, Hirotsugu KAKEHI, Yoshiyuki MASUMORI, Naoya TAKAHASHI, Shunji OKAYAMA, Yutaka SUNAYA, Toshiyuki HORIO, Tomoyo KINUYA, Seigo |
| description | Objective: To perform an exploratory analysis on the safety and effectiveness of radium-223 (Ra-223) by patient baseline age, using the results of a post-marketing surveillance study of Ra-223 in castration-resistant prostate cancer patients with bone metastasis in Japan. Method: The safety analysis population of 296 patients was stratified into two groups based on age ( |
| doi_str_mv | 10.18893/kakuigaku.oa.2105 |
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Method: The safety analysis population of 296 patients was stratified into two groups based on age (<75 and ≥ 75 years-old [yo]), and their characteristics, drugrelated treatment-emergent adverse events (TEAEs), and clinical laboratory values were evaluated. Additionally, these endpoints were evaluated in patients aged ≥ 80 yo. Results: There were 148 patients in each of the <75-yo and ≥ 75-yo age groups, and 69 patients in the ≥ 80-yo age group. The characteristics of patients in the <75-yo group were suggestive of more aggressive disease at diagnosis of prostate cancer and a greater proportion of patients had prior chemotherapy compared with patients in the ≥ 75-yo age group. The incidences of overall drugrelated TEAEs and drug-related hematological TEAEs were slightly higher in the <75-yo age group; however, there was little difference in the incidences of drug-related TEAEs leading to drug discontinuation (1.4–4.1%) between patient groups. Changes in total alkaline phosphatase and prostate-specific antigen values were similar in all groups. Conclusions: Ra-223 therapy seemed tolerable regardless of age in real-world practice in Japan. Especially, there were no new safety concerns of Ra-223 in elderly patients.</description><identifier>EISSN: 2189-9932</identifier><identifier>DOI: 10.18893/kakuigaku.oa.2105</identifier><identifier>PMID: 34645727</identifier><language>jpn</language><publisher>Japan: The Japanese Society of Nuclear Medicine</publisher><subject>Aged ; bone metastases ; Bone Neoplasms - radiotherapy ; castration-resistant prostate cancer ; Humans ; Japan ; Japanese patients ; Laboratories, Clinical ; Male ; post-marketing surveillance study ; Product Surveillance, Postmarketing ; Prostatic Neoplasms, Castration-Resistant ; Radioisotopes ; Radium - adverse effects ; radium-223 ; Treatment Outcome</subject><ispartof>KAKUIGAKU, 2021, Vol.58(1), pp.91-101</ispartof><rights>2021 Japanese Society of Nuclear Medicine</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,1879,4012,27906,27907,27908</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34645727$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>HOSONO, Makoto</creatorcontrib><creatorcontrib>UEMURA, Hirotsugu</creatorcontrib><creatorcontrib>KAKEHI, Yoshiyuki</creatorcontrib><creatorcontrib>MASUMORI, Naoya</creatorcontrib><creatorcontrib>TAKAHASHI, Shunji</creatorcontrib><creatorcontrib>OKAYAMA, Yutaka</creatorcontrib><creatorcontrib>SUNAYA, Toshiyuki</creatorcontrib><creatorcontrib>HORIO, Tomoyo</creatorcontrib><creatorcontrib>KINUYA, Seigo</creatorcontrib><title>Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age</title><title>KAKUIGAKU</title><addtitle>kakuigaku</addtitle><description>Objective: To perform an exploratory analysis on the safety and effectiveness of radium-223 (Ra-223) by patient baseline age, using the results of a post-marketing surveillance study of Ra-223 in castration-resistant prostate cancer patients with bone metastasis in Japan. Method: The safety analysis population of 296 patients was stratified into two groups based on age (<75 and ≥ 75 years-old [yo]), and their characteristics, drugrelated treatment-emergent adverse events (TEAEs), and clinical laboratory values were evaluated. Additionally, these endpoints were evaluated in patients aged ≥ 80 yo. Results: There were 148 patients in each of the <75-yo and ≥ 75-yo age groups, and 69 patients in the ≥ 80-yo age group. The characteristics of patients in the <75-yo group were suggestive of more aggressive disease at diagnosis of prostate cancer and a greater proportion of patients had prior chemotherapy compared with patients in the ≥ 75-yo age group. The incidences of overall drugrelated TEAEs and drug-related hematological TEAEs were slightly higher in the <75-yo age group; however, there was little difference in the incidences of drug-related TEAEs leading to drug discontinuation (1.4–4.1%) between patient groups. Changes in total alkaline phosphatase and prostate-specific antigen values were similar in all groups. Conclusions: Ra-223 therapy seemed tolerable regardless of age in real-world practice in Japan. Especially, there were no new safety concerns of Ra-223 in elderly patients.