2015
DOI: 10.1093/annonc/mdv307
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Objective tumor response to denosumab in patients with giant cell tumor of bone: a multicenter phase II trial

Abstract: A RANK ligand-specific inhibitor, denosumab, was predicted to reduce osteolysis and control disease progression in patients with giant cell tumor of bone (GCTB). We report, for the first time, the results of the response of GCTB to denosumab obtained from a prospective independent imaging assessment. The findings demonstrate that denosumab has robust clinical efficacy in the treatment of GCTB.

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Cited by 109 publications
(96 citation statements)
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“…In our study, SUV max values were reduced in 16 of 17 patients (94%) at first evaluation after median 4.7 weeks, suggesting that 18F-FDG PET/CT is an early and sensitive indicator of tumor response. Similar results were observed in two phase II studies, where 25 of 26 patients (96%) [10] and 14 of 17 patients [15] had a metabolic response according to EORTC criteria. However, whether 18F-FDG PET/CT improves treatment decisions based on clinical observations and conventional radiographic investigations is still unknown.…”
Section: Discussionsupporting
confidence: 86%
See 1 more Smart Citation
“…In our study, SUV max values were reduced in 16 of 17 patients (94%) at first evaluation after median 4.7 weeks, suggesting that 18F-FDG PET/CT is an early and sensitive indicator of tumor response. Similar results were observed in two phase II studies, where 25 of 26 patients (96%) [10] and 14 of 17 patients [15] had a metabolic response according to EORTC criteria. However, whether 18F-FDG PET/CT improves treatment decisions based on clinical observations and conventional radiographic investigations is still unknown.…”
Section: Discussionsupporting
confidence: 86%
“…Radiological evaluation criteria in GCTB are not established. Modified RECIST and inverse Choi criteria for CT and MRI and EORTC criteria for 18F-FDG PET/CT have been applied [10,15], and a varying degree of objective responses has been observed using the different criteria. In our study, SUV max values were reduced in 16 of 17 patients (94%) at first evaluation after median 4.7 weeks, suggesting that 18F-FDG PET/CT is an early and sensitive indicator of tumor response.…”
Section: Discussionmentioning
confidence: 99%
“…25 Recently, denosumab (monoclonal antibody against receptor activator of nuclear factor k ligand) has been approved for use in patients with unresectable or metastatic GCT tumour of the bone with encouraging results. 26 …”
Section: -21mentioning
confidence: 99%
“…Beispiele, wie das eines herkömmlich nicht operablen Riesenzelltumors des proximalen Humerus, welcher initial medikamentöse behandelt wurde, veranschaulichen diese Forderung (l " Abb. 1) [11]. Die am hĂ€ufigsten angewandten Techniken der klassischen Frakturversorgung kommen auch bei pathologischen Frakturen zum Einsatz, wobei ganz entscheidende adjuvante Maßnahmen nötig sein können: In der Regel wird das Tumorbett je nach EntitĂ€t lokal weit bis marginal reseziert oder intralĂ€sional unter Verwendung zytotoxischer Adjuvanzien (z.…”
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