659 PHASE 2 TRIAL OF NEOADJUVANT LHRH PLUS ESTRAMUSTINE FOR HIGH RISK PROSTATE CANCER FOLLOWED BY RADICAL PROSTATECTOMY

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced II1 Apr 2010659 PHASE 2 TRIAL OF NEOADJUVANT LHRH PLUS ESTRAMUSTINE FOR HIGH RISK PROSTATE CANCER FOLLOWED BY RADICAL PROSTATECTOMY Takuya Koie, Teppei Okamoto, Kengo Imanishi, Naoki Sugiyama, Yuichiro Suzuki, Kazuyuki Mori, Shigemasa Kudoh, Takahiro Yoneyama, Yasuhiro Hashimoto, Noritaka Kamimura, and Chikara Ohyama Takuya KoieTakuya Koie More articles by this author , Teppei OkamotoTeppei Okamoto More articles by this author , Kengo ImanishiKengo Imanishi More articles by this author , Naoki SugiyamaNaoki Sugiyama More articles by this author , Yuichiro SuzukiYuichiro Suzuki More articles by this author , Kazuyuki MoriKazuyuki Mori More articles by this author , Shigemasa KudohShigemasa Kudoh More articles by this author , Takahiro YoneyamaTakahiro Yoneyama More articles by this author , Yasuhiro HashimotoYasuhiro Hashimoto More articles by this author , Noritaka KamimuraNoritaka Kamimura More articles by this author , and Chikara OhyamaChikara Ohyama More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1046AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Effective treatment for high risk prostate cancer (PC) has not yet been established. We examined efficacy and safety of neo-adjuvant therapy with LHRH agonist + estramustine (EMP) (LHRH+EMP) followed by retropubic radical prostatectomy (RRP). METHODS Risk stratification was performed according to the D□fAmico□fs method. Eighty seven patients with high risk PC were enrolled onto this trial from September 2005 and August 2009. The LHRH + EMP therapy included administration of LHRH and 280 mg/day EMP for 6 months prior to the RRP. Post-therapy pathological evaluation to no residual disease at RRP (pT0), and PSA-free survival were endpoints of interest. RESULTS The average age of the patients was 67.2 years (range 49 to 78 years), and mean initial PSA level was 22.5 ng/ml (range 4.2 to 95.6 ng/ml). The median Gleason sum score was 8 (range 6 to 9), and clinical stage T2c or greater was 76 patients (87.4%). Eighty-six (98.9%) completed 6 months of LHRH+EMP neo-adjuvant therapy without delay for RP. The pT0 was achieved in 4 patients (4.6%). The negative surgical margin was 73 patients (83.9%). At a mean follow-up period of 22.2 months, the PSA-free survival was 75.1%. The 2-year PSA-free survival was 83.8% with negative surgical margin, and 35.9% with positive surgical margin (P <0.0001) (Figure). CONCLUSIONS Six months of LHRH+EMP neo-adjuvant therapy followed by RP is safe and effective. Although the present study is not randomized, this treatment may improve PSA-free survival in high-risk prostate cancer. A prospective randomized trial is warranted. Hirosaki, Japan© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e258 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Takuya Koie More articles by this author Teppei Okamoto More articles by this author Kengo Imanishi More articles by this author Naoki Sugiyama More articles by this author Yuichiro Suzuki More articles by this author Kazuyuki Mori More articles by this author Shigemasa Kudoh More articles by this author Takahiro Yoneyama More articles by this author Yasuhiro Hashimoto More articles by this author Noritaka Kamimura More articles by this author Chikara Ohyama More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...