Prescrire Int. 2012 Sep;21(130):204-6.
The standard treatment used to prevent clinical repercussions of bone metastases from solid tumours consists of an intravenous bisphosphonate such as pamidronic acid. Denosumab,a monoclonal antibody injected subcutaneously, has been licensed in the European Union for use in this setting. Three double-blind randomised trials including a total of about 6000 patients showed no tangible difference between denosumab and zoledronic acid in terms of mortality, disease progression, quality of life, or pain. The authors resorted to a composite endpoint in order to demonstrate a statistically significant difference in favour of denosumab. Overall, toxicity was similar with denosumab and zoledronic acid in the 3 trials. Adverse effects that were more frequent with denosumab than with zoledronic acid included jaw osteonecrosis (1.8% versus 1.3%) and hypocalcaemia (9.3% versus 4.7%). However, renal failure was less frequent (2.6% versus 3.7%). Denosumab is administered subcutaneously and zoledronic acid by intravenous infusion. It is not known whether local and systemic reactions to administration are different. In practice, there is no tangible reason to choose denosumab rather than a bisphosphonate.
用于预防实体瘤骨转移临床后果的标准治疗方法是静脉注射双膦酸盐类药物,如帕米膦酸。皮下注射的单克隆抗体地诺单抗已在欧盟获批用于此情况。三项双盲随机试验共纳入约6000名患者,结果显示地诺单抗和唑来膦酸在死亡率、疾病进展、生活质量或疼痛方面无明显差异。作者采用了一个复合终点来证明地诺单抗具有统计学上的显著优势。总体而言,在这三项试验中,地诺单抗和唑来膦酸的毒性相似。地诺单抗比唑来膦酸更常出现的不良反应包括颌骨坏死(1.8%对1.3%)和低钙血症(9.3%对4.7%)。然而,肾衰竭的发生率较低(2.6%对3.7%)。地诺单抗通过皮下注射给药,唑来膦酸通过静脉输注给药。尚不清楚给药的局部和全身反应是否不同。实际上,没有切实的理由选择地诺单抗而非双膦酸盐类药物。