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An evaluation of the real world use and clinical utility of the Cxbladder Monitor assay in the follow-up of patients previously treated for bladder cancer.
BMC Urology ( IF 2 ) Pub Date : 2020-02-11 , DOI: 10.1186/s12894-020-0583-0
Madhusudan Koya 1 , Sue Osborne 1 , Christophe Chemaslé 2 , Sima Porten 3 , Anne Schuckman 4 , Andrew Kennedy-Smith 5
Affiliation  

BACKGROUND Surveilling recurrent urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. OBJECTIVE To audit the clinical utility of a new surveillance protocol incorporating the Cxbladder Monitor (CxbM) test in real-world practice. METHODS Three hospitals implemented a new surveillance protocol. Patients were risk stratified, and then provided urine samples for CxbM testing. Low-risk CxbM-positive patients and all high-risk patients had cystoscopy at 2-3 months. Low-risk CxbM-negative patients had cystoscopy at ~ 12 months. RESULTS 443 CxbM tests were conducted on samples from 309 patients: 257 (83.2%) low-risk and 52 (16.8%) high-risk. No pathology-confirmed recurrences were seen in low-risk CxbM-negative patients (n = 108) during the first post-CxbM cystoscopy undertaken a mean ± SD 10.3 ± 3.9 months after testing. Three recurrences were detected during cystoscopy at 2.7 ± 3.4 months in 53 low-risk CxbM-positive patients. In 49 high-risk patients, 39 (79.6%) were CxbM-negative with no pathology-confirmed recurrences. Ten high-risk patients (20.4%) were CxbM-positive with four confirmed recurrences; 2 high-grade and 2 low-grade. The median time to first cystoscopy was 12.13 (95% CI: 11.97-12.4) months in patients with a CxbM-negative result versus 1.63 (95% CI: 1.13-2.3) months in patients with a CxbM-positive result (p < 0.00001). No positive cases were missed, no patients progressed to invasive or metastatic disease, and no patient died of cancer over 35 months of follow-up. CONCLUSIONS CxbM accurately identified a high proportion of patients (77.8%) who were safely managed with only one cystoscopy per year. Including CxbM in the protocol for patient surveillance provided clinical utility by reducing the average number of annual cystoscopies by approximately 39%, thereby sparing patients the potential discomfort and anxiety, without compromising detection rates. No advantage was observed for risk stratification prior to CxbM.

中文翻译:

在先前接受过膀胱癌治疗的患者的随访中,对Cxbladder Monitor测定法在现实世界中的使用和临床实用性进行了评估。

背景技术对复发性尿路上皮癌(UC)进行监视需要频繁的膀胱镜检查,这是侵入性的,昂贵的且耗时的。准确的尿液生物标志物有可能减少治疗后监测期间所需的膀胱镜检查数量。目的在现实世界中审核结合了Cxbladder Monitor(CxbM)测试的新监视协议的临床实用性。方法3家医院实施了新的监视协议。对患者进行风险分层,然后提供尿液样本用于CxbM测试。低危CxbM阳性患者和所有高危患者均在2-3个月时进行了膀胱镜检查。低风险CxbM阴性患者在〜12个月时进行了膀胱镜检查。结果对309例患者的样本进行了443 CxbM测试:257(83.2%)低风险和52(16.8%)高风险。低CxbM阴性患者(n = 108)在第一次CxbM膀胱镜检查后平均病理±10.3±3.9个月,未见病理证实的复发。53例低危CxbM阳性患者在2.7±3.4个月的膀胱镜检查中发现3例复发。在49位高危患者中,有39位(79.6%)为CxbM阴性,无经病理证实的复发。十例高危患者(20.4%)CxbM阳性,确诊复发四例;2个高等级和2个低等级。CxbM阴性结果患者首次膀胱镜检查的中位时间为12.13(95%CI:11.97-12.4)个月,而CxbM阳性结果患者为1.63(95%CI:1.13-2.3)个月(p <0.00001 )。没有遗漏任何阳性病例,也没有任何患者发展为浸润性或转移性疾病,在随访的35个月中,没有患者死于癌症。结论CxbM准确地识别出每年仅接受一次膀胱镜检查安全治疗的高比例患者(77.8%)。通过将年度膀胱镜检查的平均次数减少约39%,从而在不影响检测率的情况下,使患者避免了潜在的不适和焦虑,将CxbM纳入患者监测方案可提供临床应用。在CxbM之前未观察到风险分层的优势。从而在不影响检测率的情况下,使患者避免了潜在的不适和焦虑。在CxbM之前未观察到风险分层的优势。从而在不影响检测率的情况下,使患者避免了潜在的不适和焦虑。在CxbM之前未观察到风险分层的优势。
更新日期:2020-04-22
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