Annals of Oncology 15:743-750, 2004
© 2004 European Society for Medical Oncology
Original Paper |
Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial
Received 25 July 2003; revised 8 January 2004; accepted 15 January 2004Background:
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.
1 University of Texas Southwestern Medical Center, Dallas, TX, USA; 2 Chief Department of Clinical Chemotherapy, Cancer Research Center, Moscow; 3 Oncological Center, Altai Region, Barnul, Russia; 4 Department of Oncology, St Vincent’s Hospital, Fitzroy, Victoria, Australia; 5 Tygerberg Hospital, Tygerberg, Cape Town, South Africa; 6 Biostatistics, F. Hoffmann-LaRoche Ltd., Basel, Switzerland; 7 Clinical Science, F. Hoffmann-LaRoche Inc., Nutley, New Jersey, USA
Key words: bisphosphonate, breast cancer, metastatic bone disease, oral ibandronate, skeletal events
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