地舒单抗治疗骨转移患者效果如何呢？

It is the first approved monoclonal antibody specifically targeting RANK ligand. RANK ligand is a transmembrane or soluble protein that is necessary for osteoclasts to maintain their structure, function, and survival. The mRNA of human RANKL is mainly found in bones, bone marrow and lymphoid tissues. Its main function in bones is to stimulate the differentiation and activity of osteoclasts and inhibit the apoptosis of osteoclasts. Osteoclasts are responsible for bone resorption, and osteoclast precursors must have low levels of macrophage colony-stimulating factor and RANKL during their differentiation into mature osteoclasts.

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 can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures.

A set of trial data clearly demonstrates the effect of denosumab in the treatment of patients with bone metastases. The trial was divided into treatment groups (denosumab 60 mg subcutaneously every 6 months, n=3902) or placebo (n=3906). The primary outcome measure was the incidence of new vertebral fractures over the 3-year period, and secondary outcomes included the incidence of hip and nonvertebral 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 T-score value of the spine or total hip 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, 7.2% in the placebo group, P < 0.0001), the incidence of hip fractures was relatively reduced by 40% (0.7% in the treatment group, 1.2% in the placebo group, P = 0.036), and the incidence of non-vertebral fractures was relatively reduced by 20% ( 6.5% in the treatment group and 8.0% in the placebo group, P =0.011).

It can be seen that the effect of treating patients with bone metastases is relatively good.