地诺单抗治疗骨转移的治疗效果怎么样呢？

It has now been launched in my country, and more and more patients are consulting their medical partners about the therapeutic effect of denosumab in the treatment of bone metastases. Below, the medical companion tour will take you to understand the effect of denosumab from some trial data.

A randomized, placebo-controlled phase III clinical trial, DEFEND (Denosumab Fortifies Bone Density), evaluated the effect of denosumab 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 (mean was -1.61). They were randomly divided into a treatment group (denosumab 60 mg subcutaneous injection, once every 6 months, n = 166) or a placebo group (n = 166). All patients were supplemented with 1000 mg of vegetarian calcium every day, and 25-hydroxyvitamin D was passed through the subjects' plasma. The level determines whether vitamin D supplementation is 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, denosumab significantly increased spinal BMD compared with placebo (a 6.5% increase in the treatment group versus 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.

In 2010, denosumab was launched in the United States, and the FDA approved denosumab for the treatment of bone metastases from solid tumors based on the results of three published key clinical trials. A comprehensive analysis of these three studies showed that compared with zoledronic acid, denosumab prolonged the time to first adverse bone event (ARE) in patients by 17%, or significantly delayed the median time to first SRE by 8.2 months (27.6 months vs. 19.4 months). months), denosumab also prolonged the time from first episode to recurrence of SRE by 18% in the study; in addition, for patients with mild or no pain at study entry, denosumab also significantly prolonged the time to worsening pain compared with zoledronic acid.

It can be seen that the effect of treating bone metastases is very obvious, which brings good news to more and more patients with bone metastases.