Long-term denosumab therapy safe for patients with breast, prostate cancer
the ONA take:
No new safety signals were identified for long-term denosumab therapy in patients with metastatic breast or prostate cancer and bone metastases, according to a new study published online ahead of print in the journal Supportive Care in Cancer.
In the initial blinded phase 3 studies, patients with metastatic breast or prostate cancer received subcutaenous denosumab 120 mg every 4 weeks or intravenous zolendronic acid 4 mg every 4 weeks.
Denosumab was found to be superior in efficacy to zoledronic acid, and therefore patients could opt to participate in an open-label extension to receive long-term denosumab for up to an additional 2 years.
Researchers analyzed the data from the open-label extension to evaluate the safety results of extended denosumab therapy.
Results showed no new safety signals among patients who continued denosumab or among patients who switched from zoledronic acid to denosumab. Osteonecrosis of the jaw rates increased with increasing exposure to denosumab, while hypocalcemia rates were similar between the blinded treatment and open-label extension phases.
No new safety signals were identified for long-term denosumab therapy in patients with metastatic breast or prostate cancer and bone metastases.
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