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

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Annals of Surgical Oncology

, Volume 22, Issue 9, pp 2860–2868

First Online: 02 June 2015Received: 01 January 2015DOI: 10.1245-s10434-015-4634-9

Cite this article as: Rutkowski, P., Ferrari, S., Grimer, R.J. et al. Ann Surg Oncol 2015 22: 2860. doi:10.1245-s10434-015-4634-9


BackgroundSurgical 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.

MethodsPatients 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.

ResultsOverall, 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.

ConclusionFor patients with resectable GCTB, neoadjuvant denosumab therapy resulted in beneficial surgical downstaging, including either no surgery or a less morbid surgical procedure.

Electronic supplementary materialThe online version of this article doi:10.1245-s10434-015-4634-9 contains supplementary material, which is available to authorized users.

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Autor: Piotr Rutkowski - Stefano Ferrari - Robert J. Grimer - Paul D. Stalley - Sander P. D. Dijkstra - Andrzej Pienkowski - Gu


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