Pd48-11 en Bloc vs. Conventional Transurethral Resection of Bladder Tumor: Two-Year Oncological Follow-Up of a Single-Center Prospective, Randomized, Controlled, Non-Inferiority Trial

You have accessJournal of UrologyBladder Cancer: Non-invasive III (PD48)1 May 2024PD48-11 EN BLOC VS. CONVENTIONAL TRANSURETHRAL RESECTION OF BLADDER TUMOR: TWO-YEAR ONCOLOGICAL FOLLOW-UP OF A SINGLE-CENTER PROSPECTIVE, RANDOMIZED, CONTROLLED, NON-INFERIORITY TRIAL Pietro Diana, Andrea Gallioli, Angelo Territo, Óscar Rodriguez-Faba, Josep Maria Gaya, Francesco Sanguedolce, Jordi Huguet, Ruben Parada, Isabel Sanz, Raul Sanchez, Alba Farré, Ferran Algaba, Joan Palou, and Alberto Breda Pietro DianaPietro Diana , Andrea GallioliAndrea Gallioli , Angelo TerritoAngelo Territo , Óscar Rodriguez-FabaÓscar Rodriguez-Faba , Josep Maria GayaJosep Maria Gaya , Francesco SanguedolceFrancesco Sanguedolce , Jordi HuguetJordi Huguet , Ruben ParadaRuben Parada , Isabel SanzIsabel Sanz , Raul SanchezRaul Sanchez , Alba FarréAlba Farré , Ferran AlgabaFerran Algaba , Joan PalouJoan Palou , and Alberto BredaAlberto Breda View All Author Informationhttps://doi.org/10.1097/01.JU.0001008712.53259.7d.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: High-quality randomized controlled trials (RCTs) comparing en-bloc resection of bladder tumor (ERBT) versus conventional transurethral resection of bladder tumor (cTURBT) report up to 1-yr follow-up (FU) after TURBT and they are still showing controversial results. Recently, the EB-STaR study showed lower recurrence rate in ERBT at 1 year follow-up. We provide an updated analysis of an RCT comparing the oncological outcome of ERBT vs. cTURBT at 2-year FU. METHODS: This is an updated analysis of a single-center prospective, randomized trial analysing patients subjected to ERBT vs cTURBT for bladder cancer (BC). Inclusion criteria: tumor size of ≤3 cm, and ≤3 lesions, and no sign of extravesical invasion. The trial (NCT04712201) was approved by the Institutional Review Board (2017/09c). RESULTS: From April 2018 to June 2021, a total of 248 patients were assessed for eligibility. After excluding patients that were diagnosed with T0, T2 or benign lesions (n=29), and lost in FU (n=1) we relied on a cohort of 218 patients all reaching at least 2-yr FU. No significative difference were found between groups in disease characteristics (all p>0.05). One-hundred twenty-three (56%) were ERBT and 95 (44%) were cTURBT. The median FU was 29 months (IQR 18-43). ERBT vs cTURBT recurrence and progression to muscle invasive bladder cancer rates were 38/123 (31%) vs 28/95 (29%) and 5/123 (4%) vs 4/95 (4%). Bladder 2-year recurrence rate (RR) was 46/218 (21%). RR after ERBT and cTURBT were 27/123 (22%) and 19/95 (20%), respectively. Patients with low-grade (LG) tumors 22/126; 17% had recurrence in 12/70 (17%) ERBT vs 10/56 (18%) cTURBT. Patients with high-grade/CIS (HG) disease 24/92; 26.1% experienced recurrence in 15/53 (28%) ERBT vs 9/39 (23%) cTURBT (all p>0.05). Comparing ERBT vs cTURBT groups, patients had recurrence in 0/11 (0%) vs 2/12 (17%) low-risk BC, 12/47 (25%) vs 5/42 (12%) intermediate-risk BC, and 15/65 (23%) vs 12/41 (29%) high/very high risk BC (all p>0.05). The Kaplan-Meier curve revealed that RFS at 2-yr was similar between ERBT vs cTURBT overall (log rank ;0.036 p=0.85), by grade (log rank 0.022; p=0.88), risk stratification (log rank 0.004; p=0.95). PFS at 2-yr was similar between ERBT vs cTURBT overall (log rank ;0.014 p=0.91). CONCLUSIONS: This is the longest FU of a RCT comparing ERBT vs cTURBT. No statistical difference was found in the comparison of RR, RFS and PFS between ERBT and cTURBT at 2-year FU in the overall population as well as sub-stratifying by grade and risk groups. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e992 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Pietro Diana More articles by this author Andrea Gallioli More articles by this author Angelo Territo More articles by this author Óscar Rodriguez-Faba More articles by this author Josep Maria Gaya More articles by this author Francesco Sanguedolce More articles by this author Jordi Huguet More articles by this author Ruben Parada More articles by this author Isabel Sanz More articles by this author Raul Sanchez More articles by this author Alba Farré More articles by this author Ferran Algaba More articles by this author Joan Palou More articles by this author Alberto Breda More articles by this author Expand All Advertisement PDF downloadLoading ...