Results of a prospective, randomized, double-blind, double-dummy, Phase 3 study comparing denosumab with zoledronic acid for the treatment of breast cancer patients with bone metastases

Purpose This study evaluated whether additional palliative benefits could be derived from the second-line use of the more potent bisphosphonate zoledronic acid in metastatic breast cancer patients with either progressive bone metastases or skeletal-related events (SRE), despite first-line therapy with either pamidronate or clodronate. Patients and Methods This prospective study evaluated the impact of second-line zoledronic acid on pain, quality of life, and markers of bone turnover (for example, urinary N-telopeptide [NTX]). Patients received monthly zoledronic acid (4mg) for 3 months. Study evaluations were made weekly during the first month and again at week 8. No changes in chemotherapy or endocrine therapy were allowed in the month before or after commencing study treatment. Results Thirty-one women completed this study. By week 8, patients had experienced significant improvements in pain control (P < .001). There was a downward trend in urinary NTX levels over the same time period (P = .008). Overall, there was a trend towards a positive correlation between improvement in pain control and reduction in week one urinary NTX relative to baseline (Spearman's rho r = 0.27; P = .15). Conclusion This is the first study to demonstrate that patients with either progressive bone metastases or SREs while on clodronate or pamidronate can have relevant palliative benefits with a switch to the more potent bisphosphonate zoledronic acid. This is reflected by significant improvements in pain control and bone turnover markers. If confirmed in randomized trials, these findings have major implications to the use of bisphosphonates in both the metastatic and adjuvant settings.

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PCN4 ECONOMIC EVALUATION OF INTRAVENOUS (IV) ZOLEDRONIC ACID VS. OTHER IV BISPHOSPHONATES IN THE PREVENTION OF BONE COMPLICATIONS IN BREAST CANCER PATIENTS WITH BONE METASTASES: A UK BUDGET IMPACT ANALYSIS

Value in Health ◽

10.1016/s1098-3015(10)62910-5 ◽

2005 ◽

Vol 8 (3) ◽

pp. 344

Author(s):

M Botteman ◽

M Aapro ◽

JW Hay ◽

J Stephens ◽

J Brandman

Keyword(s):

Breast Cancer ◽

Economic Evaluation ◽

Zoledronic Acid ◽

Bone Metastases ◽

Cancer Patients ◽

Impact Analysis ◽

Budget Impact ◽

Budget Impact Analysis ◽

Breast Cancer Patients ◽

Bone Complications

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Renal safety of zoledronic acid administration beyond 24 months in breast cancer patients with bone metastases

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.19669 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 19669-19669

Author(s):

M. K. Altundag ◽

M. Dincer ◽

H. Harputluoglu ◽

S. Aksoy ◽

Y. Ozisik ◽

...

Keyword(s):

Breast Cancer ◽

Zoledronic Acid ◽

Bone Metastases ◽

Cancer Patients ◽

Breast Cancer Patients ◽

Skeletal Complications ◽

Few Data ◽

Acid Administration ◽

Renal Safety

19669 Background: Zoledronic acid (ZA) delays the onset or reduces the incidence of skeletal complications in breast cancer patients with bone metastases. However there are few data on the long-term renal safety of ZA. Methods: We retrospectively evaluated 43 breast cancer patients with bone metastases who received ZA more than 24 months. The following parameters measured prior to first ZA use and after the last dose of ZA administration were compared: serum creatinine (SCr), blood urea nitrogen (BUN), alkaline phosphatase (ALP), calcium (Ca), and phosphorous (P). Results: Forty-three breast cancer patients with documented bone metastases were evaluated. Median age at the start of treatment was 53 years (range, 37 to 77). Median overall duration of ZA administration was 36 months (25 to 62). There were no statistically significant differences in the pre- and post-treatment levels of SCr, BUN, Ca and P. However, ALP levels after long-term ZA administration were decreased significantly (P <0.05). Conclusion: More than 24 months of ZA administration did not adversely affect the renal function. ZA can be used safely in breast cancer patients with bone metastases beyond 2 years. [Table: see text] No significant financial relationships to disclose.

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