Oral ibandronate for the treatment of metastatic bone disease in breast cancer: Efficacy and safety results from a randomized, double-blind, placebo-controlled trial
Date
2004
Authors
Tripathy, D.
Lichinitzer, M.
Lazarev, A.
MacLachlan, S. A.
Apffelstaedt, J.
Budde, M.
Bergstrom, B.
Abdi, E.
Abramson, N.
Baker, T. M.
Journal Title
Journal ISSN
Volume Title
Publisher
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. © 2004 European Society for Medical Oncology.
Description
Keywords
bisphosphonic acid derivative, cytotoxic agent, ibandronic acid, narcotic analgesic agent, placebo, abdominal pain, adult, aged, article, bone disease, bone metastasis, bone pain, breast cancer, cancer growth, cancer radiotherapy, clinical trial, controlled clinical trial, controlled study, diarrhea, dose response, double blind procedure, drug approval, drug efficacy, drug fatality, drug safety, drug tolerability, drug use, dyspepsia, esophagitis, European Union, female, flatulence, fracture, human, hypocalcemia, major clinical study, male, morbidity, multivariate analysis, nausea, nausea and vomiting, nephrotoxicity, pathologic fracture, Poisson distribution, priority journal, randomized controlled trial, regression analysis, risk assessment, risk reduction, uremia, vertebra fracture, Administration, Oral, Adult, Aged, Aged, 80 and over, Analgesics, Bone Neoplasms, Breast Neoplasms, Diphosphonates, Double-Blind Method, Drug Administration Schedule, Female, Humans, Middle Aged, Morbidity, Pain, Placebos
Citation
Annals of Oncology
15
5
15
5