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

Identifieur interne : 000295 ( PascalFrancis/Curation ); précédent : 000294; suivant : 000296

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

Auteurs : J.-J. Body [Belgique] ; I. J. Diel [Allemagne] ; M. R. Lichinitser [Russie] ; E. D. Kreuser [Allemagne] ; W. Dornoff [Allemagne] ; V. A. Gorbunova [Russie] ; M. Budde [Suisse] ; B. Bergström [États-Unis]

Source :

RBID : Pascal:03-0511102

Descripteurs français

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.
pA  
A01 01  1    @0 0923-7534
A03   1    @0 Ann. oncol.
A05       @2 14
A06       @2 9
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.
A45       @0 22 ref.
A47 01  1    @0 03-0511102
A60       @1 P
A61       @0 A
A64 01  1    @0 Annals of oncology
A66 01      @0 GBR
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
C03 01  X  FRE  @0 Acide ibandronique @2 NK @2 FR @5 01
C03 01  X  ENG  @0 Ibandronic acid @2 NK @2 FR @5 01
C03 01  X  SPA  @0 Acido ibandrónico @2 NK @2 FR @5 01
C03 02  X  FRE  @0 Homme @5 04
C03 02  X  ENG  @0 Human @5 04
C03 02  X  SPA  @0 Hombre @5 04
C03 03  X  FRE  @0 Femelle @5 07
C03 03  X  ENG  @0 Female @5 07
C03 03  X  SPA  @0 Hembra @5 07
C03 04  X  FRE  @0 Tumeur maligne @5 10
C03 04  X  ENG  @0 Malignant tumor @5 10
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
C03 09  X  SPA  @0 Ensayo clínico fase III @5 15
C03 10  X  FRE  @0 Traitement @5 16
C03 10  X  ENG  @0 Treatment @5 16
C03 10  X  SPA  @0 Tratamiento @5 16
C03 11  X  FRE  @0 Anticancéreux @5 17
C03 11  X  ENG  @0 Antineoplastic agent @5 17
C03 11  X  SPA  @0 Anticanceroso @5 17
C03 12  X  FRE  @0 Chimiothérapie @5 18
C03 12  X  ENG  @0 Chemotherapy @5 18
C03 12  X  SPA  @0 Quimioterapia @5 18
C03 13  X  FRE  @0 Voie intraveineuse @5 19
C03 13  X  ENG  @0 Intravenous administration @5 19
C03 13  X  SPA  @0 Vía intravenosa @5 19
C03 14  X  FRE  @0 Antimétastatique @5 20
C03 14  X  ENG  @0 Antimetastatic agent @5 20
C03 14  X  SPA  @0 Antimetastásico @5 20
C03 15  X  FRE  @0 Complication @5 21
C03 15  X  ENG  @0 Complication @5 21
C03 15  X  SPA  @0 Complicación @5 21
C03 16  X  FRE  @0 Lésion @5 22
C03 16  X  ENG  @0 Lesion @5 22
C03 16  X  SPA  @0 Lesión @5 22
C03 17  X  FRE  @0 Bisphosphonates @5 25
C03 17  X  ENG  @0 Bisphosphonates @5 25
C03 17  X  SPA  @0 Bisfosfonatos @5 25
C03 18  X  FRE  @0 Diphosphonique acide dérivé @5 26
C03 18  X  ENG  @0 Diphosphonic acid derivatives @5 26
C03 18  X  SPA  @0 Difosfonico ácido derivado @5 26
C03 19  X  FRE  @0 Squelette @5 78
C03 19  X  ENG  @0 Skeleton @5 78
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
C07 02  X  ENG  @0 Diseases of the osteoarticular system @5 62
C07 02  X  SPA  @0 Sistema osteoarticular patología @5 62
N21       @1 342
N82       @1 PSI

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Pascal:03-0511102

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<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>
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<term>Acide ibandronique</term>
<term>Homme</term>
<term>Femelle</term>
<term>Tumeur maligne</term>
<term>Glande mammaire</term>
<term>Métastatique</term>
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<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>
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</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>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>22429</s2>
<s5>354000114378040100</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2003 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>22 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>03-0511102</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<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>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>04</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Femelle</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Female</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Hembra</s0>
<s5>07</s5>
</fC03>
<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>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Glande mammaire</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Mammary gland</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Glándula mamaria</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Métastatique</s0>
<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>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Metástasis</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Os</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Bone</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Hueso</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Essai clinique phase III</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Phase III trial</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Ensayo clínico fase III</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Anticancéreux</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Antineoplastic agent</s0>
<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>
<fC03 i1="13" i2="X" l="SPA">
<s0>Vía intravenosa</s0>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE">
<s0>Antimétastatique</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG">
<s0>Antimetastatic agent</s0>
<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>
</fC03>
<fC03 i1="16" i2="X" l="FRE">
<s0>Lésion</s0>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="ENG">
<s0>Lesion</s0>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA">
<s0>Lesión</s0>
<s5>22</s5>
</fC03>
<fC03 i1="17" i2="X" l="FRE">
<s0>Bisphosphonates</s0>
<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>
</fC03>
<fC03 i1="18" i2="X" l="FRE">
<s0>Diphosphonique acide dérivé</s0>
<s5>26</s5>
</fC03>
<fC03 i1="18" i2="X" l="ENG">
<s0>Diphosphonic acid derivatives</s0>
<s5>26</s5>
</fC03>
<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>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Système ostéoarticulaire pathologie</s0>
<s5>62</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Diseases of the osteoarticular system</s0>
<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>
</standard>
</inist>
</record>

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