狄诺塞麦治疗骨转移效果

(denosumab, also known as AMG-162, trade name Prolia) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B (RANK) ligand, inhibits osteoclast activation and development, reduces bone resorption, and increases bone density. On November 18, 2010, the FDA approved denosumab for the treatment of bone metastases from solid tumors. The approval of this indication was based on the results of a total of three published phase III pivotal clinical trials comparing it with zoledronic acid.

These three randomized, double-blind trials included a total of 5723 cancer patients: Trial 1 was breast cancer patients with bone metastases; Trial 2 was prostate cancer patients with bone metastases; Trial 3 was solid tumors other than breast and prostate cancer with bone metastases and multiple myeloma. The efficacy of denosumab was compared with that of zoledronic acid (a bisphosphonate) in breast cancer, prostate cancer and other solid tumors with bone metastases, as well as in multiple myeloma. A comprehensive analysis of these three studies showed that compared with zoledronic acid: denosumab prolonged the time to the first adverse bone event (ARE) in patients by 17%, or significantly delayed the median time to the first SRE by 8.2 months (27.6 months vs. 19.4 months for zoledronic acid). months); denosumab prolonged the time from first episode to recurrence of SRE by 18% in the study; for patients with mild or no pain at study entry, denosumab also significantly prolonged the time to worsening pain compared with zoledronic acid. Compared with zoledronic acid, in addition to its outstanding clinical advantages, denosumab is easy to use and can be used as the first choice for patients with bone metastases in terms of monthly subcutaneous injection, no need for intravenous infusion, no need to monitor renal function, and no need to endure the first-pass effect caused by intravenous infusion of zoledronic acid.

Based on this, the European Committee for Medicinal Products for Human Use (CHMP) and the China National Medical Products Administration have successively approved the marketing application for denosumab. Based on this, NCCN guidelines also recommend its use for patients with bone metastases from solid tumors.