Clinical evaluation of two consecutive UroVysion fluorescence in situ hybridization tests to detect intravesical recurrence of bladder cancer: a prospective blinded comparative study in Japan
Clinical evaluation of two consecutive UroVysion fluorescence in situ hybridization tests to detect intravesical recurrence of bladder cancer: a prospective blinded comparative study in Japan
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DOI：
10.1007/s10147-018-1311-6
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发表时间：
2018-12-01
影响因子：
3.3
通讯作者：
Akaza, Hideyuki
中科院分区：
文献类型：
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作者：
Kojima, Takahiro;Nishiyama, Hiroyuki;Akaza, Hideyuki
BackgroundWe评估了UroVysion荧光原位杂交检测膀胱内复发的膀胱癌在后续经尿道膀胱肿瘤切除术（TURBT）后，MethodsIn这一前瞻性，盲法，比较研究，486例TURBT治疗的患者在过去20年内在12个中心注册。在中心检测实验室进行一次或两次尿细胞学和UroVysion检测。对于首次分析中未发现膀胱癌可疑结果的患者，在3个月后重复相同的检查集作为第二次分析。共有468名和399名患者分别有资格进行第一次和第二次分析。我们确定了两个连续的UroVysion tests. Results膀胱癌的敏感性和特异性确定在44例患者在第一次分析。UroVysion检测的灵敏度为50.0%（95% CI 35.2-64.8%），灵敏度为72.4%（68.3-76.8%）。尿细胞学检查的敏感性为4.5%（0.0-10.7%），特异性为99.8%（99.3-100.0%）。第一次和第二次UroVysion测试结果的一致率为72%（kappa系数0.157）。有趣的是，两个连续的阳性UroVysion测试结果的患者有最高的癌症检出率（14.8%），这是大于在任何（7.2%）或没有（1.2%）的两个测试在3个月follow.ConclusionsThe UroVysion测试提供了更高的敏感性比尿细胞学检测膀胱癌在TURBT随访。连续两次UroVysion试验可能是预测膀胱内复发的更好指标。
BackgroundWe evaluated the use of UroVysion fluorescence in situ hybridization tests to detect the intravesical recurrence of bladder cancer during follow-up after a transurethral resection of bladder tumor (TURBT).MethodsIn this prospective, blinded, comparative study, 486 patients treated by TURBT within the prior 2years were registered at 12 centers. Urine cytology and UroVysion tests were performed once or twice at a central testing laboratory. For the patients with no suspicious findings of bladder cancer in the first analysis, the same examination set was repeated 3months later as the second analysis. Totals of 468 and 399 patients were eligible for the first and second analyses, respectively. We determined the sensitivity and specificity of two consecutive UroVysion tests.ResultsBladder cancers were identified in 44 patients at the first analysis. The UroVysion test had 50.0% (95% CI 35.2-64.8%) sensitivity and 72.4% (68.3-76.8%). Urine cytology had 4.5% (0.0-10.7%) sensitivity and 99.8% (99.3-100.0%) specificity. The concordant rate of the first and second UroVysion test results was 72% (kappa coefficient 0.157). Interestingly, the patients with two consecutive positive UroVysion test results had the highest cancer detection rate (14.8%), which is greater than those of the patients with a positive result in either (7.2%) or neither (1.2%) of the two tests at the 3-month follow-up.ConclusionsThe UroVysion test provided higher sensitivity than urine cytology to detect bladder cancer during post-TURBT follow-up. Two consecutive UroVysion tests might be a better indicator to predict intravesical recurrence.