地舒单抗对骨转移有多大的疗效呢?
How effective is it against bone metastasis?
The therapeutic effect of denosumab in the treatment of bone metastases:
Data on the safety and usefulness of denosumab for bone metastases from solid tumors come from three global randomized, double-blind controlled trials. In these three trials, patients were randomly assigned to denosumab (120 mg every four weeks) or zoledronate (4 mg every four weeks). Patients with creatinine clearance less than 30 mL/min were excluded. The primary endpoint of the trial was that time to first bone-related events (SREs) was non-inferior to zoledronic acid.
Study 20050136 (NCT00321464) included 2046 patients with advanced breast cancer with bone metastases. Forty percent of patients had experienced bone-related events, 40% had received chemotherapy within 6 weeks before randomization, 5% had received oral bisphosphonates, and 7% of patients were from Japan. The median age of all patients was 57 years, 80% of patients were white, and 99% were female.
Study 20050244 (NCT00330759) enrolled 1,776 adults with bone metastases from solid tumors (excluding breast cancer, prostate cancer, multiple myeloma, etc.). At the time of randomization, 87% of patients were receiving systemic anticancer treatment, 52% had experienced bone-related events, 64% were male, 87% were white, and the median age was 60 years. Among all patients, 40% had non-small cell lung cancer, 10% had multiple myeloma, 9% had renal cell carcinoma, and 6% had small cell lung cancer. Other types of tumors each account for no less than 5% of the enrolled population.
Study 20050103 (NCT00321620) enrolled 1901 men with castration-resistant prostate cancer with bone metastases. 26% of patients had a previous bone-related event, 15% had a PSA less than 10 ng/mL, and 14% had received chemotherapy within 6 weeks before randomization. The median age of all patients was 71 years, and 86% of patients were white.
Experimental results show that compared with zoledronic acid, it effectively delays the onset of the first bone-related event.
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