Annals of Oncology 14:1399-1405, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
1 Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium; 2 Department of Obstetrics and Gynaecology, University Hospital, Heidelberg, Germany; 3 Department of Clinical Chemotherapy, Cancer Research Center, Moscow, Russia; 4 Krankenhaus der Barmherzigen Brueder, Onkologische Ambulanz, Regensburg; 5 Mutterhaus der Borromaeerinnen, Trier, Germany; 6 Cancer Research Center, Department of Chemotherapy, Moscow, Russia; 7 F. Hoffmann-La Roche Ltd, Basel, Switzerland; 8 F. Hoffmann-La Roche Inc., Nutley, NJ, USA
Received 23 January 2003; revised 26 March 2003; accepted 14 May 2003
Background:
This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer.
Patients and methods:
A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3–4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly.
Results
SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated.
Conclusions:
These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.
Key words: bisphosphonate, bone metastases, breast cancer, ibandronate, pain, radiotherapy
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