UnivTrevesV1, PascalFrancis, Corpus, bibRecord, 000C20

Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

Identifieur interne : 000C20 ( PascalFrancis/Corpus ); précédent : 000C19; suivant : 000C21

Intravenous 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. Bergström

Source :

Annals of oncology [ 0923-7534 ] ; 2003.

RBID : Pascal:03-0511102

Descripteurs français

Pascal (Inist)
- Acide ibandronique, Homme, Femelle, Tumeur maligne, Glande mammaire, Métastatique, Métastase, Os, Essai clinique phase III, Traitement, Anticancéreux, Chimiothérapie, Voie intraveineuse, Antimétastatique, Complication, Lésion, Bisphosphonates, Diphosphonique acide dérivé, Squelette.

English descriptors

KwdEn :
- Antimetastatic agent, Antineoplastic agent, Bisphosphonates, Bone, Chemotherapy, Complication, Diphosphonic acid derivatives, Female, Human, Ibandronic acid, Intravenous administration, 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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08	`01`	`1`	`ENG`	`@1 Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases`
A11	`01`	`1`		`@1 BODY (J.-J.)`
A11	`02`	`1`		`@1 DIEL (I. J.)`
A11	`03`	`1`		`@1 LICHINITSER (M. R.)`
A11	`04`	`1`		`@1 KREUSER (E. D.)`
A11	`05`	`1`		`@1 DORNOFF (W.)`
A11	`06`	`1`		`@1 GORBUNOVA (V. A.)`
A11	`07`	`1`		`@1 BUDDE (M.)`
A11	`08`	`1`		`@1 BERGSTRÖM (B.)`
A14	`01`			`@1 Université Libre de Bruxelles, Institut Jules Bordet @2 Brussels @3 BEL @Z 1 aut.`
A14	`02`			`@1 Department of Obstetrics and Gynaecology, University Hospital @2 Heidelberg @3 DEU @Z 2 aut.`
A14	`03`			`@1 Department of Clinical Chemotherapy, Cancer Research Center @2 Moscow @3 RUS @Z 3 aut.`
A14	`04`			`@1 Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz @2 Regensburg @3 DEU @Z 4 aut.`
A14	`05`			`@1 Mutterhaus der Borromaeerinnen @2 Trier @3 DEU @Z 5 aut.`
A14	`06`			`@1 Cancer Research Center, Department of Chemotherapy @2 Moscow @3 RUS @Z 6 aut.`
A14	`07`			`@1 F. Hoffmann-La Roche Ltd @2 Basel @3 CHE @Z 7 aut.`
A14	`08`			`@1 F. Hoffmann-La Roche Inc. @2 Nutley, NJ @3 USA @Z 8 aut.`
A20				`@1 1399-1405`
A21				`@1 2003`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 22429 @5 354000114378040100`
A44				`@0 0000 @1 © 2003 INIST-CNRS. All rights reserved.`
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A47	`01`	`1`		`@0 03-0511102`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Annals of oncology`
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C01	`01`		`ENG`	@0 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.
C02	`01`	`X`		`@0 002B02R02`
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C03	`01`	`X`	`SPA`	`@0 Acido ibandrónico @2 NK @2 FR @5 01`
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C03	`03`	`X`	`FRE`	`@0 Femelle @5 07`
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C03	`03`	`X`	`SPA`	`@0 Hembra @5 07`
C03	`04`	`X`	`FRE`	`@0 Tumeur maligne @5 10`
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C03	`04`	`X`	`SPA`	`@0 Tumor maligno @5 10`
C03	`05`	`X`	`FRE`	`@0 Glande mammaire @5 11`
C03	`05`	`X`	`ENG`	`@0 Mammary gland @5 11`
C03	`05`	`X`	`SPA`	`@0 Glándula mamaria @5 11`
C03	`06`	`X`	`FRE`	`@0 Métastatique @5 12`
C03	`06`	`X`	`ENG`	`@0 Metastatic @5 12`
C03	`06`	`X`	`SPA`	`@0 Metastásico @5 12`
C03	`07`	`X`	`FRE`	`@0 Métastase @5 13`
C03	`07`	`X`	`ENG`	`@0 Metastasis @5 13`
C03	`07`	`X`	`SPA`	`@0 Metástasis @5 13`
C03	`08`	`X`	`FRE`	`@0 Os @5 14`
C03	`08`	`X`	`ENG`	`@0 Bone @5 14`
C03	`08`	`X`	`SPA`	`@0 Hueso @5 14`
C03	`09`	`X`	`FRE`	`@0 Essai clinique phase III @5 15`
C03	`09`	`X`	`ENG`	`@0 Phase III trial @5 15`
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C03	`10`	`X`	`FRE`	`@0 Traitement @5 16`
C03	`10`	`X`	`ENG`	`@0 Treatment @5 16`
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C03	`14`	`X`	`SPA`	`@0 Antimetastásico @5 20`
C03	`15`	`X`	`FRE`	`@0 Complication @5 21`
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C03	`15`	`X`	`SPA`	`@0 Complicación @5 21`
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C03	`16`	`X`	`ENG`	`@0 Lesion @5 22`
C03	`16`	`X`	`SPA`	`@0 Lesión @5 22`
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C03	`19`	`X`	`SPA`	`@0 Esqueleto @5 78`
C07	`01`	`X`	`FRE`	`@0 Glande mammaire pathologie @2 NM @5 61`
C07	`01`	`X`	`ENG`	`@0 Mammary gland diseases @2 NM @5 61`
C07	`01`	`X`	`SPA`	`@0 Glándula mamaria patología @2 NM @5 61`
C07	`02`	`X`	`FRE`	`@0 Système ostéoarticulaire pathologie @5 62`
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N21				`@1 342`
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Format Inist (serveur)

