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Zoledronic acid plus everolimus improved outcomes in renal cell carcinoma
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The addition of zoledronic acid to everolimus significantly reduced bone resorption markers and extended tumor control in patients with renal cell carcinoma, according to results of a phase 2 study.
Patients with renal cell carcinoma often experience morbidity from bone metastases. Prior research suggests bone turnover markers identify zoledronic acid-treated patients at risk for skeletal-related events.
In the current study, Reuben J. Broom, MD, of Auckland City Hospital in New Zealand, and colleagues sought to compare how the effect of zoledronic acid on bone metastases in patients with renal cell carcinoma. The analysis included 30 treatment-naive patients with at least one bone metastasis.
Researchers randomly assigned patients 1:1 to 10 mg daily everolimus (Afinitor, Novartis) alone or everolimus plus 4 mg zoledronic acid IV four times weekly. Treatment continued until disease progression.
Urine N-telopeptide level served as the primary outcome measure. Secondary outcomes included plasma C-telopeptide levels, quality of life, PFS, skeletal-related events and safety.
At 12 weeks, the decline in mean urine N-telopeptide level among patients assigned the combination relative to everolimus alone was 68.4% (95% CI, 60.1-74.9). The reduction in mean C-telopeptide among patients assigned the combination relative to everolimus alone was 76.2% (95% CI, 67.3-82.7).
Patients assigned everolimus plus zoledronic acid experienced significantly longer median PFS (7.5 months vs. 5.4 months; P=.009), as well as longer median time to first skeletal-related event (9.6 months vs. 5.2 months; P=.03).
Although researchers observed no difference in the FACT-BP quality-of-life measurement between treatment arms (P=.5), they did report benefit for the combination treatment in relation to Brief Pain Inventory severity (P=.05) and interference (P=.06).
Median time to first skeletal-related event also was longer in the combination.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.
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