Xgeva (denosumab) has delayed the development of bone metastases in men with prostate cancer. The U.S. Food and Drug Administration (FDA) approved denosumab in September, 2011 to treat osteoporosis and prevent fractures in cancer patients with bone metastases. Prostate cancer deaths are usually the result of bone metastases.
"If you have prostate cancer, ask about Xgeva."
Lead study author, Matthew Smith, M.D., Ph.D, of the Massachusetts General Hospital Cancer Center, calls this "a significant accomplishment that should lead to better treatment strategies."
The study showed Xgeva delayed metastasis-free survival for an average of more than four months.
Prostate cancer most commonly spreads to the bone. This can cause pain and fractures and lead to the need for surgery or radiotherapy.
This study involved 1,432 prostate cancer patients from 319 centers in 30 countries. The participants' tumors were no longer responding to hormone (androgen-deprivation) therapy, and while the cancer had not yet spread, they had elevated PSA levels, which indicated they were at risk for metastasis.
Participants were randomly selected to receive injections of denosumab or a placebo every four weeks. During the two-year study, patients received a bone scan every four months, and X-ray skeletal surveys were performed every year.
Once a bone scan detected metastasis, which was confirmed with other tests, the therapy was stopped because other drugs are approved to treat metastatic prostate cancer.
There was no overall survival difference between the two groups. However, since the drug was discontinued once metastasis occurred, judging survival rates is difficult.
Dr. Smith, a professor of medicine at Harvard Medical School, reports being a consultant to Amgen, the manufacturer of Xgeva. The company supported this study.
This research received Online First publication in The Lancet.