Denosumab in patients with giant-cell tumor of bone in Norway: results from a nationwide cohort

Abstract

Background: Denosumab is a relatively new treatment option for patients with giant-cell tumor of bone (GCTB). The purpose of this study was to report the results for patients treated in Norway. Materials and methods: Patients treated with denosumab for GCTB were identified from the clinical databases at the Norwegian sarcoma reference centers. Data were retrieved from the clinical databases and supplemented by retrospective review of patient records. Denosumab was given as a subcutaneous injection every 4 weeks with loading doses on day 8 and 15 in cycle 1. Results: Eighteen patients treated with denosumab for GCTB were identified. Denosumab was given for recurrent disease in seven cases and as first-line treatment in 11 patients, of which 6 received therapy as part of a neoadjuvant/adjuvant strategy and 5 for surgically unsalvageable primary tumor. Ten of 12 patients with unresectable disease are still on denosumab without progression with median treatment duration of 41 months (range 18-60). Two patients discontinued treatment due to osteonecrosis of the jaw and reduced compliance, respectively. In the adjuvant group, four patients experienced disease recurrence after stopping denosumab. In three of six patients, the extent of surgery was reduced due to neoadjuvant therapy. Seventeen of 18 patients underwent response evaluation with 18F-FDG PET/CT at median 4.7 weeks from starting denosumab. Median baseline SUV max was 11.0 and median SUV max at evaluation was 4.9 (p < 0.001). Conclusions: In a nationwide GCTB patient cohort, denosumab was an effective agent and durable responses were observed. Our results do not support the use of adjuvant therapy in routine clinical practice. 18F-FDG PET/CT could be a valuable tool for early response evaluation.

Short‐term Preoperative Denosumab With Surgery in Unresectable or Recurrent Giant Cell Tumor of Bone

“…Despite the encouraging results, a few questions still exit. First, consensus regarding denosumab treatment dose and duration has not been reached, with published reports describing widely varying denosumab treatment durations. Second, very few studies have exclusively evaluated the combination regime of “neoadjuvant” denosumab with surgery without postoperative denosumab use, especially for those unresectable or recurrent GCTB.…”

Pre-operative denosumab is associated with higher risk of local recurrence in giant cell tumor of bone: a systematic review and meta-analysis

“…On MRI, marrow replacement by tissue with different signal intensity were reported [18]. For 18F-FDG PET/CT, studies found 94-96% cases underwent denosumab treatment had decreased SUVmax values [10,29]. Ueda et al [11] used CT/MRI and 18FDG-PET/PET-CT to assess objective response of giant cell tumor of bone after denosumab treatment and found a 35%/82%/71% response rate according to RECIST/ EORTC/Choi Criteria respectively, suggesting a robust radiographic response after denosumab treatment.…”

Denosumab: Current Use in the Treatment of Primary Bone Tumors

“…In a recent retrospective study, denosumab was administered to 18 patients to treat primary (n=11; 61%) or recurrent (n=7; 39%) giant cell tumor of bone. 37 Ten patients who had unresectable tumors did not show disease progression after 18 to 60 months of denosumab administration. This study also identified positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro-D-glucose integrated with computed tomography as a useful tool for assessing patient response to denosumab treatment.…”