Subject(s)
Antimetabolites, Antineoplastic/administration & dosage , Azacitidine/administration & dosage , Leukemia, Myeloid, Acute/drug therapy , Abnormal Karyotype , Aged , Female , Follow-Up Studies , Humans , Leukemia, Myeloid, Acute/genetics , Randomized Controlled Trials as Topic , Risk , Treatment OutcomeABSTRACT
PURPOSE: This trial is the first to compare directly the clinical response to and safety of oral and intravenous (IV) ibandronic acid for metastatic bone disease. METHODS: Patients > or =18 years with breast, prostate, lung, urogenital or colon cancer received IV ibandronic acid 6 mg infused over 15 min every 28 days or oral ibandronic acid 50 mg/day. Clinical response was determined using bone scintigraphy, radiography and serum C-terminal telopeptide of type I collagen (S-CTX) at months 3-6. Adverse events and biochemical safety measures were recorded. RESULTS: A total of 84.6 and 88.5% of patients had a complete/partial response to IV and oral ibandronic acid, respectively. Median percentage decreases in S-CTX were -39 and -35%, respectively. Bone pain scores decreased and analgesic use increased from month 0-3 and were stable from months 3-6. Both formulations improved physical and functioning scores. CONCLUSION: Oral and IV ibandronic acid for bone metastases have similar efficacy and tolerability.
Subject(s)
Bone Density Conservation Agents/administration & dosage , Bone Neoplasms/drug therapy , Bone Neoplasms/secondary , Bone Resorption/drug therapy , Diphosphonates/administration & dosage , Administration, Oral , Aged , Female , Humans , Ibandronic Acid , Infusions, Intravenous , Male , Neoplasms/drug therapy , Prognosis , Prospective Studies , Quality of LifeABSTRACT
Conventional management of metastatic bone disease involves local and systemic therapies in various combinations, along with symptomatic management to provide optimal care. In recent years, it has become clear that adding bisphosphonates to these treatments reduces the incidence and severity of skeletal complications. Bisphosphonates can also relieve metastatic bone pain and improve quality of life, although the extent to which they have demonstrated these effects may differ between agents. While bisphosphonates are the standard of care for the treatment of bone metastases, clinical trials are investigating additional indications for these agents, including the use of intensive dosing regimens for the relief of severe or opioid-resistant metastatic bone pain and adjuvant treatment for the prevention of bone metastases and cancer treatment-induced bone loss. Current and future indications demand effective, well-tolerated and convenient bisphosphonates, and the benefits of different drugs must be balanced against their limitations. The cost-effectiveness of bisphosphonate treatment is also a consideration, given the high economic burden of metastatic bone disease from breast cancer.
