Oral ibandronate for the treatment of metastatic bone disease in breast cancer: Efficacy and safety results from a randomized, double-blind, placebo-controlled trial

Debu Tripathy, M. Lichinitzer, A. Lazarev, S. A. MacLachlan, J. Apffelstaedt, M. Budde, B. Bergstrom, E. Abdi, N. Abramson, T. M. Baker, L. W. Kirkegaard, J. R. Schmidt, D. Bell, R. Bell, R. J. Belt, J. I. Bernstein, R. G. Just, R. A. Burningham, B. Trafficante, V. CaggianoT. Cartwright, I. N. Chernozemsky, P. Clingan, P. Conkling, J. B. Craig, A. B. Grosbach, D. Decker, E. Dickman, W. Dugan, W. Dunlap, P. D. Eisenberg, J. Ellerton, M. Ettinger, Frederick (Fred) Ey, G. Falkson, C. Falkson, K. Fink, J. Fleagle, T. Forlenza, V. A. Gorbunova, G. E. Gross, T. Grotes, J. Grygiel, A. Gudgeon, I. D. Werner, D. Hacking, G. W. Harrer, V. Harvey, R. Hirsch, A. Koletsky, J. P. Jordaan, D. Kaye Cash, R. Sh Khasanov, J. A. LaFata, S. LaFollette, P. Koshla, G. Landers, H. C. Lebos, J. Lloyd Wade, T. Lowenthal, R. Lyons, S. A. McLachlan, R. Murray, D. Perez, K. Phadke, B. Rapoport, P. G. Rausch, B. Robinson, G. Sarna, A. Saven, M. Schwartz, V. F. Semiglazov, J. Stewart, K. Sunderland, L. Thomas, C. L. Vogel, M. Martinez-Rio, D. A. Vorobiof, S. Wilks, P. Woolley

Research output: Contribution to journalArticle

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Abstract

Background: We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer. Patients and methods: Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored. Results: SMPR was significantly reduced with oral ibandronate [placebo 1.2, 20 mg group 0.97 (P = 0.024), 50 mg group 0.98 (P = 0.037)]. Ibandronate 50 mg significantly reduced the need for radiotherapy (P = 0.005 versus placebo). The relative risk of skeletal events was reduced by 38% (20 mg dose) and 39% (50 mg dose) versus placebo (P = 0.009 and P = 0.005). The tolerability profile of ibandronate was similar to placebo. Conclusions: Oral ibandronate is an effective and well-tolerated treatment for metastatic bone disease. The 50 mg dose is being further evaluated in clinical trials, and this dose was recently approved in the European Union for the prevention of skeletal events in patients with breast cancer and bone metastases.

Original languageEnglish (US)
Pages (from-to)743-750
Number of pages8
JournalAnnals of Oncology
Volume15
Issue number5
DOIs
StatePublished - May 2004

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Bone Diseases
Placebos
Breast Neoplasms
Safety
Bone and Bones
Therapeutics
Neoplasm Metastasis
Morbidity
Bone Neoplasms
European Union
Risk Reduction Behavior
Analgesics
ibandronic acid
Radiotherapy
Regression Analysis
Clinical Trials
Pain

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Oral ibandronate for the treatment of metastatic bone disease in breast cancer : Efficacy and safety results from a randomized, double-blind, placebo-controlled trial. / Tripathy, Debu; Lichinitzer, M.; Lazarev, A.; MacLachlan, S. A.; Apffelstaedt, J.; Budde, M.; Bergstrom, B.; Abdi, E.; Abramson, N.; Baker, T. M.; Kirkegaard, L. W.; Schmidt, J. R.; Bell, D.; Bell, R.; Belt, R. J.; Bernstein, J. I.; Just, R. G.; Burningham, R. A.; Trafficante, B.; Caggiano, V.; Cartwright, T.; Chernozemsky, I. N.; Clingan, P.; Conkling, P.; Craig, J. B.; Grosbach, A. B.; Decker, D.; Dickman, E.; Dugan, W.; Dunlap, W.; Eisenberg, P. D.; Ellerton, J.; Ettinger, M.; Ey, Frederick (Fred); Falkson, G.; Falkson, C.; Fink, K.; Fleagle, J.; Forlenza, T.; Gorbunova, V. A.; Gross, G. E.; Grotes, T.; Grygiel, J.; Gudgeon, A.; Werner, I. D.; Hacking, D.; Harrer, G. W.; Harvey, V.; Hirsch, R.; Koletsky, A.; Jordaan, J. P.; Cash, D. Kaye; Khasanov, R. Sh; LaFata, J. A.; LaFollette, S.; Koshla, P.; Landers, G.; Lebos, H. C.; Wade, J. Lloyd; Lowenthal, T.; Lyons, R.; McLachlan, S. A.; Murray, R.; Perez, D.; Phadke, K.; Rapoport, B.; Rausch, P. G.; Robinson, B.; Sarna, G.; Saven, A.; Schwartz, M.; Semiglazov, V. F.; Stewart, J.; Sunderland, K.; Thomas, L.; Vogel, C. L.; Martinez-Rio, M.; Vorobiof, D. A.; Wilks, S.; Woolley, P.

In: Annals of Oncology, Vol. 15, No. 5, 05.2004, p. 743-750.

