Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
Identifieur interne : 001A45 ( Istex/Curation ); précédent : 001A44; suivant : 001A46Intravenous 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.
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.
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DOI: 10.1093/annonc/mdg367
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Kreuser</name><affiliation><mods:affiliation>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg;</mods:affiliation></affiliation><affiliation wicri:level="1"><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation wicri:level="1"><mods:affiliation>Mutterhaus der Borromaeerinnen, Trier, Germany;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Mutterhaus der Borromaeerinnen, Trier</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea></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="1"><mods:affiliation>Cancer Research Center, Department of Chemotherapy, Moscow, Russia;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Russie</country><wicri:regionArea>Cancer Research Center, Department of Chemotherapy, Moscow</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea></affiliation></author><author><name sortKey="Budde, M" sort="Budde, M" uniqKey="Budde M" first="M." last="Budde">M. Budde</name><affiliation wicri:level="1"><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea></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="1"><mods:affiliation>F. Hoffmann-La Roche Inc., Nutley, NJ, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>F. Hoffmann-La Roche Inc., Nutley, NJ</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium;</mods:affiliation><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Université Libre de Bruxelles, Institut Jules Bordet, Brussels</wicri:regionArea></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></record>Pour manipuler ce document sous Unix (Dilib)
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