Pan Yue, Jin Haiyong, Chen Wei, Yu Zhixian, Ye Tingyu, Zheng Yuancai, Weng Zhiliang, Wang Feng
Department of Urology, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, People's Republic of China.
Int Urol Nephrol. 2014 Dec;46(12):2319-26. doi: 10.1007/s11255-014-0824-9. Epub 2014 Sep 16.
The aim of this study was to evaluate the efficacy and safety of zoledronic acid (ZA) in the combination of docetaxel-based chemotherapy for castration-resistant prostate cancer with bone metastases.
We conducted a prospective study in recruiting 105 prostate cancer patients with bone metastases from 2008 to 2010. Patients were randomly divided into two groups, 53 in the docetaxel-based chemotherapy + ZA(Group A) and 52 in the docetaxel-based chemotherapy + placebo(Group B). The different outcome between patients treated with chemotherapy combined with ZA and those with chemotherapy alone was evaluated. The Cox multivariate analyses of clinical features and different treatment methods of the 105 patients were conducted.
There was a response of prostate-specific antigen (PSA) in 33 (62.3 %) in Group A and 28 (53.8 %) in Group B (P = 0.20). The combined approach group had better bone progression-free survival (BPFS) (9.0 vs. 6.0 months, P < 0.05) and overall survival (OS) (19.0 vs. 15.0 months, P = 0.02), but no statistical evidence of benefit was observed in terms of PSA response. Cox multivariate analysis identified the following independent prognostic factors: received ZA, high Hb level and more than 6 cycles of chemotherapy. There were no clinical relevant differences in the frequencies of adverse events between these two groups.
Zoledronic acid treatment combined with docetaxel-based chemotherapy could have a better bone pain control and improve BPFS and OS for prostate cancer patients with bone metastases. The PSA response and SREs rate are similar.
本研究旨在评估唑来膦酸（ZA）联合多西他赛化疗用于去势抵抗性前列腺癌伴骨转移患者的疗效和安全性。
我们于2008年至2010年进行了一项前瞻性研究，招募了105例前列腺癌伴骨转移患者。患者被随机分为两组，53例接受多西他赛化疗+ZA（A组），52例接受多西他赛化疗+安慰剂（B组）。评估了化疗联合ZA治疗的患者与单纯化疗患者之间的不同结局。对这105例患者的临床特征和不同治疗方法进行了Cox多因素分析。
A组33例（62.3%）前列腺特异性抗原（PSA）有反应，B组28例（53.8%）有反应（P = 0.20）。联合治疗组有更好的无骨进展生存期（BPFS）（9.0个月对6.0个月，P < 0.05）和总生存期（OS）（19.0个月对15.0个月，P = 0.02），但在PSA反应方面未观察到统计学上的获益证据。Cox多因素分析确定了以下独立预后因素：接受ZA治疗、高血红蛋白水平和化疗超过6个周期。两组不良事件发生频率无临床相关差异。
唑来膦酸治疗联合多西他赛化疗可为前列腺癌伴骨转移患者更好地控制骨痛，并改善BPFS和OS。PSA反应和骨相关事件发生率相似。
