A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease
Radium-223 dichloride (radium-223) mimics calcium and emits high-energy, short-range alpha-particles resulting in an antitumor effect on bone metastases. This open-label, phase IIa nonrandomized study investigated safety and short-term efficacy of radium-223 in breast cancer patients with bone-domin...
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| Veröffentlicht in: | Breast cancer research and treatment 2014-06, Vol.145 (2), p.411-418 |
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| creator | Coleman, Robert Aksnes, Anne-Kirsti Naume, Bjørn Garcia, Camilo Jerusalem, Guy Piccart, Martine Vobecky, Nancy Thuresson, Marcus Flamen, Patrick |
| description | Radium-223 dichloride (radium-223) mimics calcium and emits high-energy, short-range alpha-particles resulting in an antitumor effect on bone metastases. This open-label, phase IIa nonrandomized study investigated safety and short-term efficacy of radium-223 in breast cancer patients with bone-dominant disease. Twenty-three advanced breast cancer patients with progressive bone-dominant disease, and no longer candidates for further endocrine therapy, were to receive radium-223 (50 kBq/kg IV) every 4 weeks for 4 cycles. The coprimary end points were change in urinary N-telopeptide of type 1 (uNTX-1) and serum bone alkaline phosphatase (bALP) after 16 weeks of treatment. Exploratory end points included sequential
18
F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) to assess metabolic changes in osteoblastic bone metastases. Safety data were collected for all patients. Radium-223 significantly reduced uNTX-1 and bALP from baseline to end of treatment. Median uNTX-1 change was −10.1 nmol bone collagen equivalents/mmol creatinine (−32.8 %;
P
= 0.0124); median bALP change was −16.7 ng/mL (−42.0 %;
P
= 0.0045). Twenty of twenty-three patients had FDG PET/CT identifying 155 hypermetabolic osteoblastic bone lesions at baseline: 50 lesions showed metabolic decrease (≥25 % reduction of maximum standardized uptake value from baseline) after 2 radium-223 injections [32.3 % metabolic response rate (mRR) at week 9], persisting after the treatment period (41.5 % mRR at week 17). Radium-223 was safe and well tolerated. Radium-223 targets areas of increased bone metabolism and shows biological activity in advanced breast cancer patients with bone-dominant disease. |
| doi_str_mv | 10.1007/s10549-014-2939-1 |
| format | Article |
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18
F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) to assess metabolic changes in osteoblastic bone metastases. Safety data were collected for all patients. Radium-223 significantly reduced uNTX-1 and bALP from baseline to end of treatment. Median uNTX-1 change was −10.1 nmol bone collagen equivalents/mmol creatinine (−32.8 %;
P
= 0.0124); median bALP change was −16.7 ng/mL (−42.0 %;
P
= 0.0045). Twenty of twenty-three patients had FDG PET/CT identifying 155 hypermetabolic osteoblastic bone lesions at baseline: 50 lesions showed metabolic decrease (≥25 % reduction of maximum standardized uptake value from baseline) after 2 radium-223 injections [32.3 % metabolic response rate (mRR) at week 9], persisting after the treatment period (41.5 % mRR at week 17). Radium-223 was safe and well tolerated. Radium-223 targets areas of increased bone metabolism and shows biological activity in advanced breast cancer patients with bone-dominant disease.