Intravesical chemotherapy

膀胱内化疗
  • 文章类型: Journal Article
    非肌肉浸润性膀胱癌(NMIBC)涵盖了所有膀胱癌(BC)诊断的约四分之三。膀胱内卡介苗(BCG)一直是内镜切除术后患者的长期黄金标准治疗方法。然而,尽管疗效合理,复发率仍然不理想,而这个,结合治疗耐受性和卡介苗短缺,促使人们对替代治疗方式进行了调查。这种情况的进展主要是针对BCG无反应疾病的患者,目前有四种FDA批准的治疗方法用于这些患者。最近,已经出现了为未接受治疗的患者寻找BCG替代品的试验。我们通过PubMed进行了文献检索,以查找有关BCG替代品的最新出版物,以及对clinicaltrials.gov的搜索和最近正在进行的临床试验的会议演示。研究表明,联合膀胱内化疗,BCG联合膀胱内治疗,与卡介苗联合静脉治疗在该疾病空间初步具有良好的疗效和安全性。正在进行的审判正在进行中,我们预计随着这些研究的成熟,NMIBC治疗方案将发生变化。
    Non-muscle-invasive bladder cancer (NMIBC) encompasses approximately three-quarters of all bladder cancer (BC) diagnoses. Intravesical Bacillus Calmette-Guerin (BCG) has been the long-standing gold standard treatment for patients following endoscopic resection. However, despite reasonable efficacy, recurrence rates are still suboptimal, and this, combined with treatment tolerability and BCG shortages, has prompted an investigation into alternative treatment modalities. Advances in this landscape have been predominantly for patients with BCG-unresponsive disease, and there are currently four FDA-approved treatments for these patients. More recently, trials have emerged looking for alternatives to BCG for patients who are treatment-naïve. We performed a literature search via PubMed to find recent publications on alternatives to BCG, as well as a search on clinicaltrials.gov and recent conference presentations for ongoing clinical trials. Studies have shown that combination intravesical chemotherapy, combination intravesical therapy with BCG, and combination intravenous therapy with BCG preliminarily have good efficacy and safety profiles in this disease space. Ongoing trials are underway, and we anticipate as these studies mature, there will be a shift in NMIBC treatment regimens.
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  • 文章类型: Journal Article
    背景:撒哈拉以南非洲国家(SSA)报道了一些关于非肌肉浸润性膀胱癌(NMIBC)的流行病学和危险因素的研究,包括索马里,非洲文献对NMIBC的管理知之甚少。本研究旨在评估NMIBC患者的临床组织病理学特征和与生存率相关的因素。
    方法:这项为期6年的队列研究包括196例NMIBC患者。它回顾了这些患者的临床和组织病理学特征以及预测癌症特异性生存的因素。
    结果:患者平均年龄为59.01±11.50岁,男女比例为2.8:1。尿路上皮癌(UC)是最常见的病理类型,占90.8%;TaLG和T1HG是最常见的组织病理学肿瘤分期和分级(n=90,45.9%,vs.n=56,28.6%),分别。平均肿瘤大小为4.72±2.81cm。癌症特异性死亡率(CSM)为13.3%。年龄[2.252(2.310-2.943],p<0.001],性别[1.031(0.981-1.1.242),p<0.001],肿瘤分期和分级[4.902(3.607-5.614),p<0.001],肿瘤位置[1.135(0.806-1.172),p<0.001],编号[0.510(0.410-0.920),p=0.03],肿瘤大小[1.523(0.936-1.541),p<0.001],使用膀胱内化疗或卡介苗[2.810(1.972-4.381),p<0.001],术前肾积水分级[1.517(1.172-2.154),p<0.001],和后续合规性[3.376(2.633-5.018),p<0.001]均与CSM相关。5年总生存率为57.1%,心血管疾病是死亡的主要原因(n=34),其次是糖尿病(n=28)。
    结论:我们的研究结果表明,UC是最常见的病理亚型,尽管只有不到40%的患者接受膀胱内辅助治疗,这对降低疾病发病率和死亡率至关重要。改善肿瘤护理的举措,包括肿瘤学和基本癌症治疗的亚专科培训,更好地获得泌尿外科服务,和癌症筛查计划,在这个国家非常需要优化的管理计划和护理。
    BACKGROUND: A few studies regarding the epidemiology and risk factors of Non-muscle Invasive Bladder Cancer (NMIBC) are reported from Sub-Saharan African countries (SSA), including Somalia, and the African literature is scant on the management of NMIBC. The present study aims to evaluate the clinical-histopathological characteristics and factors associated with the survival rate of patients with NMIBC.
