Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
Identifieur interne : 000295 ( PascalFrancis/Curation ); précédent : 000294; suivant : 000296Intravenous 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 :
- Annals of oncology [ 0923-7534 ] ; 2003.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
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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<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>
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<s5>19</s5>
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<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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