</description><identifier>ISSN: 0167-6806</identifier><identifier>ISSN: 1573-7217</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-014-2939-1</identifier><identifier>PMID: 24728613</identifier><identifier>CODEN: BCTRD6</identifier><language>eng</language><publisher>Boston: Springer US</publisher><subject>Aged ; Alkaline Phosphatase - blood ; Bone Neoplasms - pathology ; Bone Neoplasms - radiotherapy ; Bone Neoplasms - secondary ; Bones ; Breast cancer ; Breast Neoplasms - pathology ; Breast Neoplasms - radiotherapy ; Cancer ; Cancer patients ; Cancer research ; Cancer therapies ; Chemical elements ; Clinical Trial ; Clinical trials ; Collagen Type I - urine ; Female ; Human health sciences ; Humans ; Isotopes ; Medicine ; Medicine & Public Health ; Metastasis ; Middle Aged ; Oncologie ; Oncology ; Oncology, Experimental ; Peptides - urine ; PET imaging ; Pharmaceuticals ; Physiological aspects ; Radioisotopes - therapeutic use ; Radium - therapeutic use ; Sciences de la santé humaine ; Treatment Outcome</subject><ispartof>Breast cancer research and treatment, 2014-06, Vol.145 (2), p.411-418</ispartof><rights>The Author(s) 2014</rights><rights>COPYRIGHT 2014 Springer</rights><rights>Springer Science+Business Media New York 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c612t-a754e442aee83e0d82a2f13962900446bf47a05b2d79af892e478bcb33c47a593</citedby><cites>FETCH-LOGICAL-c612t-a754e442aee83e0d82a2f13962900446bf47a05b2d79af892e478bcb33c47a593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10549-014-2939-1$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-014-2939-1$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,777,781,882,27905,27906,41469,42538,51300</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24728613$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Coleman, Robert</creatorcontrib><creatorcontrib>Aksnes, Anne-Kirsti</creatorcontrib><creatorcontrib>Naume, Bjørn</creatorcontrib><creatorcontrib>Garcia, Camilo</creatorcontrib><creatorcontrib>Jerusalem, Guy</creatorcontrib><creatorcontrib>Piccart, Martine</creatorcontrib><creatorcontrib>Vobecky, Nancy</creatorcontrib><creatorcontrib>Thuresson, Marcus</creatorcontrib><creatorcontrib>Flamen, Patrick</creatorcontrib><title>A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>Radium-223 dichloride (radium-223) mimics calcium and emits high-energy, short-range alpha-particles resulting in an antitumor effect on bone metastases. This open-label, phase IIa nonrandomized study investigated safety and short-term efficacy of radium-223 in breast cancer patients with bone-dominant disease. Twenty-three advanced breast cancer patients with progressive bone-dominant disease, and no longer candidates for further endocrine therapy, were to receive radium-223 (50 kBq/kg IV) every 4 weeks for 4 cycles. The coprimary end points were change in urinary N-telopeptide of type 1 (uNTX-1) and serum bone alkaline phosphatase (bALP) after 16 weeks of treatment. Exploratory end points included sequential
18
F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) to assess metabolic changes in osteoblastic bone metastases. Safety data were collected for all patients. Radium-223 significantly reduced uNTX-1 and bALP from baseline to end of treatment. Median uNTX-1 change was −10.1 nmol bone collagen equivalents/mmol creatinine (−32.8 %;
P
= 0.0124); median bALP change was −16.7 ng/mL (−42.0 %;
P
= 0.0045). Twenty of twenty-three patients had FDG PET/CT identifying 155 hypermetabolic osteoblastic bone lesions at baseline: 50 lesions showed metabolic decrease (≥25 % reduction of maximum standardized uptake value from baseline) after 2 radium-223 injections [32.3 % metabolic response rate (mRR) at week 9], persisting after the treatment period (41.5 % mRR at week 17). Radium-223 was safe and well tolerated. Radium-223 targets areas of increased bone metabolism and shows biological activity in advanced breast cancer patients with bone-dominant disease.