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Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone.

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.

journal_name

Ann Surg Oncol

journal_title

Annals of surgical oncology

authors

Rutkowski P,Ferrari S,Grimer RJ,Stalley PD,Dijkstra SP,Pienkowski A,Vaz G,Wunder JS,Seeger LL,Feng A,Roberts ZJ,Bach BA

doi

10.1245/s10434-015-4634-9

subject

Has Abstract

pub_date

2015-09-01 00:00:00

pages

2860-8

issue

eissn

1068-9265

issn

1534-4681

journal_volume

pub_type

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Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone.