47 COST EFFECTIVENESS OF ZOLEDRONIC ACID FOR THE PREVENTION OF SKELETAL RELATED EVENTS IN PROSTATE CANCER PATIENTS WITH BONE METASTASES IN FRANCE AND GERMANY

2009 ◽  
Vol 8 (4) ◽  
pp. 132 ◽  
Author(s):  
M. Meijboom ◽  
M.F. Botteman ◽  
S. Kaura
Keyword(s):  
Prostate Cancer ◽  
Cost Effectiveness ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Skeletal Related Events

scholarly journals PCN73 Cost Effectiveness of Zoledronic Acid vs. Pamidronate or No therapy for the Treatment of Bone Metastases Secondary to Prostate Cancer

2011 ◽  
Vol 14 (7) ◽  
pp. A447
Author(s):  
J.A. Carter ◽  
M. Bains ◽  
D. Chandiwana ◽  
S. Kaura ◽  
M.F. Botteman
Keyword(s):  
Prostate Cancer ◽  
Cost Effectiveness ◽  
Zoledronic Acid ◽  
Bone Metastases

scholarly journals Management of skeletal-related events in patients with advanced prostate cancer and bone metastases: Incorporating new agents into clinical practice

2012 ◽  
Vol 6 (6) ◽  
pp. 465 ◽  
Author(s):  
Alan So ◽  
Joseph Chin ◽  
Neil Fleshner ◽  
Fred Saad
Keyword(s):  
Prostate Cancer ◽  
Targeted Therapy ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Therapy Monitoring ◽  
Standard Of Care ◽  
Negative Consequences ◽  
Risk Of Death ◽  
Increased Risk ◽  
Skeletal Related Events

Skeletal-related events (SREs) are a common complication of bone metastases, and have serious negative consequences for patients with castrate-resistant prostate cancer (CRPC). SREs can lead to severe pain, increased risk of death, increased health care costs and reduced quality of life. Until recently, zoledronic acid has been the sole standard of care for the prevention of SREs in men with CRPC with bone metastases. Denosumab, a receptor activator of nuclear factor kappa-B ligand (RANK-L) inhibitor, has been recently approved for use in Canada for this indication, thus presenting another option for these patients. Denosumab was shown to be superior to zoledronic acid in delaying the time to first or subsequent SREs in CRPC patients with bone metastases. This review discusses current and previous trials examining agents designed to prevent SREs in men with CRPC and bone metastases. It also discusses the practical aspects of administering a bone-targeted therapy, including choosing a bone-targeted therapy, monitoring at the onset and during therapy, switching from one therapy to another, and assessing potential complications.

The risk of renal impairment in hormone-refractory prostate cancer patients with bone metastases treated with zoledronic acid

Cancer ◽  
2007 ◽  
Vol 109 (6) ◽  
pp. 1090-1096 ◽  
Author(s):  
William K. Oh ◽  
Kevin Proctor ◽  
Mari Nakabayashi ◽  
Carolyn Evan ◽  
Lauren K. Tormey ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Renal Impairment ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Hormone Refractory Prostate Cancer ◽  
Hormone Refractory

Cost-effectiveness of zoledronic acid in the prevention of skeletal-related events in patients with bone metastases from renal cell carcinoma: Comparison between France, Germany, and the United Kingdom

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5106-5106
Author(s):  
M. F. Botteman ◽  
S. Kaura
Keyword(s):  
United Kingdom ◽  
Cost Effectiveness ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Life Years ◽  
Health Related ◽  
Skeletal Related Events ◽  
The Uk

