You have accessJournal of UrologyBladder Cancer: Invasive/Metastatic Disease II1 Apr 20101702 PHASE 2 TRIAL OF NEOADJUVANT GEMCITABINE AND CARBOPLATIN FOR MUSCLE-INVASIVE BLADDER CANCER FOLLOWED BY RADICAL CYSTECTOMY Takuya Koie, Teppei Okamoto, Kengo Imanishi, Naoki Sugiyama, Shigemasa Kudoh, Kazuyuki Mori, Tokushi Tachiwada, Takahiro Yoneyama, Yasuhiro Hashimoto, Noritaka Kamimura, Chikara Ohyama, and Yuichiro Suzuki 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 , Shigemasa KudohShigemasa Kudoh More articles by this author , Kazuyuki MoriKazuyuki Mori More articles by this author , Tokushi TachiwadaTokushi Tachiwada 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 , Chikara OhyamaChikara Ohyama More articles by this author , and Yuichiro SuzukiYuichiro Suzuki More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1549AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The neoadjuvant M-VAC followed by radical cystectomy for muscle-invasive bladder cancer has improved survival compared to radical cystectomy alone. Nevertheless, M-VAC has been associated with severe toxicity. The objective of this phase 2 study was to evaluate the objective response rate, the impact on overall survival, disease-free survival, adverse events of gemcitabine and carboplatin (GC) neoadjuvant chemotherapy in patients with locally advanced bladder cancer. METHODS Eighty seven patients with clinical stage T2-T4a, N0M0 bladder cancer were enrolled onto this trial between March 2005 and August 2009. The patients received 2 courses of GC therapy consisted of 800mg/m2 gemcitabine on days 1, 8, and 15 and carboplatin (AUC 4) on day 2. The primary endpoint was the objective response rate, and the secondary endpoints were overall survival, cancer-specific survival, disease free survival, and toxicity. RESULTS Twenty one patients (27.2%) had a complete response and 30 patients (39.0%) had a partial response. The pT0 was achieved in 20 patients (23.0%) and no muscle-invasive disease proportion was 36 patients (41.4%). At a mean follow-up period of 23.6 months, the overall and cancer-specific survival was 90% and 92.7%, respectively. The 2-year disease-free survival was 87.1%. The 2-year cancer-specific survival was 97.1% in achievement of complete or partial response, and 80% in stable disease or progressive disease (P = 0.0113). The 2-year cancer-specific survival was 100% in achievement of <pT2 stage at cystectomy, and 87.4% in □†pT2 (P = 0.0273) (Fig.). Hematologic toxicities were the main adverse events. Grade 3/4 neutropenia occurred in 33 patients (37.9%) and thrombocytopenia in 18 (20.7%). There was no grade 3/4 gastrointestinal toxicity and no renal function abnormalities. CONCLUSIONS Although this is not a randomized study, the GC neoadjuvant therapy followed by radical cystectomy is feasible and may be associated with improved survival among patients with muscle-invasive bladder cancer. A randomized trial is warranted. Hirosaki, Japan© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e657 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 Shigemasa Kudoh More articles by this author Kazuyuki Mori More articles by this author Tokushi Tachiwada 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 Yuichiro Suzuki More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...