Department of Urology, Turku University Hospital, and University of Turku, Turku, Finland.
Department of Urology, Helsinki University Hospital, Helsinki, Finland.
Eur Urol Focus. 2023 Nov;9(6):1000-1007. doi: 10.1016/j.euf.2023.04.012. Epub 2023 May 9.
Bacillus Calmette-Guérin (BCG) therapy using the Southwest Oncology Group (SWOG) maintenance protocol is the standard in non-muscle-invasive bladder cancer (NMIBC). Maintenance with monthly instillations is also widely used, but evidence comparing the two maintenance protocols is scarce.
To compare monthly and SWOG instillation schedules in maintenance BCG therapy.
DESIGN, SETTING, AND PARTICIPANTS: We retrospectively identified patients with NMIBC treated with maintenance BCG according to either the monthly or the SWOG instillation regimen in two tertiary care centers in Finland between 2009 and 2019.
We compared discontinuation rates of the monthly and SWOG maintenance protocols due to toxicity, and recurrence and progression rates by protocols. Baseline characteristics were compared with the Wilcoxon rank sum test, chi-square test, and Fisher's exact test. The Kaplan-Meier method and Cox proportional hazards model were used to evaluate the discontinuation of BCG due to toxicity and oncological efficacy.
We identified 723 patients, of whom 545 (75%) and 178 (25%) received maintenance according to the monthly and SWOG protocols, respectively. The median follow-up time was 66 (interquartile range: 45-99) mo. In the monthly and SWOG groups, 131 (24%) and 50 (28%) patients, respectively, discontinued BCG due to toxicity, with no difference in a univariate or multivariate analysis (hazard ratio 1.01, 95% confidence interval [CI]: 0.73-1.40, p = 0.940). The 5-yr recurrence-free survival rates in the monthly and SWOG groups were 65% (95% CI: 61-69%) and 71% (95% CI: 64-79%, p = 0.370), respectively. The 5-yr progression-free survival rates were 89% (95% CI: 86-92%) and 91% (95% CI: 86-96%, p = 0.240), respectively.
Monthly maintenance is a comparable alternative to the SWOG protocol.
In this study, we compared two schedules of intravesical bacillus Calmette-Guérin (BCG) treatment used in the treatment of non-muscle-invasive bladder cancer. We found that there were no significant differences between the two instillation schedules in terms of tolerability or efficacy.
西南肿瘤协作组（SWOG）维持方案的卡介苗（BCG）治疗是治疗非肌肉浸润性膀胱癌（NMIBC）的标准方案。每月进行膀胱内灌注也是广泛应用的方法，但比较两种维持方案的证据很少。
比较每月和 SWOG 膀胱内灌注方案在维持 BCG 治疗中的效果。
设计、地点和参与者：我们回顾性地确定了 2009 年至 2019 年期间，芬兰的两个三级医疗中心中，根据每月或 SWOG 灌注方案接受维持 BCG 治疗的 NMIBC 患者。
我们比较了因毒性而停止每月和 SWOG 维持方案的比例，以及根据方案评估的复发和进展率。使用 Wilcoxon 秩和检验、卡方检验和 Fisher 精确检验比较基线特征。使用 Kaplan-Meier 方法和 Cox 比例风险模型评估因毒性而停止 BCG 治疗的情况和肿瘤学疗效。
我们共纳入了 723 名患者，其中 545 名（75%）和 178 名（25%）患者分别根据每月和 SWOG 方案接受了维持治疗。中位随访时间为 66（四分位间距：45-99）个月。在每月和 SWOG 组中，分别有 131 名（24%）和 50 名（28%）患者因毒性而停止 BCG 治疗，单因素和多因素分析均无差异（风险比 1.01，95%置信区间[CI]：0.73-1.40，p=0.940）。每月和 SWOG 组的 5 年无复发生存率分别为 65%（95% CI：61-69%）和 71%（95% CI：64-79%，p=0.370）。5 年无进展生存率分别为 89%（95% CI：86-92%）和 91%（95% CI：86-96%，p=0.240）。
每月维持治疗是 SWOG 方案的一种可比较的替代方案。
在这项研究中，我们比较了两种用于治疗非肌肉浸润性膀胱癌的膀胱内卡介苗（BCG）治疗方案。我们发现，两种灌注方案在耐受性和疗效方面没有显著差异。