NO :	PASCAL 03-0511102 INIST
ET :	Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
AU :	BODY (J.-J.); DIEL (I. J.); LICHINITSER (M. R.); KREUSER (E. D.); DORNOFF (W.); GORBUNOVA (V. A.); BUDDE (M.); BERGSTRÖM (B.)
AF :	Université Libre de Bruxelles, Institut Jules Bordet/Brussels/Belgique (1 aut.); Department of Obstetrics and Gynaecology, University Hospital/Heidelberg/Allemagne (2 aut.); Department of Clinical Chemotherapy, Cancer Research Center/Moscow/Russie (3 aut.); Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz/Regensburg/Allemagne (4 aut.); Mutterhaus der Borromaeerinnen/Trier/Allemagne (5 aut.); Cancer Research Center, Department of Chemotherapy/Moscow/Russie (6 aut.); F. Hoffmann-La Roche Ltd/Basel/Suisse (7 aut.); F. Hoffmann-La Roche Inc./Nutley, NJ/Etats-Unis (8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2003; Vol. 14; No. 9; Pp. 1399-1405; Bibl. 22 ref.
LA :	Anglais
EA :	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.
CC :	002B02R02
FD :	Acide ibandronique; Homme; Femelle; Tumeur maligne; Glande mammaire; Métastatique; Métastase; Os; Essai clinique phase III; Traitement; Anticancéreux; Chimiothérapie; Voie intraveineuse; Antimétastatique; Complication; Lésion; Bisphosphonates; Diphosphonique acide dérivé; Squelette
FG :	Glande mammaire pathologie; Système ostéoarticulaire pathologie
ED :	Ibandronic acid; Human; Female; Malignant tumor; Mammary gland; Metastatic; Metastasis; Bone; Phase III trial; Treatment; Antineoplastic agent; Chemotherapy; Intravenous administration; Antimetastatic agent; Complication; Lesion; Bisphosphonates; Diphosphonic acid derivatives; Skeleton
EG :	Mammary gland diseases; Diseases of the osteoarticular system
SD :	Acido ibandrónico; Hombre; Hembra; Tumor maligno; Glándula mamaria; Metastásico; Metástasis; Hueso; Ensayo clínico fase III; Tratamiento; Anticanceroso; Quimioterapia; Vía intravenosa; Antimetastásico; Complicación; Lesión; Bisfosfonatos; Difosfonico ácido derivado; Esqueleto
LO :	INIST-22429.354000114378040100
ID :	03-0511102

