Denosumab lowers cell count in giant-cell tumor of the bone

by Bruce Sylvester – FDA Highlights – Treatment with denosumab decreases the number of tumor giant cells in patients with giant-cell tumor of the bone, and increases new bone formation, researchers reported on September 21, 2012 in Clinical Cancer Research.

“Giant-cell tumour of the bone is a rare tumour that affects mostly young  people,” said investigator Sant P. Chawla, MD, Santa Monica Oncology Center, Santa Monica, California. “Radical surgery is currently the only treatment option. In our study, the use of denosumab allowed patients to avoid radical surgery and prevented recurrence. We hope that in the future, its use may make it possible to avoid surgery completely.”

Dr. Chawla and colleagues conducted the phase 2 study. They enrolled  20 adult patients with recurrent or unresectable giant-cell tumour of the bone, who were then treated with subcutaneous denosumab every 4 weeks.

Following treatment, all 20 of the subjects had a decrease in giant cells of 90% or greater.

And 65% of the patients had new bone growth in areas where the RANK ligand had previously caused bone destruction.

“A majority of patients with giant-cell tumour of the bone are young and have to get joint replacements, which last 15 to 20 years before a repeat surgery is needed,” said Dr. Chawla. “Now, we hopefully can do minimal surgery, avoiding a joint replacement and recurrence.”

The investigators will continue to evaluate denosumab for giant-cell tumor of the bone in a larger, multinational study that is currently enrolling patients.
“In the future we hope to investigate giving the drug prior to surgery to see the effect it has, then remove the tumour and evaluate the pathological response,” he said.

Funding for this study was provided by Amgen.