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. Caggiano; T. 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; F. 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

doi:10.1093/annonc/mdh173

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, F. 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 journal › Article › peer-review

74 Scopus citations

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 language	English (US)
Pages (from-to)	743-750
Number of pages	8
Journal	Annals of Oncology
Volume	15
Issue number	5
DOIs	https://doi.org/10.1093/annonc/mdh173
State	Published - May 2004
Externally published	Yes

ASJC Scopus subject areas

Hematology
Oncology

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10.1093/annonc/mdh173

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Tripathy, D., 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., ... 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, 15(5), 743-750. https://doi.org/10.1093/annonc/mdh173

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, F, 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

@article{daf53536c93e4ba38a7574713d335f15,

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

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 F. Ey 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",

note = "Funding Information: This study was supported by Roche. Additional members of the MF 4434 Study Group: E. Abdi (Bendigo Hospital, Bendigo, Victoria, Australia), N. Abramson (Baptist Medical Center, Jacksonville, Florida, USA), T. M. Baker, L. W. Kirkegaard and J. R. Schmidt (Puget Sound Medical Research, Tacoma, Washington, USA), D. Bell (Royal North Shore Hospital, St. Leonards, New South Wales, Australia), R. Bell (Andrew Love Cancer Centre, Geelong Hospital, Geelong, Victoria, Australia), R. J. Belt (Kansas City Oncology/Hematology Clinics Business Office, Westwood, Kansas, USA), J. I. Bernstein and R. G. Just (Scripps Memorial Hospitals, La Jolla, California, USA), R. A. Burningham and B. Trafficante (The Portland Clinic LLP, Portland, Oregon, USA), V. Caggiano (Sutter Memorial Hospital, Sacramento, California, USA), T. Cartwright (Ocala Oncology Center, Ocala, Florida, USA), I. N. Chernozemsky (National Oncological Center, Sofia, Bulgaria), P. Clingan (Wollongong Hospital, Wollongong, New South Wales, Australia), P. Conkling (Sentara Norfolk General Hospital, Norfolk, Virginia, USA), J. B. Craig and A. B. Grosbach (Christus Schumpert Medical Center, Shreveport, Louisiana, USA), D. Decker (William Beaumont Hospital, Royal Oak, Michigan, USA), E. Dickman (Meridia Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, USA), W. Dugan, Jr. (Columbus Regional Hospital, Columbus, Indiana, USA), W. Dunlap (Raleigh Medical Group, Raleigh, North Carolina, USA), P. D. Eisenberg (Marin General Hospital, Green-brae, California, USA), J. Ellerton (Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, USA), M. Ettinger (Clinical Research Center of South Florida, Stuart, Florida, USA), F. Ey (Good Samaritan Hospital, Portland, Oregon, USA), G. Falkson and C. Falkson (Pretoria Academic Hospitals and University of Pretoria, Pretoria, South Africa), K. Fink (Eisenhower Army Medical Center, Fort Gordon, Georgia, USA), J. Fleagle (Boulder Medical Center, Boulder, Colorado, USA), T. Forlenza (St. Vincent{\textquoteright}s Catholic Medical Centers of New York, Staten Island, New York, USA), V. A. Gorbunova (Cancer Research Center, Moscow, Russia), G. E. Gross (East Texas Medical Center, Texas, USA), T. Grote (Forsyth Memorial Hospital, Winston-Salem, North Carolina, USA), J. Grygiel (St. Vincent{\textquoteright}s Hospital, Darlinghurst, New South Wales, Australia), A. Gudgeon and I. D. Werner (Groote Schuur Hospital, Cape Town, South Africa), D. Hacking (Durban Oncology Centre, Durban, South Africa), G. W. Harrer (Great Falls Clinic, Great Falls, Montana, USA), V. Harvey (Auckland Hospital, Auckland, New Zealand), R. Hirsch and A. Koletsky (Comprehensive Cancer Center Inc., Boca Raton, Florida, USA), J. P. Jordaan (Addington Hospital, Durban, South Africa), D. Kaye Cash (Little Rock Cancer Clinic, Little Rock, Arkansas, USA), R. Sh. Khasanov (Clinical Oncological Center, Kazan, Republic of Tatarstan, Russia), J. A. LaFata (Oncology Medical Center of North County, Vista, California, USA), S. LaFollette and P. Koshla (Rush-Presbyterian-St. Luke{\textquoteright}s Medical Center, Chicago, Illinois, USA), G. Landers (Parklands Hospital, Overport, Durban, South Africa), H. C. Lebos (Memorial Medical Center, Inc., Savannah, Georgia, USA), J. Lloyd Wade (Decatur Memorial Hospital, Illinois, USA), R. Lowenthal (Royal Hobart Hospital, Hobart, Tasmania, Australia), R. Lyons (Hematology and Oncology Associates of South Texas, San Antonio, Texas, USA), S.-A. McLachlan (St. Vincent{\textquoteright}s Hospital, Fitzroy, Victoria, Australia), R. Murray (Peter McCallum Cancer Institute, Victoria, Australia), D. Perez (Dunedin Hospital, Dunedin, Australia), K. Phadke (St. George Hospital, Kogarah, New South Wales, Australia), B. Rapoport (Medical Oncology Centre of Rosebank, Saxonwold, South Africa), P. G. Rausch (Frederick Memorial Hospital, Frederick, Maryland, USA), B. Robinson (Christchurch Hospital, Christchurch, New Zealand), G. Sarna (The Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California, USA), A. Saven (Scripps Clinic, La Jolla, California, USA), M. Schwartz (Mt. Sinai Medical Center, Miami Beach, Florida, USA), V. F. Semiglazov (Petrov Research Institute of Oncology, St. Petersburg, Russia), J. Stewart (Newcastle Mater Hospital, Waratah, New South Wales, Australia), K. Sunderland (The Canberra Hospital, Garran, Australia), L. Thomas (Patricia",

