地舒单抗对骨转移有多大疗效？

Also known as denosumab, it is a powerful and effective bone resorption inhibitor and a targeted treatment drug for osteoporosis that targets the osteoclast regulatory pathway. In June 2010, the FDA approved denosumab (trade name: Prolia) for the treatment of osteoporosis in postmenopausal women, and was later approved for the treatment of osteoporosis in men, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer.

How effective is denosumab on bone metastasis?

A 3-year randomized, double-blind, placebo-controlled phase III clinical trial FREEDOM evaluated the effectiveness and safety of this product in the treatment of osteoporosis in postmenopausal women. Patients were randomly assigned to: treatment group (60 mg subcutaneous injection of this product, once 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).

Another randomized, placebo-controlled phase III clinical trial, DEFEND, evaluated the effect of this product in preventing osteoporosis in postmenopausal women. The average age of the subjects was 59.4 years old, and the spine T-scores were between -1.0 and -2.5 (the average was -1.61). They were randomly divided into the treatment group (60 mg of this product, subcutaneous injection, once every 6 months, n=166) or the placebo group (n=166). All patients were supplemented with 1000 mg of calcium every day, and the level of 25-hydroxyvitamin D in the plasma of the subjects was used to determine whether vitamin D supplementation was needed. The main evaluation index is the change in spinal BMD measured by dual energy X-ray absorptiometry (DXA) compared with the baseline level. The results showed that after 24 months, the BMD value of the spine was significantly increased compared with placebo (a 6.5% increase in the treatment group, compared with a 0.6% decrease in the placebo group). In addition, the BMD values ​​of all tested parts such as the hip bone and distal radius in the treatment group increased significantly. At the same time, markers of bone resorption and formation were significantly reduced. The overall incidence of adverse reactions in the treatment group was similar to that in the placebo group during the observation period.