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How effective is the treatment of bone metastasis?

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

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% 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 therapy, 52% had experienced a bone-related event, 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) included 1901 men with castration-resistant prostate cancer with bone metastases. Twenty-six percent 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.

The above three trial results show that compared with zoledronic acid, denosumab effectively delays the time to the first bone-related event.

Lung cancer and other solid tumors (including multiple myeloma): denosumab: 20.5 months vs. zoledronic acid: 16.3 months.

Lung cancer and other solid tumors (excluding multiple myeloma): denosumab: 21.4 months vs. zoledronic acid: 15.4 months.

Prostate cancer bone metastasis: denosumab: 20.7 months vs. zoledronic acid: 17.1 months.

Breast cancer bone metastasis: 60% of patients in the zoledronic acid group had no serious bone-related events within 27 months (end of trial) vs. more than 50% of patients in the zoledronic acid group had serious bone-related events before the end of the trial.