Scientific publications
Unlocking the Potential of Adequate Bacillus Calmette-Guérin Immunotherapy in Very-high-risk Non-muscle-invasive Bladder Carcinoma. Scientific Publication
José Daniel Subiela 1 , Wojciech Krajewski 2 , Daniel A González-Padilla 3 , Jan Laszkiewicz 2 , Javier Taborda 4 , Júlia Aumatell 5 , Miguel Sanchez Encinas 5 , Giuseppe Basile 6 , Marco Moschini 6 , Jorge Caño-Velasco 7 , Enrique Lopez Perez 4 , Pedro Del Olmo Durán 4 , Andrea Gallioli 8 , Andrzej Tukiendorf 9 , David D'Andrea 10 , Jeremy Yuen-Chun Teoh 11 , Alejandra Serna Céspedes 4 , Renate Pilcher 12 , Luca Afferi 13 , Francesco Del Giudice 14 , Juan Gomez Rivas 15 , Simone Albisinni 16 , Francesco Soria 17 , Guillaume Ploussard 18 , Laura S Mertens 19 , Paweł Rajwa 20 , Ekaterina Laukhtina 21 , Benjamin Pradere 22 , Karl Tully 23 , Félix Guerrero-Ramos 24 , Óscar Rodríguez-Faba 8 , Mario Alvarez-Maestro 25 , Jose Luis Dominguez-Escrig 26 , Tomasz Szydełko 2 , Victoria Gomez Dos Santos 4 , Miguel Ángel Jiménez Cidre 4 , Francisco Javier Burgos Revilla 4 ; European Association of Urology-Young Academic Urologists EAU-YAU: Urothelial Carcinoma Working Group
Background: The European Association of Urology (EAU) recommends discussing upfront radical cystectomy for all patients with very high risk (VHR) non-muscle-invasive bladder carcinoma (NMIBC), but the role of bacillus Calmette-Guérin (BCG) treatment remains controversial.
Objective: To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG.
Design, setting, and participants: A multi-institutional retrospective study involving patients with VHR NMIBC who received adequate BCG therapy from 2007 to 2020 was conducted.
Outcome measurements and statistical analysis: A survival analysis estimated recurrence-free survival (RFS), progression-free survival (PFS), and the cumulative incidence of cancer-specific mortality (CSM) after accounting for other causes of mortality as competing risk events and of the overall mortality (OM). Conditional survival probabilities for 0-4 yr without events were computed. Cox regression assessed the predictors of oncological outcomes.
Results and limitation: A total of 640 patients, with a median 47 (32-67) mo follow-up for event-free individuals, were analyzed. High-grade RFS and PFS at 5 yr were 53% (49-57%) and 78% (74-82%), respectively. The cumulative incidence of CSM and OM at 5 yr was 13% (10-16%) and 16% (13-19%), respectively. Conditional RFS, PFS, overall survival, and cancer-specific survival at 4 yr were 91%, 96%, 87%, and 94%, respectively. Cox regression identified tumor grade (hazard ratio [HR]: 1.54; 1.1-2) and size (HR: 1.3; 1.1-1.7) as RFS predictors. Tumor multiplicity predicted RFS (HR: 1.6; 1.3-2), PFS (HR: 2; 1.2-3.3), and CSM (HR: 2; 1.2-3.2), while age predicted OM (HR: 1.48; 1.1-2).
Conclusions: Patients with VHR NMIBC who receive adequate BCG therapy have a more favorable prognosis than predicted by EAU risk groups, especially among those with a sustained response, in whom continuing maintenance therapy emerges as a viable alternative to radical cystectomy.
Patient summary: Our research shows that a sustained response to bacillus Calmette-Guérin in patients can lead to favorable outcomes, serving as a viable alternative to cystectomy for select cases.
CITATION Eur Urol Oncol. 2024 Feb 13:S2588-9311(24)00043-9. doi: 10.1016/j.euo.2024.01.017.
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