Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
Identifieur interne : 001B62 ( Istex/Corpus ); précédent : 001B61; suivant : 001B63Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
Auteurs : J.-J. Body ; I. J. Diel ; M. R. Lichinitser ; E. D. Kreuser ; W. Dornoff ; V. A. Gorbunova ; M. Budde ; B. Bergstro MSource :
- Annals of Oncology [ 0923-7534 ] ; 2003-09.
English descriptors
Abstract
Background: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. Patients and methods: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3–4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. Conclusions: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.
Url:
DOI: 10.1093/annonc/mdg367
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ISTEX:20E80C36FAB1ABDF5083D8C2F7C7351C923791FALe document en format XML
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Diel</name><affiliation><mods:affiliation>Department of Obstetrics and Gynaecology, University Hospital, Heidelberg, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Lichinitser, M R" sort="Lichinitser, M R" uniqKey="Lichinitser M" first="M. R." last="Lichinitser">M. R. Lichinitser</name><affiliation><mods:affiliation>Department of Clinical Chemotherapy, Cancer Research Center, Moscow, Russia;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Kreuser, E D" sort="Kreuser, E D" uniqKey="Kreuser E" first="E. D." last="Kreuser">E. D. Kreuser</name><affiliation><mods:affiliation>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation><mods:affiliation>Mutterhaus der Borromaeerinnen, Trier, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Gorbunova, V A" sort="Gorbunova, V A" uniqKey="Gorbunova V" first="V. A." last="Gorbunova">V. A. 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Body</name><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Diel, I J" sort="Diel, I J" uniqKey="Diel I" first="I. J." last="Diel">I. J. Diel</name><affiliation><mods:affiliation>Department of Obstetrics and Gynaecology, University Hospital, Heidelberg, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Lichinitser, M R" sort="Lichinitser, M R" uniqKey="Lichinitser M" first="M. R." last="Lichinitser">M. R. Lichinitser</name><affiliation><mods:affiliation>Department of Clinical Chemotherapy, Cancer Research Center, Moscow, Russia;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Kreuser, E D" sort="Kreuser, E D" uniqKey="Kreuser E" first="E. D." last="Kreuser">E. D. Kreuser</name><affiliation><mods:affiliation>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation><mods:affiliation>Mutterhaus der Borromaeerinnen, Trier, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Gorbunova, V A" sort="Gorbunova, V A" uniqKey="Gorbunova V" first="V. A." last="Gorbunova">V. A. Gorbunova</name><affiliation><mods:affiliation>Cancer Research Center, Department of Chemotherapy, Moscow, Russia;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland;</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author><author><name sortKey="Bergstro M, B" sort="Bergstro M, B" uniqKey="Bergstro M B" first="B." last="Bergstro M">B. Bergstro M</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Inc., Nutley, NJ, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><title level="j" type="abbrev">Ann Oncol</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2003-09">2003-09</date><biblScope unit="volume">14</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1399">1399</biblScope><biblScope unit="page" to="1405">1405</biblScope></imprint><idno type="ISSN">0923-7534</idno></series><idno type="istex">20E80C36FAB1ABDF5083D8C2F7C7351C923791FA</idno><idno type="DOI">10.1093/annonc/mdg367</idno><idno type="local">mdg367</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Key words: bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. Patients and methods: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3–4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. Conclusions: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.</div></front></TEI><istex><corpusName>oup</corpusName><author><json:item><name>J.-J. Body</name><affiliations><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item><json:item><name>I. J. Diel</name><affiliations><json:string>Department of Obstetrics and Gynaecology, University Hospital, Heidelberg, Germany;</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item><json:item><name>M. R. Lichinitser</name><affiliations><json:string>Department of Clinical Chemotherapy, Cancer Research Center, Moscow, Russia;</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item><json:item><name>E. D. Kreuser</name><affiliations><json:string>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg;</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item><json:item><name>W. Dornoff</name><affiliations><json:string>Mutterhaus der Borromaeerinnen, Trier, Germany;</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item><json:item><name>V. A. Gorbunova</name><affiliations><json:string>Cancer Research Center, Department of Chemotherapy, Moscow, Russia;</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item><json:item><name>M. Budde</name><affiliations><json:string>F. Hoffmann-La Roche Ltd, Basel, Switzerland;</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item><json:item><name>B. Bergström</name><affiliations><json:string>F. Hoffmann-La Roche Inc., Nutley, NJ, USA</json:string><json:string>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Key words: bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy</value></json:item></subject><language><json:string>eng</json:string></language><originalGenre><json:string>other</json:string></originalGenre><abstract>Background: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. Patients and methods: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3–4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. 