Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer.
نویسندگان
چکیده
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.
منابع مشابه
Zoledronic acid in the management of metastatic bone disease
Many patients with advanced cancer experience decreased bone strength due to metastatic foci, underlying osteoporosis and/or cancer treatment induced bone loss. The clinical consequences of metastatic disease involving the skeleton are widespread. This review focuses on the efficacy, pharmacology, and safety when using intravenous biphosphonate such a zoledronic acid for cancer bone metastases....
متن کاملThe incidence of skeletal complications experienced by patients with metastatic prostate cancer is illustrated by the placebo group of a recent study of zoledronic acid in men with hormone-refractory prostate cancer
1522. 27.Saad F, Gleason D, Murray R, et al.,“Long-term reduction of bone pain with zoledronic acid in patients with advanced prostate cancer metastatic to bone”, [poster], Poster presented at:American Urological Association Annual Meeting;April 26 May 1, 2003; Chicago, Illinois,Abstract 1473. 28.Major P P, Cook R J, Chen B-L and Zheng M,“Zoledronic acid reduces the need for radiation to bone i...
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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 (4 mg, given intravenously over 15 minutes, every...
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عنوان ژورنال:
- Journal of the National Cancer Institute
دوره 97 3 شماره
صفحات -
تاریخ انتشار 2004