Chawla S, Blay JY, Rutkowski P, et al. - Among patients with surgically salvageable or unsalvageable giant-cell tumour of bone (GCTB), whether denosumab has safety and activity was determined in this phase 2 multicentre, open-label study performed at 30 sites in 12 countries. Three cohorts were included: cohort 1 comprised of patients with surgically unsalvageable GCTB, cohort 2 included patients with surgically salvageable GCTB with planned surgery expected to cause severe morbidity and cohort 3 involved patients enrolled from a prior study of denosumab for GCTB. During the treatment phase, 120 mg subcutaneous denosumab was administered to patients once every 4 weeks, with loading doses (120 mg subcutaneously) delivered on study days 8 and 15 to those in cohorts 1 and 2 (patients in cohort 3 did not receive loading doses). Hypophosphataemia, osteonecrosis of the jaw, and anaemia were identified as the most commonly occurred grade 3 or worse adverse events, during the treatment phase. Of 526 patients, 138 (26%) suffered serious adverse events; the most frequent being osteonecrosis of the jaw, bone giant cell tumour, and back pain. In this study, the observed types and frequencies of adverse events were compatible with the recognized safety profile of denosumab, which demonstrated long-term disease control for patients with GCTB with unresectable and resectable tumours. Findings revealed a favourable overall risk to benefit ratio for denosumab in patients with GCTB.