A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
Fred Saad,Donald M. Gleason,Robin Murray,Simon Tchekmedyian,Peter Venner,Louis Lacombe,Joseph L. Chin,Jeferson J. Vinholes,J. Allen Goas,Bee Chen +9 more
TLDR
Zoledronic acid at 4 mg reduced skeletal-related events in prostate cancer patients with bone metastases and urinary markers of bone resorption were statistically significantly decreased in patients who received zoledronic Acid at either dose.Abstract:
Background: Bone metastases are a common cause of morbidity in patients with prostate carcinoma. We studied the effect of a new bisphosphonate, zoledronic acid, which blocks bone destruction, on skeletal complications in prostate cancer patients with bone metastases. Methods: Patients with hormone-refractory prostate cancer and a history of bone metastases were randomly assigned to a double-blind treatment regimen of intravenous zoledronic acid at 4 mg (N = 214), zoledronic acid at 8 mg (subsequently reduced to 4 mg; 8/4) (N = 221), or placebo (N = 208) every 3 weeks for 15 months. Proportions of patients with skeletal-related events, time to the first skeletal-related event, skeletal morbidity rate, pain and analgesic scores, disease progression, and safety were assessed. All statistical tests were two-sided. Results: Approximately 38% of patients who received zoledronic acid at 4 mg, 28% who received zoledronic acid at 8/4 mg, and 31% who received placebo completed the study. A greater proportion of patients who received placebo had skeletal-related events than those who received zoledronic acid at 4 mg (44.2% versus 33.2%; difference = –11.0%, 95% confidence interval [CI] = –20.3% to –1.8%; P = .021) or those who received zoledronic acid at 8/4 mg (38.5%; difference versus placebo = –5.8%, 95% CI = –15.1% to 3.6%; P = .222). Median time to first skeletalrelated event was 321 days for patients who received placebo, was not reached for patients who received zoledronic acid at 4 mg ( P= .011 versus placebo), and was 363 days for those who received zoledronic acid at 8/4 mg ( P= .491 versus placebo). Compared with urinary markers in patients who received placebo, urinary markers of bone resorption were statistically significantly decreased in patients who received zoledronic acid at either dose (P = .001). Pain and analgesic scores increased more in patients who received placebo than in patients who received zoledronic acid, but there were no differences in disease progression, performance status, or quality-of-life scores among the groups. Zoledronic acid at 4 mg given as a 15-minute infusion was well tolerated, but the 8-mg dose was associated with renal function deterioration. Conclusion: Zoledronic acid at 4 mg reduced skeletalrelated events in prostate cancer patients with bone metastases. [J Natl Cancer Inst 2002;94:1458–68]read more
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Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Ian F. Tannock,Ronald de Wit,William R. Berry,Jozsef Horti,Anna Pluzanska,Kim N. Chi,Stéphane Oudard,Christine Theodore,Nicholas D. James,Ingela Turesson,Mark Rosenthal,Mario A. Eisenberger +11 more
TL;DR: When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plusprednisone.
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Sipuleucel-T immunotherapy for castration-resistant prostate cancer.
Philip W. Kantoff,Celestia S. Higano,N. Shore,E. Roy Berger,Eric J. Small,David F. Penson,Charles H. Redfern,Anna C. Ferrari,Robert Dreicer,Robert B. Sims,Yi Xu,Mark W. Frohlich,Paul F. Schellhammer +12 more
TL;DR: The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer and immune responses to the immunizing antigen were observed in patients who received sipuleUcel- T.
Journal ArticleDOI
Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Howard I. Scher,Karim Fizazi,Fred Saad,Mary-Ellen Taplin,Cora N. Sternberg,Kurt Miller,Ronald de Wit,Peter F.A. Mulders,Kim N. Chi,Neal D. Shore,Andrew J. Armstrong,Thomas W. Flaig,Aude Flechon,Paul N. Mainwaring,Mark D. Fleming,John D. Hainsworth,Mohammad Hirmand,Bryan Selby,Lynn Seely,Johann S. de Bono,B Ch +20 more
TL;DR: Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy, and was shown with respect to all secondary end points.
Journal ArticleDOI
EAU guidelines on prostate cancer
Axel Heidenreich,Gunnar Aus,Michel Bolla,Steven Joniau,Vsevolod Matveev,Hans Schmid,F. Zattoni +6 more
TL;DR: The guidelines have been updated and level of evidence/grade of recommendation added to the text enables readers to better understand the quality of the data forming the basis of the recommendations.
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Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy
Charles J. Ryan,Matthew R. Smith,Johann S. de Bono,Arturo Molina,Christopher J. Logothetis,Paul de Souza,Karim Fizazi,Paul N. Mainwaring,Josep M. Piulats,Siobhan Ng,Joan Carles,Peter F.A. Mulders,Ethan Basch,Eric J. Small,Fred Saad,D. Schrijvers,Hendrik Van Poppel,Som D. Mukherjee,Henrik Suttmann,Winald R. Gerritsen,Thomas W. Flaig,Daniel J. George,Evan Y. Yu,Eleni Efstathiou,Allan J. Pantuck,Eric Winquist,Celestia S. Higano,Mary-Ellen Taplin,Youn C. Park,Thian Kheoh,Thomas W. Griffin,Howard I. Scher,Dana E. Rathkopf +32 more
TL;DR: Abiraterone improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer.
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