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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 9/2015

Open Access 01-09-2015 | Bone and Soft Tissue Sarcomas

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

Authors: Piotr Rutkowski, MD, PhD, Stefano Ferrari, MD, Robert J. Grimer, MB, BS, Paul D. Stalley, MB, BS, Sander P. D. Dijkstra, PhD, Andrzej Pienkowski, MD, PhD, Gualter Vaz, MD, Jay S. Wunder, MD, Leanne L. Seeger, MD, Amy Feng, PhD, Zachary J. Roberts, MD, PhD, Bruce A. Bach, MD, PhD

Published in: Annals of Surgical Oncology | Issue 9/2015

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Abstract

Background

Surgical resection with curative intent for giant cell tumor of bone (GCTB) 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 (additional doses on days 8 and 15 of the first cycle). 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 (54 % were women; median age 34 years). Lesions (67 % primary and 33 % recurrent) were located in the axial (15 %) and appendicular skeleton (85 %). At the data cutoff date, most patients had not yet undergone surgery (n = 106; 48 %) or had a less morbid procedure (n = 84; 38 %) than originally planned. Median (interquartile range) time on denosumab was 19.5 (12.4–28.6) months for the 106 patients who had not undergone surgery and were continuing on monthly denosumab. Native joint preservation was 96 % (n = 24/25) for patients with planned joint/prosthesis replacement and 86 % (n = 30/35) for patients with planned joint resection/fusion. Of the 116 patients who had surgery (median postsurgical follow-up 13.0 [8.5–17.9] months), local recurrence occurred in 17 (15 %) 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.
Appendix
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Metadata
Title
Surgical Downstaging in an Open-Label Phase II Trial of Denosumab in Patients with Giant Cell Tumor of Bone
Authors
Piotr Rutkowski, MD, PhD
Stefano Ferrari, MD
Robert J. Grimer, MB, BS
Paul D. Stalley, MB, BS
Sander P. D. Dijkstra, PhD
Andrzej Pienkowski, MD, PhD
Gualter Vaz, MD
Jay S. Wunder, MD
Leanne L. Seeger, MD
Amy Feng, PhD
Zachary J. Roberts, MD, PhD
Bruce A. Bach, MD, PhD
Publication date
01-09-2015
Publisher
Springer US
Published in
Annals of Surgical Oncology / Issue 9/2015
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-015-4634-9

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