The oncological risk of patients with Ta high-grade (TaHG) non-muscle-invasive bladder cancer (NMIBC) remains uncertain. We aimed to evaluate the oncological outcomes of TaHG patients treated with Bacillus Calmette-Guérin (BCG) by applying the 2021 European Association of Urology (EAU) and the American Association of Urology (AUA) risk stratifications and assessing the prognostic value of individual risk factors.
We identified 529 TaHG patients without carcinoma in situ (CIS) treated with BCG from 16 tertiary centers between 2003 and 2024. BCG failure was defined as the development of BCG-unresponsive status, BCG relapsing status or identification of muscle invasive bladder cancer during follow-up. TaHG patients were stratified according to the number of EAU and AUA risk factors in three groups (0, 1, 2-3 risk factors), and in intermediate risk (IR-TaHG) and high-risk (HR-TaHG) according to both EAU and AUA risk stratifications. Cumulative incidence analyses and Cox regression models analyzed the 5-yr risk of HG-recurrence, progression and BCG failure among TaHG patients stratified according to the number of EAU and AUA risk factors.
At a median follow-up of 40 months (IQR: 37-42), 114 (22%) TaHG patients experienced a HG-recurrence, 49 (9%) patients had progression and 107 (20%) had BCG failure. No differences in the risk of HG-recurrence, progression and rates of BCG failure were detected in TaHG patients stratified according to the number of EAU or AUA risk factors (all P < 0.05). No differences in the risk of 5-year HG-recurrence were observed between IR-TaHG and HR-TaHG patients according to both EAU (26% vs. 31%, P = 0.10) and AUA risk stratifications (24% vs. 29%, P = 0.07). Similarly, no differences in the 5-yr risk of progression were detected among IR-TaHG and HR-TaHG according to EAU (13% vs. 15%, P = 0.3) and AUA risk stratifications (12% vs. 15%, P = 0.2). No differences in the risk of BCG failure were observed between IR-TaHG and HR-TaHG according to both EAU and AUA risk stratifications (all P > 0.05).
We observed no differences in HG-recurrence, progression, or BCG failure rates among patients with TaHG NMIBC, regardless of the number of EAU or AUA risk factors harbored. These findings may speculatively support the increasing need for BCG-adapted risk stratification and the consideration of all TaHG tumors without CIS as a homogenous population with a similar oncological risk, regardless of individual risk factors.
Urologic oncology. 2026 Apr 02 [Epub ahead of print]
Paolo Zaurito, Pietro Scilipoti, Mattia Longoni, Mario de Angelis, Aleksander Ślusarczyk, Alessandro Viti, Alfonso Santangelo, Giovanni Tremolada, Francesco Soria, Benjamin Pradere, Wojciech Krajewski, David D'Andrea, Andrea Mari, Francesco Del Giudice, Renate Pichler, José Daniel Subiela, Gautier Marcq, Andrea Gallioli, Luca Afferi, Riccardo Mastroianni, Giuseppe Simone, Simone Albisinni, Laura S Mertens, Ekaterina Laukhtina, Katharina Oberneder, José Luis Rodríguez Elena, Javier Aranda, Alfonso Lafuente Puentedura, Jorge Caño Velasco, Roberto Contieri, Rodolfo Hurle, Keiichiro Mori, Piotr Radziszewski, Shahrokh F Shariat, Paolo Gontero, Morgan Rouprêt, Francesco Montorsi, Andrea Salonia, Alberto Briganti, Marco Moschini, European Association of Urology - Young Academic Urologists (EAU-YAU), Urothelial carcinoma working group
Department of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy., Department of General, Oncological and Functional Urology, Medical University of Warsaw, Warsaw, Poland., Department of Surgical Sciences, Division of Urology, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy., Department of Urology UROSUD, La Croix Du Sud Hospital, Quint-Fonsegrives, France., Department of Urology and Oncologic Urology, Wrocław Medical University, Wroclaw, Poland., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria., Department of Experimental and Clinical Medicine, University of Florence - Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy., Department of Maternal Infant and Urologic Sciences, "Sapienza" University of Rome, Policlinico Umberto I Hospital, Rome Italy., Department of Urology, Medical University of Innsbruck, Innsbruck, Austria., Department of Urology, Instituto Ramón y Cajal de Investigación Sanitaria, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain., Department of Urology, Claude Huriez Hospital, CHU Lille, Lille, France., Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain., Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland., IRCCS "Regina Elena" National Cancer Institute, Rome, Italy., Department of Urology, University of Tor Vergata, Rome, Italy., Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Urology, Hospital Universitario de Cáceres, Cáceres, Spain., Department of Urology, Gregorio Marañón University Hospital, Madrid, Spain., Department of Urology, Humanitas Clinical and Research Institute IRCCS Rozzano, Milan, Italy., Department of Urology, The Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, University of Texas Southwestern, Dallas, TX; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York, NY; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic., GRC 5 Predictive Onco-Uro, AP-HP, Urology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France., Department of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: .