A Phase II Trial of Intravesical Gemcitabine and Docetaxel in the Treatment of Bacillus Calmette-Guérin‒Naïve Nonmuscle-Invasive Urothelial Carcinoma of the Bladder

No AccessJournal of UrologyOriginal Clinical Article23 Apr 2024A Phase II Trial of Intravesical Gemcitabine and Docetaxel in the Treatment of Bacillus Calmette-Guérin‒Naïve Nonmuscle-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 Corresponding Author: Max R. Kates, MD, The James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, 1800 Orleans St, Baltimore, MD 21287 ([email protected]) View All Author Informationhttps://doi.org/10.1097/JU.0000000000003977AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail Abstract Purpose: Combination intravesical gemcitabine and docetaxel (GemDoce) has demonstrated efficacy as second-line therapy for patients with bacillus Calmette-Guérin (BCG)‒unresponsive nonmuscle-invasive urothelial carcinoma of the bladder (NMIBC). In the context of widespread BCG shortages, we performed a phase 2 prospective trial to assess GemDoce for BCG-naïve NMIBC. Materials and Methods: This study is a prospective, single-arm, open-label phase 2 trial for patients with BCG-naïve high-risk NMIBC. Intravesical GemDoce was given weekly for 6 weeks as induction followed by monthly maintenance therapy for 2 years among responders. The primary end point was 3-month complete response, and key secondary end points included adverse events (AEs) and 12-month recurrence-free survival. Results: Twenty-five patients were enrolled between August 2020 and August 2022 with median follow-up of 19.6 months. The pretrial pathologic stages were high-grade (HG) T1 with carcinoma in situ (CIS; n = 7), HGT1 without CIS (n = 6), HGTa (n = 9), and CIS alone (n = 3). The 3-month complete response rate was 100% and recurrence-free survival at 12 months was 92%. Two patients with pretrial 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. 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Data analysis and interpretation: Kates, Patel, Gabrielson, Collins, Trock, Bivalacqua, Hahn. Data acquisition: Kates, Patel, Chan, Schwartz, Singla. Drafting the manuscript: Kates, Patel, Gabrielson. Critical revision of the manuscript for scientific and factual content: Kates, Patel, Gabrielson, Chan, Schwartz, Collins, Singla, Trock, Bivalacqua, Hahn. Statistical analysis: Kates, Gabrielson, Collins, Trock. Supervision: Kates, Patel, Singla, Bivalacqua. © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Supplementary Materials Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Keywordsbladder cancerintravesical therapygemcitabinedocetaxelACKNOWLEDGMENTSWe dedicate this study to the memory of Alan Partin, MD, PhD, who allocated a gift from the Chad Holliday Research Fund to support this trial. We also thank Aliya Lalji, Azeem Bhatti, and Ting Wang.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 Corresponding Author: Max R. Kates, MD, The James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, 1800 Orleans St, Baltimore, MD 21287 ([email protected]) More articles by this author Expand All Funding/Support: None. Conflict of Interest Disclosures: The Authors have no conflicts of interest to disclose. Ethics Statement: This study received Institutional Review Board approval (IRB No. J2020). Author Contributions: Conception and design: Kates, Patel, Bivalacqua. Data analysis and interpretation: Kates, Patel, Gabrielson, Collins, Trock, Bivalacqua, Hahn. Data acquisition: Kates, Patel, Chan, Schwartz, Singla. Drafting the manuscript: Kates, Patel, Gabrielson. Critical revision of the manuscript for scientific and factual content: Kates, Patel, Gabrielson, Chan, Schwartz, Collins, Singla, Trock, Bivalacqua, Hahn. Statistical analysis: Kates, Gabrielson, Collins, Trock. Supervision: Kates, Patel, Singla, Bivalacqua. Advertisement PDF downloadLoading ...