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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Acknowledgments
The authors thank Ludmila Mirilenka, for her assistance in statistical analysis.
Funding
This study was funded by Belarusian Ministry of Health.
Authors’ contribution
AI Rolevich contributed to protocol development, data collection, data analysis, and manuscript writing; AG Zhegalik, AA Mokhort, AA Minich, and VYu Vasilevich collected the data; SL Polyakov contributed to data collection, data analysis, and manuscript writing; SA Krasny and OG Sukonko developed the protocol and edited the manuscript editing.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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Rolevich, A.I., Zhegalik, A.G., Mokhort, A.A. et al. 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. World J Urol 35, 745–752 (2017). https://doi.org/10.1007/s00345-016-1927-y
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DOI: https://doi.org/10.1007/s00345-016-1927-y