Abstract
Previous studies suggest switching from pamidronate to a more potent bone-targeted agent is associated with biomarker and palliative response in breast cancer patients with bone metastases. Until now, this has not been addressed in a double-blind, randomized trial. Breast cancer patients with high-risk bone metastases, despite >3 months of pamidronate, were randomized to either continue pamidronate or switch to zoledronic acid every 4 weeks for 12 weeks. Primary outcome was the proportion of patients achieving a fall in serum C-telopeptide (sCTx) at 12 weeks. Secondary outcomes included difference in mean sCTx, pain scores, quality of life, toxicity, and skeletal-related events (SREs). Seventy-three patients entered the study; median age 61 years (range 37–87). Proportion of patients achieving a fall in sCTx over the 12-week evaluation period was 26/32 (81 %) with zoledronic acid and 18/29 (62 %) with pamidronate (p = 0.095). Mean decrease in sCTx (mean difference between groups = 50 ng/L, 95 % CI 18–84; p = 0.003) was significantly greater in patients who received zoledronic acid. Quality of life, pain scores, toxicity, and frequency of new SREs were comparable between the two arms. While a switch from pamidronate to zoledronic acid resulted in reduction in mean sCTx, there were no significant differences between the arms for proportion of patients achieving a reduction in sCTx, quality of life, pain scores, toxicity or SREs. Given the lack of palliative improvement, the current data do not support a switching strategy.
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Acknowledgement
This study was funded by the Canadian Breast Cancer Foundation-Ontario Chapter, research project grant program.
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The funding source had no role in study design, data collection, analysis, interpretation, or manuscript writing.
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Mark Clemons has received educational grants and travel sponsorship from Novartis. Susan Dent has received speaker honoraria from Novartis and attended advisory boards for Amgen. All other authors declare that they have no conflict of interest.
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Clinical Trials identifier: NCT01907880.
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Jacobs, C., Kuchuk, I., Bouganim, N. et al. A randomized, double-blind, phase II, exploratory trial evaluating the palliative benefit of either continuing pamidronate or switching to zoledronic acid in patients with high-risk bone metastases from breast cancer. Breast Cancer Res Treat 155, 77–84 (2016). https://doi.org/10.1007/s10549-015-3646-2
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DOI: https://doi.org/10.1007/s10549-015-3646-2