高危非肌层浸润性膀胱癌 (NMIBC) 患者接受卡介苗 (BCG) 滴注以降低进展风险。对于极高危 NMIBC 患者，可考虑立即根治性膀胱切除术，因为尽管接受 BCG 治疗但疾病进展的患者预后较差。然而，指南建议的进展风险分层是基于未接触 BCG 的患者的数据。我们评估了当代原发性高级别/3 级 (HG/G3) T1 NMIBC 患者 (n = 1268) 的进展风险，这些患者接受了至少一次 BCG 滴注并接受了至少一次膀胱镜评估。主要终点是所有患者和接受足够 BCG 的亚组的 1 年进展风险，定义为至少 5 次诱导滴注和至少 2 次滴注作为 6 个月内的第二个 BCG 疗程。进展定义为逼尿肌侵犯或淋巴结或远处转移。开始 BCG 治疗的原发性 HG/G3 T1 NMIBC 患者的 1 年进展风险为 6.5%（95% CI 5.2-8.0），1 年后进展风险为 4.6%（95% CI 3.3-6.4）为接受足够 BCG 的患者 (n = 746) 进行第二个 BCG 疗程的首次滴注。总之，接受 BCG 治疗的 HG/G3 T1 NMIBC 患者的当代进展风险似乎较低，尤其是接受充分 BCG 治疗的患者。患者摘要：我们的研究表明，对于接受膀胱内卡介苗（卡介苗）的高度膀胱肿瘤患者，首次注射卡介苗后 1 年疾病进展的风险为 6.5%。对于继续接受 BCG 维持治疗的患者，第一次 BCG 维持滴注后病情进展的风险为 4.6%。版权所有 © 2024 作者。由 Elsevier B.V. 出版。保留所有权利。

Patients with high-risk non-muscle-invasive bladder cancer (NMIBC) receive bacillus Calmette-Guérin (BCG) instillations to reduce the risk of progression. For patients with very high-risk NMIBC, immediate radical cystectomy may be considered, as patients who experience disease progression despite BCG treatment have a worse prognosis. However, guideline-recommended stratification for the risk of progression is based on data from patients who were not exposed to BCG. We evaluated the risk of progression in a contemporary cohort of patients with primary high-grade/grade 3 (HG/G3) T1 NMIBC (n = 1268) who received at least one BCG instillation and underwent at least one cystoscopic evaluation. The primary endpoint was the 1-yr risk of progression for all patients and for the subgroup that received adequate BCG, defined as at least five induction instillations and at least two instillations provided as a second BCG course within 6 mo. Progression was defined as detrusor muscle invasion or lymph node or distant metastasis. The 1-yr risk of progression was 6.5% (95% confidence interval [CI] 5.2-8.0) for patients with primary HG/G3 T1 NMIBC who started BCG treatment, and 4.6% (95% CI 3.3-6.4) 1 yr after the first instillation of the second BCG course for patients who received adequate BCG (n = 746). In conclusion, the contemporary risk of progression for patients with HG/G3 T1 NMIBC who receive BCG appears to be low, especially for patients who receive adequate BCG treatment. PATIENT SUMMARY: Our study shows that for patients with a high-grade bladder tumor who received in-bladder BCG (bacillus Calmette-Guérin), the risk of disease progression was 6.5% at 1 yr after their first BCG instillation. For patients who continued with BCG maintenance treatments, the risk of progression was 4.6% after the first BCG maintenance instillation.Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.