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 downstagi

SUBMITTER: Rutkowski P 

PROVIDER: S-EPMC4531146 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature