Yonsei Med J.  2007 Dec;48(6):1001-1008. 10.3349/ymj.2007.48.6.1001.

A Prospective, Multicenter, Open-label Trial of Zoledronic Acid in Patients with Hormone Refractory Prostate Cancer

• Hong SJ
• Cho KS
• Cho HY
• Ahn H
• Kim CS
• Chung BH

• KMID: 1786216
• DOI: http://doi.org/10.3349/ymj.2007.48.6.1001

Abstract

PURPOSE: The short-term safety and efficacy of zoledronic acid for the treatment of skeletal metastasis was evaluated in patients with hormone-refractory prostate cancer. PATIENTS AND METHODS: A total of 19 hormone-refractory prostate cancer patients with bone metastases were enrolled. All patients received up to six infusions of zoledronic acid (4mg, given intravenously over 15 minutes, every 3-4 weeks). Safety was assessed by monitoring a`dverse events and serum creatinine levels. Efficacy was assessed by monitoring skeletal-related events, brief pain inventory score, quality of life score, type of pain medication, and analgesic score. Mean age of patients was 67.3 years (46-86 years), mean time from diagnosis of bone metastases was 27.6 months (0-117 months), and mean time from diagnosis of hormone-refractory disease was 7.5 months (0-26 months). RESULTS: There was no clinically significant change in serum creatinine levels. Eleven adverse events (musculoskeletal disorders and systemic disorders) in 8 patients were classed as having a possible relationship to study drug. Fifteen patients completed six courses of zoledronic acid infusion. There were no significant changes in the brief pain inventory composite scores, quality of life questionnaire scores or analgesic score. No new skeletal-related events developed during the treatment period. CONCLUSION: Zoledronic acid administered in this study as a 15-minute infusion demonstrated an acceptable and well-known safety profile in patients with refractory prostate cancer with bone metastases. However, prospective placebo- controlled clinical trials are required to elucidate the efficacy of zoledronic acid.

Keyword

Prostatic neoplasms; neoplasm metastasis; zoledronic acid

MeSH Terms

Aged
Aged, 80 and over
Antineoplastic Agents, Hormonal/therapeutic use
Bone Density Conservation Agents/adverse effects/therapeutic use
Bone Neoplasms/drug therapy/secondary
Creatinine/blood
Diphosphonates/adverse effects/*therapeutic use
Drug Resistance, Neoplasm
Humans
Imidazoles/adverse effects/*therapeutic use
Male
Middle Aged
Prospective Studies
Prostatic Neoplasms/*drug therapy/pathology
Quality of Life
Treatment Outcome

Figure

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  Fig. 1 Change of brief pain inventory composite scores.

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  Fig. 2 Change of mean analgesic scores.

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