Unlocking the Potential of Adequate Bacillus Calmette-Guérin Immunotherapy in Very-high-risk Non-muscle-invasive Bladder Carcinoma: A Multicenter Analysis of Oncological Outcomes and Risk Dynamics.

Bacillus Calmette-Guérin Non–muscle-invasive bladder carcinoma Very high risk

Journal

European urology oncology
ISSN: 2588-9311
Titre abrégé: Eur Urol Oncol
Pays: Netherlands
ID NLM: 101724904

Informations de publication

Date de publication:
13 Feb 2024
Historique:
received: 25 10 2023
revised: 09 12 2023
accepted: 29 01 2024
medline: 15 2 2024
pubmed: 15 2 2024
entrez: 14 2 2024
Statut: aheadofprint

Résumé

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. To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG. A multi-institutional retrospective study involving patients with VHR NMIBC who received adequate BCG therapy from 2007 to 2020 was conducted. 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. 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). 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. 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.

Sections du résumé

BACKGROUND 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 OBJECTIVE
To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG.
DESIGN, SETTING, AND PARTICIPANTS METHODS
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 METHODS
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 RESULTS
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 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 RESULTS
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.

Identifiants

pubmed: 38355375
pii: S2588-9311(24)00043-9
doi: 10.1016/j.euo.2024.01.017
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Auteurs

José Daniel Subiela (JD)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain. Electronic address: jdsubiela@gmail.com.

Wojciech Krajewski (W)

Department of Minimally Invasive Robotic Urology, Center of Excellence in Urology, Wrocław Medical University, Wrocław, Poland.

Daniel A González-Padilla (DA)

Department of Urology, Clínica Universidad de Navarra, Madrid, Spain.

Jan Laszkiewicz (J)

Department of Minimally Invasive Robotic Urology, Center of Excellence in Urology, Wrocław Medical University, Wrocław, Poland.

Javier Taborda (J)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain.

Júlia Aumatell (J)

Servicio de Urología, Hospital Universitario Rey Juan Carlos, Universidad Rey Juan Carlos Móstoles, Madrid, Spain.

Miguel Sanchez Encinas (M)

Servicio de Urología, Hospital Universitario Rey Juan Carlos, Universidad Rey Juan Carlos Móstoles, Madrid, Spain.

Giuseppe Basile (G)

Division of Experimental Oncology, Department of Urology, Urological Research Institute, Vita-Salute San Raffaele University, Milan, Italy.

Marco Moschini (M)

Division of Experimental Oncology, Department of Urology, Urological Research Institute, Vita-Salute San Raffaele University, Milan, Italy.

Jorge Caño-Velasco (J)

Department of Urology, Hospital Universitario Gregorio Marañon, Madrid, Spain.

Enrique Lopez Perez (E)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain.

Pedro Del Olmo Durán (P)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain.

Andrea Gallioli (A)

Department of Urology, Fundaciò Puigvert, Autonomous University of Barcelona, Barcelona, Spain.

Andrzej Tukiendorf (A)

Institute of Health Sciences, Opole University, Opole, Poland; University Clinical Hospital in Opole, Opole, Poland.

David D'Andrea (D)

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.

Jeremy Yuen-Chun Teoh (J)

S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region.

Alejandra Serna Céspedes (A)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain.

Renate Pilcher (R)

Medical University of Innsbruck, Department of Urology, Comprehensive Cancer Center Innsbruck (CCCI), Innsbruck, Austria.

Luca Afferi (L)

Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland.

Francesco Del Giudice (F)

Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" University of Rome, Rome, Italy.

Juan Gomez Rivas (J)

Department of Urology, Hospital Clínico San Carlos, Madrid, Spain.

Simone Albisinni (S)

Urology Unit, Department of Surgical Sciences, Tor Vergata University Hospital, University of Rome Tor Vergata, Rome, Italy.

Francesco Soria (F)

Division of Urology, Department of Surgical Sciences Molinette Hospital University of Torino School of Medicine, Torino, Italy.

Guillaume Ploussard (G)

Department of Urology, La Croix du Sud Hospital, Quint Fonsegrives, France.

Laura S Mertens (LS)

Department of Urology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.

Paweł Rajwa (P)

Department of Urology, Medical University of Silesia, Zabrze, Poland.

Ekaterina Laukhtina (E)

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.

Benjamin Pradere (B)

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, La Croix du Sud Hospital, Quint Fonsegrives, France.

Karl Tully (K)

Department of Urology and Neurourology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.

Félix Guerrero-Ramos (F)

Department of Urology, Hospital Universitario 12 de Octubre, Madrid, Spain; ROC Clinic, Madrid, Spain; Department of Urology, Hospital Universitario HM Sanchinarro, Madrid, Spain.

Óscar Rodríguez-Faba (Ó)

Department of Urology, Fundaciò Puigvert, Autonomous University of Barcelona, Barcelona, Spain.

Mario Alvarez-Maestro (M)

Department of Urology, Hospital Universitario La Paz, Madrid, Spain.

Jose Luis Dominguez-Escrig (JL)

Department of Urology, Fundación Instituto Valenciano de Oncología, Valencia, Spain.

Tomasz Szydełko (T)

Department of Minimally Invasive Robotic Urology, Center of Excellence in Urology, Wrocław Medical University, Wrocław, Poland.

Victoria Gomez Dos Santos (V)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain.

Miguel Ángel Jiménez Cidre (MÁ)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain.

Francisco Javier Burgos Revilla (FJ)

Department of Urology, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcala, Madrid, Spain.

Classifications MeSH