Surgical Downstaging in an Open-Label Phase II Trial of Denosumab in Patients with Giant Cell Tumor of Bone

Abstract

© 2015, The Author.Background: Surgical resection with curative intent for giant cell tumor of bone may be associated with severe morbidity. This interim analysis evaluated reduction in surgical invasiveness after denosumab treatment in patients with resectable GCTB. Methods: Patients with primary or recurrent GCTB, for whom the initially planned surgery was associated with functional compromise or morbidity, received denosumab 120 mg subcutaneously every 4 weeks. Planned and actual GCTB-related surgical procedures before and after denosumab treatment were reported. Patients were followed for surgical outcome, adverse events, and recurrence following resection. Results: Overall, 222 patients were evaluable for surgical downstaging. Lesions were located in the axial and appendicular skeleton. At the data cutoff date, most patients had not yet undergone surgery or had a less morbid procedure than originally planned. Median time on denosumab was 19.5 months for the 106 patients who had not undergone surgery and were continuing on monthly denosumab. Native joint preservation was 96 % for patients with planned joint/prosthesis replacement and 86 % for patients with planned joint resection/fusion. Of the 116 patients who had surgery, local recurrence occurred in 17 patients. Conclusion: For patients with resectable GCTB, neoadjuvant denosumab therapy resulted in beneficial surgical downstaging, including either no surgery or a less morbid surgical procedure.

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Author Profiles

Gary Vaz
Harvard University
An Feng
Indiana University Purdue University, Indianapolis
Zoe Roberts
Washington University in St. Louis

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