地诺单抗对骨转移的效果

Is (Denosumab) effective against bone metastasis? Denosumab (Denosumab) is a human immunoglobulin G2 (IgG2) monoclonal antibody with high specificity and affinity for RANKL. RANK receptor signaling promotes osteolysis and tumor growth.

A randomized, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of this product in the treatment of osteoporosis in postmenopausal women. Patients were randomly divided into 7 denosumab treatment groups [41 to 54 subjects in each group, receiving subcutaneous injection of denosumab 6, 14, 30 mg (all once every 3 months), 14, 60, 100 or 210 mg (all once every 6 months)], and a positive control group (orally administered alendronate sodium 70 mg, once per week) and the placebo group. The main evaluation index is the change of the patient's spinal bone mineral density (BMD) from the baseline level after treatment.

The results showed that after 12 months of denosumab treatment, compared with the baseline level, the spinal BMD of patients in the treatment group increased by 3.0% to 6.7%, the control group increased by 4.6%, and the placebo group decreased by 0.8% (P < 0.001). After 24 months, the spinal BMD of patients in the treatment group increased by 4.13% to 8.89%, while that in the placebo group decreased by 1.18%. The BMD of the hip and distal 1/3 of the radius in the treatment group was also significantly increased compared with the placebo. During this period, there were no significant differences in patient tolerability, BTM levels, and adverse reaction rates between groups. Among the 7 treatment groups, the 60 mg (once every 6 months) group has an ideal balance point in terms of safety and efficacy, and this dose will continue to be used in Phase III clinical trials in the future.

A patient survey showed that the majority of patients (77%) preferred to receive twice-yearly subcutaneous injections of denosumab.

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