</description><subject>Aged</subject><subject>bone metastases</subject><subject>Bone Neoplasms - radiotherapy</subject><subject>castration-resistant prostate cancer</subject><subject>Humans</subject><subject>Japan</subject><subject>Japanese patients</subject><subject>Laboratories, Clinical</subject><subject>Male</subject><subject>post-marketing surveillance study</subject><subject>Product Surveillance, Postmarketing</subject><subject>Prostatic Neoplasms, Castration-Resistant</subject><subject>Radioisotopes</subject><subject>Radium - adverse effects</subject><subject>radium-223</subject><subject>Treatment Outcome</subject><issn>2189-9932</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkU1OwzAQhS0kBAi4AAvkC6TEdn4cdlBBAYGo-FlH43QSTFM7sh2gl-NsGAFlM7OYT--9mSHkiKUTJmUlTpawHHUXy8TChLM03yJ7nMkqqSrBd8mh91qlXJRMFjzbIbsiK7K85OUe-bz4GHrrIFi3pmcG-rXXnj6gH_vgaevsis6tD8kK3BKDNh19HN0b6r4H0yB9DONiTW1LH2Chx1XCuaDa0BsYwKBHOoeg0USldx1e6BR8iFbamsRh9AlgAp27qA8B4zQqOgpmQc-tQXqHIfLg0Z9GU9U5Ow7_EVWM2-EB2W6h93j42_fJ8-XF0_Qqub2fXU_PbpPXuHJIClU0DaZtxQuRQ562PGVcNplEhaXI2pLnIJRUJbRQSCWRMdZkmWKKc1WgEvvk-Ed3GNUKF_XgdLzIuv47ZARmP8BrjNzhBgAXdNNjvflQncuafRcL9fenNkTzAq5GI74AkSmV7w</recordid><startdate>2021</startdate><enddate>2021</enddate><creator>HOSONO, Makoto</creator><creator>UEMURA, Hirotsugu</creator><creator>KAKEHI, Yoshiyuki</creator><creator>MASUMORI, Naoya</creator><creator>TAKAHASHI, Shunji</creator><creator>OKAYAMA, Yutaka</creator><creator>SUNAYA, Toshiyuki</creator><creator>HORIO, Tomoyo</creator><creator>KINUYA, Seigo</creator><general>The Japanese Society of Nuclear Medicine</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>2021</creationdate><title>Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age</title><author>HOSONO, Makoto ; UEMURA, Hirotsugu ; KAKEHI, Yoshiyuki ; MASUMORI, Naoya ; TAKAHASHI, Shunji ; OKAYAMA, Yutaka ; SUNAYA, Toshiyuki ; HORIO, Tomoyo ; KINUYA, Seigo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-j186t-6b6cce0f92635a50f20128c48ebe734f725a3b8b7afa68b8e111c44b1b22b6eb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>jpn</language><creationdate>2021</creationdate><topic>Aged</topic><topic>bone metastases</topic><topic>Bone Neoplasms - radiotherapy</topic><topic>castration-resistant prostate cancer</topic><topic>Humans</topic><topic>Japan</topic><topic>Japanese patients</topic><topic>Laboratories, Clinical</topic><topic>Male</topic><topic>post-marketing surveillance study</topic><topic>Product Surveillance, Postmarketing</topic><topic>Prostatic Neoplasms, Castration-Resistant</topic><topic>Radioisotopes</topic><topic>Radium - adverse effects</topic><topic>radium-223</topic><topic>Treatment Outcome</topic><toplevel>online_resources</toplevel><creatorcontrib>HOSONO, Makoto</creatorcontrib><creatorcontrib>UEMURA, Hirotsugu</creatorcontrib><creatorcontrib>KAKEHI, Yoshiyuki</creatorcontrib><creatorcontrib>MASUMORI, Naoya</creatorcontrib><creatorcontrib>TAKAHASHI, Shunji</creatorcontrib><creatorcontrib>OKAYAMA, Yutaka</creatorcontrib><creatorcontrib>SUNAYA, Toshiyuki</creatorcontrib><creatorcontrib>HORIO, Tomoyo</creatorcontrib><creatorcontrib>KINUYA, Seigo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>KAKUIGAKU</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>HOSONO, Makoto</au><au>UEMURA, Hirotsugu</au><au>KAKEHI, Yoshiyuki</au><au>MASUMORI, Naoya</au><au>TAKAHASHI, Shunji</au><au>OKAYAMA, Yutaka</au><au>SUNAYA, Toshiyuki</au><au>HORIO, Tomoyo</au><au>KINUYA, Seigo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age</atitle><jtitle>KAKUIGAKU</jtitle><addtitle>kakuigaku</addtitle><date>2021</date><risdate>2021</risdate><volume>58</volume><issue>1</issue><spage>91</spage><epage>101</epage><pages>91-101</pages><eissn>2189-9932</eissn><abstract>Objective: To perform an exploratory analysis on the safety and effectiveness of radium-223 (Ra-223) by patient baseline age, using the results of a post-marketing surveillance study of Ra-223 in castration-resistant prostate cancer patients with bone metastasis in Japan. Method: The safety analysis population of 296 patients was stratified into two groups based on age (<75 and ≥ 75 years-old [yo]), and their characteristics, drugrelated treatment-emergent adverse events (TEAEs), and clinical laboratory values were evaluated. Additionally, these endpoints were evaluated in patients aged ≥ 80 yo. Results: There were 148 patients in each of the <75-yo and ≥ 75-yo age groups, and 69 patients in the ≥ 80-yo age group. The characteristics of patients in the <75-yo group were suggestive of more aggressive disease at diagnosis of prostate cancer and a greater proportion of patients had prior chemotherapy compared with patients in the ≥ 75-yo age group. The incidences of overall drugrelated TEAEs and drug-related hematological TEAEs were slightly higher in the <75-yo age group; however, there was little difference in the incidences of drug-related TEAEs leading to drug discontinuation (1.4–4.1%) between patient groups. Changes in total alkaline phosphatase and prostate-specific antigen values were similar in all groups. Conclusions: Ra-223 therapy seemed tolerable regardless of age in real-world practice in Japan. Especially, there were no new safety concerns of Ra-223 in elderly patients.</abstract><cop>Japan</cop><pub>The Japanese Society of Nuclear Medicine</pub><pmid>34645727</pmid><doi>10.18893/kakuigaku.oa.2105</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged bone metastases Bone Neoplasms - radiotherapy castration-resistant prostate cancer Humans Japan Japanese patients Laboratories, Clinical Male post-marketing surveillance study Product Surveillance, Postmarketing Prostatic Neoplasms, Castration-Resistant Radioisotopes Radium - adverse effects radium-223 Treatment Outcome |
| title | Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age |
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