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RESEARCH PRODUCT

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.

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Abstract Background: Bisphosphonates (BP), the current standard of care for patients with metastatic bone disease (MBD) due to breast cancer (BC), effectively reduce the incidence of skeletal related events (SRE) and the severity of bone pain. However, BP treatment may adversely affect kidney function and thus renal safety is a key determinant of BP risk/benefit assessment. In randomized clinical trials (RCT), Ibandronate (IBA), a third generation amino-BP available in IV and oral formulations, has demonstrated sustained effects on SRE and bone pain with a low incidence of renal adverse events. To verify those results under real life conditions, a large-scale non interventional study (NIS) is currently being conducted in Germany.Patients and methods: In accordance with the terms of the marketing authorization, BC patients with MBD receive 6 mg IBA IV every 3–4 weeks or 50 mg of oral IBA once daily (at the physician's discretion) for up to 24 weeks. Pain severity (VAS), analgesic use (WHO analgesic ladder), SRE, and renal function (serum creatinine levels and estimated creatinine clearance, eCrCl; Cockcroft-Gault formula) are recorded in 4-week-intervals.Results: For this interim analysis, data for 2676 patients, mean age 63.6 ±11.8 years, were evaluated. 1735 (65%) were BP-naïve; 317 (12%) had received prior treatment with IBA, 614 (23%) with other BPs, including zoledronic acid (ZOL) (393; 15%) and pamidronate (PAM) (210; 8%). At baseline, mean pain severity (VAS) was lower for patients pretreated with IBA (2.7 ± 2.2) compared to BP-naïve patients (3.3 ± 2.4; p < 0.0001) or patients pretreated with other BPs (3.2 ± 2.4; p= 0.0041) and analgesic use was less frequent (38% vs 49% and 47%, respectively).In patients reporting pain at baseline, mean pain severity decreased on IBA treatment throughout the observation period (VAS: 3.2 ± 2.4 to 2.4 ± 2; p < 0.0001). In parallel, there was an overall reduction of analgesic use with 57% of patients not requiring analgesics at the end of the observation period. SRE were rare (7%), irrespective of prior treatment. For patients evaluable for renal function throughout the observation period, mean eCrCl at baseline was significantly lower in patients pretreated with ZOL (70.7 ml/min) than in BP-naïve (78.9 ± 30.9 ml/min; p < 0.0001) or IBA-pretreated patients (78 ± 29.1 ml/min; p=0.00386). Changes in renal function during IBA treatment were small and balanced across all subgroups. Overall tolerability of IBA treatment was rated as very good or good by 96% of physicians and patients alike.Conclusion: In this interim analysis of a large scale NIS in BC patients with MBD, IV and oral IBA showed marked and sustained pain relief with an overall reduction of analgesic use and a renal safety profile comparable to results of RCTs. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1108.