Clinical Benefit of Zoledronic Acid for the Prevention of Skeletal Complications in Advanced Prostate Cancer

Fred Saad
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引用次数: 63

Abstract

Men with prostate cancer are at high risk of developing bone metastases that can lead to clinically significant skeletal morbidity. Recently, a randomized, placebo-controlled, phase III trial in 422 men with hormone- refractory prostate cancer and bone metastases demonstrated that zoledronic acid (4 mg every 3 weeks) significantly reduced the incidence and onset of skeletal complications and provided significant long-term reductions in bone pain compared with placebo. Patients received zoledronic acid for a 15-month core phase, with the option to continue therapy for 9 more months on the extension phase. To evaluate the continuing benefit of long-term zoledronic acid therapy, retrospective exploratory analyses were conducted based on the incidence of skeletal-related events (SREs; defined as pathologic bone fracture, spinal cord compression, surgery or radiation therapy to bone, or change in antineoplastic therapy for bone pain) occurring only during the extension phase of this trial. Quality of life parameters included assessment with the Brief Pain Inventory. Similar to results reported for the 15-month core phase and the entire 24-month study, the 9-month extension phase demonstrated that zoledronic acid significantly reduced the percentage of patients with an SRE (P = 0.017), prolonged the median time to first SRE (P = 0.036), reduced the annual incidence of SREs by 52% (P = 0.016), and reduced the risk of SREs by 53% (P = 0.022) compared with placebo. Furthermore, zoledronic acid was safe and well tolerated. Therefore, zoledronic acid provides long-term continuing clinical benefit for men with prostate cancer and bone metastases and represents a new therapeutic option for this population.

唑来膦酸预防晚期前列腺癌骨骼并发症的临床疗效
患有前列腺癌的男性发生骨转移的风险很高,这可能导致临床上显著的骨骼疾病。最近,一项针对422名激素难治性前列腺癌和骨转移患者的随机、安慰剂对照III期试验表明,与安慰剂相比,唑来膦酸(每3周4mg)显著降低了骨骼并发症的发生率和发作,并显著降低了骨痛的长期发生率。患者在15个月的核心期接受唑来膦酸治疗,并可选择在延长期继续治疗9个月。为了评估长期唑来膦酸治疗的持续益处,根据骨骼相关事件(SREs;定义为仅在本试验延长阶段发生的病理性骨折、脊髓压迫、骨手术或放射治疗或骨痛抗肿瘤治疗的改变。生活质量参数包括用简短疼痛量表进行评估。与15个月的核心期和整个24个月的研究结果相似,9个月的延长期表明,与安慰剂相比,唑来onic酸显著降低了SRE患者的百分比(P = 0.017),延长了第一次SRE的中位时间(P = 0.036),将SREs的年发病率降低了52% (P = 0.016),将SREs的风险降低了53% (P = 0.022)。此外,唑来膦酸是安全的,耐受性良好。因此,唑来膦酸为前列腺癌和骨转移患者提供了长期持续的临床益处,代表了这一人群的一种新的治疗选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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