WEDNESDAY, Feb. 23 (HealthDay News) -- A new drug called
denosumab (Xgeva) performed somewhat better than the current
standard treatment of zoledronic acid (Zometa) for preventing
fractures and other bone problems in men with hormone-resistant
prostate cancer, a new study suggests.
In many patients, prostate cancer becomes resistant to initial
hormone treatment within the first few years of diagnosis. As a
result, tumors begin to grow again and spread to other parts of the
body, including bones. This increases the risk of fractures and
other bone problems that cause pain and disability, which can
greatly reduce a man's quality of life, according to background
information in the study.
Helping to prevent these bone troubles can prove very important
to these patients, one expert said.
"The successful treatment of osteoporosis, bone pain, and complications of advanced boney disease in men with [castration]-resistant prostate cancer will increase their quality of life considerably," noted Dr. Elizabeth Kavaler, a urology specialist at Lenox Hill Hospital in New York City. She was not involved in the new study.
The research, which was funded by Xgeva's maker, Amgen, was led
by Dr. Karim Fizazi of the University of Paris Sud, in France, and
included more than 1,900 men. The men were treated for
hormone-resistant prostate cancer at 342 centers in 39 countries.
They were randomly assigned to receive either 120 milligrams of
denosumab, delivered subcutaneously (needle just under the skin)
plus an intravenous placebo (950 patients) or 4 milligrams of IV
zoledronic acid plus IV placebo (951 patients), given every four
All the patients were advised to take supplemental calcium and
vitamin D to help strengthen their bones. This advice was followed
by 90 percent of patients in the denosumab group and 87 percent of
those in the zoledronic acid group.
The median time to the first bone problems was just under 21
months in the denosumab group and a little more than 17 months in
the zoledronic acid group.
Overall, bone problems occurred in 36 percent of patients who
took denosumab and 41 percent of those who took zoledronic
"The 5 percent reduction in skeletal related events, including pathologic fractures and spinal cord compression, seen in the denosumab group versus the zoledronic acid group is very encouraging," Kavaler said. "This is a difficult patient population in that their symptoms related to bone metastases can be debilitating."
Serious adverse events were recorded in 63 percent of patients
in the denosumab group and 60 percent of those in the zoledronic
Of the adverse events most likely related to the treatments,
hypocalcaemia (very low calcium concentrations) occurred in 13
percent of patients taking denosumab and in 6 percent of those
taking zoledronic acid, while osteonecrosis of the jaw (a
debilitating destruction of bone tissue) occurred in 2 percent of
the denosumab group and 1 percent of the zoledronic acid group.
The study appears online Feb. 24 in the journal
The U.S. National Cancer Institute has more about