</description><subject>Aged</subject><subject>Alkaline Phosphatase - blood</subject><subject>Bone Neoplasms - pathology</subject><subject>Bone Neoplasms - radiotherapy</subject><subject>Bone Neoplasms - secondary</subject><subject>Bones</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - pathology</subject><subject>Breast Neoplasms - radiotherapy</subject><subject>Cancer</subject><subject>Cancer patients</subject><subject>Cancer research</subject><subject>Cancer therapies</subject><subject>Chemical elements</subject><subject>Clinical Trial</subject><subject>Clinical trials</subject><subject>Collagen Type I - urine</subject><subject>Female</subject><subject>Human health sciences</subject><subject>Humans</subject><subject>Isotopes</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Oncologie</subject><subject>Oncology</subject><subject>Oncology, Experimental</subject><subject>Peptides - urine</subject><subject>PET imaging</subject><subject>Pharmaceuticals</subject><subject>Physiological aspects</subject><subject>Radioisotopes - therapeutic use</subject><subject>Radium - therapeutic use</subject><subject>Sciences de la santé humaine</subject><subject>Treatment Outcome</subject><issn>0167-6806</issn><issn>1573-7217</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1kktv1DAUhSMEokPhB7BBlpAQC1L8iu1skEYVj5EqsYG15Tg3E1eJPdjJVOXX43RKmUEgL-z4fufk5uYUxUuCLwjG8n0iuOJ1iQkvac3qkjwqVqSSrJSUyMfFChMhS6GwOCuepXSNMa4lrp8WZ5RLqgRhq-JmjXa9SYA2G_MO-eCj8W0Y3U9oUZrm9haFDkXTunksKWWodbYfQnQtIOeRaffG24w2EUyakF2eItqZyYGfErpxU4-a4KFcPL3xUzZIGYXnxZPODAle3O_nxfdPH79dfimvvn7eXK6vSisInUojKw6cUwOgGOBWUUM7wmpBa4w5F03HpcFVQ1tZm07VFLhUjW0Ys7lQ1ey8-HDw3c3NCK3NbUUz6F10o4m3OhinTyve9Xob9ppjWhHJswE7GAwOtqBDbJze0zvh3XkettpY3YCmVChNhFBKZdXb-9fG8GOGNOnRJQvDYDyEOWlS0Tx-TnmV0dd_oddhjj4PZaEqKaXC6g-1NQNo57uQu7WLqV4zlXMglGSZuvgHlVcLo7P5P3Qu358I3hwJejDD1KcwzJMLPp2C5ADaGFKK0D2MkGC9hFEfwqhzGPUSRk2y5tXx7B8Uv9OXAXoAUi75LcSjT_-v6y_duuex</recordid><startdate>20140601</startdate><enddate>20140601</enddate><creator>Coleman, Robert</creator><creator>Aksnes, Anne-Kirsti</creator><creator>Naume, Bjørn</creator><creator>Garcia, Camilo</creator><creator>Jerusalem, Guy</creator><creator>Piccart, Martine</creator><creator>Vobecky, Nancy</creator><creator>Thuresson, Marcus</creator><creator>Flamen, Patrick</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><general>Kluwer Academic Publishers</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>Q33</scope><scope>5PM</scope></search><sort><creationdate>20140601</creationdate><title>A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease</title><author>Coleman, Robert ; Aksnes, Anne-Kirsti ; Naume, Bjørn ; Garcia, Camilo ; Jerusalem, Guy ; Piccart, Martine ; Vobecky, Nancy ; Thuresson, Marcus ; Flamen, Patrick</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c612t-a754e442aee83e0d82a2f13962900446bf47a05b2d79af892e478bcb33c47a593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Alkaline Phosphatase - blood</topic><topic>Bone Neoplasms - pathology</topic><topic>Bone Neoplasms - radiotherapy</topic><topic>Bone Neoplasms - secondary</topic><topic>Bones</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - pathology</topic><topic>Breast Neoplasms - radiotherapy</topic><topic>Cancer</topic><topic>Cancer patients</topic><topic>Cancer research</topic><topic>Cancer therapies</topic><topic>Chemical elements</topic><topic>Clinical Trial</topic><topic>Clinical trials</topic><topic>Collagen Type I - urine</topic><topic>Female</topic><topic>Human health sciences</topic><topic>Humans</topic><topic>Isotopes</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metastasis</topic><topic>Middle Aged</topic><topic>Oncologie</topic><topic>Oncology</topic><topic>Oncology, Experimental</topic><topic>Peptides - urine</topic><topic>PET imaging</topic><topic>Pharmaceuticals</topic><topic>Physiological aspects</topic><topic>Radioisotopes - therapeutic use</topic><topic>Radium - therapeutic use</topic><topic>Sciences de la santé