Department of Urology, First Affiliated Hospital of Wenzhou Medical College, ShangCai Village, Wenzhou, Ou Hai District, Zhejiang 325000, People's Republic of China.
Med Oncol. 2013;30(3):657. doi: 10.1007/s12032-013-0657-x. Epub 2013 Jul 18.
The aim of this study is to compare the efficacy and safety between zoledronic acid (ZA) and clodronate (CA) in the treatment of bone metastases for prostate cancer patients. We conducted a prospective study in recruiting 137 prostate cancer patients with bone metastases from 2008 to 2010. All men were well responding to first-line hormone therapy (PSA < 2 ng/mL); Patients were randomly assigned to receive zoledronic acid (4 mg over a 30 min infusion) every 1 month or to take 4 tablets per day of clodronate (1,600 mg) for up to 3 years. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry at femoral neck, lumbar spine, and total hip, together with visual analog scale score were evaluated on baseline and 6, 12, 24, and 36 months, respectively. Toxicity and skeletal-related events (SREs) happened in both groups during this period were recorded down and compared. The ZA group had better bone progression-free survival (BPFS) (31 months vs 22 months, P = 0.04), but no statistical evidence of benefit was observed in terms of overall survival rate. The ZA group significantly increased lumbar spine BMD (4.5 ± 2.3 % vs CA group 2.3 ± 3.9 % P = 0.03), had a better response on pain-relieve effect (92 vs 76 % P = 0.002) and a rapid pain palliation (9 months vs 13 months P = 0.03). The CA group reported more gastrointestinal cases. However, the ZA group required more dose modifications. As compared to clodronate, Zoledronic acid has advantages on extending BPFS, better bone pain control and lumbar spine BMD performance for prostate cancer patients with bone metastases. The overall survival rate and SREs rate are similar.
本研究旨在比较唑来膦酸（ZA）和氯膦酸（CA）治疗前列腺癌骨转移患者的疗效和安全性。我们进行了一项前瞻性研究，招募了 2008 年至 2010 年间的 137 例前列腺癌骨转移患者。所有患者均对一线激素治疗反应良好（PSA<2ng/mL）；患者被随机分配接受唑来膦酸（4mg 输注 30 分钟）每月一次或每日服用氯膦酸 4 片（1600mg），最长 3 年。在基线和 6、12、24 和 36 个月时，通过双能 X 线吸收法测量股骨颈、腰椎和全髋关节的骨密度（BMD），并分别评估视觉模拟评分。记录并比较两组在该期间发生的毒性和骨骼相关事件（SREs）。ZA 组的骨无进展生存期（BPFS）更好（31 个月比 22 个月，P=0.04），但总体生存率无统计学获益。ZA 组腰椎 BMD 明显增加（4.5±2.3%比 CA 组 2.3±3.9%，P=0.03），疼痛缓解效果更好（92%比 76%，P=0.002），疼痛缓解更快（9 个月比 13 个月，P=0.03）。CA 组报告更多胃肠道事件。然而，ZA 组需要更多剂量调整。与氯膦酸相比，唑来膦酸在延长 BPFS、更好地控制骨痛和提高腰椎 BMD 方面对前列腺癌骨转移患者具有优势。总体生存率和 SREs 率相似。
