Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, Montréal, Quebec, Canada

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We previously reported the efficacy of zoledronic acid 4 mg versus placebo (every 3 weeks for 24 months) for the prevention of skeletal-related events (SREs) in men with advanced prostate cancer and bone metastases. We conducted several retrospective exploratory analyses to determine whether zoledronic acid has continuing efficacy during long-term treatment.

This report included analysis of the occurrence of SREs during the extension phase only (months 16-24), analysis of skeletal complications excluding the first SRE at 15 months (core phase), and stratified analysis of patients by history of SREs before study entry.

Patients (N=422) were randomized to receive zoledronic acid 4 mg or placebo. For the 132 patients who entered the extension phase, zoledronic acid significantly delayed the onset of first SRE (P=.009) and decreased the risk of developing an SRE by 53% compared with placebo (P=.022). Among all 422 patients, zoledronic acid significantly reduced the incidence of a second on-study SRE (P=.017) and significantly delayed the median time to second SRE compared with placebo (P=.006) at 15 months. Among 144 patients (34%) with a history of SREs before study entry, zoledronic acid significantly reduced the skeletal morbidity rate by 65% (P=.036) and reduced the overall risk of developing an SRE by 40% (P=.028) compared with placebo at 24 months.

This analysis confirms our previously reported results and suggests that long-term treatment with zoledronic acid provides continuing clinical benefit in patients with advanced prostate cancer, even after the occurrence of SREs.

Written by
Saad F, Chen YM, Gleason DM, Chin J.

Reference
Clin Genitourin Cancer. 2007 Sep;5(6):390-6

PubMed Abstract
PMID:17956712

UroToday.com Prostate Cancer Section

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