humaine</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Coleman, Robert</creatorcontrib><creatorcontrib>Aksnes, Anne-Kirsti</creatorcontrib><creatorcontrib>Naume, Bjørn</creatorcontrib><creatorcontrib>Garcia, Camilo</creatorcontrib><creatorcontrib>Jerusalem, Guy</creatorcontrib><creatorcontrib>Piccart, Martine</creatorcontrib><creatorcontrib>Vobecky, Nancy</creatorcontrib><creatorcontrib>Thuresson, Marcus</creatorcontrib><creatorcontrib>Flamen, Patrick</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Université de Liège - Open Repository and Bibliography (ORBI)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Coleman, Robert</au><au>Aksnes, Anne-Kirsti</au><au>Naume, Bjørn</au><au>Garcia, Camilo</au><au>Jerusalem, Guy</au><au>Piccart, Martine</au><au>Vobecky, Nancy</au><au>Thuresson, Marcus</au><au>Flamen, Patrick</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease</atitle><jtitle>Breast cancer research and treatment</jtitle><stitle>Breast Cancer Res Treat</stitle><addtitle>Breast Cancer Res Treat</addtitle><date>2014-06-01</date><risdate>2014</risdate><volume>145</volume><issue>2</issue><spage>411</spage><epage>418</epage><pages>411-418</pages><issn>0167-6806</issn><issn>1573-7217</issn><eissn>1573-7217</eissn><coden>BCTRD6</coden><abstract>Radium-223 dichloride (radium-223) mimics calcium and emits high-energy, short-range alpha-particles resulting in an antitumor effect on bone metastases. This open-label, phase IIa nonrandomized study investigated safety and short-term efficacy of radium-223 in breast cancer patients with bone-dominant disease. Twenty-three advanced breast cancer patients with progressive bone-dominant disease, and no longer candidates for further endocrine therapy, were to receive radium-223 (50 kBq/kg IV) every 4 weeks for 4 cycles. The coprimary end points were change in urinary N-telopeptide of type 1 (uNTX-1) and serum bone alkaline phosphatase (bALP) after 16 weeks of treatment. Exploratory end points included sequential
18
F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) to assess metabolic changes in osteoblastic bone metastases. Safety data were collected for all patients. Radium-223 significantly reduced uNTX-1 and bALP from baseline to end of treatment. Median uNTX-1 change was −10.1 nmol bone collagen equivalents/mmol creatinine (−32.8 %;
P
= 0.0124); median bALP change was −16.7 ng/mL (−42.0 %;
P
= 0.0045). Twenty of twenty-three patients had FDG PET/CT identifying 155 hypermetabolic osteoblastic bone lesions at baseline: 50 lesions showed metabolic decrease (≥25 % reduction of maximum standardized uptake value from baseline) after 2 radium-223 injections [32.3 % metabolic response rate (mRR) at week 9], persisting after the treatment period (41.5 % mRR at week 17). Radium-223 was safe and well tolerated. Radium-223 targets areas of increased bone metabolism and shows biological activity in advanced breast cancer patients with bone-dominant disease.</abstract><cop>Boston</cop><pub>Springer US</pub><pmid>24728613</pmid><doi>10.1007/s10549-014-2939-1</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | Breast cancer research and treatment, 2014-06, Vol.145 (2), p.411-418 |
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| language | eng |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Aged Alkaline Phosphatase - blood Bone Neoplasms - pathology Bone Neoplasms - radiotherapy Bone Neoplasms - secondary Bones Breast cancer Breast Neoplasms - pathology Breast Neoplasms - radiotherapy Cancer Cancer patients Cancer research Cancer therapies Chemical elements Clinical Trial Clinical trials Collagen Type I - urine Female Human health sciences Humans Isotopes Medicine Medicine & Public Health Metastasis Middle Aged Oncologie Oncology Oncology, Experimental Peptides - urine PET imaging Pharmaceuticals Physiological aspects Radioisotopes - therapeutic use Radium - therapeutic use Sciences de la santé humaine Treatment Outcome |
| title | A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease |
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