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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

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Abstract

Background

We 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).

Methods

In this prospective, blinded, comparative study, 486 patients treated by TURBT within the prior 2 years 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 3 months 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.

Results

Bladder 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.

Conclusions

The 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.

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Acknowledgements

This study was supported by Abbott Japan Co., Ltd., Tokyo, Japan. Editorial support in the preparation of this manuscript was provided by Cactus Communications. Support for this assistance was funded by Abbott Japan Co., Ltd. We thank the members of the Tsukuba Clinical Research and Development Organization (T-CReDO) at the University of Tsukuba for their critical advice in conducting the study and data management during the study period.

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Authors and Affiliations

  1. Department of Urology, University of Tsukuba, Tsukuba, Ibaraki, Japan

    Takahiro Kojima & Hiroyuki Nishiyama

  2. UroVysion Clinical Evaluation Group, Tokyo, Japan

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

  3. Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan

    Seiichiro Ozono

  4. Center for Innovative Clinical Medicine, Okayama University, Okayama, Japan

    Shiro Hinotsu

  5. Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba, Tsukuba, Ibaraki, Japan

    Naoto Keino

  6. Division of Urology, Harasanshin Hospital, Fukuoka, Japan

    Akito Yamaguchi & Seiji Naito

  7. Department of Urology, Nagasaki University, Nagasaki, Japan

    Hideki Sakai

  8. Department of Urology, Mitsui Memorial Hospital, Tokyo, Japan

    Yutaka Enomoto

  9. Department of Urology, Juntendo University, Tokyo, Japan

    Shigeo Horie

  10. Department of Urology, Nara Medical University, Kashihara, Nara, Japan

    Kiyohide Fujimoto

  11. Department of Urology, Yamaguchi University, Yamaguchi, Japan

    Hideyasu Matsuyama

  12. Department of Urology, Anjo Kosei Hospital, Anjo, Aichi, Japan

    Takehiko Okamura

  13. Department of Urology, Chutoen General Medical Center, Shizuoka, Japan

    Yusuke Kanimoto

  14. Department of Urology, Keio University, Tokyo, Japan

    Mototsugu Oya

  15. Department of Urology, Osaka University, Osaka, Japan

    Norio Nonomura

  16. Department of Strategic Investigation on Comprehensive Cancer Network Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan

    Hideyuki Akaza

Authors
  1. Takahiro Kojima
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  2. Hiroyuki Nishiyama
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  3. Seiichiro Ozono
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  4. Shiro Hinotsu
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  5. Naoto Keino
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  6. Akito Yamaguchi
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  7. Hideki Sakai
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  8. Yutaka Enomoto
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  9. Shigeo Horie
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  10. Kiyohide Fujimoto
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  11. Hideyasu Matsuyama
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  12. Takehiko Okamura
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  13. Yusuke Kanimoto
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  14. Mototsugu Oya
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  15. Norio Nonomura
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  16. Seiji Naito
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  17. Hideyuki Akaza
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Corresponding author

Correspondence to Hiroyuki Nishiyama.

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Conflict of interest

The following authors received financial support from Abbott Japan. TK, AY, YE, TO, YK, and MO, funding and travel support. HN, SO, HS, KF and HM, payments for review and consulting, funding, and travel support. SHi and SN, payments for review and consulting, and travel support. NK, SHo and NN, funding. HA, consulting fee and travel support.

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Cite this article

Kojima, T., Nishiyama, H., Ozono, S. et al. 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. Int J Clin Oncol 23, 1140–1147 (2018). https://doi.org/10.1007/s10147-018-1311-6

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  • DOI: https://doi.org/10.1007/s10147-018-1311-6

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