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trial</title><publicationDate>2001</publicationDate></json:item></refBibs><genre><json:string>other</json:string></genre><host><volume>14</volume><publisherId><json:string>annonc</json:string></publisherId><pages><last>1405</last><first>1399</first></pages><issn><json:string>0923-7534</json:string></issn><issue>9</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1569-8041</json:string></eissn><title>Annals of Oncology</title></host><categories><wos><json:string>science</json:string><json:string>oncology</json:string></wos><scienceMetrix><json:string>health sciences</json:string><json:string>clinical medicine</json:string><json:string>oncology & carcinogenesis</json:string></scienceMetrix></categories><publicationDate>2003</publicationDate><copyrightDate>2003</copyrightDate><doi><json:string>10.1093/annonc/mdg367</json:string></doi><id>20E80C36FAB1ABDF5083D8C2F7C7351C923791FA</id><score>0.17179027</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/20E80C36FAB1ABDF5083D8C2F7C7351C923791FA/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/20E80C36FAB1ABDF5083D8C2F7C7351C923791FA/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/20E80C36FAB1ABDF5083D8C2F7C7351C923791FA/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</title><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Oxford University Press</publisher><availability><p>OUP</p></availability><date>2003</date></publicationStmt><notesStmt><note>Received 23 January 2003; revised 26 March 2003; accepted 14 May 2003</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</title><author xml:id="author-1"><persName><forename type="first">J.-J.</forename><surname>Body</surname></persName><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author><author xml:id="author-2"><persName><forename type="first">I. J.</forename><surname>Diel</surname></persName><affiliation>Department of Obstetrics and Gynaecology, University Hospital, Heidelberg, Germany;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author><author xml:id="author-3"><persName><forename type="first">M. R.</forename><surname>Lichinitser</surname></persName><affiliation>Department of Clinical Chemotherapy, Cancer Research Center, Moscow, Russia;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author><author xml:id="author-4"><persName><forename type="first">E. D.</forename><surname>Kreuser</surname></persName><affiliation>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author><author xml:id="author-5"><persName><forename type="first">W.</forename><surname>Dornoff</surname></persName><affiliation>Mutterhaus der Borromaeerinnen, Trier, Germany;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author><author xml:id="author-6"><persName><forename type="first">V. A.</forename><surname>Gorbunova</surname></persName><affiliation>Cancer Research Center, Department of Chemotherapy, Moscow, Russia;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author><author xml:id="author-7"><persName><forename type="first">M.</forename><surname>Budde</surname></persName><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author><author xml:id="author-8"><persName><forename type="first">B.</forename><surname>Bergström</surname></persName><affiliation>F. Hoffmann-La Roche Inc., Nutley, NJ, USA</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation></author></analytic><monogr><title level="j">Annals of Oncology</title><title level="j" type="abbrev">Ann Oncol</title><idno type="pISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2003-09"></date><biblScope unit="volume">14</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1399">1399</biblScope><biblScope unit="page" to="1405">1405</biblScope></imprint></monogr><idno type="istex">20E80C36FAB1ABDF5083D8C2F7C7351C923791FA</idno><idno type="DOI">10.1093/annonc/mdg367</idno><idno type="local">mdg367</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2003</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Background: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. Patients and methods: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3–4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. Conclusions: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>KWD</head><item><term>Key words: bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2003-09">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-12-22">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/20E80C36FAB1ABDF5083D8C2F7C7351C923791FA/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="US-ASCII"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="other" xml:lang="en"><front><journal-meta><journal-id journal-id-type="hwp">annonc</journal-id><journal-id journal-id-type="nlm-ta">Ann Oncol</journal-id><journal-id journal-id-type="publisher-id">annonc</journal-id><journal-title>Annals of Oncology</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Oncol</abbrev-journal-title><issn pub-type="ppub">0923-7534</issn><issn pub-type="epub">1569-8041</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="other">mdg367</article-id><article-id pub-id-type="doi">10.1093/annonc/mdg367</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original articles</subject><subj-group><subject>Breast cancer</subject></subj-group></subj-group></article-categories><title-group><article-title>Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Body</surname><given-names>J.-J.</given-names></name><xref rid="BBAGCBAG">1</xref><xref rid="FN1">+</xref></contrib><contrib contrib-type="author"><name><surname>Diel</surname><given-names>I. J.</given-names></name><xref rid="BBAIFACF">2</xref></contrib><contrib contrib-type="author"><name><surname>Lichinitser</surname><given-names>M. R.</given-names></name><xref rid="BBAJBICI">3</xref></contrib><contrib contrib-type="author"><name><surname>Kreuser</surname><given-names>E. D.</given-names></name><xref rid="BBAHJBHH">4</xref></contrib><contrib contrib-type="author"><name><surname>Dornoff</surname><given-names>W.