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释放卡介苗充分免疫疗法在极高风险非肌层浸润性膀胱癌中的潜力:肿瘤学结局与风险动态的多中心分析

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.

作者信息

Subiela José Daniel, Krajewski Wojciech, González-Padilla Daniel A, Laszkiewicz Jan, Taborda Javier, Aumatell Júlia, Sanchez Encinas Miguel, Basile Giuseppe, Moschini Marco, Caño-Velasco Jorge, Lopez Perez Enrique, Del Olmo Durán Pedro, Gallioli Andrea, Tukiendorf Andrzej, D'Andrea David, Yuen-Chun Teoh Jeremy, Serna Céspedes Alejandra, Pichler Renate, Afferi Luca, Del Giudice Francesco, Gomez Rivas Juan, Albisinni Simone, Soria Francesco, Ploussard Guillaume, Mertens Laura S, Rajwa Paweł, Laukhtina Ekaterina, Pradere Benjamin, Tully Karl, Guerrero-Ramos Félix, Rodríguez-Faba Óscar, Alvarez-Maestro Mario, Dominguez-Escrig Jose Luis, Szydełko Tomasz, Gomez Dos Santos Victoria, Jiménez Cidre Miguel Ángel, Burgos Revilla Francisco Javier

机构信息

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

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

出版信息

Eur Urol Oncol. 2024 Dec;7(6):1367-1375. doi: 10.1016/j.euo.2024.01.017. Epub 2024 Feb 13.

Abstract

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.

摘要

背景

欧洲泌尿外科学会(EAU)建议对所有具有极高风险(VHR)的非肌层浸润性膀胱癌(NMIBC)患者进行术前根治性膀胱切除术,但卡介苗(BCG)治疗的作用仍存在争议。

目的

分析接受充分BCG治疗的VHR NMIBC患者(EAU风险组)的肿瘤学结局。

设计、设置和参与者:进行了一项多机构回顾性研究,纳入了2007年至2020年接受充分BCG治疗的VHR NMIBC患者。

结局测量和统计分析

生存分析估计无复发生存期(RFS)、无进展生存期(PFS)以及将其他死亡原因作为竞争风险事件考虑后的癌症特异性死亡率(CSM)和总死亡率(OM)的累积发生率。计算了0至4年无事件发生的条件生存概率。Cox回归评估肿瘤学结局的预测因素。

结果和局限性

共分析了640例患者,无事件发生个体的中位随访时间为47(32 - 67)个月。5年时高级别RFS和PFS分别为53%(49 - 57%)和78%(74 - 82%)。5年时CSM和OM的累积发生率分别为13%(10 - 16%)和16%(13 - 19%)。4年时的条件RFS、PFS、总生存率和癌症特异性生存率分别为91%、96%、87%和94%。Cox回归确定肿瘤分级(风险比[HR]:1.54;1.1 - 2)和大小(HR:1.3;1.1 - 1.7)为RFS的预测因素。肿瘤多灶性预测RFS(HR:1.6;1.3 - 2)、PFS(HR:2;1.2 - 3.3)和CSM(HR:2;1.2 - 3.2),而年龄预测OM(HR:1.48;1.1 - 2)。

结论

接受充分BCG治疗的VHR NMIBC患者的预后比EAU风险组预测的更有利,特别是在那些有持续反应的患者中,持续维持治疗成为根治性膀胱切除术的可行替代方案。

患者总结

我们的研究表明,患者对卡介苗的持续反应可导致良好结局,在某些情况下是膀胱切除术的可行替代方案。

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