Safety and efficacy of the new bisphosphonate ibandronate in the management of bone metastasis following rapid infusion.

BACKGROUND: We evaluated the safety and efficacy of the new BP ibandronate, given as a rapid infusion.

PATIENTS AND METHODS: We administered 4 mg of ibandronate as an intravenous infusion over 30 minutes. Thirty patients (16 breast cancers, 4 prostate cancers, 10 multiple myelomas) with bone metastases received 4 mg of ibandronate injected intravenously over 30 minutes in normal saline 0.9%, 250cc every 3 or 4 weeks. The patients were followed-up over 2 hours after infusion. A total of 198 infusions were administered over a period of 24 months and the patients were followed-up for long-term ibandronate-related side-effects, as well as for any potential clinical benefit.

RESULTS: Following the first administration of ibantronate, serum levels of calcium, phosphate and alkaline phosphatase were significantly decreased and the difference was statistically significant (p < 0.001) for all three parameters examined. The reduced time of infusion (30 minutes vs 2 hours) did not correlate with any side-effects during or post-administration. Serum levels of creatinine and urea nitrogen did not increase significantly, while changes in temperature and blood pressure were not detected in the patients examined. With regard to efficacy, all the patients, after repeated administrations, reduced the doses of analgesics needed; 26 out of 30 patients had stable disease in the bones while 1 out of 30 patients had significant improvement of bone lesions in consecutive bone scans.

CONCLUSION: Infusional administration of ibandronate is efficient in the management of hypercalcaemia of malignancy and it results in a reduced need for analgesics. The rapid infusion over 30 minutes is safe and could be given in the setting of a day care unit.