Mp16-14 a Phase Ii Trial of Intravesical Gemcitabine and Docetaxel (Gemdoce) in the Treatment of BCG-Naïve Non-Muscle Invasive Urothelial Carcinoma of the Bladder

You have accessJournal of UrologyBladder Cancer: Non-invasive I (MP16)1 May 2024MP16-14 A PHASE II TRIAL OF INTRAVESICAL GEMCITABINE AND DOCETAXEL (GEMDOCE) IN THE TREATMENT OF BCG-NAÏVE NON-MUSCLE INVASIVE UROTHELIAL CARCINOMA OF THE BLADDER Sunil H. Patel, Andrew T. Gabrielson, Sin Chan, Deborah Schwartz, Connie Collins, Nirmish Singla, Bruce Trock, Trinity J. Bivalacqua, Noah Hahn, and Max R. Kates Sunil H. PatelSunil H. Patel , Andrew T. GabrielsonAndrew T. Gabrielson , Sin ChanSin Chan , Deborah SchwartzDeborah Schwartz , Connie CollinsConnie Collins , Nirmish SinglaNirmish Singla , Bruce TrockBruce Trock , Trinity J. BivalacquaTrinity J. Bivalacqua , Noah HahnNoah Hahn , and Max R. KatesMax R. Kates View All Author Informationhttps://doi.org/10.1097/01.JU.0001008640.01272.9d.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Combination intravesical Gemcitabine and Docetaxel (GemDoce) has demonstrated efficacy as a 2nd line therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In the context of widespread BCG shortages, we performed a Phase 2 prospective trial to assess GemDoce for BCG-naïve NMIBC. METHODS: This study is a prospective single-arm open-label phase II trial for patients with BCG-naïve high risk NMIBC. Intravesical gemcitabine and docetaxel was given weekly for 6 weeks as induction followed by monthly maintenance therapy for 2 years among responders. The primary endpoint was 3-month complete response (CR), and key secondary endpoints included adverse events (AE) and 12-month CR. RESULTS: A total of 25 patients were enrolled between August 2020-August 2022 with median follow-up of 19.6 months. The pre-trial pathologic stages were: HGT1 with CIS (n=7), HGT1 without CIS (n=6), HGTa (n=9), and CIS alone (n=3) (Table 1). The 3-month and 12-month CR rate was 100% and 88%, respectively (Figure 1). Two patients with pre-trial HGT1 had HGT1 recurrences at 9 and 12 months. No patients progressed to T2 disease, underwent radical cystectomy, or had any radiographic evidence of progressive disease. Grade 1 AEs were common (23/25 patients) including hematuria, urinary frequency, urgency, and fatigue. Five patients (20%) experienced a Grade 3 AE including hematuria and UTI (Table 2). CONCLUSIONS: In this single-arm phase II trial, GEMDOCE was well-tolerated with promising efficacy for patients with BCG-naïve HR NMIBC. Download PPT Source of Funding: Chad Holliday Research Fund © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e245 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Sunil H. Patel More articles by this author Andrew T. Gabrielson More articles by this author Sin Chan More articles by this author Deborah Schwartz More articles by this author Connie Collins More articles by this author Nirmish Singla More articles by this author Bruce Trock More articles by this author Trinity J. Bivalacqua More articles by this author Noah Hahn More articles by this author Max R. Kates More articles by this author Expand All Advertisement PDF downloadLoading ...