</given-names></name><xref rid="BBAIHCGA">5</xref></contrib><contrib contrib-type="author"><name><surname>Gorbunova</surname><given-names>V. A.</given-names></name><xref rid="BBAIFGIF">6</xref></contrib><contrib contrib-type="author"><name><surname>Budde</surname><given-names>M.</given-names></name><xref rid="BBABEDIJ">7</xref></contrib><contrib contrib-type="author"><name><surname>Bergström</surname><given-names>B.</given-names></name><xref rid="BBAJEIFG">8</xref><xref rid="BBAJEIFG">8</xref><xref rid="FN2">§</xref></contrib><aff><target target-type="aff" id="BBAGCBAG"></target><label>1</label>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium; <target target-type="aff" id="BBAIFACF"></target><label>2</label>Department of Obstetrics and Gynaecology, University Hospital, Heidelberg, Germany; <target target-type="aff" id="BBAJBICI"></target><label>3</label>Department of Clinical Chemotherapy, Cancer Research Center, Moscow, Russia; <target target-type="aff" id="BBAHJBHH"></target><label>4</label>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg; <target target-type="aff" id="BBAIHCGA"></target><label>5</label>Mutterhaus der Borromaeerinnen, Trier, Germany; <target target-type="aff" id="BBAIFGIF"></target><label>6</label>Cancer Research Center, Department of Chemotherapy, Moscow, Russia; <target target-type="aff" id="BBABEDIJ"></target><label>7</label>F. Hoffmann-La Roche Ltd, Basel, Switzerland; <target target-type="aff" id="BBAJEIFG"></target><label>8</label>F. Hoffmann-La Roche Inc., Nutley, NJ, USA</aff></contrib-group><pub-date pub-type="ppub"><month>09</month><year>2003</year></pub-date><volume>14</volume><issue>9</issue><fpage>1399</fpage><lpage>1405</lpage><permissions><copyright-year>2003</copyright-year></permissions><abstract xml:lang="en"><p><bold>Background:</bold></p><p>This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer.</p><p><bold>Patients and methods:</bold></p><p>A total of 466 patients were randomised to receive placebo (<italic>n</italic> = 158), or 2 mg (<italic>n</italic> = 154) or 6 mg (<italic>n</italic> = 154) ibandronate every 3–4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly.</p><p><bold>Result</bold>s</p><p>SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (<italic>P</italic> = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated.</p><p><bold>Conclusions:</bold></p><p>These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.</p></abstract><kwd-group kwd-group-type="KWD" xml:lang="en"><kwd><bold>Key words:</bold> bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy</kwd></kwd-group><custom-meta-wrap><custom-meta><meta-name>hwp-legacy-fpage</meta-name><meta-value>1399</meta-value></custom-meta></custom-meta-wrap></article-meta><notes><p content-type="arthw-misc">Received 23 January 2003; revised 26 March 2003; accepted 14 May 2003</p></notes></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</title></titleInfo><name type="personal"><namePart type="given">J.-J.</namePart><namePart type="family">Body</namePart><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">I. J.</namePart><namePart type="family">Diel</namePart><affiliation>Department of Obstetrics and Gynaecology, University Hospital, Heidelberg, Germany;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. R.</namePart><namePart type="family">Lichinitser</namePart><affiliation>Department of Clinical Chemotherapy, Cancer Research Center, Moscow, Russia;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E. D.</namePart><namePart type="family">Kreuser</namePart><affiliation>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Dornoff</namePart><affiliation>Mutterhaus der Borromaeerinnen, Trier, Germany;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V. A.</namePart><namePart type="family">Gorbunova</namePart><affiliation>Cancer Research Center, Department of Chemotherapy, Moscow, Russia;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Budde</namePart><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland;</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Bergström</namePart><affiliation>F. Hoffmann-La Roche Inc., Nutley, NJ, USA</affiliation><affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="other" displayLabel="other"></genre><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">2003-09</dateIssued><copyrightDate encoding="w3cdtf">2003</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Background: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. Patients and methods: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3–4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. Conclusions: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.</abstract><note>Received 23 January 2003; revised 26 March 2003; accepted 14 May 2003</note><subject lang="en"><genre>KWD</genre><topic>Key words: bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy</topic></subject><relatedItem type="host"><titleInfo><title>Annals of Oncology</title></titleInfo><titleInfo type="abbreviated"><title>Ann Oncol</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0923-7534</identifier><identifier type="eISSN">1569-8041</identifier><identifier type="PublisherID">annonc</identifier><identifier type="PublisherID-hwp">annonc</identifier><identifier type="PublisherID-nlm-ta">Ann Oncol</identifier><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>14</number></detail><detail type="issue"><caption>no.</caption><number>9</number></detail><extent unit="pages"><start>1399</start><end>1405</end></extent></part></relatedItem><identifier type="istex">20E80C36FAB1ABDF5083D8C2F7C7351C923791FA</identifier><identifier type="DOI">10.1093/annonc/mdg367</identifier><identifier type="local">mdg367</identifier><recordInfo><recordContentSource>OUP</recordContentSource></recordInfo></mods></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api.istex.fr/document/20E80C36FAB1ABDF5083D8C2F7C7351C923791FA/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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