Denosumab in the Treatment of Giant Cell Tumor of Bone ：A Health Technology Assessment / 中国药房

ABSTRACT

OBJECTIVE：To provide evidence-ba sed evidence for clinical treatment and decision by evaluating efficacy ，safety and cost-effectiveness of denosumab in the treatment of giant cell tumor of bone （GCTB）. METHODS ：Retrieved from PubMed ， the Cochrane Library ，ScienceDirect，CNKI，Wanfang database and VIP as well as health technology assessment （HTA）organi- zation websites ，HTA reports ，randomized controlled trials （RCTs），single-arm trials and retrospective studies were included about denosumab in the treatment of GCTB in the adults and adolescents with mature bone ，and their qualities were evaluated. HTA reports were analyzed with descriptive analysis qualitatively ；Meta-analysis was conducted for single-arm clinical studies and retrospective studies by using R version 3.6.0 software. RESULTS ：Among 49 screened literatures ，there were 6 HTA reports ，5 single-arm trials and 3 retrospective studies ．No eligible RCTs were retrieved. HTA reports of various countries generally believed that denosumab possessed good efficacy and safety ；HTA reports of France ，Austrila and other contries showed that denosumab possessed economics. For the GCTB patients who was unresectable ，denosumab would bring the clinical benefits to about 81％ [95％CI（77％，86％）] of patients. The complete response rate and partial response rate was around 14％[95％CI（10％，19％）] and 51％[95％CI（32％，70％）]，respectively. For the GCTB patients was resectable ，denosumab would prevent some patients from receiving surgery （35％）[95％CI（21％，49％）] or bring surgical down staging to them （40％）[95％CI（36％，45％）]，the postoperative recurrence rate after experiencing the denosumab therapy was about 19％[95％CI（7％，35％）]，and median relapse time was approximately 6.73 months [ 95％CI（3.92，9.55）] after receiving surgery. Main grade 3-4 or high frequercy ADR requiring treatment was back pain ，limbs pain ，hypophosphatemia and jaw osteonecrosis. CONCLUSIONS ：Based on the currently available evidence，among the studies and regions covered in this study ，denosumab has favorable efficacy ，safety and cost-effectiveness in the treatment of TCTB.