TY - JOUR
T1 - Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer
T2 - an open-label trial
AU - Pecherstorfer, Martin
AU - Rivkin, Saul
AU - Body, Jean-Jacques
AU - Diel, Ingo
AU - Bergström, Bengt
PY - 2006
Y1 - 2006
N2 - BACKGROUND AND OBJECTIVE: Despite their widespread use in metastatic bone disease, some bisphosphonate drugs are associated with adverse events (AEs), particularly renal toxicity, adding to treatment burdens and increasing healthcare costs. Ibandronic acid is a single-nitrogen bisphosphonate with high efficacy against bone events and metastatic bone pain, and a renal safety profile compar- able to that of placebo. In this study, the safety of ibandronic acid was examined over a period of 4 years.PATIENTS AND METHODS: During an initial 96-week period, breast cancer patients with bone metastases were randomised in double-blind fashion to placebo or ibandronic acid 6mg administered by intravenous infusion over 1-2 hours every 3-4 weeks as part of a previously reported phase III trial (MF 4265 study). All patients completing the phase III trial were offered open-label active treatment for a further 96 weeks (extension phase). A total of 62 patients received ibandronic acid 6mg in this extension phase and were classified according to their initial treatment (placebo/ibandronic acid 6mg [placebo/6mg] and ibandronic acid 6mg/ibandronic acid 6mg [6mg/6mg] groups). Safety was assessed by AE reports and clinical laboratory evaluations.RESULTS: During the 4-year study, most patients experienced at least one AE, with malignancy progression being most commonly reported. However, fewer treatment-related AEs were reported in the extension phase (placebo/6mg: 6.3% [1/16]; 6mg/6mg: 13.0% [6/46]) than in the initial phase of the study (placebo: 56.3% [9/16]; 6mg: 67.4% [31/46]). Serious AEs were mainly due to malignancy progression. There were no clinically relevant renal AEs, and in both groups, serum creatinine levels were similar for up to 4 years.CONCLUSION: This 96-week open-label safety extension of a phase III, placebo-controlled trial demonstrates that long-term use of intravenous ibandronic acid is well tolerated.
AB - BACKGROUND AND OBJECTIVE: Despite their widespread use in metastatic bone disease, some bisphosphonate drugs are associated with adverse events (AEs), particularly renal toxicity, adding to treatment burdens and increasing healthcare costs. Ibandronic acid is a single-nitrogen bisphosphonate with high efficacy against bone events and metastatic bone pain, and a renal safety profile compar- able to that of placebo. In this study, the safety of ibandronic acid was examined over a period of 4 years.PATIENTS AND METHODS: During an initial 96-week period, breast cancer patients with bone metastases were randomised in double-blind fashion to placebo or ibandronic acid 6mg administered by intravenous infusion over 1-2 hours every 3-4 weeks as part of a previously reported phase III trial (MF 4265 study). All patients completing the phase III trial were offered open-label active treatment for a further 96 weeks (extension phase). A total of 62 patients received ibandronic acid 6mg in this extension phase and were classified according to their initial treatment (placebo/ibandronic acid 6mg [placebo/6mg] and ibandronic acid 6mg/ibandronic acid 6mg [6mg/6mg] groups). Safety was assessed by AE reports and clinical laboratory evaluations.RESULTS: During the 4-year study, most patients experienced at least one AE, with malignancy progression being most commonly reported. However, fewer treatment-related AEs were reported in the extension phase (placebo/6mg: 6.3% [1/16]; 6mg/6mg: 13.0% [6/46]) than in the initial phase of the study (placebo: 56.3% [9/16]; 6mg: 67.4% [31/46]). Serious AEs were mainly due to malignancy progression. There were no clinically relevant renal AEs, and in both groups, serum creatinine levels were similar for up to 4 years.CONCLUSION: This 96-week open-label safety extension of a phase III, placebo-controlled trial demonstrates that long-term use of intravenous ibandronic acid is well tolerated.
KW - Adult
KW - Aged
KW - Bone Density Conservation Agents/administration & dosage
KW - Bone Neoplasms/drug therapy
KW - Breast Neoplasms/drug therapy
KW - Creatinine/blood
KW - Diphosphonates/administration & dosage
KW - Disease Progression
KW - Drug Administration Schedule
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Ibandronic Acid
KW - Infusions, Intravenous
KW - Injections, Intravenous
KW - Leg/blood supply
KW - Middle Aged
KW - Neoplasm Metastasis
KW - Pulmonary Embolism/chemically induced
KW - Survival Rate
KW - Thrombosis/chemically induced
KW - Time Factors
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=33745049789&partnerID=8YFLogxK
U2 - 10.2165/00044011-200626060-00002
DO - 10.2165/00044011-200626060-00002
M3 - Journal article
C2 - 17163265
SN - 1173-2563
VL - 26
SP - 315
EP - 322
JO - Clinical Drug Investigation
JF - Clinical Drug Investigation
IS - 6
ER -