Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
Identifieur interne : 001A84 ( Main/Curation ); précédent : 001A83; suivant : 001A85Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
Auteurs : J.-J. Body [Belgique] ; I. J. Diel [Allemagne, Belgique] ; M. R. Lichinitser [Russie, Belgique] ; E. D. Kreuser [Belgique] ; W. Dornoff [Allemagne, Belgique] ; V. A. Gorbunova [Russie, Belgique] ; M. Budde [Suisse, Belgique] ; B. Bergstro M [États-Unis, Belgique]Source :
- Annals of Oncology [ 0923-7534 ] ; 2003-09.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Antimetastatic agent, Antineoplastic agent, Bisphosphonates, Bone, Chemotherapy, Complication, Diphosphonic acid derivatives, Female, Human, Ibandronic acid, Intravenous administration, Key words: bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy, Lesion, Malignant tumor, Mammary gland, Metastasis, Metastatic, Phase III trial, Skeleton, Treatment.
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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Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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 wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>F. Hoffmann-La Roche Inc., Nutley, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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>Antimetastatic agent</term><term>Antineoplastic agent</term><term>Bisphosphonates</term><term>Bone</term><term>Chemotherapy</term><term>Complication</term><term>Diphosphonic acid derivatives</term><term>Female</term><term>Human</term><term>Ibandronic acid</term><term>Intravenous administration</term><term>Key words: bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy</term><term>Lesion</term><term>Malignant tumor</term><term>Mammary gland</term><term>Metastasis</term><term>Metastatic</term><term>Phase III trial</term><term>Skeleton</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Acide ibandronique</term><term>Anticancéreux</term><term>Antimétastatique</term><term>Bisphosphonates</term><term>Chimiothérapie</term><term>Complication</term><term>Diphosphonique acide dérivé</term><term>Essai clinique phase III</term><term>Femelle</term><term>Glande mammaire</term><term>Homme</term><term>Lésion</term><term>Métastase</term><term>Métastatique</term><term>Os</term><term>Squelette</term><term>Traitement</term><term>Tumeur maligne</term><term>Voie intraveineuse</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</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><double idat="0923-7534:2003:Body J:intravenous:ibandronate:reduces"><INIST><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</title><author><name sortKey="Body, J J" sort="Body, J J" uniqKey="Body J" first="J.-J." last="Body">J.-J. Body</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Université Libre de Bruxelles, Institut Jules Bordet</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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 wicri:level="3"><inist:fA14 i1="02"><s1>Department of Obstetrics and Gynaecology, University Hospital</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></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 wicri:level="3"><inist:fA14 i1="03"><s1>Department of Clinical Chemotherapy, Cancer Research Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></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 wicri:level="1"><inist:fA14 i1="04"><s1>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz</s1><s2>Regensburg</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Regensburg</wicri:noRegion><wicri:noRegion>Onkologische Ambulanz</wicri:noRegion><wicri:noRegion>Regensburg</wicri:noRegion></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Mutterhaus der Borromaeerinnen</s1><s2>Trier</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Trier</wicri:noRegion><wicri:noRegion>Mutterhaus der Borromaeerinnen</wicri:noRegion><wicri:noRegion>Mutterhaus der Borromaeerinnen</wicri:noRegion></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 wicri:level="3"><inist:fA14 i1="06"><s1>Cancer Research Center, Department of Chemotherapy</s1><s2>Moscow</s2><s3>RUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>F. Hoffmann-La Roche Ltd</s1><s2>Basel</s2><s3>CHE</s3><sZ>7 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>F. Hoffmann-La Roche Ltd</wicri:noRegion></affiliation></author><author><name sortKey="Bergstrom, B" sort="Bergstrom, B" uniqKey="Bergstrom B" first="B." last="Bergström">B. Bergström</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>F. 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Body</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Université Libre de Bruxelles, Institut Jules Bordet</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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 wicri:level="3"><inist:fA14 i1="02"><s1>Department of Obstetrics and Gynaecology, University Hospital</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></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 wicri:level="3"><inist:fA14 i1="03"><s1>Department of Clinical Chemotherapy, Cancer Research Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></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 wicri:level="1"><inist:fA14 i1="04"><s1>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz</s1><s2>Regensburg</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Regensburg</wicri:noRegion><wicri:noRegion>Onkologische Ambulanz</wicri:noRegion><wicri:noRegion>Regensburg</wicri:noRegion></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Mutterhaus