Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases.
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.


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.
Body
J-J
JJ
Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium. jjbody@bordet.be
Diel
I J
IJ
Lichinitser
M R
MR
Kreuser
E D
ED
Dornoff
W
W
Gorbunova
V A
VA
Budde
M
M
Bergström
B
B
D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004164:Diphosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D015994:Incidence; D007275:Injections, Intravenous; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid