连续膀胱内注射吉西他滨/多西他赛 (Gem/Doce) 已成为卡介苗 (BCG) 治疗非肌层浸润性膀胱癌 (NMIBC) 的潜在替代方案。我们的目的是确定 BCG 和 Gem/Doce 对于主要由高级别 (HG) Ta 病组成的中危 (IR) NMIBC 患者的比较疗效。接受 BCG 或 Gem/Doce 治疗的 IR-NMIBC 患者2013 年至 2023 年期间也包括在内。向诱导后没有复发证据的患者提供维持 BCG（根据西南肿瘤学组方案）和每月 Gem/Doce 维持 1 年。根据美国泌尿外科协会指南进行膀胱镜常规监测。 Kaplan-Meier 方法用于评估高级别和任何级别的无复发生存率 (RFS)。进行 Cox 回归分析以寻找复发的预测因素。在 483 名患者中，127 名患有 IR-NMIBC； 66 名患者接受了 BCG，61 名患者接受了 Gem/Doce。 BCG 组的中位年龄为 69 岁（四分位距 [IQR] 61-76），Gem/Doce 组的中位年龄为 72 岁（IQR 62-76）。 BCG 组的中位随访时间为 53.1 个月（IQR 25.3-71.2），Gem/Doce 组的中位随访时间为 20.2 个月（IQR 8.28-33.1）。 BCG 组与 Gem/Doce 组原发性高级别肿瘤的 2 年高级别 RFS 率分别为 81% 和 61%，相应的任何级别 RFS 率分别为 60% 和 41%。 Gem/Doce 诱导可预测原发性高级别肿瘤的任何级别复发（风险比 [HR] 1.87，95% 置信区间 [CI] 1.1-3.2）和高级别复发（HR 3.4 95% CI 1.27-9.13） ，而接受维持治疗可降低任何级别复发的风险（HR 0.4，95% CI 0.22-0.72）。这项研究因其回顾性设计而受到限制。对于 IR-NMIBC 患者，BCG 与原发性高级别肿瘤的任何级别的 RFS 和高级别 RFS 相关。接受 Gem/Doce 治疗时，维持治疗与更好的 RFS 相关。 Gem/Doce 治疗应考虑标准化和长期维持治疗方案。我们比较了接受两种不同膀胱内治疗的中危膀胱癌患者的结果。卡介苗 (BCG) 比吉西他滨多西他赛 (Gem/Doce) 效果更好。每月维持治疗可改善接受 Gem/Doce 治疗的患者的无复发生存期。我们的结论是，维持治疗对于接受 Gem/Doce 的患者至关重要，以避免治疗后膀胱癌复发。版权所有 © 2024 欧洲泌尿外科协会。由 Elsevier B.V. 出版。保留所有权利。

Sequential intravesical gemcitabine/docetaxel (Gem/Doce) has emerged as a potential alternative to bacillus Calmette-Guérin (BCG) for the treatment of non-muscle-invasive bladder cancer (NMIBC). Our aim was to determine the comparative effectiveness of BCG and Gem/Doce for patients with intermediate-risk (IR) NMIBC, composed mainly of high-grade (HG) Ta disease.Patients with IR-NMIBC who received either BCG or Gem/Doce during 2013-2023 were included. Maintenance BCG (as per the Southwest Oncology Group protocol) and monthly Gem/Doce maintenance for 1 yr were offered to patients with no evidence of recurrence after induction. Routine surveillance with cystoscopy was performed according to the American Urological Association guidelines. The Kaplan-Meier method was used to assess high-grade and any-grade recurrence-free survival (RFS). Cox regression analysis was performed to find predictors of recurrence.Of 483 patients, 127 had IR-NMIBC; 66 patients received BCG and 61 received Gem/Doce. Median age was 69 yr (interquartile range [IQR] 61-76) for the BCG group and 72 yr (IQR 62-76) for the Gem/Doce group. Median follow-up was 53.1 mo (IQR 25.3-71.2) for the BCG group and 20.2 mo (IQR 8.28-33.1) for the Gem/Doce group. The 2-yr high-grade RFS rates for primary high-grade tumors for BCG versus Gem/Doce groups were 81% versus 61%, with corresponding any-grade RFS rates of 60% versus 41%. Induction with Gem/Doce predicted any-grade recurrence (hazard ratio [HR] 1.87, 95% confidence interval [CI] 1.1-3.2) and high-grade recurrence for primary high-grade tumors (HR 3.4 95% CI 1.27-9.13), while receipt of maintenance therapy decreased the risk of any-grade recurrence (HR 0.4, 95% CI 0.22-0.72). This study is limited by its retrospective design.For patients with IR-NMIBC, BCG was associated with superior any-grade RFS and high-grade RFS for primary high-grade tumors. Maintenance therapy was associated with better RFS when receiving Gem/Doce. Standardization and longer maintenance therapy protocols should be considered for Gem/Doce treatment.We compared outcomes for patients who received two different in-bladder treatments for intermediate-risk bladder cancer. Bacillus Calmette-Guérin (BCG) led to better outcomes than gemcitabine + docetaxel (Gem/Doce). Monthly maintenance therapy improved recurrence-free survival for patients who received Gem/Doce. We conclude that maintenance therapy is essential for patients receiving Gem/Doce to avoid bladder cancer recurrence after treatment.Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.