报告高风险非肌层浸润性膀胱癌 (HRNMIBC) 的真实结果，包括卡介苗 (BCG) 和根治性膀胱切除术 (RC)，因为无法对这些癌症进行随机比较。我们详细介绍了连续参与者筛选比较 RC 与 BCG 的 BRAVO 随机对照试验（国际标准随机对照试验编号 [ISRCTN]12509361）。对患者进行前瞻性登记，并使用病例记录审查来确定结果。主要结果是总体生存率。次要结局包括复发、进展、转移和膀胱癌特异性生存。总共筛查了 193 名患者，其中 106 名 (54.9%) 接受了 BCG，43 名 (22.3%) 为原发性 RC，37 名 (19.2%) 为“其他”治疗和 7 例 (3.6%) 膀胱内高温丝裂霉素 C 治疗。 55 例 (28.5%) 患者发生全因死亡，中位时间（四分位距 [IQR]）为 29.0（19.5-42.0）个月。在多变量分析中，总体死亡率在老年患者中更为常见（风险比 [HR] 2.63，95% 置信区间 [CI] 1.35-5.13；年龄 >70 岁的 Cox P = 0.004）、从地区医院招募的患者（HR 0.53） ，95% CI 0.3-0.95；P = 0.032）和未接受 RC 作为首次治疗的患者（HR 2.16，95% CI 1.17-3.99；P = 0.014）。总共有 17 名 (8.8%) 患者在中位 (IQR) 为 22.5(19-36.25) 个月时死于膀胱癌 (BC)。在多变量分析中，BC特异性死亡率在老年患者（HR 4.87，95% CI 1.1-21.6；P = 0.037）和Tis/T1疾病患者（HR 2.26，95% CI 1.23-4.16；P = 0.008）中更为常见）但不随初始治疗而变化。HRNMIBC 患者死亡风险很高。选择 RC 作为初始治疗的人比其他人的死亡风险更低，尽管这可能反映了适应性和选择。© 2024 作者。 BJU International 约翰·威利 (John Wiley) 出版

To report real-world outcomes for high-risk non-muscle-invasive bladder cancer (HRNMIBC), including bacillus Calmette-Guérin (BCG) and radical cystectomy (RC), as randomised comparisons of these have not been possible.We detail consecutive participants screened for the BRAVO randomised controlled trial comparing RC with BCG (International Standard Randomised Controlled Trial Number [ISRCTN]12509361). Patients were prospectively registered and case-note review used for outcomes. The primary outcome was overall survival. Secondary outcomes included recurrence, progression, metastasis, and bladder cancer-specific survival.A total of 193 patients were screened, including 106 (54.9%) who received BCG, 43 (22.3%) primary RC, 37 (19.2%) 'other' treatment and seven (3.6%) hyperthermic intravesical mitomycin C. All-cause death occurred in 55 (28.5%) patients at median (interquartile range [IQR]) of 29.0 (19.5-42.0) months. In multivariable analysis, overall mortality was more common in older patients (hazard ratio [HR] 2.63, 95% confidence interval [CI] 1.35-5.13; Cox P = 0.004 for age >70 years), those recruited from district hospitals (HR 0.53, 95% CI 0.3-0.95; P = 0.032) and those who did not undergo RC as their first treatment (HR 2.16, 95% CI 1.17-3.99; P = 0.014). In all, 17 (8.8%) patients died from bladder cancer (BC) at median (IQR) of 22.5 (19-36.25) months. In multivariable analysis, BC-specific mortality was more common in older patients (HR 4.87, 95% CI 1.1-21.6; P = 0.037) and those with Tis/T1 disease (HR 2.26, 95% CI 1.23-4.16; P = 0.008) but did not vary with initial treatment.Patients with HRNMIBC are at high-risk of mortality. Those choosing RC as their initial treatment have lower risks of mortality than others, although this may reflect fitness and selection.© 2024 The Author(s). BJU International published by John Wiley & Sons Ltd on behalf of BJU International.