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Denosumab superior to zoledronic acid for pain reduction in metastatic breast cancer

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2010 ASCO Breast Cancer Symposium

NATIONAL HARBOR, Md. — Patients with skeletal-related events associated with metastatic breast cancer who were assigned denosumab reported less pain and were pain-free for a longer duration when compared with patients assigned zoledronic acid. Alison T. Stopeck, MD, presented the results during a poster session at the 2010 Breast Cancer Symposium.

Stopeck, director of the Clinical Breast Cancer Program at the University of Arizona Cancer Center, and colleagues utilized the Brief Pain Inventory to assess severity at baseline, day 8 and before each monthly visit through 73 weeks in 2,046 patients with metastatic breast cancer. Patients were assigned 120 mg subcutaneous denosumab (Prolia, Amgen) or 4 mg IV zoledronic acid (Zometa, Novartis) every 4 weeks.

Pain severity scores were defined as no pain/mild pain (0-4) and moderate/severe (5-10). Time to pain improvement, defined as greater than a 2-point decrease from baseline, was assessed to determine palliation.

Compared with patients assigned zoledronic acid, patients with no pain/mild pain at baseline (n=1,042) had a superior median time to development of moderate/severe pain when assigned to denosumab (176 days vs. 295 days; HR=0.78; 95% CI, 0.67–0.92).

Additionally, the proportion of patients with no pain/mild pain at baseline who reported moderate/severe pain was significantly lower for denosumab vs. zoledronic acid throughout the study period.

At 13 weeks, 17.3% of patients assigned denosumab reported no pain or mild pain compared with 22.1% of those assigned zoledronic acid. Although 14.8% of patients assigned denosumab reported no pain or mild pain vs. 26.7% of those assigned zoledronic acid, time to pain improvement was similar across groups (82 days vs. 85 days; HR=1.02; 95% CI, 0.91–1.15).

For more information:

• Stopeck A. #265. Presented at: the 2010 Breast Cancer Symposium; Oct. 1-3, 2010; National Harbor, Md.

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