Altundag, K., Dizdar, O., Ozsaran, Z., Ozkok, S., Saip, P., Eralp, Y., . . . Karahoca, M. (2012). Phase II study of loading-dose ibandronate treatment in patients with breast cancer and bone metastases suffering from moderate to severe pain. Onkologie, 35, 254–258.

To determine the efficacy and safety of loading dose IV ibandronate in women with metastatic breast cancer and bone metastases

Ibandronate 6 mg per day was administered for 15 minutes on days 1, 2, and 3 of the study, and patients were followed up until day 14 of the study. Pain was assessed by visual analog scale (VAS) and functional performance index on days 1, 7, and 14. Patients were supplied with a pain diary and instructed to record at the same time each evening. Assessments for opioid use were performed using the Morphine Equivalent Daily Dose (MEDD) index.

• N = 13   
• AGE = 18 years or older
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Painful bone metastases

• SITE: Multi-site 
• SETTING TYPE: Outpatient 
• LOCATION: Turkey

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care

• Phase II, open- label, single-arm study for women with breast cancer and painful bone metastases

• VAS
• Karnofsky Performance Scale Index
• Patient diary
• MEDD
• Lab tests (e.g., red and white cell counts, thrombocyte and neutrophil count, hemoglobin and hematocrit levels, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, gamma-glut, total protein, blood urea nitrogen, Cr, Mg, Ph, Ca, CrCl)

Pain intensity decreased on days 7 and 14 versus day 1 using the VAS. Mean Karnofsky index score increased (80.8 [SD = 13.1] and 80.8 [SD = 13.2] on days 7 and 14 versus 77.7 [SD = 11.7] on day 1; p < 0.005 on both days).

This study demonstrates the short-term safety of an intensive ibandronate dosing schedule as indicated by the good tolerability profile and lack of effect on safety parameters including hematology, blood chemistry, and urine analysis. Intensive ibandronate therapy provides a well-tolerated alternative treatment option to analgesic use for patients requiring rapid relief of moderate to severe metastatic bone pain, particularly patients experiencing breakthrough or opioid-resistant pain.

• Small sample (less than 30)

Ibandronate therapy provides alternative pain relief to patients with breast cancer who have bone metastases and, thus, should improve quality of life with good tolerance and no renal safety concerns.