Posted February 16, 2010
Denosumab, a fully human monoclonal antibody against RANKL, demonstrated therapeutic activity in patients with giant cell tumor of bone.
In an open-label, single-group study, researchers assigned 37 patients
with recurrent or unresectable giant cell tumor to 120 mg subcutaneous
denosumab monthly with loading doses on days eight and 15 of the first month.
“To our knowledge, this is the first report that clearly shows a
promising systemic treatment option for this rare type of tumor,”
Maurice Balke, MD, orthopedic surgeon, Cologne-Merheim Medical Center,
Germany, and Jendrik Hardes, MD, department of orthopedic surgery,
University Hospital Muenster, Germany,
wrote in an accompanying editorial.
The primary endpoint was tumor response, defined as elimination of 90%
or more of giant cells or no radiological progression of the target lesion up
to week 25. The endpoint was met by 86% of patients at 25 weeks. Response was
confirmed in 20 patients using histology and in 10 of 15 using radiology.
The most frequently reported adverse events were pain in an extremity,
back pain and headache. Serious adverse events were reported in five patients,
although none were deemed to be related to treatment.
“More studies on the mechanism of action of denosumab are needed
and will hopefully give further insight into the biology of giant cell tumor of
bone,” Balke and Hardes wrote.
Thomas D. Lancet Oncol.
2010;doi:10.1016/S1470-2045(10)70010-3.
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