Efficacy
Between September 2008 and February 2016, 532 patients with giant cell tumour of bone (GCTB) were enrolled in 3 cohorts. Cohort 1 consisted of 267 patients with surgically unsalvageable GCTB, cohort 2 had 253 patients with surgically salvageable GCTB with planned surgery expected to result in severe morbidity and cohort 3 had 12 patients from a previous study of denosumab for GCTB. Patients in all cohorts received 120 mg subcutaneous denosumab once every 4 weeks, in addition cohorts 1 and 2 received loading doses (120 mg subcutaneously) on days 8 and 15. The primary end point was safety.r
After a median follow-up of 65.8 months (cohort 1), 53.4 months (cohort 2), 76.4 months (cohort 3) the most common treatment related grade 3 or more adverse events were hypophosphataemia (5%), osteonecrosis of the jaw (3%), pain in extremity (2%) and anaemia (2%). Median time to progression or recurrence for cohort 1 was not reached, 11% had disease progression during the first treatment phase.
© Lancet Oncol 2019
Kaplan-Meier graphs of investigator-determined progression-free survival in patients with surgically unsalvageable disease (cohort 1) r
© Lancet Oncol 2019
Kaplan-Meier graphs of time to progression in cohort 2 all patients (A) patients who underwent surgery (B) r
© Lancet Oncol 2019