José Daniel Subiela, Irene de la Parra, Javier Taborda, Alberto Artiles Medina, Renate Pichler, Wojciech Krajewski, Cesar Mínguez Ojeda, Ana Fernández Mardomingo, Pedro Del Olmo Durán, Enrique López Pérez, Daniel A González-Padilla, Júlia Aumatell, Keiichiro Mori, Pietro Scilipoti, Mattia Longoni, Mario de Angelis, Jorge Caño-Velasco, Alfonso Lafuente Puentedura, Lucia Polanco Pujol, Roberto Contieri, Andrea Gallioli, Andrzej Tukiendorf, David D'Andrea, Jeremy Yuen-Chun Teoh, Luca Afferi, Francesco Del Giudice, Gautier Marcq, Simone Albisinni, Francesco Soria, Laura S Mertens, Ekaterina Laukhtina, Karl Tully, Andrea Mari, Félix Guerrero-Ramos, Mario Alvarez-Maestro, Carlos Casanova Martín, Franklin Anagua Melendres, Oscar Buisan, José Agustín López-González, José Luis Dominguez-Escrig, Javier Aranda, José Luis Rodríguez Elena, Giuseppe Basile, Victoria Gómez Dos Santos, Marco Moschini, Benjamin Pradere, Eduardo Albers Acosta, Fernando Lozano Palacio, Albert Carrión Puig, Pablo Gajate, Ana Saiz, Paolo Gontero, Francisco Javier Burgos Revilla
{"title":"定义T1级非肌浸润性膀胱癌患者卡介苗免疫治疗的统计学治愈。","authors":"José Daniel Subiela, Irene de la Parra, Javier Taborda, Alberto Artiles Medina, Renate Pichler, Wojciech Krajewski, Cesar Mínguez Ojeda, Ana Fernández Mardomingo, Pedro Del Olmo Durán, Enrique López Pérez, Daniel A González-Padilla, Júlia Aumatell, Keiichiro Mori, Pietro Scilipoti, Mattia Longoni, Mario de Angelis, Jorge Caño-Velasco, Alfonso Lafuente Puentedura, Lucia Polanco Pujol, Roberto Contieri, Andrea Gallioli, Andrzej Tukiendorf, David D'Andrea, Jeremy Yuen-Chun Teoh, Luca Afferi, Francesco Del Giudice, Gautier Marcq, Simone Albisinni, Francesco Soria, Laura S Mertens, Ekaterina Laukhtina, Karl Tully, Andrea Mari, Félix Guerrero-Ramos, Mario Alvarez-Maestro, Carlos Casanova Martín, Franklin Anagua Melendres, Oscar Buisan, José Agustín López-González, José Luis Dominguez-Escrig, Javier Aranda, José Luis Rodríguez Elena, Giuseppe Basile, Victoria Gómez Dos Santos, Marco Moschini, Benjamin Pradere, Eduardo Albers Acosta, Fernando Lozano Palacio, Albert Carrión Puig, Pablo Gajate, Ana Saiz, Paolo Gontero, Francisco Javier Burgos Revilla","doi":"10.1111/bju.16913","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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. 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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.</p><p><strong>Results: </strong>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%]). 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引用次数: 0
摘要
目的：评估T1级（T1HG）非肌浸润性膀胱癌（NMIBC）患者接受适当卡介苗免疫治疗后肿瘤预后的治愈率和条件生存概率。患者和方法：这项多机构回顾性队列研究纳入了2007年至2020年间治疗的1403例T1HG NMIBC患者，坚持现代指南，包括强制性第二次经尿道膀胱肿瘤切除术和足够的卡介苗，定义为6次诱导剂量中的至少5次和3次维持剂量中的至少2次。使用混合治愈模型计算无复发生存期（RFS）、无进展生存期（PFS）、癌症特异性生存期（CSS）和总生存期（OS），治愈率定义为从未经历感兴趣事件的患者的比例。同时计算5年以上的条件生存概率。结果：RFS的治愈率为41%(95%可信区间[CI] 36%-46%)， PFS的治愈率为71% (95% CI 65%-76%)， CSS的治愈率为76% (95% CI 70%-83%)， OS的治愈率为38% （95% CI 28%-49%）。根据欧洲泌尿外科风险分层协会的数据，高危亚组患者的治愈率明显较低，尤其是PFS （61% [95% CI 50%-72%]）和CSS （59% [95% CI 34-84%]）。条件生存分析表明，患者预后随着时间的推移而改善，在诊断后5年无事件的患者中，5年条件RFS、PFS、CSS和OS概率超过90%。结论：我们发现卡介苗免疫治疗在选择的T1HG NMIBC患者中实现了统计学治愈，大约70%的病例避免了进展为肌肉浸润性膀胱癌。在无事件发生5年的患者中，发生任何不良肿瘤事件（复发、进展或死亡）的概率小于10%。
Defining statistical cure in patients with T1 high-grade non-muscle-invasive bladder carcinoma treated with BCG immunotherapy.
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.
期刊介绍：
BJUI is one of the most highly respected medical journals in the world, with a truly international range of published papers and appeal. Every issue gives invaluable practical information in the form of original articles, reviews, comments, surgical education articles, and translational science articles in the field of urology. BJUI employs topical sections, and is in full colour, making it easier to browse or search for something specific.
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