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. 2025 Aug 29.
doi: 10.1111/bju.16913. Online ahead of print.

Defining statistical cure in patients with T1 high-grade non-muscle-invasive bladder carcinoma treated with BCG immunotherapy

José Daniel Subiela  1 , Irene de la Parra  1 , Javier Taborda  1 , Alberto Artiles Medina  1 , Renate Pichler  2 , Wojciech Krajewski  3 , Cesar Mínguez Ojeda  1 , Ana Fernández Mardomingo  1 , Pedro Del Olmo Durán  1 , Enrique López Pérez  1 , Daniel A González-Padilla  4 , Júlia Aumatell  5 , Keiichiro Mori  6 , Pietro Scilipoti  7 , Mattia Longoni  7 , Mario de Angelis  7 , Jorge Caño-Velasco  8 , Alfonso Lafuente Puentedura  8 , Lucia Polanco Pujol  8 , Roberto Contieri  9 , Andrea Gallioli  10 , Andrzej Tukiendorf  11   12 , David D'Andrea  13 , Jeremy Yuen-Chun Teoh  14 , Luca Afferi  15 , Francesco Del Giudice  16 , Gautier Marcq  17   18   19 , Simone Albisinni  20 , Francesco Soria  21 , Laura S Mertens  22 , Ekaterina Laukhtina  13 , Karl Tully  23 , Andrea Mari  24 , Félix Guerrero-Ramos  25   26   27 , Mario Alvarez-Maestro  28 , Carlos Casanova Martín  28 , Franklin Anagua Melendres  29 , Oscar Buisan  29 , José Agustín López-González  30 , José Luis Dominguez-Escrig  30 , Javier Aranda  31 , José Luis Rodríguez Elena  31 , Giuseppe Basile  32 , Victoria Gómez Dos Santos  1 , Marco Moschini  7 , Benjamin Pradere  32 , Eduardo Albers Acosta  33 , Fernando Lozano Palacio  34 , Albert Carrión Puig  34 , Pablo Gajate  35 , Ana Saiz  36 , Paolo Gontero  21 , Francisco Javier Burgos Revilla  1 ; From Young Academic Urologist: Urothelial Carcinoma Working Group
Affiliations

Defining statistical cure in patients with T1 high-grade non-muscle-invasive bladder carcinoma treated with BCG immunotherapy

José Daniel Subiela et al. BJU Int. .

Abstract

Objective: To assess cure fraction and conditional survival probabilities for oncological outcomes in patients with T1 high-grade (T1HG) non-muscle-invasive bladder carcinoma (NMIBC) treated with adequate Bacillus Calmette-Guérin (BCG) immunotherapy.

Patients and methods: This multi-institutional retrospective cohort study included 1403 patients with T1HG NMIBC treated between 2007 and 2020, adhering to modern guidelines including mandatory second transurethral resection of bladder tumour and adequate BCG, defined as at least five of six induction doses and at least two of three maintenance doses. Cure fraction, defined as the proportion of patients who will never experience the event of interest, was calculated for recurrence-free survival (RFS), progression-free survival (PFS), cancer-specific survival (CSS) and overall survival (OS) using a mixture cure model. Conditional survival probabilities over 5 years were also computed.

Results: Cure fractions were 41% (95% confidence interval [CI] 36%-46%) for RFS, 71% (95% CI 65%-76%) for PFS, 76% (95% CI 70%-83%) for CSS, and 38% (95% CI 28%-49%) for OS. Patients in very-high-risk subgroups, according to the European Association of Urology risk stratification, showed significantly lower cure fractions, particularly for PFS (61% [95% CI 50%-72%]) and CSS (59% [95% CI 34-84%]). Conditional survival analysis demonstrated that patient prognoses improved over time, with 5-year conditional RFS, PFS, CSS and OS probabilities exceeding 90% for patients who were event-free at 5 years from diagnosis.

Conclusions: We found that BCG immunotherapy achieves a statistical cure in select T1HG NMIBC patients, with avoidance of progression to muscle-invasive bladder carcinoma in approximately 70% of cases. The probability of experiencing any adverse oncological event (recurrence, progression or death) is less than 10% among patients who remain event-free for 5 years.

Keywords: BCG immunotherapy; cure fraction; non‐muscle‐invasive bladder cancer; progression; recurrence.

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References

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