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A Randomized Feasibility Trial Comparing Surveillance Regimens for Patients with Low and Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer
Bladder Cancer ( IF 1.1 ) Pub Date : 2021-06-03 , DOI: 10.3233/blc-201535
Ryan M Reyes 1 , Emily Rios 2 , Shane Barney 2 , Cory M Hugen 2 , Joel E Michalek 3 , Yair Lotan 4 , Edward M Messing 5 , Robert S Svatek 1, 2
Affiliation  

BACKGROUND:Surveillance regimens for non-muscle invasive bladder cancer (NMIBC) are disparate and controlled trials could inform guidelines. The feasibility of randomizing patients to variable frequency surveillance is unknown. OBJECTIVES:To determine patient willingness to randomization to high frequency (HF) versus low frequency (LF) surveillance regimen for NMIBC and compare patient comfort and healthcare costs across regimens. METHODS:A non-blinded, two-arm, randomized-controlled study of patients with low or low-intermediate risk NMIBC was conducted at two institutions where patients were offered randomization to HF vs. LF surveillance following initial tumor resection. The HF group underwent cystoscopy every three months for 2 years, then every 6 months for 2 years, then annually. The LF group underwent cystoscopy at 9 months following the 3-month cystoscopy, then annually. Assuming 75%of patients approached would agree to enrollment, a sample size of n = 35 patients per arm provided a one-sided 95%exact Clopper-Pearson confidence lower-limit of 60%. RESULTS:Of 70 patients approached, 45 (64.3%) agreed to participate and 25 (35.7%) declined enrollment due to preference for HF. Twelve biopsies were performed, including 4 (19%) of 21 patients in the HF group and 8 (33.3%) of 24 patients in the LF group. Disease recurrence (low grade Ta) was observed in 3 (14.3%) and 5 (20.8%) patients in the HF and LF groups, respectively. No patients experienced high grade recurrence or progression. Groups reported similar patient-reported procedure-related discomfort and quality of life measures over time. Patient out-of-pocket cost and healthcare systems costs were $383.80 more per patient annually in the HF group. CONCLUSIONS:Randomization to variable frequency surveillance is challenging as over a third of patients declined participation. However, these data provide important preliminary insights into the potential effects of surveillance frequency on oncologic and economic outcomes in patients with low and low-intermediate risk bladder cancer.

中文翻译:

一项比较低和中低风险非肌肉浸润性膀胱癌患者监测方案的随机可行性试验

背景:非肌肉浸润性膀胱癌 (NMIBC) 的监测方案各不相同,对照试验可为指南提供信息。将患者随机分组进行可变频率监测的可行性尚不清楚。目的:确定患者对 NMIBC 的高频 (HF) 与低频 (LF) 监测方案进行随机分组的意愿,并比较不同方案的患者舒适度和医疗保健成本。方法:在两个机构对低或中低风险 NMIBC 患者进行了一项非盲法、双臂、随机对照研究,在这些机构中,患者在初始肿瘤切除后被随机分配到 HF 与 LF 监测。HF 组每 3 个月接受一次膀胱镜检查,持续 2 年,然后每 6 个月接受 2 年,然后每年一次。LF 组在 3 个月膀胱镜检查后 9 个月接受膀胱镜检查,然后每年一次。假设 75% 的接近患者同意入组,每组 n = 35 名患者的样本量提供了 60% 的单边 95% 精确 Clopper-Pearson 置信下限。结果:在 70 名患者中,45 名 (64.3%) 同意参加,25 名 (35.7%) 因偏好 HF 而拒绝入组。进行了 12 次活检,包括 HF 组 21 名患者中的 4 名(19%)和 LF 组 24 名患者中的 8 名(33.3%)。HF 组和 LF 组分别有 3 名(14.3%)和 5 名(20.8%)患者出现疾病复发(低级 Ta)。没有患者经历高度复发或进展。随着时间的推移,各组报告了类似的患者报告的与手术相关的不适和生活质量测量。在 HF 组中,每位患者每年的自付费用和医疗保健系统成本增加了 383.80 美元。结论:由于超过三分之一的患者拒绝参与,对变频监测的随机化具有挑战性。然而,这些数据提供了重要的初步见解,以了解监测频率对低中低风险膀胱癌患者的肿瘤学和经济结果的潜在影响。
更新日期:2021-06-04
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