Denosumab has robust clinical efficacy in the treatment of patients with giant cell tumor of bone (GCTB), a new study published online ahead of print in the journal Annals of Oncology has shown.
GCTB is a rare primary bone tumor that expresses receptor activator of nuclear factor-kappa B (RANK) and RANK ligand (RANKL). Therefore, researchers sought to evaluate the efficacy of denosumab, a RANKL specific inhibitor in patients with GCTB.
For the phase 2 trial, researchers enrolled 17 patients with GCTB. All patients received denosumab 120 mg every 4 weeks, with a loading dose of 120 mg on days 8 and 15. Patients were treated for a median of 13.1 months.
Results showed that 88% of patients achieved an objective tumor response based on best response using any tumor response criteria. Based on the modified RECIST criteria, 35% of patients achieved an objective tumor response.
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Researchers found that 82% and 71% had an objective tumor response based on the modified EORTC and Choi criteria, respectively.
Denosumab is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
- Ueda T, Morioka H, Nishida Y, et al. Objective tumor response to denosumab in patients with giant cell tumor of bone: a multicenter phase 2 trial. Ann Oncol. 2015. [epub ahead of print] doi: 10.1093/annonc/mdv307.