    METHODS: This six-year cohort study included 196 patients with NMIBC. It reviewed the clinical and histopathological characteristics and factors predicting cancer-specific survival for these patients.
    RESULTS: The mean patient age was 59.01 ± 11.50 years, with a male-to-female ratio of 2.8:1. Urothelial carcinoma (UC) constituted the most common pathological type, accounting for 90.8%; Ta LG and T1HG were the most common histopathological tumour stage and grade (n = 90, 45.9%, vs. n = 56, 28.6%), respectively. The mean tumour size was 4.72 ± 2.81 cm. The cancer-specific mortality(CSM) was 13.3%. Age [2.252(2.310-2.943], p < 0.001], Gender [1.031(0.981-1.1.242),p < 0.001], tumour stage and grade [4.902(3.607-5.614),p < 0.001], tumour location [1.135(0.806-1.172),p < 0.001], number [0.510(0.410-0.920),p = 0.03], tumour size [1.523(0.936-1.541),p < 0.001], use of intravesical chemotherapy or BCG [2.810(1.972-4.381),p < 0.001], preoperative hydronephrosis grade [1.517(1.172-2.154),p < 0.001], and follow-up compliance [3.376(2.633-5.018),p < 0.001] were all associated with CSM. The 5-year overall survival was 57.1%, and cardiovascular diseases were the leading cause of mortality (n = 34), followed by diabetes (n = 28).
    CONCLUSIONS: Our study findings revealed that UC constituted the most common pathological subtype, though less than forty per cent of our patients receive intravesical adjuvant therapies, which are crucial to minimizing disease morbidity and mortality. Initiatives improving uro-oncological care, including subspecialty training in oncology and essential cancer therapies, better access to urology services, and cancer screening programs, are much needed for optimal management plans and care in the country.
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  • 文章类型: Journal Article
    背景:高品位,非肌肉浸润性膀胱癌(NMIBC)通常用膀胱内芽孢杆菌卡介苗治疗。化学热疗(CHT)可能是治疗NMIBC的一种新型替代疗法。
    目的:评估使用战斗膀胱再循环系统(BRS)治疗NMIBC的CHT患者的无复发生存率(RFS)。
    方法:这是一项前瞻性多机构研究,对2012年至2020年间接受CHT的1,028例NMIBC连续患者进行。共有835例患者接受了CHT和丝裂霉素C(MMC)治疗。在开始CHT之前,经尿道膀胱肿瘤切除术(TURBT)证实了疾病。如果怀疑复发/进展,随访包括膀胱镜检查和随后的TURBT。主要终点是RFS。次要终点是无进展生存期(PFS)和CHT的不良事件。
    结论:中位随访时间为22.4个月(四分位距(IQR):12.8-35.8)。中位年龄为70.4岁(IQR:62.1-78.6)。共有557人(66.7%),172(20.6)和74(8.9%)的患者被归类为卡介苗,BCG无反应和BCG故障,分别。卡介苗初始治疗12个月和24个月时的RFS分别为87.6%(95%CI85.0%-90.4%)和75.0%(95%CI71.3%-78.8%),分别。BCG无反应队列在12个月和24个月时的RFS分别为78.1%(95%CI72.0%-84.7%)和57.4%(95%CI49.7%-66.3%),分别。对于有/无乳头状疾病和仅有乳头状疾病的CIS,BCG无反应队列在24个月时的RFS分别为43.6%(95%CI31.4%-60.4%)和64.5%(95%CI55.4%-75.1%),分别。216例(25.6%)患者发生轻微不良事件,17例(2.0%)患者发生严重事件。
    结论:CHT联合MMC使用CombatBRS在中期内有效,并且具有良好的不良事件特征。
    BACKGROUND: High grade, non-muscle invasive bladder cancer (NMIBC) is usually treated with intravesical Bacillus Calmette-Guérin. Chemohyperthermia therapy (CHT) may be a novel alternative therapy for the treatment of NMIBC.
