地诺单抗治疗骨转移的治疗效果如何？

Denosumab (Prolia, produced by Amgen Pharmaceuticals) is an injectable monoclonal antibody. On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It is also used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures. Denosumab was approved for the first time in 27 EU member states, as well as Norway, Iceland, and Liechtenstein. In June of the same year, Denosumab was approved by the FDA for marketing.

How effective is Denosumab in the treatment of bone metastasis?

A 3-year randomized, double-blind, placebo-controlled phase III clinical trial FREEDOM evaluated the efficacy and safety of denosumab in the treatment of osteoporosis in postmenopausal women. Patients were randomly assigned to: treatment group (Denosumab 60 mg subcutaneous injection every 6 months, n = 3902) or placebo (n = 3906). The primary evaluation indicator was the incidence of new vertebral fractures during the 3-year period, and secondary indicators included the incidence of hip fractures and non-vertebral fractures and the time to first fracture during the observation period. The subjects were aged between 60 and 90 years old, with an average age of 72.3 years. The basic value of spine or total hip T-score was between -4.0 and -2.5 (the average was -2.8). About 23% of the subjects had a history of at least one fracture before entering this trial. All patients were also supplemented with 1000 mg of vegetarian calcium and 400 to 800 IU of vitamin D every day. The results showed that compared with the placebo group, the incidence of new vertebral fractures in the treatment group was reduced by 68% (2.3% in the treatment group and 7.2% in the placebo group, P<0.0001), and the incidence of hip fractures was relatively reduced by 40%. % (0.7% in the treatment group and 1.2% in the placebo group, P=0.036), and the incidence of nonvertebral fractures was relatively reduced by 20% (6.5% in the treatment group and 8.0% in the placebo group, P=0.011).

From the above research data, it can be seen that the therapeutic effect of Denosumab in the treatment of bone metastases is very good.