You have accessJournal of UrologyProstate Cancer: Advanced1 Apr 2011716 PHASE III STUDY OF INTERMITTENT MAB VS CONTINUOS MAB Fernando M. Calais da Silva, Fernando Calais da Silva, Aldo Bono, Peter Whelan, Maurizio Brausi, Anton Queimadelos, Jose Portillo, and Ziya Kirkali Fernando M. Calais da SilvaFernando M. Calais da Silva Lisbon, Portugal More articles by this author , Fernando Calais da SilvaFernando Calais da Silva Lisbon, Portugal More articles by this author , Aldo BonoAldo Bono Varese, Italy More articles by this author , Peter WhelanPeter Whelan Leeds, United Kingdom More articles by this author , Maurizio BrausiMaurizio Brausi Modena, Italy More articles by this author , Anton QueimadelosAnton Queimadelos Santiago Compostela, Spain More articles by this author , Jose PortilloJose Portillo Santander, Spain More articles by this author , and Ziya KirkaliZiya Kirkali Izmir, Turkey More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1684AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Few randomised studies have compared intermittent hormonal therapy with continuous therapy for the treatment of advanced prostate cancer. The main publication in 2009 was based upon data with a median follow up of 51 months. We present updated results with extended follow up. The objective is to investigate if intermittent therapy is associated with a shorter survival time. METHODS 766 patients with locally advanced or metastatic prostate cancer received a three month induction treatment. 626 patients whose PSA decreased below 4 ng/ml or to 80% below the initial value, were randomised. Intervention: Patients received cyproterone acetate (CPA) 200 mg for two weeks and then monthly depot injections of a LHRH analogue plus 200 mg of CPA daily during induction. Patients randomised to the intermittent arm ceased treatment while those randomised to the continuous arm received 200 mg of CPA daily sa LHRH analogue RESULTS A total of 474 patients are known to have died, 90 are lost to follow up, of which 37 withdrew mainly for patient refusal and change of therapy. There was no difference in survival, p = 0.61, with hazard ratio 0.96 (95% CI 0.80 to 1.14) and 239 deaths on the intermittent and 235 on the continuous arm. A slight excess of cancer deaths in the intermittent treatment arm (136 versus 109) is balanced by a slight excess of cardiovascular deaths in the continuous arm (68 versus 62), and deaths from other causes (58 versus 41). The hazard ratio of a cancer death is 1.27 (95% CI 0.98, 1.64), p = 0.06 in the intermittent arm compared to the continuous, For cardiovascular deaths the hazard ratios are 1.05 (95% CI 0.75, 1.49), p = 0.77, continuous compared to intermittent, and for other deaths the hazard ratio for continuous compared to intermittent is 1.38 (95% CI 0.93, 2.06), p=0.11. The extended follow up has accumulated a further 135 deaths since the last analysis which used data up to 2005 and exceeds the number of events specified in the original power analysis. The extra 5 years of follow up now means that the study has accumulated almost 3000 person years at risk among the 626 randomised patients and the median follow up is now 57 months compared to 51 months in the publication. CONCLUSIONS Intermittent therapy should be considered for use in routine practice since it is associated with no reduction in survival, no clinically meaningful impairment in quality of life, better sexual activity, and considerable economic benefit to individual and community. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e288 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Fernando M. Calais da Silva Lisbon, Portugal More articles by this author Fernando Calais da Silva Lisbon, Portugal More articles by this author Aldo Bono Varese, Italy More articles by this author Peter Whelan Leeds, United Kingdom More articles by this author Maurizio Brausi Modena, Italy More articles by this author Anton Queimadelos Santiago Compostela, Spain More articles by this author Jose Portillo Santander, Spain More articles by this author Ziya Kirkali Izmir, Turkey More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...