Current European Association of Urology guidelines universally recommend a second transurethral resection (ReTUR) for all T1 non-muscle-invasive bladder cancer (NMIBC) cases. However, ReTUR is an invasive and costly procedure that is often negative for residual disease, and may represent overtreatment in appropriately selected patients who have undergone complete initial TUR. Our aim was to report 2-yr oncological outcomes and confirm the safety of a novel, response-guided strategy with selective ReTUR for patients with T1 NMIBC.
The prospective, observational, multicenter HuNIRe trial enrolled patients with T1 NMIBC from 2020 to 2024. Patients with complete TUR underwent urine cytology at 3-4 wk and cystoscopy at 4-6 wk. ReTUR was performed only if cytology was positive (Paris system 3-6) or disease was detected on cystoscopy; otherwise, patients proceeded directly to bacillus Calmette-Guérin (BCG) induction therapy. The primary endpoints were 2-yr recurrence-free survival (RFS) and progression-free survival (PFS). Secondary endpoints included comparison of outcomes between the groups with and without ReTUR, and between the overall HuNIRe cohort and a retrospective cohort of patients with T1 NMIBC who underwent routine ReTUR. Kaplan-Meier estimates and the log-rank test were used for survival analysis.
A total of 90 patients were prospectively enrolled. The protocol successfully avoided ReTUR in 71% (n = 64) of patients, who proceeded directly to BCG therapy. Only 29% (n = 26) of the patients required ReTUR according to early evaluation; importantly, no patient was upstaged to MIBC at ReTUR. After median follow-up of 26 mo, 2-yr survival rates for the entire cohort were 69% for RFS and 91% for PFS. There were no significant differences between the groups with and without ReTUR in RFS (p = 0.9) or PFS (p = 0.6). Oncological outcomes were also comparable between the HuNIRe cohort and a retrospective cohort that underwent routine ReTUR (2-yr RFS: 74% vs 74%; 2-yr PFS: 91% vs 92%).
Results from the HuNIRe trial confirm that a risk-adapted approach to ReTUR in selected patients with T1 NMIBC after complete initial TUR is feasible, although oncological outcomes should be interpreted with caution owing to the short follow-up. This strategy spared 71% of patients from ReTUR, and could support a tailored, response-guided approach rather than the blanket guideline recommendation for ReTUR.
European urology oncology. 2026 Feb 06 [Epub ahead of print]
Roberto Contieri, Marco Paciotti, Alessandro Uleri, Alberto Saita, Gianluigi Taverna, Omid Sedigh, Sabato Barra, Piergiuseppe Colombo, Angelo Porreca, Edoardo Beatrici, Vittorio Fasulo, Pier Paolo Avolio, Nicola Frego, Alessio Finocchiaro, Ludovica Cella, Devis Collura, Miriam Cieri, Giorgio Guazzoni, Nicolò Maria Buffi, Giovanni Lughezzani, Paolo Casale, Massimo Lazzeri, Rodolfo Hurle
Department of Biomedical Sciences, Humanitas University, Milan, Italy; Department of Urology, IRCCS Humanitas Research Hospital, Milan, Italy., Department of Urology, IRCCS Humanitas Research Hospital, Milan, Italy., Urology Unit, Humanitas Mater Domini, Varese, Italy., Department of Complex Structure Urology and Reconstructive Andrology, Humanitas Gradenigo Hospital, Turin, Italy., Department of Urology, ASST Melegnano-Martesana, Milan, Italy., Department of Pathology, IRCCS Humanitas Research Hospital, Milan, Italy., Department of Biomedical Sciences, Humanitas University, Milan, Italy; Department of Urology, Humanitas Gavazzeni, Bergamo, Italy., Department of Biomedical Sciences, Humanitas University, Milan, Italy., Department of Biomedical Sciences, Humanitas University, Milan, Italy; Department of Urology, IRCCS Humanitas Research Hospital, Milan, Italy. Electronic address: .