5106 Background: Zoledronic acid (ZOL) significantly reduces the risk of new skeletal-related events (SREs) in patients (pts) with bone metastases from RCC. This study assessed and compared the cost-effectiveness of ZOL in pts with RCC from French, German, and United Kingdom (UK) societal perspectives. Methods: This analysis was based on a retrospective analysis of RCC pts with bone metastases who were enrolled in a 9-mo trial of ZOL or placebo (PBO) plus concomitant antineoplastic therapy. A model was developed to simulate costs and quality-adjusted life-years (QALYs) experienced by study pts. The model included data and assumptions regarding SRE incidence, mortality, drug and administration costs, SRE costs, reduced quality of life (QOL) because of SREs and bone pain, and therapy duration. SRE costs were estimated using diagnosis-related group tariff information and published literature. Consistent with similar economic analyses, it was assumed that QOL decreased 20% to 80% (depending on SRE type) for 1 mo after each SRE experienced. Sensitivity analyses were performed to test the effects of alternate assumptions, with < 30,000/QALY considered cost-effective. Results: Compared with PBO-treated pts (n = 19), ZOL-treated pts (n = 27) experienced 1.07 fewer SREs/pt and gained discounted QALYs of approximately 0.1563 in France and Germany and 0.1575 in the UK. Discounted SRE-related costs were substantially lower among pts treated with ZOL vs PBO (-4,196 in France, -3,880 in Germany, and -3,355 in the UK). After including drug therapy costs, ZOL saved 1,358, 1,223, and 719 per pt in France, Germany, and the UK, respectively. In multivariate sensitivity analyses, ZOL saved costs in 67% to 77% of cases, depending on the country. ZOL resulted in a cost per QALY gained < 30,000 in approximately 93% of cases. Conclusions: Treatment with ZOL reduces SREs, improves QOL, and lowers health-related costs compared with PBO in French, German, and UK pts with bone metastases from RCC. Use of ZOL in these populations therefore provides health-related cost savings and is a cost-effective use of healthcare resources. [Table: see text]

MER-101–03, a multicenter, phase II study to compare MER-101 20mg tablets to intravenous zoledronic acid 4mg in prostate cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5161-5161
Author(s):  
C. McHugh ◽  
K. Madigan ◽  
A. Walsh ◽  
J. Fox ◽  
T. W. Leonard ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Phase Ii ◽  
Performance Status ◽  
Hormone Refractory Prostate Cancer ◽  
Open Label ◽  
Secondary Endpoints ◽  
Hormone Refractory

5161 Background: The primary objective of this study is to examine the pharmacodynamic effects of two different regimens of zoledronic acid, Orazol 20 mg tablets versus Zometa 4mg IV infusion once-monthly therapy on biomarkers in male bisphosphonate-naïve hormone-refractory prostate cancer patients. Methods: The study is an open-label, multi-center phase II clinical trial to compare oral Orazol 20 mg tablets weekly, to infusions of intravenous Zometa 4mg monthly, in males with hormone-refractory prostate cancer, bone metastases, and no prior bisphosphonate treatment. Patients were assigned into one of three cohorts. The three treatments administered were IV Zometa, 4 mg, 15 minute infusion, Day 0 and Day 28; Orazol po, 20 mg, Days 0, 7, 14, 21, 28, 35, 42, and 49; and Orazol po, 20 mg, Days 0, 1, 2, 3, 28, 35, 42, and 49. The study population consisted of men with hormone refractory prostate cancer as evidenced by history of rising PSA levels (last 2 of 3 PSA levels must be above nadir), who are bisphosphonate-naive, and have radiographically-confirmed bone metastases. Efficacy assessments: The primary endpoints are the assessment of response of four biomarkers, urinary NTX, serum CTX, serum bone specific alkaline phosphatase, and serum calcium on days -7, 0, 7, 14, 21, 28, 35, 42, 49, and 56. Secondary endpoints are assessments of performance and pain scores based on ECOG performance status, BPI, and analgesic use. Safety assessments include physical examinations, vital signs and body weight, hematology panel, urinalysis, and blood chemistry panel. Results: The results demonstrated a rapid decrease for all four biomarkers. This decrease was seen at seven days, and was sustained throughout the study. There were no statistically significant differences between any of the treatments in the primary and secondary endpoints. Conclusions: From the results of MER-101–03, Orazol weekly therapy appears to be as effective as Zometa, based on the biomarkers analyzed. Orazol offers a substantial improvement in therapy over IV infusion for patients, with efficacy that is at least comparable based on the results obtained here. No significant financial relationships to disclose.

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