狄诺塞麦对骨转移有多大的效果？

The US FDA approved it on November 18, 2010 to prevent bone-related events (SREs) in tumor patients whose cancer has metastasized and damaged bone. So-called bone-related events include pathological fractures caused by cancer, hypercalcemia, bone surgery or radiotherapy, and spinal cord compression. However, the approved population for denosumab does not include patients with multiple myeloma or other leukemias.

So, how effective is denosumab on bone metastases?

The therapeutic effect of denosumab in the treatment of bone metastases:

A randomized, double-blind phase III clinical study showed that denosumab was significantly more effective than zoledronic acid in Asian patients with bone metastases from solid tumors.

This study included a total of 485 adult patients (ECOG score 0-2) who had been diagnosed with bone metastases from solid tumors (mainly breast cancer and non-small cell lung cancer). They were randomly divided into the denosumab group (n = 326, 120 mg, subcutaneous injection, once every 4 weeks) and the zoledronic acid group (n = 159,4 mg, intravenous injection, once every 4 weeks) at a ratio of 2:1. They were treated for 49 weeks and followed up until 73 weeks. The primary endpoint was the percent change from baseline in urinary creatinine-adjusted urinary type I collagen cross-linked amino terminal peptide (uNTx/uCr) at 13 weeks, with additional endpoints being the change from baseline in bone-specific alkaline phosphatase (S-BALP) at 13 weeks and time to first bone-related event during the study period.

The results showed that the change in uNTx/uCr was -81.9% in the denosumab group and -75.2% in the zoledronic acid group. There was a significant difference between the two groups. The mean changes in S-BALP from baseline were -36.8% in the denosumab group and -30.3% in the zoledronic acid group, with significant differences between the two groups. The proportion of patients who had a bone-related event in the first year of the study was lower in the denosumab group than in the zoledronic acid group. There was no significant difference in the incidence of adverse events between the two groups.

It is not difficult to see from the above research results that the efficacy of preventing bone-related events after bone metastasis of solid tumors is better than that of zoledronic acid, and there is no risk of safety.