• T Ueda, H Morioka, Y Nishida, S Kakunaga, H Tsuchiya, Y Matsumoto, Y Asami, T Inoue, and T Yoneda.
• Department of Orthopaedic Surgery, Osaka National Hospital, Osaka uedat@onh.go.jp.
• Ann. Oncol. 2015 Oct 1; 26 (10): 2149-54.

BackgroundGiant cell tumor of bone (GCTB) is a rare primary bone tumor, characterized by osteoclast-like giant cells that express receptor activator of nuclear factor-kappa B (RANK), and stromal cells that express RANK ligand (RANKL), a key mediator of osteoclast activation. A RANKL-specific inhibitor, denosumab, was predicted to reduce osteolysis and control disease progression in patients with GCTB.Patients And MethodsSeventeen patients with GCTB were enrolled. Patients were treated with denosumab at 120 mg every 4 weeks, with a loading dose of 120 mg on days 8 and 15. To evaluate efficacy, objective tumor response was evaluated prospectively by an independent imaging facility on the basis of prespecified criteria.ResultsThe proportion of patients with an objective tumor response was 88% based on best response using any tumor response criteria. The proportion of patients with an objective tumor response using individual response criteria was 35% based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, 82% based on the modified European Organization for Research and Treatment of Cancer (EORTC) criteria, and 71% based on inverse Choi criteria. The median time of study treatment was 13.1 months.ConclusionThe findings demonstrate that denosumab has robust clinical efficacy in the treatment of GCTB.© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

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