地舒单抗治疗骨转移效果如何？

It is used to prevent bone-related events in patients with bone metastases from solid tumors; then, how effective is denosumab in treating bone metastases?

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

In a phase III randomized, controlled clinical study, the subjects were patients with prostate cancer bone metastases that were resistant to hormone therapy. Compared with zoledronic acid, denosumab also achieved encouraging results in terms of efficiency and safety in treating bone metastases. Desosumab showed advantages over zoledronic acid in delaying or preventing the first SHE.

This situation significantly inhibited osteolytic bone metabolism (uMTx) and bone-specific alkaline phosphatase (BSAP). Another RCT study of denosumab versus zoledronic acid in solid tumor bone metastases excluding breast and prostate cancer, and multiple myeloma bone disease (MBD of MM) obtained similar results to those in the breast and prostate cancer studies.

There was a statistically significant reduction in the occurrence of SRE. The experiment enrolled 1,776 patients with bone metastases who had not used bisphosphonates, including NSCLC, MM, SCLC, renal cancer, etc.; they were used once every 28 days, with subcutaneous injection of denosumab, intravenous infusion of zoledronic acid, and placebo.

The study results show that monthly subcutaneous injection of denosumab 120 mg is not inferior to zoledronic acid in delaying or preventing the incidence of SRE in bone metastasis of various tumors.

This situation also showed an advantage in terms of time to first SRE (20.6 months vs. 16.3 months). Compared with zoledronic acid, denosumab also significantly inhibited uNTx/Cr and showed a stronger anti-resorptive effect (reduced by 76% vs. 65%).

In view of this, the U.S. Food and Drug Administration (FDA) approved it for the prevention of bone disease in patients with cancer metastasis. It also includes fractures caused by cancer and bone pain requiring radiation therapy.