    OBJECTIVE: To evaluate the recurrence-free survival (RFS) of patients treated with CHT using the Combat bladder recirculation system (BRS) for NMIBC.
    METHODS: This was a prospective multi-institutional study of 1,028 consecutive patients with NMIBC undergoing CHT between 2012 and 2020. A total of 835 patients were treated with CHT with Mitomycin C (MMC). Disease was confirmed on transurethral resection of bladder tumor (TURBT) prior to starting CHT. Follow-up included cystoscopy and subsequent TURBT if recurrence/progression was suspected. The primary endpoint was RFS. Secondary endpoints were progression-free survival (PFS) and adverse events from CHT.
    CONCLUSIONS: Median follow up was 22.4 months (Interquartile range (IQR): 12.8 -35.8). Median age was 70.4 years (IQR: 62.1 -78.6). A total of 557 (66.7%), 172 (20.6) and 74 (8.9%) of patients were classified to BCG naïve, BCG unresponsive and BCG failure, respectively. The RFS at 12 months and 24 months for BCG naïve was 87.6% (95% CI 85.0% - 90.4%) and 75.0% (95% CI 71.3% - 78.8%), respectively. The RFS at 12 months and 24 months for BCG unresponsive cohort was 78.1% (95% CI 72.0% - 84.7%) and 57.4% (95% CI 49.7% - 66.3%), respectively. The RFS at 24 months for the BCG unresponsive cohort for CIS with/without papillary disease and papillary only disease were 43.6% (95% CI 31.4% -60.4%) and 64.5% (95% CI 55.4% - 75.1%), respectively. Minor adverse events occurred in 216 (25.6%) patients and severe events occurred in 17 (2.0%) patients.
    CONCLUSIONS: CHT with MMC using the Combat BRS is effective in the medium term and has a favorable adverse event profile.
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  • 文章类型: Case Reports
    膀胱癌肉瘤或肉瘤样癌是一种罕见但侵袭性的膀胱癌,其特征是恶性上皮和间质成分。到目前为止,文献中只报道了少数病例。在这份报告中,我们讨论了一例74岁女性非吸烟者,该患者在过去4个月内出现间歇性血尿和血块通过.X线图像显示膀胱左侧壁靠近膀胱输尿管连接处的不规则肿块(6.2x6cm)。通过经尿道膀胱肿瘤切除术(TUR-BT)将肿块完全切除。组织病理学研究显示高级别癌肉瘤,免疫组织化学显示波形蛋白弥漫性阳性,泛细胞角蛋白(CK)和CK7,上皮膜抗原(EMA),CK5/6患者拒绝根治性膀胱切除术,只同意接受膀胱内化疗(吉西他滨),经过四年多的随访,她仍然活着。膀胱癌肉瘤是一种罕见的肿瘤,主要影响老年人,最常见的是根治性膀胱切除术和不同的联合治疗方法,如化疗和放疗。然而,肿瘤切除后膀胱灌注化疗可能是一些患者早期膀胱癌肉瘤的替代选择,从而避免了积极治疗的需要,特别是对于拒绝接受根治性手术的老年患者。
    Carcinosarcoma or sarcomatoid carcinoma of the urinary bladder is a rare but aggressive bladder cancer characterized by malignant epithelial and mesenchymal components, with only a few cases reported in the literature so far. In this report, we discuss a case of a 74-year-old female nonsmoker who presented with intermittent hematuria and passage of clots in the last four months. Radiographic images showed an irregular mass lesion (6.2 x 6 cm) in the left lateral wall of the urinary bladder near to left vesicoureteral junction. The mass was completely removed with transurethral resection of the bladder tumor (TUR-BT). Histopathological study revealed high-grade carcinosarcoma, and immunohistochemistry showed diffuse positivity for vimentin, pan-cytokeratin (CK) and CK7, epithelial membrane antigen (EMA), and CK5/6. The patient declined radical cystectomy and only agreed to receive intravesical chemotherapy (gemcitabine), and she remains alive after more than four years of follow-up. Carcinosarcoma of the urinary bladder is a rare tumor primarily affecting older people, and it is most commonly treated with radical cystectomy and different combination treatments such as chemotherapy and radiation. However, tumor resection followed by intravesical chemotherapy may be an alternative option in the early stages of bladder carcinosarcoma for some patients, thereby avoiding the need for aggressive treatments, especially for elderly patients who decline to undergo radical surgery.
