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

Kojima, Takahiro; Nishiyama, Hiroyuki; Ozono, Seiichiro; Hinotsu, Shiro; Keino, Naoto; Yamaguchi, Akito; Sakai, Hideki; Enomoto, Yutaka; Horie, Shigeo; Fujimoto, Kiyohide; Matsuyama, Hideyasu; Okamura, Tomonori; Kanimoto, Yusuke; Oya, Mototsugu; Nonomura, Norio; Naito, Seiji; Akaza, Hideyuki

doi:10.1007/s10147-018-1311-6

Cited by 16 publications

(15 citation statements)

References 16 publications

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“…Numerous studies have evaluated the efficacy of FISH in urothelial carcinoma ( 5 – 10 ), whereas data on the evaluation of UroVysion probes in non-urothelial carcinoma are scarce. This study found that the positive rate of FISH in urachal carcinoma of late stage with hematuria was rather high at 71.43%, which was not significantly different from that in urothelial carcinoma (71.43 vs. 87.18%, P = 0.245).…”

Section: Discussionmentioning

confidence: 99%

“…This method has been approved for the screening of patients with hematuria and the monitoring of recurrent urothelial carcinoma. Moreover, many studies have been performed using the application of FISH in urothelial carcinoma ( 5 – 10 ). Thus, patients with hematuria who are positive for urinary FISH are often diagnosed with urothelial carcinoma.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of UroVysion for Urachal Carcinoma Detection

Liu

et al. 2020

Front. Med.

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Background: Patients with hematuria who are positive for urinary fluorescence in situ hybridization (FISH) are generally considered to have urothelial carcinoma. We determined whether UroVysion FISH could be used for the diagnosis of urachal carcinoma. Methods: Seven cases of urachal carcinoma with haematuria subjected to FISH analysis were retrospectively analyzed in our hospital from May 2012 to November 2019. Paraffin-embedded tissue sections from one FISH-positive and one FISH-negative urachal carcinoma were processed in strict accordance with the instructions of the UroVysion kit. Meanwhile, FISH data from the other 414 hematuria patients were collected as controls. Results: All 7 patients with urachal carcinoma were diagnosed with adenocarcinoma. According to Sheldon stage, six patients had stage IIIa and one patient had stage IVb. The sensitivity and specificity of urinary FISH for the diagnosis of urachal carcinoma were 71.43% (5/7) and 94.61% (281/297), respectively. The rates of polysomy for chromosomes 3 and 7 in positive patients were both 100% (5/5), whereas the rate of polysomy for chromosome 17 was 40% (2/5), and the chromosome 9p21 region (p16) gene deletion rate was 20% (1/5). Histological assessment and cytological FISH were consistent for urachal carcinoma. No significant difference was observed in the diagnostic efficacy between urachal carcinoma and urothelial carcinoma (71.43 vs. 87.18%, P = 0.245). Conclusions: Taken together, UroVysion FISH was found to be positive in a high proportion of pathologically confirmed urachal carcinoma of late stage with hematuria. Its chromosomal aberrations may be different from those of urothelial carcinoma, but more studies are needed to clarify their genetic background. Not all tumors showing abnormalities by FISH are urothelial carcinomas.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Evaluation of UroVysion for Urachal Carcinoma Detection

Liu

et al. 2020

Front. Med.

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“…In Japan, a prospective comparative study showed that the UroVysion test provided higher sensitivity than urine cytology in detecting BC during follow-up after TURBT [5]. Based on these outcomes, UroVysion was approved in Japan in 2017 as a genetic test for the diagnosis of BC recurrence.…”

Section: Discussionmentioning

confidence: 99%

“…In this point, recently, the UroVysion test (UroVysion Bladder Cancer Kit:Abbot Molecular, Des Plaines IL), a multicolor fluorescence in situ hybridization technique that detects aneuploidy of chromosomes 3, 7, and 17 and the loss of 9p21 locus, showed promising results as a more sensitive tool for the initial diagnosis and monitoring in several studies conducted in Western countries [3,4]. Moreover, in Japan, a large comparative study of two consecutive UroVysion tests enrolled 486 BC patients and demonstrated higher sensitivity of the tests than did urine cytology [5]. The UroVysion test had 50.0% (95% CI 35.2-64.8%) sensitivity and 72.4% (68.3-76.8%) specificity.…”

