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| |  Ibandronate Offers Pain Relief With Renal Safety in Women With Breast Cancer, Metastatic Bone Disease: Presented at SABCS By Wayne Kuznar SAN ANTONIO, Tex -- December 11, 2009 -- Ibandronate is associated with significant and sustained pain relief in women with breast cancer and metastatic bone disease, while showing a favourable renal safety profile, according to a study presented here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). Renal safety is a key determinant of the risk/benefit assessment of a bisphosphonate, as some have been shown to have adverse effects on kidney function, said lead investigator Marcus Schmidt, MD, University Hospital, Mainz, Germany who presented the data here on December 10. In the interim analysis, 2,676 patients from the trial were evaluable. Women with metastatic breast disease received either intravenous ibandronate 6 mg every 3 to 4 weeks or oral ibandronate 50 mg once daily for up to 24 weeks. Nearly two-thirds (65%) of patients were naïve to bisphosphonate treatment at study entry; 12% received prior therapy with ibandronate; 14.7% received prior zoledronic acid; and 7.8% received previous pamidronate. At baseline, the mean pain severity score was lower for patients pretreated with ibandronate compared with those who were bisphosphonate-naïve or those pretreated with other bisphosphonates (2.7 vs 3.3 vs 3.4, respectively). Among the patients who reported pain at baseline, 64% had a reduction in their pain severity score throughout the observation period; and the mean pain severity score decreased from 3.2 at baseline to 2.4 at follow-up (P < .0001). “With the declining pain levels observed with ibandronate, the degree of pain medication decreased as well,” said Dr. Schmidt. Some 96% of patients and physicians rated the overall tolerability of ibandronate as “good” or “very good.” Of the 2,026 patients who were evaluable for renal function throughout the study period, the mean creatinine clearance at baseline was lower in patients pretreated with zoledronic acid (70.7 mL/min) compared with those not pretreated with a bisphosphonate (78.9 mL/min) or those pretreated with ibandronate (78 mL/min). A baseline creatinine clearance <=60 mL/min was 60% more likely in those pretreated with zoledronic acid compared with ibandronate pretreatment (P =.0061). The changes in renal function during ibandronate were small. [Presentation title: Ibandronate Shows Marked Pain Relief and a Favorable Renal Safety Profile - Updated Results of a Non Interventional Study in Breast Cancer Patients With Metastatic Bone Disease. Abstract 1108]
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