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  • 文章类型: Journal Article
    目的:探讨在先前的膀胱内治疗失败后,转换膀胱内化疗药物对短期复发的高风险非肌层浸润性膀胱癌(NMIBC)是否有益。
    方法:2010年6月至2015年10月,205例接受一线膀胱灌注化疗(IVC)后一年内肿瘤复发的NMIBC患者分为两组。经过第二次完整的经尿道电切术(TUR),我们立即改变了107例患者的膀胱内滴注剂(A组)。相比之下,其余98例患者(B组)继续使用原来的膀胱内滴注剂.经尿道膀胱肿瘤切除术(TURBT)后,所有患者均立即滴注表柔比星(EPI),吉西他滨(GEM),或羟基喜树碱(HCPT),其次是定期诱导和维持滴注。使用卡方检验评估复发和进展率,使用Kaplan-Meier方法计算无复发生存期(RFS)和无进展生存期(PFS)。
    结果:在这项研究中,两组间5年肿瘤复发率或进展率无显著差异(p>0.05),Kaplan-Meier曲线显示两组间无进展生存期或无复发生存期无显著差异.
    结论:转换IVC药物不能改善短期复发性高危NMIBC患者的RFS和PFS。
    OBJECTIVE: To explore if switching intravesical chemotherapeutic agents is beneficial in short-term recurrences of high-risk non-muscle-invasive bladder cancer (NMIBC) following the failure of preceding intravesical therapy.
    METHODS: From June 2010 to October 2015, 205 patients with NMIBC who experienced tumor recurrence within a year after receiving first-line intravesical chemotherapy (IVC) were classified into two groups. After a second complete transurethral resection (TUR) process, we immediately altered the intravesical instillation agent for 107 patients (group A). In contrast, the remaining 98 patients (group B) continued using their original intravesical instillation agent. After transurethral resection of the bladder tumor (TURBT), all patients received either an immediate instillation of epirubicin (EPI), gemcitabine (GEM), or hydroxycamptothecin (HCPT), followed by regular induction and maintenance instillations. Recurrence and progression rates were evaluated using the Chi-square test, and recurrence-free survival (RFS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method.
    RESULTS: In this study, there was no significant difference in either the 5-year tumor recurrence or progression rates between the two groups (p > 0.05) The Kaplan-Meier plot showed no difference in progression-free or recurrence-free survival between the two groups.
    CONCLUSIONS: Switching IVC agents does not improve RFS and PFS for patients with short-term recurrent high-risk NMIBC.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    目的:尽管当前的欧洲泌尿外科协会(EAU)指南建议中危非肌层浸润性膀胱癌(NMIBC)患者应在经尿道膀胱肿瘤电切术(TURBT)后接受膀胱内化疗或卡介苗(BCG)不超过一年,对于最佳化疗持续时间尚无共识.因此,我们探讨了中危NMIBC患者维持膀胱内化疗的最佳持续时间.
    方法:这是一个真实的单中心回顾性队列研究。共纳入158例经病理证实为中危NMIBC的患者,根据滴注次数将其分为4个亚组。我们使用Cox回归分析和生存分析图探讨肿瘤3年复发的预后。通过接收操作特性曲线(ROC)确定最佳持续时间。
    结果:中位随访时间为5.2年。与滴注1-2个月相比,滴注少于1个月的危害比(HR)值,维持滴注3-6个月和>6个月分别为3.57、1.57和0.22(95%CI1.27-12.41;0.26-9.28;0.07-0.80,P=0.03;0.62;0.02)。我们发现,维持膀胱灌注化疗超过6个月的中危NMIBC患者的3年无复发生存率有显著改善。通过ROC进行10.5个月的维持化疗可达到最佳效果。
    结论:在我们的计划中,吡柔比星膀胱内滴注的最佳持续时间为10.5个月。这种新认识为中危型NMIBC的精准医疗模式提供了宝贵的经验。
    OBJECTIVE: Although the current European Association of Urology(EAU) guideline recommends that patients with intermediate-risk non-muscle-invasive bladder cancer (NMIBC) should accept intravesical chemotherapy or Calmette-Guerin (BCG) for no more than one year after transurethral resection of bladder tumor(TURBT), there is no consensus on the optimal duration of chemotherapy. Hence, we explored the optimal duration of maintenance intravesical chemotherapy in patients with intermediate-risk NMIBC.
