615 Long-term efficacy and safety of zoledronic acid in men with advanced prostate cancer and bone metastases

2004 ◽  
Vol 3 (2) ◽  
pp. 156 ◽  
Author(s):  
F. Saad ◽  
D. Gleason ◽  
R. Murray ◽  
P. Venner ◽  
S. Tchekmedyian ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Advanced Prostate Cancer ◽  
Efficacy And Safety ◽  
Term Efficacy

scholarly journals Bone Metastases in Advanced Prostate Cancer

2005 ◽  
Vol 00 (00) ◽  
pp. 1
Author(s):  
Fred Saad ◽  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Advanced Prostate Cancer ◽  
Bone Pain ◽  
Controlled Trial ◽  
Open Label ◽  
Acid Therapy ◽  
Clinically Significant

Men with advanced prostate cancer are at high risk for development of bone metastases,resulting in clinically significant skeletal morbidity and severe bone pain. Studies of early-generation bisphosphonates,clodronate, and pamidronate,demonstrated transient palliative effects on bone pain in patients with bone metastases, but failed to demonstrate long-term clinical benefit.A small,open-label study of ibandronate demonstrated significant reductions in pain,but these results have not been confirmed in a larger,randomized,controlled trial. Currently,zoledronic acid is the only bisphosphonate that has demonstrated statistically significant reductions in skeletal morbidity – including durable pain reduction– in this patient population in a randomized placebocontrolled trial.Therefore,zoledronic acid therapy should be considered to prevent skeletal morbidity and improve the quality of life of prostate cancer patients with bone metastases.

647 PHASE 1–2 STUDY OF MDV3100 IN PRE- AND POST-DOCETAXEL ADVANCED PROSTATE CANCER: LONG-TERM EFFICACY RESULTS

2011 ◽  
Vol 185 (4S) ◽  
Author(s):  
Celestia Higano ◽  
Tomasz Beer ◽  
Evan Yu ◽  
Mary-Ellen Taplin ◽  
Eleni Efstathiou ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Advanced Prostate Cancer ◽  
Phase 1 ◽  
Term Efficacy

Efficacy and safety of zoledronic acid in men with castration-sensitive prostate cancer and bone metastases: Results of CALGB 90202 (Alliance).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 27-27 ◽  
Author(s):  
Matthew Raymond Smith ◽  
Susan Halabi ◽  
Charles J. Ryan ◽  
Walter Michael Stadler ◽  
Arif Hussain ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Statistical Power ◽  
Phase Iii ◽  
Rank Test ◽  
Rank Statistic ◽  
Type I ◽  
Efficacy And Safety ◽  
Castration Resistant Prostate Cancer

27 Background: Zoledronic acid (ZA) decreases risk of skeletal-related events (SREs) in men with castration-resistant prostate cancer (CRPC) and bone metastases. This phase III study evaluated efficacy and safety of earlier treatment with ZA in men with castration-sensitive metastatic prostate cancer. Methods: CALGB 90202 was a randomized, double-blinded, placebo-controlled phase III trial in men with castration-sensitive prostate cancer and bone metastases who had initiated androgen deprivation therapy within six months of study entry. Subjects were randomized 1:1 in blinded manner to receive ZA (4 mg intravenously every 4 weeks) or placebo (P). After progression to CRPC, all patients crossed over to open-label ZA. The primary endpoint was time to first SRE. Target sample size was 680. Time to SRE was defined as interval between date of randomization and date of first SRE (radiation to bone, or clinical fracture, or surgery to bone, or death due to prostate cancer). With 470 SRE events, the log-rank test has 88% power to detect a 23% decrease in hazard rate of SRE event assuming a one-sided type I error rate of 0.05. The study was discontinued prematurely after the corporate supporter withdrew study drug supply. Primary analysis was based on the stratified log-rank statistic adjusting on the stratification factors following observation of 284 SREs (60% of total events). Results: Between June 2004 and April 2012, 645 patients were randomly assigned to ZA or P. Median time to first SRE was 32.5 months in the ZA group and 29.8 months in the P group (hazard ratio (HR) 0.96 [0.76-1.22]; stratified log-rank P=0.74). A total of 271 deaths were observed; median follow-up time for surviving patients was 24.4 months (20.6, 28.3). Overall survival was similar between groups (HR= 0.89 [0.70-1.14]; stratified P=0.34). Rates of grade 3 or higher adverse events were similar between groups (15% vs. 12% in ZA and P). Conclusions: In men with castration-sensitive prostate cancer and bone metastases, early treatment with zoledronic acid was not associated with lower risk for SREs or death. Early termination limited statistical power of the study. Clinical trial information: NCT00079001.

Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors

Cancer ◽  
2004 ◽  
Vol 100 (12) ◽  
pp. 2613-2621 ◽  
Author(s):  
Lee S. Rosen ◽  
David Gordon ◽  
N. Simon Tchekmedyian ◽  
Ronald Yanagihara ◽  
Vera Hirsh ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Solid Tumors ◽  
Lung Carcinoma ◽  
Skeletal Metastases ◽  
Efficacy And Safety ◽  
Cell Lung Carcinoma ◽  
Term Efficacy ◽  
Nonsmall Cell Lung Carcinoma

Prevention of Bone Metastases in Patients with High-risk Nonmetastatic Prostate Cancer Treated with Zoledronic Acid: Efficacy and Safety Results of the Zometa European Study (ZEUS)

2015 ◽  
Vol 67 (3) ◽  
pp. 482-491 ◽  
Author(s):  
Manfred Wirth ◽  
Teuvo Tammela ◽  
Virgilio Cicalese ◽  
Francisco Gomez Veiga ◽  
Karl Delaere ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
High Risk ◽  
Bone Metastases ◽  
Efficacy And Safety ◽  
European Study
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