Wirth M.P., Schmidt K., Miller K., Eickenberg H.U., Lein M., Haus U., Stoeckle M., Graefen M., Stenzl A., Effert P.

Presented on March, 22 2007

INTRODUCTION & OBJECTIVES: The majority of patients with advanced prostate cancer will develop bone metastases, which can lead to painful, debilitating skeletal complications termed skeletal-related events (SREs: pathologic fractures, spinal cord compression, surgery to bone, palliative radiotherapy to bone, and change in antineoplastic therapy to treat bone pain). SREs can contribute to poor prognosis and reduced quality of life. A trial was conducted in Germany to verify the efficacy of zoledronic acid in reducing the incidence of SREs and pain, and to gain further insight into the benefits of therapy.

MATERIAL & METHODS: In a prospective, single-arm multicenter study, patients with prostate cancer with bone metastases were treated with zoledronic acid 4 mg every 4 weeks for 15 months. The primary endpoint was rate of SREs. Secondary endpoints (eg, pain reduction, consumption of analgesics) were recorded every 3 months.

RESULTS: Patients (N = 308) were treated in 36 medical centers in Germany between 2002 and 2005. Among patients available for analysis of efficacy (n = 284), 67 (23.6%) had at least 1 SRE during the course of study (primarily radiation therapy and pathologic fracture/spinal cord compression). The mean time to first SRE was 11.5 months. Patients who had not previously experienced an SRE (n = 248) had a 59% reduced risk of SREs and a longer mean time to first SRE (11.6 versus 8.3 months for 36 patients with history of SREs). Patients with a prior SRE had an increased risk (odds ratio = 2.4) of developing an additional SRE.

CONCLUSIONS: This study suggests that early treatment with zoledronic acid (before the appearance of SREs) in patients with bone metastases from prostate cancer may be of benefit by lowering risk of SREs and prolonging time to first SRE. Additional trials are needed to support these data.

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