    METHODS: This was a real-world single-center retrospective cohort study. In total 158 patients with pathologically confirmed intermediate-risk NMIBC were included, who were divided into 4 subgroups based on the number of instillations given. We used Cox regression analysis and survival analysis chart to explore the 3-yr recurrence outcomes of tumor.The optimal duration was determined by receive operating characteristic curve (ROC).
    RESULTS: The median follow-up was 5.2 years. Compared with instillation for 1-2 months, the Hazard Ratios(HR) values of instillation for less than 1 month, maintenance instillation for 3-6 months and > 6 months were 3.57、1.57 and 0.22(95% CI 1.27-12.41;0.26-9.28;0.07-0.80, P = 0.03;0.62;0.02, respectively). We found a significant improvement in 3-yr relapse-free survival in intermediate-risk NMIBC patients who maintained intravesical instillation chemotherapy for longer than 6 months, and the best benefit was achieved with 10.5 months of maintenance chemotherapy by ROC.
    CONCLUSIONS: In our scheme, the optimal duration of intravesical instillation with pirrubicin is 10.5 months. This new understanding provides valuable experience for the precise medical treatment model of intermediate-risk NMIBC.
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  • 文章类型: Journal Article
    手术切除仍然是膀胱癌治疗的首选选择。然而,由于高复发率和不良预后,手术的有效性通常受到限制。因此,膀胱内化疗与原位免疫治疗协同是提高治疗效果的有吸引力的方法。在这里,开发了一种基于热敏PLEL水凝胶给药系统的组合策略。将GEM负载的PLEL水凝胶膀胱内滴注以直接杀死肿瘤细胞,然后将掺入CpG的PLEL水凝胶皮下注射到两个腹股沟中以促进与GEM协同的免疫应答。结果表明,载药PLEL水凝胶具有响应生理温度的溶胶-凝胶相变行为,并表现出持续的药物释放。PLEL辅助联合治疗在体内有较好的抑瘤效果和较强的免疫刺激作用。因此,这种与PLEL水凝胶系统的联合治疗具有巨大的潜力,为膀胱癌的临床相关和有价值的选择提供了建议.
    Surgical resection remains the prefer option for bladder cancer treatment. However, the effectiveness of surgery is usually limited for the high recurrence rate and poor prognosis. Consequently, intravesical chemotherapy synergize with immunotherapy in situ is an attractive way to improve therapeutic effect. Herein, a combined strategy based on thermo-sensitive PLEL hydrogel drug delivery system was developed. GEM loaded PLEL hydrogel was intravesical instilled to kill tumor cells directly, then PLEL hydrogel incorporated with CpG was injected into both groins subcutaneously to promote immune responses synergize with GEM. The results demonstrated that drug loaded PLEL hydrogel had a sol-gel phase transition behavior in response to physiological temperature and presented sustained drug release, and the PLEL-assisted combination therapy could have better tumor suppression effect and stronger immunostimulating effect in vivo. Hence, this combined treatment with PLEL hydrogel system has great potential and suggests a clinically-relevant and valuable option for bladder cancer.
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  • 文章类型: Journal Article
    目的:阐明根治性膀胱切除术中单次灌注化疗的必要性和效果。
    方法:对2013年1月至2019年4月接受膀胱癌根治性膀胱切除术的患者进行回顾性评估,根据术中化疗滴注情况分为非滴注组和滴注组。使用单变量和多变量Cox回归来确定总生存期和无病生存期的临床预测因子。进行Kaplan-Meier分析和对数秩检验以分析总生存率和无病生存率。
    结果:在参与研究的320名患者中,113例行根治性膀胱切除术,术中滴注化疗。单因素Cox分析表明,术中滴注不是总生存期或无病生存期的危险因素(HR:1.04,95%CI:0.66-1.63,p=0.864;HR:1.11,95%CI:0.76-1.62,p=0.602)。如Kaplan-Meier分析所示,两组的总生存期(p=0.857)和无病生存期(p=0.600)无显著差异.亚组分析表明,在非肌肉侵入性(p=0.852和0.836)和肌肉侵入性(p=0.929和0.805)患者中,术中滴注与统计学上更好的总体生存率和无病生存率无关。
    结论:根治性膀胱切除术期间单次术中滴注化疗与更好的无病生存率或总生存率无关。在根治性膀胱切除术中,没有必要将单次灌注化疗视为常规程序。
    To clarify the necessity and effect of a single intraoperative instillation of chemotherapy during radical cystectomy.
