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© 2004 Oxford University Press
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Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer
For the Zoledronic Acid Prostate Cancer Study Group
Affiliations of authors: Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, Montréal, Québec, Canada (FS); Advanced Clinical Therapeutics, Tucson, AZ (DMG); Division of Hematology and Medical Oncology, Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia (RM); Pacific Shores Medical Group, Long Beach, CA (ST); Cross Cancer Institute, Edmonton, Alberta, Canada (PV), Le Centre de Recherche en Cancerologie del Université Laval, Québec, Québec, Canada (LL); London Health Sciences Centre, East London, Ontario, Canada (JLC); Irmandade de Santa Casa de Misericordia de Porto Alegre, Rio Grande do Sul, Brazil (JJV); Novartis Pharmaceuticals Corporation, East Hanover, NJ (JAG, MZ)
Correspondence to: Fred Saad, MD, Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, 1560 Rue Sherbrooke E., Montréal, PQ H2L 4M1 Québec, Canada (e-mail: fred.saad{at}ssss.gouv.qc.ca)
ABSTRACT
In a placebo-controlled randomized clinical trial, zoledronic acid (4 mg via a 15-minute infusion every 3 weeks for 15 months) reduced the incidence of skeletal-related events (SREs) in men with hormone-refractory metastatic prostate cancer. Among 122 patients who completed a total of 24 months on study, fewer patients in the 4-mg zoledronic acid group than in the placebo group had at least one SRE (38% versus 49%, difference = –11.0%, 95% confidence interval [CI] = –20.2% to –1.3%; P = .028), and the annual incidence of SREs was 0.77 for the 4-mg zoledronic acid group versus 1.47 for the placebo group (P= .005). The median time to the first SRE was 488 days for the 4-mg zoledronic acid group versus 321 days for the placebo group (P = .009). Compared with placebo, 4 mg of zoledronic acid reduced the ongoing risk of SREs by 36% (risk ratio = 0.64, 95% CI = 0.485 to 0.845; P = .002). Patients in the 4-mg zoledronic acid group had a lower incidence of SREs than did patients in the placebo group, regardless of whether they had an SRE prior to entry in the study. Long-term treatment with 4 mg of zoledronic acid is safe and provides sustained clinical benefits for men with metastatic hormone-refractory prostate cancer.
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Correspondence about this Article
- Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer
- Christopher C. Parker
J Natl Cancer Inst 2004 96: 1480.[Extract] [Full Text] [PDF]
- RESPONSE: Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer
- Fred Saad
J Natl Cancer Inst 2004 96: 1480-1481.[Extract] [Full Text] [PDF]
- Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-Refractory Prostate Cancer
- Tawee Tanvetyanon
J Natl Cancer Inst 2005 97: 70.[Extract] [Full Text] [PDF]
- RESPONSE: Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-Refractory Prostate Cancer
- Fred Saad
J Natl Cancer Inst 2005 97: 70-71.[Extract] [Full Text] [PDF]
- Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-Refractory Prostate Cancer
- Tal Grenader, Linda Shavit, Beatrice Uziely, and Tamar Peretz
J Natl Cancer Inst 2005 97: 235-236.[Extract] [Full Text] [PDF]
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