Tan Wei Shen, Grajales Valentina, Contieri Roberto, Hensley Patrick, Bree Kelly, Msaouel Pavlos, Guo Charles C, Nogueras-Gonzalez Graciela M, Navai Neema, Dinney Colin P, Kamat Ashish M
Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Department of Urology, University of Kentucky, Lexington, KY, USA.
Eur Urol Open Sci. 2023 May 13;53:16-22. doi: 10.1016/j.euros.2023.04.013. eCollection 2023 Jul.
Data for bladder-sparing treatment (BST) in bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) patients report short-term outcomes limited to 1-2 yr.
To assess long-term survival outcomes of BCG-unresponsive NMIBC patients treated with BST.
BCG-unresponsive NMIBC patients diagnosed between January 2000 and September 2021 from an institutional NMIBC registry were evaluated.
Long-term survival outcomes for patients receiving BST, early radical cystectomy (RC), and delayed RC were compared.
The primary endpoints were overall survival (OS) and cancer-specific survival (CSS).
In total, 114 patients with a median follow-up of 71.2 mo (interquartile range: 32.6-132.2) were analyzed. There were no significant differences in OS (hazard ratio [HR]: 1.40, 95% confidence interval [CI]: 0.68-2.89, = 0.4) or CSS (HR: 0.88, 95% CI: 0.22-3.55, = 0.9) between patients undergoing early RC ( = 38) and BST ( = 76). At 60 mo, BST patients had a high-grade recurrence-free rate, muscle-invasive disease/metastasis progression-free rate, and avoidance of RC rate of 37%, 83%, and 58%, respectively. Current smoker status (HR: 4.44, 95% CI: 1.41-13.97, = 0.011) was the only variable predictive of high-grade recurrence following a multivariable analysis. The median time to RC from BCG-unresponsive date was 2.1 and 11.7 mo for those undergoing early RC and delayed RC (after BST), respectively. Patients treated with early RC had a higher incidence of cT1 disease (53% vs 36%, = 0.049) and lymphovascular invasion (LVI; 11% vs 0%, = 0.011) compared to patients treated with BST. Survival outcomes were similar between groups: 10-yr OS-58% versus 50% (HR: 1.40, 95% CI: 0.68-2.89, = 0.4), and 10-yr CSS-81% versus 85% (HR: 0.88, 95% CI: 0.22-3.55, = 0.9).
An analysis of long-term survival of BCG-unresponsive NMIBC patients receiving BST suggests that it may be safe in patients without LVI and/or variant histology and nonsmokers. Survival outcomes for patients treated with BST may not be inferior to those receiving early RC.
Bladder-sparing treatment can be offered to appropriately selected patients who have bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer. Long-term outcomes may not be inferior to those for patients who opt for early radical cystectomy.
卡介苗（BCG）无反应的非肌肉浸润性膀胱癌（NMIBC）患者保留膀胱治疗（BST）的数据报告的短期结果仅限于1 - 2年。
评估接受BST治疗的BCG无反应NMIBC患者的长期生存结果。
设计、设置和参与者：对2000年1月至2021年9月间从机构NMIBC登记处诊断出的BCG无反应NMIBC患者进行评估。
比较接受BST、早期根治性膀胱切除术（RC）和延迟RC患者的长期生存结果。
主要终点是总生存（OS）和癌症特异性生存（CSS）。
总共分析了114例患者，中位随访时间为71.2个月（四分位间距：32.6 - 132.2）。早期RC组（n = 38）和BST组（n = 76）患者的OS（风险比[HR]：1.40，95%置信区间[CI]：0.68 - 2.89，P = 0.4）或CSS（HR：0.88，95% CI：0.22 - 3.55，P = 0.9）无显著差异。在60个月时，BST组患者的高级别无复发率、肌肉浸润性疾病/转移无进展率和避免RC率分别为37%、83%和58%。多变量分析显示，当前吸烟状态（HR：4.44，95% CI：1.41 - 13.97，P = 0.011）是高级别复发的唯一预测变量。从BCG无反应日期到RC的中位时间，早期RC组和延迟RC组（BST后）分别为2.1个月和11.7个月。与接受BST治疗的患者相比，接受早期RC治疗的患者cT1疾病发生率更高（53%对36%，P = 0.049）和淋巴管浸润（LVI；11%对0%，P = 0.011）。两组生存结果相似：10年OS分别为58%对50%（HR：1.40，95% CI：0.68 - 2.89，P = 0.4），10年CSS分别为81%对85%（HR：0.88，95% CI：0.22 - 3.55，P = 0.9）。
对接受BST的BCG无反应NMIBC患者的长期生存分析表明，对于无LVI和/或组织学变异且不吸烟的患者可能是安全的。接受BST治疗患者的生存结果可能不低于接受早期RC的患者。
可以为适当选择的卡介苗（BCG）无反应的非肌肉浸润性膀胱癌患者提供保留膀胱治疗。长期结果可能不低于选择早期根治性膀胱切除术的患者。
