Waitemata District Health Board, Auckland, New Zealand.
Mid Central District Health Board, Palmerston North, New Zealand.
BMC Urol. 2020 Feb 11;20(1):12. doi: 10.1186/s12894-020-0583-0.
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.
To audit the clinical utility of a new surveillance protocol incorporating the Cxbladder Monitor (CxbM) test in real-world practice.
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.
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.
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.
监测复发性尿路上皮癌（UC）需要频繁进行膀胱镜检查，这种检查具有侵袭性、昂贵且耗时。一种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次数。
审计在实际实践中纳入 Cxbladder Monitor（CxbM）检测的新监测方案的临床实用性。
三家医院实施了一项新的监测方案。患者进行风险分层，然后提供尿液样本进行 CxbM 检测。低风险 CxbM 阳性患者和所有高风险患者在 2-3 个月时进行膀胱镜检查。低风险 CxbM 阴性患者在约 12 个月时进行膀胱镜检查。
对 309 名患者的 443 次 CxbM 检测结果进行了分析：257 名（83.2%）为低风险，52 名（16.8%）为高风险。在首次 CxbM 膀胱镜检查后平均 10.3 ± 3.9 个月（检测后），108 名低风险 CxbM 阴性患者未发现病理学证实的复发。在 53 名低风险 CxbM 阳性患者中，有 3 名在 2.7 ± 3.4 个月的膀胱镜检查中发现复发。在 49 名高风险患者中，有 39 名（79.6%）为 CxbM 阴性，无病理学证实的复发。10 名高风险患者（20.4%）为 CxbM 阳性，其中 4 例确诊复发，2 例为高级别，2 例为低级别。CxbM 阴性结果患者的首次膀胱镜检查中位时间为 12.13（95%CI：11.97-12.4）个月，CxbM 阳性结果患者的首次膀胱镜检查中位时间为 1.63（95%CI：1.13-2.3）个月（p<0.00001）。在 35 个月的随访期间，未漏诊阳性病例，无患者进展为侵袭性或转移性疾病，也无患者死于癌症。
CxbM 准确识别了很大一部分（77.8%）患者，这些患者仅每年进行一次膀胱镜检查即可安全管理。在患者监测方案中纳入 CxbM 通过减少约 39%的年度膀胱镜检查数量提供了临床实用性，从而使患者避免了潜在的不适和焦虑，而不会影响检测率。在进行 CxbM 检测之前进行风险分层没有观察到优势。
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