Objective tumor response to denosumab in patients with giant cell tumor of bone: A multicenter phase II trial

Takafumi Ueda, H. Morioka, Y. Nishida, S. Kakunaga, H. Tsuchiya, Y. Matsumoto, Y. Asami, T. Inoue, T. Yoneda

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Abstract

Background: Giant 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 methods: Seventeen 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. Results: The 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. Conclusion: The findings demonstrate that denosumab has robust clinical efficacy in the treatment of GCTB.

Original languageEnglish
Article numbermdv307
Pages (from-to)2149-2154
Number of pages6
JournalAnnals of Oncology
Volume26
Issue number10
DOIs
Publication statusPublished - 2015 Oct

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Keywords

  • Denosumab
  • Giant cell tumor of bone
  • Objective tumor response
  • Primary bone tumor
  • RANKL

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Ueda, T., Morioka, H., Nishida, Y., Kakunaga, S., Tsuchiya, H., Matsumoto, Y., Asami, Y., Inoue, T., & Yoneda, T. (2015). Objective tumor response to denosumab in patients with giant cell tumor of bone: A multicenter phase II trial. Annals of Oncology, 26(10), 2149-2154. [mdv307]. https://doi.org/10.1093/annonc/mdv307