地诺单抗治疗骨转移疗效如何呢？

(Xgeva) was first approved in the United States in 2010 for the prevention of bone-related events in adults with bone metastases from solid tumors. It was also approved in Europe in 2011 for the same indication. As medical research advances, the U.S. Food and Drug Administration has approved the expansion of its denosumab (Xgeva) for the treatment of giant cell tumor of bone (GCTB) in adults and certain adolescents, making it the first drug to treat the rare disease in the United States.

How effective is denosumab (Xgeva) in the treatment of bone metastases?

A 3-year randomized, double-blind, placebo-controlled phase III clinical trial FREEDOM evaluated the efficacy and safety of denosumab (Xgeva) in the treatment of osteoporosis in postmenopausal women. Patients were randomly assigned to: treatment group: denosumab (Xgeva) 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 (Xgeva) in treating bone metastases is very good.