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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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, Volume 15, No. 5, Year 2004
Notification
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Description
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. © 2004 European Society for Medical Oncology.
Authors & Co-Authors
Tripathy, Debu
United States, Richardson
The University of Texas at Dallas
Lichinitzer, M.
Russian Federation, Moscow
Cancer Research Center
Lazarev, A.
Russian Federation, Omsk
Oncological Center
MacLachlan, S. A.
Australia, Fitzroy
St. Vincent's Hospital Melbourne
Apffelstaedt, Justus P.A.
South Africa, Tygerberg
Tygerberg Hospital
Budde, Michael
Switzerland, Basel
F. Hoffmann-la Roche ag
Bergström, Bengt
Switzerland, Basel
F. Hoffmann-la Roche ag
Abdi, Ehtesham A.
Australia, Bendigo
Bendigo Hospital
Abramson, N.
United States, Jacksonville
Baptist Medical Center Downtown
Baker, T. M.
United States, Tacoma
Puget Sound Hospital
Kirkegaard, L. W.
United States, Tacoma
Puget Sound Hospital
Schmidt, J. R.
United States, Tacoma
Puget Sound Hospital
Bell, D.
Australia, Sydney
Royal North Shore Hospital
Bell, R.
Australia, Geelong
Geelong Hospital
Belt, R. J.
United States, Westwood
Ks City Oncol./hematol. Clin. Bus.
Bernstein, J. I.
United States, San Diego
Scripps Memorial Hospital
Just, R. G.
United States, San Diego
Scripps Memorial Hospital
Burningham, R. A.
United States, Portland
The Portland Clinic
Trafficante, B.
United States, Portland
The Portland Clinic
Caggiano, Vincent
United States, Sacramento
Sutter Memorial Hospital
Cartwright, T.
United States
Ocala Oncology Center
Chernozemsky, I. N.
Bulgaria, Sofia
National Oncology Center Bulgaria
Clingan, Philip R.
Australia, Wollongong
Wollongong Hospital
Conkling, Paul R.
United States, Norfolk
Sentara Norfolk General Hospital
Craig, J. B.
United States, Shreveport
Christus Schumpert - St. Mary Place
Grosbach, A. B.
United States, Shreveport
Christus Schumpert - St. Mary Place
Decker, David A.
United States, Royal Oak
William Beaumont Hospital
Dickman, E.
United States, Cleveland
Cleveland Clinic Foundation
Dugan, W.
United States, Columbus
Columbus Regional Hospital, Indiana
Dunlap, W.
United States, Raleigh
Raleigh Medical Group
Eisenberg, P. D.
United States, Greenbrae
Marin General Hospital
Ellerton, J.
Unknown Affiliation
Ettinger, M.
United States, Stuart
Clinical Research Center of South Florida
Ey, F.
United States, Portland
Legacy Good Samaritan Hospital and Medical Center
Falkson, Geoffrey G.
South Africa, Pretoria
University of Pretoria
Falkson, Carla Isadora
South Africa, Pretoria
University of Pretoria
Fink, K.
United States, Fort Gordon
Eisenhower Army Medical Center
Fleagle, J.
United States, Boulder
Boulder Medical Center
Forlenza, T.
United States, New York
Saint Vincent Catholic Medical Centers
Gorbunova, Vera A.
Russian Federation, Moscow
Cancer Research Center
Gross, G. E.
United States, Houston
Texas Medical Center
Grotes, T.
United States, Winston Salem
Forsyth Medical Center
Grygiel, J.
Australia, Sydney
St. Vincent's Hospital Sydney
Gudgeon, Anne
South Africa, Observatory
Groote Schuur Hospital
Werner, I. Dudley
South Africa, Observatory
Groote Schuur Hospital
Hacking, D.
South Africa, Durban
Durban Oncology Centre
Harrer, G. W.
Unknown Affiliation
Harvey, Vernon J.
New Zealand, Auckland
Auckland City Hospital
Hirsch, R.
United States, Boca Raton
Comprehensive Cancer Center Inc.
Koletsky, Alan J.
United States, Boca Raton
Comprehensive Cancer Center Inc.
Jordaan, Johannes Petrus J.
South Africa, Durban
Addington Hospital
Cash, D. Kaye
United States, Little Rock
Little Rock Orthop. Clin.
Khasanov, R. Sh
Russian Federation, Kazan
Regional Clinical Oncological Center
LaFata, John A.
United States, Vista
Oncology Med. Center of North County
LaFollette, S.
United States, Chicago
Rush University Medical Center
Koshla, P.
United States, Chicago
Rush University Medical Center
Landers, G.
South Africa, Durban
Parklands Hospital
Lebos, H. C.
United States, Savannah
Memorial Health University Medical Center
Wade, J. Lloyd
United States
Decatur Meomorial Hospital
Lowenthal, T.
Australia, Hobart
Royal Hobart Hospital
Lyons, R.
United States, San Antonio
Hematol. Oncol. Assoc. of S. Texas
McLachlan, Sue Anne
Australia, Fitzroy
St. Vincent's Hospital Melbourne
Murray, Robin M.
Australia, Melbourne
Peter Maccallum Cancer Centre
Perez, D.
New Zealand, Dunedin
Dunedin Hospital
Phadke, K.
Australia, Sydney
St George Hospital
Rapoport, Bernardo L.
South Africa, Johannesburg
Medical Oncology Centre of Rosebank
Rausch, P. G.
United States, Frederick
Frederick Memorial Hospital
Robinson, Bridget Anne
New Zealand, Christchurch
Christchurch Hospital new Zealand
Sarna, G.
United States, Los Angeles
Cedars-sinai Medical Center
Saven, A.
United States, San Diego
Scripps Clinic
Schwartz, M.
United States, Miami Beach
Mount Sinai Medical Center Miami Beach
Semiglazov, Vladimir Fedorovich
Russian Federation, Saint Petersburg
N.n. Petrov Research Institute of Oncology of the Ussr Ministry of Health
Stewart, J.
Australia, Waratah
Newcastle Mater Misericordiae Hospital
Sunderland, K.
Australia, Canberra
Canberra Hospital
Thomas, L.
Unknown Affiliation
Vogel, Charles L.
Unknown Affiliation
Martinez-Rio, M.
Unknown Affiliation
Vorobiof, Daniel Alberto
South Africa, Johannesburg
Sandton Oncology Centre
Wilks, S.
United States, San Antonio
Wilford Hall Ambulatory Surgical Center
Woolley, P.
United States, Pittsburgh
University of Pittsburgh Medical Center
Statistics
Citations: 87
Authors: 80
Affiliations: 63
Identifiers
Doi:
10.1093/annonc/mdh173
ISSN:
09237534
Research Areas
Cancer
Disability
Health System And Policy
Study Approach
Quantitative