Lancet Oncol 2019 12 6;20(12):1719-1729. Epub 2019 Nov 6.
Chemotherapy Unit, IRCCS Istituto Ortopedico Rizzoli/Department of Experimental, Diagnostic and Specialty Medicine, Università di Bologna, Bologna, Italy. Electronic address:
Background: Giant-cell tumour of bone (GCTB) is a rare, locally aggressive osteoclastogenic stromal tumour of the bone. This phase 2 study aimed to assess the safety and activity of denosumab in patients with surgically salvageable or unsalvageable GCTB.
Methods: In this multicentre, open-label, phase 2 study done at 30 sites in 12 countries we enrolled adults and skeletally mature adolescents (aged ≥12 years) weighing at least 45 kg with histologically confirmed and radiographically measurable GCTB, Karnofsky performance status 50% or higher (Eastern Cooperative Oncology Group status 0, 1, or 2), and measurable active disease within 1 year of study enrolment. Read More