Research output: Contribution to journalArticle

Tripathy, D, Lichinitzer, M, Lazarev, A, MacLachlan, SA, Apffelstaedt, J, Budde, M, Bergstrom, B, Abdi, E, Abramson, N, Baker, TM, Kirkegaard, LW, Schmidt, JR, Bell, D, Bell, R, Belt, RJ, Bernstein, JI, Just, RG, Burningham, RA, Trafficante, B, Caggiano, V, Cartwright, T, Chernozemsky, IN, Clingan, P, Conkling, P, Craig, JB, Grosbach, AB, Decker, D, Dickman, E, Dugan, W, Dunlap, W, Eisenberg, PD, Ellerton, J, Ettinger, M, Ey, FF, Falkson, G, Falkson, C, Fink, K, Fleagle, J, Forlenza, T, Gorbunova, VA, Gross, GE, Grotes, T, Grygiel, J, Gudgeon, A, Werner, ID, Hacking, D, Harrer, GW, Harvey, V, Hirsch, R, Koletsky, A, Jordaan, JP, Cash, DK, Khasanov, RS, LaFata, JA, LaFollette, S, Koshla, P, Landers, G, Lebos, HC, Wade, JL, Lowenthal, T, Lyons, R, McLachlan, SA, Murray, R, Perez, D, Phadke, K, Rapoport, B, Rausch, PG, Robinson, B, Sarna, G, Saven, A, Schwartz, M, Semiglazov, VF, Stewart, J, Sunderland, K, Thomas, L, Vogel, CL, Martinez-Rio, M, Vorobiof, DA, Wilks, S & Woolley, P 2004, 'Oral ibandronate for the treatment of metastatic bone disease in breast cancer: Efficacy and safety results from a randomized, double-blind, placebo-controlled trial', Annals of Oncology, vol. 15, no. 5, pp. 743-750. https://doi.org/10.1093/annonc/mdh173
Tripathy, Debu ; Lichinitzer, M. ; Lazarev, A. ; MacLachlan, S. A. ; Apffelstaedt, J. ; Budde, M. ; Bergstrom, B. ; Abdi, E. ; Abramson, N. ; Baker, T. M. ; Kirkegaard, L. W. ; Schmidt, J. R. ; Bell, D. ; Bell, R. ; Belt, R. J. ; Bernstein, J. I. ; Just, R. G. ; Burningham, R. A. ; Trafficante, B. ; Caggiano, V. ; Cartwright, T. ; Chernozemsky, I. N. ; Clingan, P. ; Conkling, P. ; Craig, J. B. ; Grosbach, A. B. ; Decker, D. ; Dickman, E. ; Dugan, W. ; Dunlap, W. ; Eisenberg, P. D. ; Ellerton, J. ; Ettinger, M. ; Ey, Frederick (Fred) ; Falkson, G. ; Falkson, C. ; Fink, K. ; Fleagle, J. ; Forlenza, T. ; Gorbunova, V. A. ; Gross, G. E. ; Grotes, T. ; Grygiel, J. ; Gudgeon, A. ; Werner, I. D. ; Hacking, D. ; Harrer, G. W. ; Harvey, V. ; Hirsch, R. ; Koletsky, A. ; Jordaan, J. P. ; Cash, D. Kaye ; Khasanov, R. Sh ; LaFata, J. A. ; LaFollette, S. ; Koshla, P. ; Landers, G. ; Lebos, H. C. ; Wade, J. Lloyd ; Lowenthal, T. ; Lyons, R. ; McLachlan, S. A. ; Murray, R. ; Perez, D. ; Phadke, K. ; Rapoport, B. ; Rausch, P. G. ; Robinson, B. ; Sarna, G. ; Saven, A. ; Schwartz, M. ; Semiglazov, V. F. ; Stewart, J. ; Sunderland, K. ; Thomas, L. ; Vogel, C. L. ; Martinez-Rio, M. ; Vorobiof, D. A. ; Wilks, S. ; Woolley, P. / Oral ibandronate for the treatment of metastatic bone disease in breast cancer : Efficacy and safety results from a randomized, double-blind, placebo-controlled trial. In: Annals of Oncology. 2004 ; Vol. 15, No. 5. pp. 743-750.
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abstract = "Background: We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer. Patients and methods: Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored. Results: SMPR was significantly reduced with oral ibandronate [placebo 1.2, 20 mg group 0.97 (P = 0.024), 50 mg group 0.98 (P = 0.037)]. Ibandronate 50 mg significantly reduced the need for radiotherapy (P = 0.005 versus placebo). The relative risk of skeletal events was reduced by 38{\%} (20 mg dose) and 39{\%} (50 mg dose) versus placebo (P = 0.009 and P = 0.005). The tolerability profile of ibandronate was similar to placebo. Conclusions: Oral ibandronate is an effective and well-tolerated treatment for metastatic bone disease. The 50 mg dose is being further evaluated in clinical trials, and this dose was recently approved in the European Union for the prevention of skeletal events in patients with breast cancer and bone metastases.",
author = "Debu Tripathy and M. Lichinitzer and A. Lazarev and MacLachlan, {S. A.} and J. Apffelstaedt and M. Budde and B. Bergstrom and E. Abdi and N. Abramson and Baker, {T. M.} and Kirkegaard, {L. W.} and Schmidt, {J. R.} and D. Bell and R. Bell and Belt, {R. J.} and Bernstein, {J. I.} and Just, {R. G.} and Burningham, {R. A.} and B. Trafficante and V. Caggiano and T. Cartwright and Chernozemsky, {I. N.} and P. Clingan and P. Conkling and Craig, {J. B.} and Grosbach, {A. B.} and D. Decker and E. Dickman and W. Dugan and W. Dunlap and Eisenberg, {P. D.} and J. Ellerton and M. Ettinger and Ey, {Frederick (Fred)} and G. Falkson and C. Falkson and K. Fink and J. Fleagle and T. Forlenza and Gorbunova, {V. A.} and Gross, {G. E.} and T. Grotes and J. Grygiel and A. Gudgeon and Werner, {I. D.} and D. Hacking and Harrer, {G. W.} and V. Harvey and R. Hirsch and A. Koletsky and Jordaan, {J. P.} and Cash, {D. Kaye} and Khasanov, {R. Sh} and LaFata, {J. A.} and S. LaFollette and P. Koshla and G. Landers and Lebos, {H. C.} and Wade, {J. Lloyd} and T. Lowenthal and R. Lyons and McLachlan, {S. A.} and R. Murray and D. Perez and K. Phadke and B. Rapoport and Rausch, {P. G.} and B. Robinson and G. Sarna and A. Saven and M. Schwartz and Semiglazov, {V. F.} and J. Stewart and K. Sunderland and L. Thomas and Vogel, {C. L.} and M. Martinez-Rio and Vorobiof, {D. A.} and S. Wilks and P. Woolley",
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TY - JOUR

T1 - Oral ibandronate for the treatment of metastatic bone disease in breast cancer

T2 - Efficacy and safety results from a randomized, double-blind, placebo-controlled trial

AU - Tripathy, Debu

AU - Lichinitzer, M.