year = "2004",

month = may,

doi = "10.1093/annonc/mdh173",

language = "English (US)",

volume = "15",

pages = "743--750",

journal = "Annals of Oncology",

issn = "0923-7534",

publisher = "Elsevier Ltd",

number = "5",

}

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, F.

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.

N1 - Funding Information: This study was supported by Roche. Additional members of the MF 4434 Study Group: E. Abdi (Bendigo Hospital, Bendigo, Victoria, Australia), N. Abramson (Baptist Medical Center, Jacksonville, Florida, USA), T. M. Baker, L. W. Kirkegaard and J. R. Schmidt (Puget Sound Medical Research, Tacoma, Washington, USA), D. Bell (Royal North Shore Hospital, St. Leonards, New South Wales, Australia), R. Bell (Andrew Love Cancer Centre, Geelong Hospital, Geelong, Victoria, Australia), R. J. Belt (Kansas City Oncology/Hematology Clinics Business Office, Westwood, Kansas, USA), J. I. Bernstein and R. G. Just (Scripps Memorial Hospitals, La Jolla, California, USA), R. A. Burningham and B. Trafficante (The Portland Clinic LLP, Portland, Oregon, USA), V. Caggiano (Sutter Memorial Hospital, Sacramento, California, USA), T. Cartwright (Ocala Oncology Center, Ocala, Florida, USA), I. N. Chernozemsky (National Oncological Center, Sofia, Bulgaria), P. Clingan (Wollongong Hospital, Wollongong, New South Wales, Australia), P. Conkling (Sentara Norfolk General Hospital, Norfolk, Virginia, USA), J. B. Craig and A. B. Grosbach (Christus Schumpert Medical Center, Shreveport, Louisiana, USA), D. Decker (William Beaumont Hospital, Royal Oak, Michigan, USA), E. Dickman (Meridia Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, USA), W. Dugan, Jr. (Columbus Regional Hospital, Columbus, Indiana, USA), W. Dunlap (Raleigh Medical Group, Raleigh, North Carolina, USA), P. D. Eisenberg (Marin General Hospital, Green-brae, California, USA), J. Ellerton (Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, USA), M. Ettinger (Clinical Research Center of South Florida, Stuart, Florida, USA), F. Ey (Good Samaritan Hospital, Portland, Oregon, USA), G. Falkson and C. Falkson (Pretoria Academic Hospitals and University of Pretoria, Pretoria, South Africa), K. Fink (Eisenhower Army Medical Center, Fort Gordon, Georgia, USA), J. Fleagle (Boulder Medical Center, Boulder, Colorado, USA), T. Forlenza (St. Vincent’s Catholic Medical Centers of New York, Staten Island, New York, USA), V. A. Gorbunova (Cancer Research Center, Moscow, Russia), G. E. Gross (East Texas Medical Center, Texas, USA), T. Grote (Forsyth Memorial Hospital, Winston-Salem, North Carolina, USA), J. Grygiel (St. Vincent’s Hospital, Darlinghurst, New South Wales, Australia), A. Gudgeon and I. D. Werner (Groote Schuur Hospital, Cape Town, South Africa), D. Hacking (Durban Oncology Centre, Durban, South Africa), G. W. Harrer (Great Falls Clinic, Great Falls, Montana, USA), V. Harvey (Auckland Hospital, Auckland, New Zealand), R. Hirsch and A. Koletsky (Comprehensive Cancer Center Inc., Boca Raton, Florida, USA), J. P. Jordaan (Addington Hospital, Durban, South Africa), D. Kaye Cash (Little Rock Cancer Clinic, Little Rock, Arkansas, USA), R. Sh. Khasanov (Clinical Oncological Center, Kazan, Republic of Tatarstan, Russia), J. A. LaFata (Oncology Medical Center of North County, Vista, California, USA), S. LaFollette and P. Koshla (Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois, USA), G. Landers (Parklands Hospital, Overport, Durban, South Africa), H. C. Lebos (Memorial Medical Center, Inc., Savannah, Georgia, USA), J. Lloyd Wade (Decatur Memorial Hospital, Illinois, USA), R. Lowenthal (Royal Hobart Hospital, Hobart, Tasmania, Australia), R. Lyons (Hematology and Oncology Associates of South Texas, San Antonio, Texas, USA), S.-A. McLachlan (St. Vincent’s Hospital, Fitzroy, Victoria, Australia), R. Murray (Peter McCallum Cancer Institute, Victoria, Australia), D. Perez (Dunedin Hospital, Dunedin, Australia), K. Phadke (St. George Hospital, Kogarah, New South Wales, Australia), B. Rapoport (Medical Oncology Centre of Rosebank, Saxonwold, South Africa), P. G. Rausch (Frederick Memorial Hospital, Frederick, Maryland, USA), B. Robinson (Christchurch Hospital, Christchurch, New Zealand), G. Sarna (The Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California, USA), A. Saven (Scripps Clinic, La Jolla, California, USA), M. Schwartz (Mt. Sinai Medical Center, Miami Beach, Florida, USA), V. F. Semiglazov (Petrov Research Institute of Oncology, St. Petersburg, Russia), J. Stewart (Newcastle Mater Hospital, Waratah, New South Wales, Australia), K. Sunderland (The Canberra Hospital, Garran, Australia), L. Thomas (Patricia

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.

UR - http://www.scopus.com/inward/record.url?scp=2642518197&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=2642518197&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdh173

DO - 10.1093/annonc/mdh173

M3 - Article

C2 - 15111341

AN - SCOPUS:2642518197

SN - 0923-7534

VL - 15

SP - 743

EP - 750

JO - Annals of Oncology

JF - Annals of Oncology

IS - 5

ER -

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

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