Links to Exploration step

Pascal:03-0511102

Le document en format XML

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<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>
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<fA03 i2="1"><s0>Ann. oncol.</s0>
</fA03>
<fA05><s2>14</s2>
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<fA06><s2>9</s2>
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<fA08 i1="01" i2="1" l="ENG"><s1>Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>BODY (J.-J.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>DIEL (I. J.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>LICHINITSER (M. R.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>KREUSER (E. D.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>DORNOFF (W.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>GORBUNOVA (V. A.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>BUDDE (M.)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>BERGSTRÖM (B.)</s1>
</fA11>
<fA14 i1="01"><s1>Université Libre de Bruxelles, Institut Jules Bordet</s1>
<s2>Brussels</s2>
<s3>BEL</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Obstetrics and Gynaecology, University Hospital</s1>
<s2>Heidelberg</s2>
<s3>DEU</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Clinical Chemotherapy, Cancer Research Center</s1>
<s2>Moscow</s2>
<s3>RUS</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz</s1>
<s2>Regensburg</s2>
<s3>DEU</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Mutterhaus der Borromaeerinnen</s1>
<s2>Trier</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Cancer Research Center, Department of Chemotherapy</s1>
<s2>Moscow</s2>
<s3>RUS</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>F. Hoffmann-La Roche Ltd</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>F. Hoffmann-La Roche Inc.</s1>
<s2>Nutley, NJ</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA20><s1>1399-1405</s1>
</fA20>
<fA21><s1>2003</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
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<fA45><s0>22 ref.</s0>
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<fA47 i1="01" i2="1"><s0>03-0511102</s0>
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<fA60><s1>P</s1>
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<fA61><s0>A</s0>
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<fA64 i1="01" i2="1"><s0>Annals of oncology</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02R02</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Acide ibandronique</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Ibandronic acid</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Acido ibandrónico</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Homme</s0>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Human</s0>
<s5>04</s5>
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<fC03 i1="02" i2="X" l="SPA"><s0>Hombre</s0>
<s5>04</s5>
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<fC03 i1="03" i2="X" l="FRE"><s0>Femelle</s0>
<s5>07</s5>
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<fC03 i1="03" i2="X" l="ENG"><s0>Female</s0>
<s5>07</s5>
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<fC03 i1="03" i2="X" l="SPA"><s0>Hembra</s0>
<s5>07</s5>
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<fC03 i1="04" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s5>10</s5>
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<fC03 i1="05" i2="X" l="FRE"><s0>Glande mammaire</s0>
<s5>11</s5>
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<fC03 i1="05" i2="X" l="ENG"><s0>Mammary gland</s0>
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<s5>11</s5>
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<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Metastatic</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Metastásico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Métastase</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Metastasis</s0>
<s5>13</s5>
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<fC03 i1="07" i2="X" l="SPA"><s0>Metástasis</s0>
<s5>13</s5>
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<fC03 i1="08" i2="X" l="FRE"><s0>Os</s0>
<s5>14</s5>
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<s5>14</s5>
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<s5>14</s5>
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<s5>15</s5>
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<s5>15</s5>
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<s5>16</s5>
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<s5>16</s5>
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<s5>16</s5>
