Annals of Oncology Advance Access originally published online on April 17, 2007
Annals of Oncology 2007 18(7):1165-1171; doi:10.1093/annonc/mdm119
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© 2007 European Society for Medical Oncology
breast cancer |
Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases
1 Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium
2 NN Blokhin Russian Cancer Research Center, Moscow, Russia
3 Institut National de la Santé et de la Recherche Médicale, Research Unit 664 and Synarc, Molecular Markers, Lyon, France
4 Hoffmann-La Roche Inc., Nutley, NJ, USA
* Correspondence to: Prof. J.-J. Body, Institut Jules Bordet, Université Libre de Bruxelles, 1 rue Héger-Bordet, 1000 Brussels, Belgium. Tel: +32-2-541-3303; Fax: +32-2-541-3311; E-mail: jj.body{at}bordet.be
Background: Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers.
Patients and methods: Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary end point was mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX) at week 12. Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type I collagen (PINP) and osteocalcin (OC) were also measured and bone pain and safety assessed.
Results: Both bisphosphonates significantly reduced S-CTX (mean ibandronate 76% ± 29 (SD) versus mean zoledronic acid 73% ± 47; P < 0.001 for both versus baseline) and U-CTX (ibandronate 78% ± 50 versus zoledronic acid 86% ± 17; P < 0.001). The difference in S-CTX between treatments was 0.6% (confidence interval –1.7% to 3.0%), which was within the prespecified noninferiority margin. Bone ALP, PINP and OC decreased by 26%–47% compared with baseline with both bisphosphonates. Compared with zoledronic acid, ibandronate patients reported fewer adverse events overall (65.0% versus 75.9%), and on days 1–3 (8.0% versus 47.5%), including less pyrexia (overall incidence 0% versus 16.8%) and bone pain (5.8% versus 12.4%).
Conclusions: Oral ibandronate was well tolerated and statistically noninferior to zoledronic acid for percentage change in the bone resorption marker, S-CTX.
Key words: bisphosphonates, bone markers, bone metastases, ibandronate, zoledronic acid
Received for publication December 8, 2006. Revision received February 9, 2007. Accepted for publication March 2, 2007.
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E. Yaman, M. Benekli, U. Coskun, B. Ozturk, A. O. Kaya, R. Yildiz, and S. Buyukberber Reply to the article "Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases" by J.-J. Body et al. (Ann Oncol 2007; 18: 1165-1171) Ann. Onc., February 1, 2008; 19(2): 397 - 398. [Full Text] [PDF]
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J.-J. Body Reply to Letter to the editor, by E. Yaman et al. (Ann Oncol) Ann. Onc., February 1, 2008; 19(2): 398 - 398. [Full Text] [PDF]
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