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|The Lancet Oncology Publishes Results Of XGEVA® (denosumab) In Patients With Giant Cell Tumor Of Bone|
Based on the investigators' interim assessment, 96 percent (163/169) of patients with surgically unsalvageable GCTB had no disease progression after a median follow-up of 13 months. In those with salvageable GCTB whose surgery was associated with severe morbidity, 74 percent (74/100) of patients required no surgery, and 62 percent (16/26) of patients who had surgery underwent a less morbid procedure than planned. Overall, 72 percent of patients had objective tumor response, per protocol defined criteria, including 25 percent of patients who had an objective tumor response according to modified RECIST(Response Evaluation Criteria In Solid Tumors).
The overall safety profile was found to be consistent with the known safety profile of XGEVA in patients with advanced cancer. Osteonecrosis of the jaw was reported in one percent (3/281) of patients. Hypocalcemia adverse events, all non-serious, were reported in five percent (15/281) of patients. The most common severe adverse events were low phosphate levels, back pain, pain in extremity, depression, musculoskeletal pain and anemia. Serious adverse events were reported in nine percent (25/281) of patients. No treatment-related deaths were reported.
"These results demonstrate the effectiveness of XGEVA in the treatment of giant cell tumor of bone and reinforce our understanding of this rare disease in which RANK Ligand plays a central role," said
GCTB is a rare, osteolytic tumor of the bone that often results in complete destruction of the affected bone, leading to bone fracture, joint dysfunction, deformity or amputation. GCTB typically affects individuals between the ages of 20 to 40.
XGEVA was approved
XGEVA is a fully human monoclonal antibody that binds to RANK Ligand (RANKL), a protein essential for the formation, function and survival of osteoclasts - the cells responsible for bone resorption. Giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor. Signaling through the RANK receptor contributes to osteolysis and tumor growth. XGEVA prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors and osteoclast-like giant cells.
About Giant Cell Tumor of Bone
Most GCTB tumors occur in the long bones of the body, often around joints, but can also spread to the lungs in rare cases.4,5 Although giant cell tumors are slow growing, patients can experience severe bone pain, soft tissue and joint swelling, loss of mobility and pathologic fracture.4,5 Historically, there have been no approved therapies for GCTB. Surgery is the main treatment option for patients with resectable GCTB; however, surgery, such as amputation, may be associated with significant morbidity.1 These tumors also have a higher recurrence rate within the first three years of surgical intervention.1 When tumors recur, they become more difficult to treat and more likely to spread to other parts of the body.1
In 2013, XGEVA was approved by the
XGEVA Important Safety Information
Osteonecrosis of the Jaw (ONJ)
Atypical Subtrochanteric and Diaphyseal Femoral Fracture
The most common adverse reactions in patients receiving XGEVA for giant cell tumor of bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. The most common serious adverse reactions were osteonecrosis of the jaw and osteomyelitis.
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1 Thomas D, Henshaw R, Skubitz K, et. al. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010;11:275–280.