Section: Introductionmentioning

confidence: 99%

Risk for intravesical recurrence of bladder cancer stratified by the results on two consecutive UroVysion fluorescence in situ hybridization tests: a prospective follow-up study in Japan

et al. 2020

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Background A previous comparative study in Japan has demonstrated that the two consecutive UroVysion tests are useful tools to detect the presence of bladder cancer during follow-up after transurethral resection, but they also presented their high rates of false-positive results. Here, we aimed to evaluate the relationship between the UroVysion tests and subsequent intravesical recurrence. Methods In the previous study, patients without bladder cancer during the first analysis showed the same examination set repeated 3 months later as the second analysis. In this follow-up study, 326 patients showed negative findings confirmed on cystoscopy during the second UroVysion test. Recurrence-free survival was assessed using a median follow-up of 27 months. Results In the two consecutive UroVysion tests, 214 patients (65.6%) showed negative UroVysion results in both tests, whereas 91 presented a positive result on either tests and 21 patients presented positive results in both tests. During the follow-up, 40 patients (12.3%) had an intravesical recurrence with non-muscle-invasive bladder cancer. The recurrence rates in patients with negative results in both tests, those with one positive result in either tests, and those with positive results in both tests were 8.4%, 16.5%, and 33.3%, respectively. The multivariate analysis indicated that the history of bladder cancer and the consecutive UroVysion test pattern were independent risk factors for recurrence. Conclusions Our data confirmed the effectiveness of two consecutive UroVysion tests in predicting intravesical recurrence after TURBT. Further prospective studies would help determine an appropriate interval for cystoscopy follow-up.

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“…Fritsche et al, (2010) Ho et al, (2013) reported that UroVysion FISH has a high specificity (83.4%) for the patients with hematuria and it facilitates conservation of health resources and minimizes trauma by deferring cystoscopic or ureteroscopic examinations. Kojima et al, (2018) reported in their prospective, blinded, comparative study for the Japanese that UroVysion FISH had a higher sensitivity than urine cytology to detect bladder cancer after TURBT. On the other hand, there are some reports insisting that urine cytology and UroVysion FISH are comparable.…”

Section: Discussionmentioning

confidence: 99%

Examination of Diagnostic Accuracy of UroVysion Fluorescence In Situ Hybridization for Bladder Cancer in a Single Community of Japanese Hospital Patients

Nagai

Okamura

Yanase

et al. 2019

Asian Pac J Cancer Prev

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Objective: UroVysion (Abbott Molecular, Inc., Illinois, USA) is based on multicolor fluorescence in situ hybridization (FISH). It has been used successfully in the USA following its Food and Drug Administration approval in 2001. However, the technology was not approved for use in Japan until 2017. Cystoscopy and urine cytology are the most frequently used examinations to detect bladder cancer in Japan, and there are only a few reports regarding the performance of UroVysion. Therefore, the aim of this study is to examine the diagnostic accuracy of UroVysion FISH in Japanese patients whose tumors are detected by cystoscopy before transurethral resection of bladder tumor (TURBT). Methods: From April 2018 to July 2018, a total of 40 patients who were diagnosed as having bladder tumors by cystoscopy, and therefore underwent TURBT were registered in this study. One day before TURBT, urine cytology and UroVysion FISH were used in order to compare the accuracy with which they could detect bladder carcinoma, as confirmed by pathological results of TURBT. Results: The pathological results of TURBT showed urothelial carcinoma in 33 cases. Urine cytology showed positive results for 0 cases (0%), suspicious results for 10 cases (30.3%), and negative results for 23 cases (69.7%). On the other hand, UroVysion FISH indicated 9 positive cases (27.3%) and 24 negative cases (72.7%). There were 19 cases of urothelial carcinoma (57.6%) that were not detected by either method. Conclusion: We conclude that UroVysion FISH alone is insufficient to detect bladder cancer and that cystoscopy is essential for the optimum detection or follow up of bladder cancer cases in our hospital.

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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

Cited by 16 publications

References 16 publications

Evaluation of UroVysion for Urachal Carcinoma Detection

Evaluation of UroVysion for Urachal Carcinoma Detection

Risk for intravesical recurrence of bladder cancer stratified by the results on two consecutive UroVysion fluorescence in situ hybridization tests: a prospective follow-up study in Japan

Examination of Diagnostic Accuracy of UroVysion Fluorescence In Situ Hybridization for Bladder Cancer in a Single Community of Japanese Hospital Patients

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