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

Research output: Contribution to journalArticle

45 Citations (Scopus)

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 - Oct 2015

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Giant Cell Tumor of Bone
RANK Ligand
Neoplasms
Osteoclasts
Receptor Activator of Nuclear Factor-kappa B
Osteolysis
Time and Motion Studies
Giant Cells
Stromal Cells
Disease Progression
Denosumab
B-Lymphocytes
Therapeutics
Bone and Bones
Research

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Ueda, T., Morioka, H., Nishida, Y., Kakunaga, S., Tsuchiya, H., Matsumoto, Y., ... 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

Objective tumor response to denosumab in patients with giant cell tumor of bone : A multicenter phase II trial. / Ueda, Takafumi; Morioka, H.; Nishida, Y.; Kakunaga, S.; Tsuchiya, H.; Matsumoto, Y.; Asami, Y.; Inoue, T.; Yoneda, T.

In: Annals of Oncology, Vol. 26, No. 10, mdv307, 10.2015, p. 2149-2154.

Research output: Contribution to journalArticle

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, vol. 26, no. 10, mdv307, pp. 2149-2154. https://doi.org/10.1093/annonc/mdv307
Ueda, Takafumi ; Morioka, H. ; Nishida, Y. ; Kakunaga, S. ; Tsuchiya, H. ; Matsumoto, Y. ; Asami, Y. ; Inoue, T. ; Yoneda, T. / Objective tumor response to denosumab in patients with giant cell tumor of bone : A multicenter phase II trial. In: Annals of Oncology. 2015 ; Vol. 26, No. 10. pp. 2149-2154.
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