Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
Identifieur interne : 001A84 ( Main/Exploration ); 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
Affiliations:
- Allemagne, Belgique, Russie, Suisse, États-Unis
- Bade-Wurtemberg, District de Karlsruhe, District fédéral central, New Jersey, Région de Bruxelles-Capitale
- Bruxelles, Heidelberg, Moscou
- Université libre de Bruxelles
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Le document en format XML
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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. 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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><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Russie</li><li>Suisse</li><li>États-Unis</li></country><region><li>Bade-Wurtemberg</li><li>District de Karlsruhe</li><li>District fédéral central</li><li>New Jersey</li><li>Région de Bruxelles-Capitale</li></region><settlement><li>Bruxelles</li><li>Heidelberg</li><li>Moscou</li></settlement><orgName><li>Université libre de Bruxelles</li></orgName></list><tree><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Body, J J" sort="Body, J J" uniqKey="Body J" first="J.-J." last="Body">J.-J. Body</name></region><name sortKey="Bergstro M, B" sort="Bergstro M, B" uniqKey="Bergstro M B" first="B." last="Bergstro M">B. Bergstro M</name><name sortKey="Body, J J" sort="Body, J J" uniqKey="Body J" first="J.-J." last="Body">J.-J. Body</name><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name><name sortKey="Diel, I J" sort="Diel, I J" uniqKey="Diel I" first="I. J." last="Diel">I. J. Diel</name><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><name sortKey="Gorbunova, V A" sort="Gorbunova, V A" uniqKey="Gorbunova V" first="V. A." last="Gorbunova">V. A. Gorbunova</name><name sortKey="Kreuser, E D" sort="Kreuser, E D" uniqKey="Kreuser E" first="E. D." last="Kreuser">E. D. Kreuser</name><name sortKey="Lichinitser, M R" sort="Lichinitser, M R" uniqKey="Lichinitser M" first="M. R." last="Lichinitser">M. R. Lichinitser</name></country><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Diel, I J" sort="Diel, I J" uniqKey="Diel I" first="I. J." last="Diel">I. J. Diel</name></region><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name></country><country name="Russie"><region name="District fédéral central"><name sortKey="Lichinitser, M R" sort="Lichinitser, M R" uniqKey="Lichinitser M" first="M. R." last="Lichinitser">M. R. Lichinitser</name></region><name sortKey="Gorbunova, V A" sort="Gorbunova, V A" uniqKey="Gorbunova V" first="V. A." last="Gorbunova">V. A. Gorbunova</name></country><country name="Suisse"><noRegion><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name></noRegion></country><country name="États-Unis"><region name="New Jersey"><name sortKey="Bergstro M, B" sort="Bergstro M, B" uniqKey="Bergstro M B" first="B." last="Bergstro M">B. Bergstro M</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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