Abstract
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.
Original language | English (US) |
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Pages (from-to) | 1399-1405 |
Number of pages | 7 |
Journal | Annals of Oncology |
Volume | 14 |
Issue number | 9 |
DOIs | |
State | Published - Sep 1 2003 |
Externally published | Yes |
Keywords
- Bisphosphonate
- Bone metastases
- Breast cancer
- Ibandronate
- Pain
- Radiotherapy
ASJC Scopus subject areas
- Hematology
- Oncology