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Denosumab reduced breast cancer skeletal-related events further than zoledronic acid

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San Antonio Breast Cancer Symposium

Denosumab prevented more skeletal-related events than the standard of care zoledronic acid for patients with breast cancer and was also better tolerated, according to Alison Stopeck, MD.

“Denosumab was superior to Zometa. It had less toxicity and it was easier on the patients,” said Stopeck, associate professor of medicine at the University of Arizona Cancer Center, who presented the results of a phase-3, double-blind study at the 2009 San Antonio Breast Cancer Symposium.

Stopeck and colleagues recruited 2,046 patients with bone metastases who had never received treatment with IV bisphosphonates. Patients were randomly assigned to treatment with 120 mg subcutaneous denosumab (Amgen) or 4 mg IV zoledronic acid (Zometa, Novartis) every four weeks.

Stopeck said denosumab significantly delayed time to first on-study skeletal-related event compared with zoledronic acid (HR=0.82; 95% CI, 0.71-0.95), as well as time to first, and subsequent, on-study skeletal-related event (rate ratio=0.77; 95% CI, 0.66-0.89). Patients assigned to denosumab had 491 skeletal-related events compared with 623 for patients assigned to zoledronic acid.

“Patients on denosumab took longer to develop moderate-to-severe pain compared to zoledronic acid,” Stopeck said.

At 34 months, 30.7% of patients in the denosumab arm experienced at least one skeletal-related event (95% CI, 33.5%-39.4%) compared with 36.5% of those assigned to zoledronic acid. Denosumab also reduced mean skeletal morbidity rate (0.45 vs. 0.58; P=.004). – by Jason Harris

Stopeck A. #22. Presented at: the 2009 San Antonio Breast Cancer Symposium; Dec. 8-12, 2009; San Antonio, Texas.

Before we had bisphosphonates if a breast cancer patient had bone metastases for two years, she had a 64% chance of developing a skeletal-related event: fracture or pain. With the advent of bisphosphonates, this was reduced to 43% with the less potent bisphosphonates, then 34% with the more potent zoledronic acid. Denosumab shows further the improvement with a 27% incidence rate.

– Theresa Guise, MD
Professor of Oncology, Indiana University School of Medicine