Defining statistical cure in patients with T1 high-grade non-muscle-invasive bladder carcinoma treated with BCG immunotherapy
Por:
Subiela, JD, de la Parra, I, Taborda, J, Medina, AA, Pichler, R, Krajewski, W, Ojeda, CM, Mardomingo, AF, Durán, PD, Pérez, EL, González-Padilla, DA, Aumatell, J, Mori, K, Scilipoti, P, Longoni, M, de Angelis, M, Caño-Velasco, J, Puentedura, AL, Pujol, LP, Contieri, R, Gallioli, A, Tukiendorf, A, D'Andrea, D, Teoh, JY, Afferi, L, Del Giudice, F, Marcq, G, Albisinni, S, Soria, F, Mertens, LS, Laukhtina, E, Tully, K, Mari, A, Guerrero-Ramos, F, Alvarez-Maestro, M, Martín, CC, Melendres, FA, Buisan, O, López-González, JA, Dominguez-Escrig, JL, Aranda, J, Elena, JLR, Basile, G, Santos, VGD, Moschini, M, Pradere, B, Acosta, EA, Palacio, FL, Puig, AC, Gajate, P, Saiz, A, Gontero, P, Revilla, FJB
Publicada:
1 feb 2026
Ahead of Print:
1 ago 2025
Resumen:
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-Gu & eacute;rin (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.
Filiaciones:
Subiela, JD:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
de la Parra, I:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
Taborda, J:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
Medina, AA:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
Pichler, R:
Med Univ Innsbruck, Comprehens Canc Ctr Innsbruck CCCI, Dept Urol, Innsbruck, Austria
Krajewski, W:
Wroclaw Med Univ, Univ Ctr Excellence Urol, Dept Minimally Invas & Robot Urol, Wroclaw, Poland
Ojeda, CM:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
Mardomingo, AF:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
Durán, PD:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
Pérez, EL:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
González-Padilla, DA:
Clin Univ Navarra, Dept Urol, Madrid, Spain
Aumatell, J:
Univ Rey Juan Carlos Mostoles, Hosp Univ Rey Juan Carlos, Serv Urol, Madrid, Spain
Mori, K:
Jikei Univ, Sch Med, Dept Urol, Tokyo, Japan
Scilipoti, P:
Univ Vita Salute San Raffaele, Urol Res Inst, Dept Urol, Div Expt Oncol, Milan, Italy
Longoni, M:
Univ Vita Salute San Raffaele, Urol Res Inst, Dept Urol, Div Expt Oncol, Milan, Italy
de Angelis, M:
Univ Vita Salute San Raffaele, Urol Res Inst, Dept Urol, Div Expt Oncol, Milan, Italy
Caño-Velasco, J:
Hosp Univ Gregorio Maranon, Dept Urol, Madrid, Spain
Puentedura, AL:
Hosp Univ Gregorio Maranon, Dept Urol, Madrid, Spain
Pujol, LP:
Hosp Univ Gregorio Maranon, Dept Urol, Madrid, Spain
Contieri, R:
Humanitas Clin & Res Inst IRCCS, Dept Urol, Milan, Italy
Gallioli, A:
Autonomous Univ Barcelona, Dept Urol, Fundacio Puigvert, Barcelona, Spain
Tukiendorf, A:
Opole Univ, Inst Hlth Sci, Opole, Poland
Univ Clin Hosp Opole, Opole, Poland
D'Andrea, D:
Med Univ Vienna, Comprehens Canc Ctr, Dept Urol, Vienna, Austria
Teoh, JY:
Chinese Univ Hong Kong, SH Ho Urol Ctr, Dept Surg, Hong Kong, Peoples R China
Afferi, L:
Luzerner Kantonsspital, Dept Urol, Luzern, Switzerland
Del Giudice, F:
Sapienza Univ Rome, Policlin Umberto Hosp 1, Dept Maternal Infant & Urol Sci, Rome, Italy
Marcq, G:
McGill Univ, Hlth Ctr, Dept Urol, Montreal, PQ, Canada
CHU Lille, Claude Huriez Hosp, Urol Dept, Lille, France
Univ Lille, Inst Pasteur Lille, CANTHER Canc Heterogene Plast & Resistance Therapi, CNRS,INSERM,CHU Lille, Lille, France
Albisinni, S:
Univ Tor Vergata, Dept Urol, Rome, Italy
Soria, F:
Univ Studies Torino, San Giovanni Battista Hosp, Dept Surg Sci, Div Urol, Turin, Italy
Mertens, LS:
Netherlands Canc Inst, Dept Urol, Amsterdam, Netherlands
Laukhtina, E:
Med Univ Vienna, Comprehens Canc Ctr, Dept Urol, Vienna, Austria
Tully, K:
Ruhr Univ Bochum, Marien Hosp Herne, Dept Urol & Neurourol, Herne, Germany
Mari, A:
Univ Florence, Careggi Hosp, Dept Clin & Expt Med, Unit Oncol Minimally Invas Urol & Androl, Florence, Italy
Guerrero-Ramos, F:
Hosp Univ 12 Octubre, Dept Urol, Madrid, Spain
ROC Clin, Madrid, Spain
Hosp Univ HM Sanchinarro, Dept Urol, Madrid, Spain
Alvarez-Maestro, M:
Hosp Univ La Paz, Dept Urol, Madrid, Spain
Martín, CC:
Hosp Univ La Paz, Dept Urol, Madrid, Spain
Melendres, FA:
Univ Barcelona, Hosp Univ Bellvitge, Dept Urol, Lhospitalet De Llobregat, Spain
Buisan, O:
Univ Barcelona, Hosp Univ Bellvitge, Dept Urol, Lhospitalet De Llobregat, Spain
López-González, JA:
Fdn Inst Valenciano Oncol, Dept Urol, Valencia, Spain
Dominguez-Escrig, JL:
Fdn Inst Valenciano Oncol, Dept Urol, Valencia, Spain
Aranda, J:
Hosp Univ Caceres, Dept Urol, Caceres, Spain
Elena, JLR:
Hosp Univ Caceres, Dept Urol, Caceres, Spain
Basile, G:
La Croix Du Sud Hosp, Dept Urol UROSUD, Quint Fonsegrives, France
Santos, VGD:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
Moschini, M:
Univ Vita Salute San Raffaele, Urol Res Inst, Dept Urol, Div Expt Oncol, Milan, Italy
Pradere, B:
La Croix Du Sud Hosp, Dept Urol UROSUD, Quint Fonsegrives, France
Acosta, EA:
Autonomous Univ Madrid, La Princesa Univ Hosp, Dept Urol, IIS Princesa, Madrid, Spain
Palacio, FL:
Hosp Univ Vall dHebron, Dept Urol, Barcelona, Spain
Puig, AC:
Hosp Univ Vall dHebron, Dept Urol, Barcelona, Spain
Gajate, P:
Ramon & Cajal Univ Hosp, Med Oncol Dept, IRYCIS, Madrid, Spain
Saiz, A:
Ramon & Cajal Univ Hosp, Pathol Dept, IRYCIS, Madrid, Spain
Gontero, P:
Univ Studies Torino, San Giovanni Battista Hosp, Dept Surg Sci, Div Urol, Turin, Italy
Revilla, FJB:
Univ Alcala, Hosp Univ Ramon & Cajal, Dept Urol, IRYCIS, Madrid, Spain
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