AU - Lazarev, A.

AU - MacLachlan, S. A.

AU - Apffelstaedt, J.

AU - Budde, M.

AU - Bergstrom, B.

AU - Abdi, E.

AU - Abramson, N.

AU - Baker, T. M.

AU - Kirkegaard, L. W.

AU - Schmidt, J. R.

AU - Bell, D.

AU - Bell, R.

AU - Belt, R. J.

AU - Bernstein, J. I.

AU - Just, R. G.

AU - Burningham, R. A.

AU - Trafficante, B.

AU - Caggiano, V.

AU - Cartwright, T.

AU - Chernozemsky, I. N.

AU - Clingan, P.

AU - Conkling, P.

AU - Craig, J. B.

AU - Grosbach, A. B.

AU - Decker, D.

AU - Dickman, E.

AU - Dugan, W.

AU - Dunlap, W.

AU - Eisenberg, P. D.

AU - Ellerton, J.

AU - Ettinger, M.

AU - Ey, Frederick (Fred)

AU - Falkson, G.

AU - Falkson, C.

AU - Fink, K.

AU - Fleagle, J.

AU - Forlenza, T.

AU - Gorbunova, V. A.

AU - Gross, G. E.

AU - Grotes, T.

AU - Grygiel, J.

AU - Gudgeon, A.

AU - Werner, I. D.

AU - Hacking, D.

AU - Harrer, G. W.

AU - Harvey, V.

AU - Hirsch, R.

AU - Koletsky, A.

AU - Jordaan, J. P.

AU - Cash, D. Kaye

AU - Khasanov, R. Sh

AU - LaFata, J. A.

AU - LaFollette, S.

AU - Koshla, P.

AU - Landers, G.

AU - Lebos, H. C.

AU - Wade, J. Lloyd

AU - Lowenthal, T.

AU - Lyons, R.

AU - McLachlan, S. A.

AU - Murray, R.

AU - Perez, D.

AU - Phadke, K.

AU - Rapoport, B.

AU - Rausch, P. G.

AU - Robinson, B.

AU - Sarna, G.

AU - Saven, A.

AU - Schwartz, M.

AU - Semiglazov, V. F.

AU - Stewart, J.

AU - Sunderland, K.

AU - Thomas, L.

AU - Vogel, C. L.

AU - Martinez-Rio, M.

AU - Vorobiof, D. A.

AU - Wilks, S.

AU - Woolley, P.

PY - 2004/5

Y1 - 2004/5

N2 - Background: We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer. Patients and methods: Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored. Results: SMPR was significantly reduced with oral ibandronate [placebo 1.2, 20 mg group 0.97 (P = 0.024), 50 mg group 0.98 (P = 0.037)]. Ibandronate 50 mg significantly reduced the need for radiotherapy (P = 0.005 versus placebo). The relative risk of skeletal events was reduced by 38% (20 mg dose) and 39% (50 mg dose) versus placebo (P = 0.009 and P = 0.005). The tolerability profile of ibandronate was similar to placebo. Conclusions: Oral ibandronate is an effective and well-tolerated treatment for metastatic bone disease. The 50 mg dose is being further evaluated in clinical trials, and this dose was recently approved in the European Union for the prevention of skeletal events in patients with breast cancer and bone metastases.

AB - Background: We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer. Patients and methods: Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored. Results: SMPR was significantly reduced with oral ibandronate [placebo 1.2, 20 mg group 0.97 (P = 0.024), 50 mg group 0.98 (P = 0.037)]. Ibandronate 50 mg significantly reduced the need for radiotherapy (P = 0.005 versus placebo). The relative risk of skeletal events was reduced by 38% (20 mg dose) and 39% (50 mg dose) versus placebo (P = 0.009 and P = 0.005). The tolerability profile of ibandronate was similar to placebo. Conclusions: Oral ibandronate is an effective and well-tolerated treatment for metastatic bone disease. The 50 mg dose is being further evaluated in clinical trials, and this dose was recently approved in the European Union for the prevention of skeletal events in patients with breast cancer and bone metastases.

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DO - 10.1093/annonc/mdh173

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