Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer.
Saad, Fred 1; Gleason, Donald M. 2; Murray, Robin 3; Tchekmedyian, Simon 4; Venner, Peter 5; Lacombe, Louis 6; Chin, Joseph L. 7; Vinholes, Jeferson J. 8; Goas, J. Allen 9; Zheng, Ming 9; For the Zoledronic Acid Prostate Cancer Study Group
[Miscellaneous Article] Journal of the National Cancer Institute. 96(11):879-882, June 2, 2004.

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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.

(C) Copyright Oxford University Press 2004.