Dr. Palmerini on Long-term Efficacy of Denosumab in Giant Cell Tumor of Bone

Emanuela Palmerini, MD, Prometeo Laboratory: Clinical and Experimental Research Contract, Chemotherapy for Rare Musculoskeletal Tumors Department, Rizzoli Orthopaedic Institute, discusses the long-term efficacy of denosumab (Xgeva) in patients with giant cell tumor of bone (GCTB).

The phase II study enrolled more than 500 patients with GCTB, which is defined as a progressive osteolytic tumor, in 3 cohorts: unresectable disease (cohort 1), resectable disease with planned high morbidity surgery (cohort 2), and prior GCTB study patients (cohort 3). Patients were treated with subcutaneous denosumab, which is a monoclonal antibody, at 120 mg every 4 weeks with loading doses on days 8 and 15. With a primary endpoint of safety and progression-free survival, results showed that the drug was able to safely control the disease in all patients with metastatic or unresectable disease.

The overall response rates in cohorts 1 and 2 were both 99%. The recurrence risk was 27% following surgery in those patients with high-risk resectable disease.

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