Tag Archives: zometa

Osteoporosis drug fights breast cancer

Doctors were mostly hoping to prevent complications and relapses when they gave young women a medicine to keep their bones strong during breast cancer treatment. Seven years later, they found it did more than that: The bone drug improved survival, as much as many chemotherapies do.

The study found a 37 percent lower risk of death among women who received the bone drug, Zometa. In absolute terms, it meant that 4 to 5 more women out of every 100 were alive seven years later.

It’s especially impressive considering that the women took the drug, given as an infusion every six months, for only three years.

“The benefit persists” long after treatment ends, said study leader Dr. Michael Gnant of Austria’s Medical University of Vienna. He presented the research this week at the San Antonio Breast Cancer Symposium.

Zometa (zow-MAY-tuh) should now be offered to all patients like those in this study — younger women forced into early menopause by hormone-blocking cancer treatments, some specialists said.

“It’s a new standard of care,” said Dr. James Ingle, a Mayo Clinic breast specialist who had no role in the study.

Bone drugs called bisphosphonates — sold as Fosamax, Boniva and Actonel — have long been sold for treating osteoporosis. Those are daily pills. Zometa, made by the Swiss company Novartis AG, is given intravenously to treat cancer that has spread to the bone.

Breast cancer cell

Breast cancer cell

Hope that it could do more grew in 2008, when Gnant reported that it lowered the risk of a cancer recurrence in a study of 1,800 premenopausal women with early-stage breast cancer. All had surgery followed by hormone blockers, and half also received Zometa.

Now, with seven years of follow-up, researchers see that Zometa not only helped keep cancer from coming back, but also improved survival. There were 33 deaths among women given the bone drug and 49 among those not treated with it.

That magnitude of benefit is comparable to many chemotherapy treatments. Researchers think because Zometa strengthens bones, it’s tougher for cancer to spread there and the drug may also have direct effects against circulating cancer cells or microscopic tumors.


Zometa’s side effects were mostly fever and bone and joint pain, and doctors saw no cases of jawbone decay, a serious problem long linked to bisphosphonates. Zometa costs more than $1,000 in the U.S. and about half as much in Europe, though the price may drop when its U.S. patent expires in 2013. Novartis helped pay for the study and Gnant consults for the company.

The bone drug proved disappointing though in a large study last year in postmenopausal women, who account for three-fourths of all breast cancers. But there was a glimmer of hope in the oldest patients.

“They benefitted substantially as long as they were well past menopause,” said Dr. Peter Ravdin, director of the breast cancer program at the UT Health Science Center in San Antonio, who also had no role in the research.

Other studies reported at the conference this week strengthen the view that Zometa works best in women with little estrogen. A consistent picture is emerging, Ravdin said.

Denosumab prevents prostate cancer fractures

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.

prostate cancer

Prostate cancer

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 weeks.

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 acid.


“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 acid group.

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 Lancet.