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07.09.2016 | Original Article

Results of a prospective randomized study assessing the efficacy of fluorescent cystoscopy-assisted transurethral resection and single instillation of doxorubicin in patients with non-muscle-invasive bladder cancer

verfasst von: Alexander I. Rolevich, Alexander G. Zhegalik, Andrey A. Mokhort, Alexander A. Minich, Vladimir Yu. Vasilevich, Sergey L. Polyakov, Sergey A. Krasny, Oleg G. Sukonko

Erschienen in: World Journal of Urology | Ausgabe 5/2017

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Abstract

Objectives

To assess the efficacy of two treatment options for non-muscle-invasive bladder cancer (NMIBC): (1) transurethral resection (TUR) guided by fluorescence cystoscopy (FC) with the use of 5-aminolevulinic acid (5-ALA) and (2) single early instillation of doxorubicin in a single-center open-label prospective randomized study with a 2 × 2 factorial design.

Patients and methods

Patients with clinical suspicion of primary or recurrent NMIBC were randomized into four study arms: FC-assisted TUR with 5-ALA and single instillation of doxorubicin, FC-assisted TUR without instillation, TUR in white light (WL) with single instillation of doxorubicin, and WL-TUR only. The study was designed to assess recurrence-free survival in arms with and without any of two interventions.

Results

Of 525 patients included, 377 (72 %) were eligible for primary outcome assessment. The median follow-up was 54.8 months. FC statistically significantly decreased the risk of disease recurrence and progression with hazard ratio (HR) 0.56 (95 % CI 0.39–0.80, p = 0.001) and 0.33 (95 % CI 0.12–0.91, p = 0.031), respectively. The HRs for recurrence and progression for single instillation of doxorubicin were 0.76 (95 % CI 0.54–1.07, p = 0.11) and 0.65 (95 % CI 0.28–1.52, p = 0.32), respectively. The overall and cancer-specific survival rates did not differ significantly based on the therapeutic interventions.

Conclusions

In patients with NMIBC, FC-assisted TUR with 5-ALA results in a substantial recurrence and progression risk reduction as compared to WL-TUR. The single early postoperative instillation of doxorubicin did not have a statistically significant impact on recurrence and progression risks.

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Titel: Results of a prospective randomized study assessing the efficacy of fluorescent cystoscopy-assisted transurethral resection and single instillation of doxorubicin in patients with non-muscle-invasive bladder cancer
verfasst von: Alexander I. Rolevich
Alexander G. Zhegalik
Andrey A. Mokhort
Alexander A. Minich
Vladimir Yu. Vasilevich
Sergey L. Polyakov
Sergey A. Krasny
Oleg G. Sukonko
Publikationsdatum: 07.09.2016
Verlag: Springer Berlin Heidelberg
Erschienen in: World Journal of Urology / Ausgabe 5/2017
Print ISSN: 0724-4983
Elektronische ISSN: 1433-8726
DOI: https://doi.org/10.1007/s00345-016-1927-y

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Results of a prospective randomized study assessing the efficacy of fluorescent cystoscopy-assisted transurethral resection and single instillation of doxorubicin in patients with non-muscle-invasive bladder cancer

Abstract

Objectives

Patients and methods

Results

Conclusions

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Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Springer Medizin

Abstract

Objectives

Patients and methods

Results

Conclusions

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