高危非肌层浸润性膀胱癌的真实世界结局：BRAVO试验筛查患者
Real-world outcomes for high-risk non-muscle-invasive bladder cancer: screened patients for the BRAVO trial
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影响因子:4.4
分区:医学2区 / 泌尿学与肾脏学2区
发表日期:2025 Feb
作者:
Samantha Conroy, Ibrahim Jubber, Aidan P Noon, Derek J Rosario, Jon Griffin, Susan Morgan, Rachel Hubbard, Steve Kennish, Stephen Mitchell, Suresh Venugopal, Kate Linton, Ramanan Rajasundaram, Syed A Hussain, James W F Catto
DOI:
10.1111/bju.16516
摘要
为了报告高危非肌层浸润性膀胱癌（HRNMIBC）的实际临床结局，包括卡介苗（BCG）和根治性膀胱切除术（RC），由于无法进行随机比较。我们详细介绍了筛查参加BRAVO随机对照试验的连续患者，该试验比较了RC与BCG（国际标准随机对照试验编号[ISRCTN] 12509361）。患者进行了前瞻性注册，并通过病例记录回顾评估结局。主要结局为总体生存率。次要结局包括复发、进展、转移和膀胱癌特异性存活。共筛查193名患者，其中106人（54.9%）接受了BCG，43人（22.3%）接受了原发性RC，37人（19.2%）接受了“其他”治疗，7人（3.6%）接受了温热腹腔内氮霉素治疗。所有原因死亡的患者有55人（28.5%），中位随访（四分位距[IQR]）为29.0个月（19.5-42.0）。多变量分析显示，整体死亡率在年龄较大的患者中更高（风险比[HR] 2.63，95%置信区间[CI] 1.35-5.13；Cox回归P=0.004，年龄>70岁），来自地区医院的患者（HR 0.53，95% CI 0.3-0.95；P=0.032）以及未接受RC作为首选治疗的患者（HR 2.16，95% CI 1.17-3.99；P=0.014）死亡风险更高。共有17人（8.8%）死于膀胱癌，中位（IQR）随访为22.5个月（19-36.25）。多变量分析显示，膀胱癌特异性死亡在年龄较大者（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，但与最初治疗无关。高危非肌层浸润性膀胱癌患者死亡风险较高。选择RC作为初治方式的患者死亡风险较低，虽可能反映其身体状况与选择偏好。
Abstract
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.