Building on their previous phase III study that showed denosumab to be superior to zoledronic acid in preventing skeletal complications in patients with breast cancer and bone metastases, Miguel Martin, M.D., Ph.D., from the Hospital General Universitario Gregorio Maranon in Madrid, and colleagues further analyzed results of the study, in which 2,046 women had been randomized to receive subcutaneous denosumab and intravenous placebo or intravenous zoledronic acid and subcutaneous placebo.

The researchers found that denosumab was superior to zoledronic acid, with significantly fewer patients having a skeletal-related event (31 versus 36 percent). The incidence of first radiation to bone was also lower (12 versus 16 percent). Compared with zoledronic acid, denosumab increased the time to first radiation to bone by 26 percent and to first skeletal-related event or hypercalcemia of malignancy by 18 percent. In addition, 10 percent more patients taking denosumab had a clinically meaningful improvement in health-related quality of life, which was independent of baseline pain levels.

"Denosumab offers an efficacious and well-tolerated treatment option for preventing skeletal complications in patients with breast cancer and bone metastases," Martin and colleagues conclude.

The study was funded by Amgen; several authors disclosed financial ties to pharmaceutical companies, including Amgen.

Abstract
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