der Borromaeerinnen</s1><s2>Trier</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Trier</wicri:noRegion><wicri:noRegion>Mutterhaus der Borromaeerinnen</wicri:noRegion><wicri:noRegion>Mutterhaus der Borromaeerinnen</wicri:noRegion></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 wicri:level="3"><inist:fA14 i1="06"><s1>Cancer Research Center, Department of Chemotherapy</s1><s2>Moscow</s2><s3>RUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>F. Hoffmann-La Roche Ltd</s1><s2>Basel</s2><s3>CHE</s3><sZ>7 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>F. Hoffmann-La Roche Ltd</wicri:noRegion></affiliation></author><author><name sortKey="Bergstrom, B" sort="Bergstrom, B" uniqKey="Bergstrom B" first="B." last="Bergström">B. Bergström</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>F. Hoffmann-La Roche Inc.</s1><s2>Nutley, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno><imprint><date when="2003">2003</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antimetastatic agent</term><term>Antineoplastic agent</term><term>Bisphosphonates</term><term>Bone</term><term>Chemotherapy</term><term>Complication</term><term>Diphosphonic acid derivatives</term><term>Female</term><term>Human</term><term>Ibandronic acid</term><term>Intravenous administration</term><term>Lesion</term><term>Malignant tumor</term><term>Mammary gland</term><term>Metastasis</term><term>Metastatic</term><term>Phase III trial</term><term>Skeleton</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Acide ibandronique</term><term>Homme</term><term>Femelle</term><term>Tumeur maligne</term><term>Glande mammaire</term><term>Métastatique</term><term>Métastase</term><term>Os</term><term>Essai clinique phase III</term><term>Traitement</term><term>Anticancéreux</term><term>Chimiothérapie</term><term>Voie intraveineuse</term><term>Antimétastatique</term><term>Complication</term><term>Lésion</term><term>Bisphosphonates</term><term>Diphosphonique acide dérivé</term><term>Squelette</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></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></INIST><ISTEX><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</title><author><name sortKey="Body, J J" sort="Body, J J" uniqKey="Body J" first="J.-J." last="Body">J.-J. Body</name></author><author><name sortKey="Diel, I J" sort="Diel, I J" uniqKey="Diel I" first="I. J." last="Diel">I. J. Diel</name></author><author><name sortKey="Lichinitser, M R" sort="Lichinitser, M R" uniqKey="Lichinitser M" first="M. R." last="Lichinitser">M. R. Lichinitser</name></author><author><name sortKey="Kreuser, E D" sort="Kreuser, E D" uniqKey="Kreuser E" first="E. D." last="Kreuser">E. D. Kreuser</name></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name></author><author><name sortKey="Gorbunova, V A" sort="Gorbunova, V A" uniqKey="Gorbunova V" first="V. A." last="Gorbunova">V. A. Gorbunova</name></author><author><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name></author><author><name sortKey="Bergstro M, B" sort="Bergstro M, B" uniqKey="Bergstro M B" first="B." last="Bergstro M">B. Bergstro M</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:20E80C36FAB1ABDF5083D8C2F7C7351C923791FA</idno><date when="2003" year="2003">2003</date><idno type="doi">10.1093/annonc/mdg367</idno><idno type="url">https://api.istex.fr/document/20E80C36FAB1ABDF5083D8C2F7C7351C923791FA/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001B62</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001B62</idno><idno type="wicri:Area/Istex/Curation">001A45</idno><idno type="wicri:Area/Istex/Checkpoint">000A77</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000A77</idno><idno type="wicri:doubleKey">0923-7534:2003:Body J:intravenous:ibandronate:reduces</idno><idno type="wicri:Area/Main/Merge">001D06</idno></publicationStmt><sourceDesc><biblStruct><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><name sortKey="Body, J J" sort="Body, J J" uniqKey="Body J" first="J.-J." last="Body">J.-J. Body</name><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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 wicri:level="3"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Obstetrics and Gynaecology, University Hospital, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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 wicri:level="3"><country xml:lang="fr" wicri:curation="lc">Russie</country><wicri:regionArea>Department of Clinical Chemotherapy, Cancer Research Center, Moscow</wicri:regionArea><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Mutterhaus der Borromaeerinnen, Trier</wicri:regionArea><wicri:noRegion>Trier</wicri:noRegion><wicri:noRegion>Trier</wicri:noRegion></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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 wicri:level="3"><country xml:lang="fr" wicri:curation="lc">Russie</country><wicri:regionArea>Cancer Research Center, Department of Chemotherapy, Moscow</wicri:regionArea><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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 wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>F. Hoffmann-La Roche Inc., Nutley, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation><affiliation wicri:level="4"><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName><orgName type="university">Université libre de Bruxelles</orgName></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></double></record>Pour manipuler ce document sous Unix (Dilib)
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