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<s5>17</s5>
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<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Chimiothérapie</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Chemotherapy</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Quimioterapia</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Voie intraveineuse</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Intravenous administration</s0>
<s5>19</s5>
</fC03>
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<s5>19</s5>
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<fC03 i1="14" i2="X" l="FRE"><s0>Antimétastatique</s0>
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<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA"><s0>Antimetastásico</s0>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE"><s0>Complication</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG"><s0>Complication</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA"><s0>Complicación</s0>
<s5>21</s5>
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<fC03 i1="16" i2="X" l="FRE"><s0>Lésion</s0>
<s5>22</s5>
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<s5>22</s5>
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<fC03 i1="16" i2="X" l="SPA"><s0>Lesión</s0>
<s5>22</s5>
</fC03>
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<s5>25</s5>
</fC03>
<fC03 i1="17" i2="X" l="ENG"><s0>Bisphosphonates</s0>
<s5>25</s5>
</fC03>
<fC03 i1="17" i2="X" l="SPA"><s0>Bisfosfonatos</s0>
<s5>25</s5>
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<s5>26</s5>
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<s5>26</s5>
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<fC03 i1="18" i2="X" l="SPA"><s0>Difosfonico ácido derivado</s0>
<s5>26</s5>
</fC03>
<fC03 i1="19" i2="X" l="FRE"><s0>Squelette</s0>
<s5>78</s5>
</fC03>
<fC03 i1="19" i2="X" l="ENG"><s0>Skeleton</s0>
<s5>78</s5>
</fC03>
<fC03 i1="19" i2="X" l="SPA"><s0>Esqueleto</s0>
<s5>78</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Glande mammaire pathologie</s0>
<s2>NM</s2>
<s5>61</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>61</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>61</s5>
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<s5>62</s5>
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<s5>62</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Sistema osteoarticular patología</s0>
<s5>62</s5>
</fC07>
<fN21><s1>342</s1>
</fN21>
<fN82><s1>PSI</s1>
</fN82>
</pA>
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<server><NO>PASCAL 03-0511102 INIST</NO>
<ET>Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases</ET>
<AU>BODY (J.-J.); DIEL (I. J.); LICHINITSER (M. R.); KREUSER (E. D.); DORNOFF (W.); GORBUNOVA (V. A.); BUDDE (M.); BERGSTRÖM (B.)</AU>
<AF>Université Libre de Bruxelles, Institut Jules Bordet/Brussels/Belgique (1 aut.); Department of Obstetrics and Gynaecology, University Hospital/Heidelberg/Allemagne (2 aut.); Department of Clinical Chemotherapy, Cancer Research Center/Moscow/Russie (3 aut.); Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz/Regensburg/Allemagne (4 aut.); Mutterhaus der Borromaeerinnen/Trier/Allemagne (5 aut.); Cancer Research Center, Department of Chemotherapy/Moscow/Russie (6 aut.); F. Hoffmann-La Roche Ltd/Basel/Suisse (7 aut.); F. Hoffmann-La Roche Inc./Nutley, NJ/Etats-Unis (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2003; Vol. 14; No. 9; Pp. 1399-1405; Bibl. 22 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B02R02</CC>
<FD>Acide ibandronique; Homme; Femelle; Tumeur maligne; Glande mammaire; Métastatique; Métastase; Os; Essai clinique phase III; Traitement; Anticancéreux; Chimiothérapie; Voie intraveineuse; Antimétastatique; Complication; Lésion; Bisphosphonates; Diphosphonique acide dérivé; Squelette</FD>
<FG>Glande mammaire pathologie; Système ostéoarticulaire pathologie</FG>
<ED>Ibandronic acid; Human; Female; Malignant tumor; Mammary gland; Metastatic; Metastasis; Bone; Phase III trial; Treatment; Antineoplastic agent; Chemotherapy; Intravenous administration; Antimetastatic agent; Complication; Lesion; Bisphosphonates; Diphosphonic acid derivatives; Skeleton</ED>
<EG>Mammary gland diseases; Diseases of the osteoarticular system</EG>
<SD>Acido ibandrónico; Hombre; Hembra; Tumor maligno; Glándula mamaria; Metastásico; Metástasis; Hueso; Ensayo clínico fase III; Tratamiento; Anticanceroso; Quimioterapia; Vía intravenosa; Antimetastásico; Complicación; Lesión; Bisfosfonatos; Difosfonico ácido derivado; Esqueleto</SD>
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Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

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