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

J. J. Body, I. J. Diel, M. R. Lichinitser, E. D. Kreuser, W. Dornoff, V. A. Gorbunova, M. Budde, B. Bergström, J. S. de Gréve, I. Mancini, S. Van Belle, F. Cavalli, B. Thuerlimann, R. Herrmann, M. Clemens, W. Eiermann, G. Kaiser, P. Nauen, R. Obenaus, A. E. Schindler & 55 others A. Vogt, K. Hoeffken, L. M. Ahlemann, U. Essers, V. G. Porta, J. M. Ferrero, P. Pouillard, A. de Gramont, N. Pinon, S. Reme, J. P. Labat, L. Guillevin, J. F. Morere, C. Krzisch, Z. Mechl, O. Bruland, O. K. Andersen, R. Bremnes, E. P. Ferreira, A. Fernandes, H. Bassara, V. F. Semiglazov, J. Hansen, I. Lorenz, A. Howell, D. Cameron, C. J. Tyrell, T. J. Powels, J. McAleer, P. J. Barrett-Lee, K. Cash, J. Craig, D. A. Decker, R. Gams, R. Gottlieb, Rasim A. Gucalp, A. Hage-Boutros, K. Havlin, J. Hon, J. Gale Katterhagen, M. Lewis, T. Panella, P. Plezia, S. Rivkin, J. Sandbach, J. Wade, P. Woolley, P. Conkling, T. J. Ervin, M. Martinez-Rio, D. Tripathy, M. Meshad, J. P. Jordaan, I. D. Werner, G. Falkson

Research output: Contribution to journalArticle

350 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1399-1405
Number of pages7
JournalAnnals of Oncology
Volume14
Issue number9
DOIs
StatePublished - Sep 1 2003
Externally publishedYes

Fingerprint

Bone Neoplasms
Breast Neoplasms
Neoplasm Metastasis
Incidence
Bone and Bones
Placebos
Morbidity
Analgesics
Pain
ibandronic acid
Bone Diseases
Diphosphonates
Therapeutics
Safety

Keywords

  • Bisphosphonate
  • Bone metastases
  • Breast cancer
  • Ibandronate
  • Pain
  • Radiotherapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Body, J. J., Diel, I. J., Lichinitser, M. R., Kreuser, E. D., Dornoff, W., Gorbunova, V. A., ... Falkson, G. (2003). Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Annals of Oncology, 14(9), 1399-1405. https://doi.org/10.1093/annonc/mdg367

Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. / Body, J. J.; Diel, I. J.; Lichinitser, M. R.; Kreuser, E. D.; Dornoff, W.; Gorbunova, V. A.; Budde, M.; Bergström, B.; de Gréve, J. S.; Mancini, I.; Van Belle, S.; Cavalli, F.; Thuerlimann, B.; Herrmann, R.; Clemens, M.; Eiermann, W.; Kaiser, G.; Nauen, P.; Obenaus, R.; Schindler, A. E.; Vogt, A.; Hoeffken, K.; Ahlemann, L. M.; Essers, U.; Porta, V. G.; Ferrero, J. M.; Pouillard, P.; de Gramont, A.; Pinon, N.; Reme, S.; Labat, J. P.; Guillevin, L.; Morere, J. F.; Krzisch, C.; Mechl, Z.; Bruland, O.; Andersen, O. K.; Bremnes, R.; Ferreira, E. P.; Fernandes, A.; Bassara, H.; Semiglazov, V. F.; Hansen, J.; Lorenz, I.; Howell, A.; Cameron, D.; Tyrell, C. J.; Powels, T. J.; McAleer, J.; Barrett-Lee, P. J.; Cash, K.; Craig, J.; Decker, D. A.; Gams, R.; Gottlieb, R.; Gucalp, Rasim A.; Hage-Boutros, A.; Havlin, K.; Hon, J.; Katterhagen, J. Gale; Lewis, M.; Panella, T.; Plezia, P.; Rivkin, S.; Sandbach, J.; Wade, J.; Woolley, P.; Conkling, P.; Ervin, T. J.; Martinez-Rio, M.; Tripathy, D.; Meshad, M.; Jordaan, J. P.; Werner, I. D.; Falkson, G.

