狄诺塞麦可以治愈骨巨细胞瘤吗？

Can (denosumab) cure giant cell tumor of bone? Denosumab is a powerful and effective bone resorption inhibitor and a targeted treatment drug for osteoporosis that targets the osteoclast regulatory pathway. On May 27, 2019, Amgen China announced today that Denosumab Injection has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection may lead to severe functional impairment, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

In 2013, the U.S. FDA approved denosumab (denosumab) produced by Amgen for the treatment of relapsed and refractory giant cell tumor of bone in adults and certain adolescents.

Denosumab was first approved in the United States in 2010 for use in patients with solid tumor bone metastases to prevent bone-related events. In 2011, it was also approved in Europe for the same indication.

A Phase II clinical trial before the FDA approved denosumab (denosumab) for the treatment of giant cell tumor of bone showed that 163 patients had no significant disease progression after an average of 10 months of follow-up. Another phase II clinical trial showed that among 100 patients who were likely to suffer severe disability if treated with surgery, 74% avoided surgery. Among 26 patients who underwent surgery, 16 had significantly less disability after surgery than expected before surgery.

The latest analysis of the study, presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2017, showed that among patients who could be surgically resected, 80% improved after treatment with neoadjuvant denosumab (denosumab): 44% underwent surgery with less impact on function, and 37% avoided surgery. In unresectable patients, denosumab resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%.

Denosumab (denosumab) can cause massive necrosis in giant cell tumors of bone. Its effect is better than the previously used bisphosphonates and interferons, and its side effects are also less than the above two drugs. If medication is started before surgery, the surgery can sometimes be simplified and the recurrence of tumors after surgery can be reduced. For patients with recurrence, the drug can shrink the tumor and facilitate re-operation.

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