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This abstract will not be presented at the 2007 Prostate Cancer Symposium but has been published in conjunction with the meeting.
Abstract No:
283
Author(s):
F. Saad
Abstract:
Background: The majority of patients diagnosed with advanced prostate cancer will develop bone metastases and may experience skeletal complications such as pathologic fractures. Fractures are associated with decreased survival in patients with prostate cancer and may result in extended convalescence or permanent impairment. Therefore, patients with bone metastases are at long-term risk of developing skeletal-related events (SREs), each of which has been associated with a reduction in quality of life. Zoledronic acid has been shown to significantly reduce skeletal morbidity compared with placebo (Saad et al. J Natl Cancer Inst. 2004;96:879-882). Methods: Exploratory analyses of the pivotal randomized, controlled clinical trial were performed to assess the effect of zoledronic acid on survival, SREs, and pain. Literature searches were performed on preclinical studies to determine the potential antitumor effects of zoledronic acid in prostate cancer models. Results: Patients with prostate cancer who received 4 mg zoledronic acid demonstrated a trend toward longer survival compared with placebo (18.2 months versus 15.6 months, respectively). Although fractures were significantly related to risk of death, the death rate was slightly lower for patients treated with zoledronic acid compared with placebo (66% versus 73%, respectively) (Saad et al. J Clin Oncol. 2006;24(suppl):230s. Abstract 4555). Zoledronic acid has demonstrated significant reductions in mean composite Brief Pain Inventory scores in a randomized controlled trial (Saad et al. J Natl Cancer Inst. 2004;96:879-882) and in mean visual analogue scale pain scores in an open-label, single-arm study (Vogel et al. Oncologist. 2004;9:687-695). Furthermore, zoledronic acid demonstrated preclinical evidence of antitumor activity in multiple prostate cancer cell lines and animal models. Conclusions: Recent exploratory analyses and preclinical studies suggest that zoledronic acid can provide quality-of-life and clinical benefits to patients with prostate cancer. Zoledronic acid is the only bisphosphonate that has demonstrated a trend toward prolonged survival compared with placebo in patients with bone metastases from prostate cancer.
3. A phase II randomized study of custirsen (OGX-011) combination therapy in patients with poor-risk hormone refractory prostate cancer (HRPC) who relapsed on or within six months of 1st-line docetaxel therapy.