In: Annals of Oncology, Vol. 14, No. 9, 01.09.2003, p. 1399-1405.

Research output: Contribution to journalArticle

Body, JJ, Diel, IJ, Lichinitser, MR, Kreuser, ED, Dornoff, W, Gorbunova, VA, Budde, M, Bergström, B, de Gréve, JS, Mancini, I, Van Belle, S, Cavalli, F, Thuerlimann, B, Herrmann, R, Clemens, M, Eiermann, W, Kaiser, G, Nauen, P, Obenaus, R, Schindler, AE, Vogt, A, Hoeffken, K, Ahlemann, LM, Essers, U, Porta, VG, Ferrero, JM, Pouillard, P, de Gramont, A, Pinon, N, Reme, S, Labat, JP, Guillevin, L, Morere, JF, Krzisch, C, Mechl, Z, Bruland, O, Andersen, OK, Bremnes, R, Ferreira, EP, Fernandes, A, Bassara, H, Semiglazov, VF, Hansen, J, Lorenz, I, Howell, A, Cameron, D, Tyrell, CJ, Powels, TJ, McAleer, J, Barrett-Lee, PJ, Cash, K, Craig, J, Decker, DA, Gams, R, Gottlieb, R, Gucalp, RA, Hage-Boutros, A, Havlin, K, Hon, J, Katterhagen, JG, Lewis, M, Panella, T, Plezia, P, Rivkin, S, Sandbach, J, Wade, J, Woolley, P, Conkling, P, Ervin, TJ, Martinez-Rio, M, Tripathy, D, Meshad, M, Jordaan, JP, Werner, ID & Falkson, G 2003, 'Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases', Annals of Oncology, vol. 14, no. 9, pp. 1399-1405. https://doi.org/10.1093/annonc/mdg367
Body, J. J. ; Diel, I. J. ; Lichinitser, M. R. ; Kreuser, E. D. ; Dornoff, W. ; Gorbunova, V. A. ; Budde, M. ; Bergström, B. ; de Gréve, J. S. ; Mancini, I. ; Van Belle, S. ; Cavalli, F. ; Thuerlimann, B. ; Herrmann, R. ; Clemens, M. ; Eiermann, W. ; Kaiser, G. ; Nauen, P. ; Obenaus, R. ; Schindler, A. E. ; Vogt, A. ; Hoeffken, K. ; Ahlemann, L. M. ; Essers, U. ; Porta, V. G. ; Ferrero, J. M. ; Pouillard, P. ; de Gramont, A. ; Pinon, N. ; Reme, S. ; Labat, J. P. ; Guillevin, L. ; Morere, J. F. ; Krzisch, C. ; Mechl, Z. ; Bruland, O. ; Andersen, O. K. ; Bremnes, R. ; Ferreira, E. P. ; Fernandes, A. ; Bassara, H. ; Semiglazov, V. F. ; Hansen, J. ; Lorenz, I. ; Howell, A. ; Cameron, D. ; Tyrell, C. J. ; Powels, T. J. ; McAleer, J. ; Barrett-Lee, P. J. ; Cash, K. ; Craig, J. ; Decker, D. A. ; Gams, R. ; Gottlieb, R. ; Gucalp, Rasim A. ; Hage-Boutros, A. ; Havlin, K. ; Hon, J. ; Katterhagen, J. Gale ; Lewis, M. ; Panella, T. ; Plezia, P. ; Rivkin, S. ; Sandbach, J. ; Wade, J. ; Woolley, P. ; Conkling, P. ; Ervin, T. J. ; Martinez-Rio, M. ; Tripathy, D. ; Meshad, M. ; Jordaan, J. P. ; Werner, I. D. ; Falkson, G. / Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. In: Annals of Oncology. 2003 ; Vol. 14, No. 9. pp. 1399-1405.
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title = "Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases",
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.",
keywords = "Bisphosphonate, Bone metastases, Breast cancer, Ibandronate, Pain, Radiotherapy",
author = "Body, {J. J.} and Diel, {I. J.} and Lichinitser, {M. R.} and Kreuser, {E. D.} and W. Dornoff and Gorbunova, {V. A.} and M. Budde and B. Bergstr{\"o}m and {de Gr{\'e}ve}, {J. S.} and I. Mancini and {Van Belle}, S. and F. Cavalli and B. Thuerlimann and R. Herrmann and M. Clemens and W. Eiermann and G. Kaiser and P. Nauen and R. Obenaus and Schindler, {A. E.} and A. Vogt and K. Hoeffken and Ahlemann, {L. M.} and U. Essers and Porta, {V. G.} and Ferrero, {J. M.} and P. Pouillard and {de Gramont}, A. and N. Pinon and S. Reme and Labat, {J. P.} and L. Guillevin and Morere, {J. F.} and C. Krzisch and Z. Mechl and O. Bruland and Andersen, {O. K.} and R. Bremnes and Ferreira, {E. P.} and A. Fernandes and H. Bassara and Semiglazov, {V. F.} and J. Hansen and I. Lorenz and A. Howell and D. Cameron and Tyrell, {C. J.} and Powels, {T. J.} and J. McAleer and Barrett-Lee, {P. J.} and K. Cash and J. Craig and Decker, {D. A.} and R. Gams and R. Gottlieb and Gucalp, {Rasim A.} and A. Hage-Boutros and K. Havlin and J. Hon and Katterhagen, {J. Gale} and M. Lewis and T. Panella and P. Plezia and S. Rivkin and J. Sandbach and J. Wade and P. Woolley and P. Conkling and Ervin, {T. J.} and M. Martinez-Rio and D. Tripathy and M. Meshad and Jordaan, {J. P.} and Werner, {I. D.} and G. Falkson",
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month = "9",
day = "1",
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language = "English (US)",
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TY - JOUR

