Kolanukuduru Kaushik P, Ben-David Reuben, Lidagoster Sarah, Almoflihi Mohammed, Tillu Neeraja, Eraky Ahmed, Alerasool Parissa, Waigankar Nikhil, Attalla Kyrollis, Mehrazin Reza, Wiklund Peter, Sfakianos John P
Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Eur Urol Focus. 2024 Sep 20. doi: 10.1016/j.euf.2024.09.006.
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.
序贯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）的一种潜在替代方案。我们的目的是确定BCG和Gem/Doce对主要由高级别（HG）Ta期疾病组成的中危（IR）NMIBC患者的相对疗效。
纳入2013年至2023年期间接受BCG或Gem/Doce治疗的IR-NMIBC患者。诱导治疗后无复发证据的患者接受维持BCG治疗（按照西南肿瘤协作组方案）或每月一次的Gem/Doce维持治疗，为期1年。根据美国泌尿外科学会指南进行常规膀胱镜监测。采用Kaplan-Meier法评估高级别和任何级别的无复发生存期（RFS）。进行Cox回归分析以寻找复发的预测因素。
483例患者中，127例患有IR-NMIBC；66例患者接受BCG治疗，61例接受Gem/Doce治疗。BCG组的中位年龄为69岁（四分位间距[IQR]61-76），Gem/Doce组为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诱导治疗可预测任何级别的复发（风险比[HR]1.87，95%置信区间[CI]1.1-3.2）以及原发性高级别肿瘤的高级别复发（HR 3.4，95%CI 1.27-9.13），而接受维持治疗可降低任何级别的复发风险（HR 0.4，95%CI 0.22-0.72）。本研究受其回顾性设计的限制。
对于IR-NMIBC患者，BCG与原发性高级别肿瘤更好的任何级别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。对于Gem/Doce治疗，应考虑标准化和更长的维持治疗方案。
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局。卡介苗（BCG）比吉西他滨+多西他赛（Gem/Doce）的治疗效果更好。每月维持治疗可改善接受Gem/Doce治疗患者的无复发生存期。我们得出结论，维持治疗对于接受Gem/Doce治疗的患者避免治疗后膀胱癌复发至关重要。