    Patients who underwent radical cystectomy for bladder cancer between January 2013 and April 2019 were retrospectively evaluated and divided into a non-instillation group and an instillation group according to the intraoperative instillation of chemotherapy. Univariate and multivariate Cox regression was used to determine the clinical predictors of overall survival and disease-free survival. Kaplan-Meier analysis and log-rank tests were performed to analyze overall survival and disease-free survival.
    Of the 320 patients who were enrolled in the study, 113 underwent radical cystectomy with intraoperative instillation of chemotherapy. Univariate Cox analysis showed that intraoperative instillation was not a risk factor for overall survival or disease-free survival (HR: 1.04, 95% CI: 0.66-1.63, p = 0.864; HR: 1.11, 95% CI: 0.76-1.62, p = 0.602, respectively). As shown in the Kaplan-Meier analysis, no significant differences were noted in overall survival (p = 0.857) and disease-free survival (p = 0.600) between the two groups. A subgroup analysis demonstrated that intraoperative instillation was not associated with a statistically better overall survival and disease-free survival in the nonmuscle invasive (p = 0.852 and 0.836) and muscle-invasive (p = 0.929 and 0.805) patients.
    A single intraoperative instillation of chemotherapy during radical cystectomy was not related to better disease-free survival or overall survival. It is unnecessary to consider single instillation of chemotherapy as a regular procedure during radical cystectomy.
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  • 文章类型: Journal Article
    目的:显示6个月(每周4次,每月5次)维持丝裂霉素C方案预防上尿路尿路上皮癌(UTUC)根治性肾输尿管切除术(RNU)后膀胱内复发(IVR)的效果。
    方法:回顾性分析了2007年至2021年在单中心医院接受RNU的119例患者。共有66例患者符合进一步分析的条件。27例患者未接受术后MMC(中位随访时间:110个月),39例患者接受6个月(每周4次,每月5次)MMC维持方案(中位随访:48个月)。主要结果是1-,2年和5年无膀胱复发生存期(BRFS)。
    结果:两组之间的BRFS差异有统计学意义(p=0.001)。1-,2,MMC组的5年BRFS为67%,63%和43%,分别。1-,MMC+组的2年和5年BRFS为95%,86%和86%,分别。单因素分析显示,没有其他潜在的预后因素对BRFS有显著影响。
    结论:6个月的MMC维持计划可有效降低UTUCRNU后IVR的风险。我们没有找到任何其他重要的预后因素来预测IVR。
    OBJECTIVE: To show the effect of a 6-month (4 times weekly followed by 5 times monthly) maintenance mitomycin C regimen on the prevention of intravesical recurrence (IVR) after radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC).
    METHODS: A total of 119 patients undergoing a RNU between 2007 and 2021 in a single center hospital were retrospectively reviewed. A total of 66 patients were eligible for further analysis. 27 patients received no post-operative MMC (median follow-up: 110 months) and 39 patients received a 6-month (4 times weekly, 5 times monthly) maintenance regimen of MMC (median follow up: 48 months). The primary outcome was the 1-, 2- and 5-year bladder recurrence free survival (BRFS).
    RESULTS: There was a significant difference (p = 0.001) in BRFS between the two groups. The 1-, 2, and 5-year BRFS for the MMC- group was 67%, 63% and 43%, respectively. The 1-, 2- and 5-year BRFS for the MMC + group was 95%, 86% and 86%, respectively. Univariate analysis showed no other potential prognostic factors that had a significant effect on the BRFS.
    CONCLUSIONS: A 6-month maintenance schedule of MMC is effective at significantly reducing the risk of IVR after RNU for UTUC. We could not find any other significant prognostic factors to predict IVR.
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