T1 - Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

AU - Body, J. J.

AU - Diel, I. J.

AU - Lichinitser, M. R.

AU - Kreuser, E. D.

AU - Dornoff, W.

AU - Gorbunova, V. A.

AU - Budde, M.

AU - Bergström, B.

AU - de Gréve, J. S.

AU - Mancini, I.

AU - Van Belle, S.

AU - Cavalli, F.

AU - Thuerlimann, B.

AU - Herrmann, R.

AU - Clemens, M.

AU - Eiermann, W.

AU - Kaiser, G.

AU - Nauen, P.

AU - Obenaus, R.

AU - Schindler, A. E.

AU - Vogt, A.

AU - Hoeffken, K.

AU - Ahlemann, L. M.

AU - Essers, U.

AU - Porta, V. G.

AU - Ferrero, J. M.

AU - Pouillard, P.

AU - de Gramont, A.

AU - Pinon, N.

AU - Reme, S.

AU - Labat, J. P.

AU - Guillevin, L.

AU - Morere, J. F.

AU - Krzisch, C.

AU - Mechl, Z.

AU - Bruland, O.

AU - Andersen, O. K.

AU - Bremnes, R.

AU - Ferreira, E. P.

AU - Fernandes, A.

AU - Bassara, H.

AU - Semiglazov, V. F.

AU - Hansen, J.

AU - Lorenz, I.

AU - Howell, A.

AU - Cameron, D.

AU - Tyrell, C. J.

AU - Powels, T. J.

AU - McAleer, J.

AU - Barrett-Lee, P. J.

AU - Cash, K.

AU - Craig, J.

AU - Decker, D. A.

AU - Gams, R.

AU - Gottlieb, R.

AU - Gucalp, Rasim A.

AU - Hage-Boutros, A.

AU - Havlin, K.

AU - Hon, J.

AU - Katterhagen, J. Gale

AU - Lewis, M.

AU - Panella, T.

AU - Plezia, P.

AU - Rivkin, S.

AU - Sandbach, J.

AU - Wade, J.

AU - Woolley, P.

AU - Conkling, P.

AU - Ervin, T. J.

AU - Martinez-Rio, M.

AU - Tripathy, D.

AU - Meshad, M.

AU - Jordaan, J. P.

AU - Werner, I. D.

AU - Falkson, G.

PY - 2003/9/1

Y1 - 2003/9/1

N2 - 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.

AB - 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.

KW - Bisphosphonate

KW - Bone metastases

KW - Breast cancer

KW - Ibandronate

KW - Pain

KW - Radiotherapy

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U2 - 10.1093/annonc/mdg367

DO - 10.1093/annonc/mdg367

M3 - Article

VL - 14

SP - 1399

EP - 1405

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

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