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

• Published in: World journal of urology 2017-05, Vol.35 (5), p.745-752
• Main Authors: Rolevich, Alexander I., Zhegalik, Alexander G., Mokhort, Andrey A., Minich, Alexander A., Vasilevich, Vladimir Yu, Polyakov, Sergey L., Krasny, Sergey A., Sukonko, Oleg G.
• Format: Article
• Language: English
• Subjects: Administration, Intravesical; Adult; Aged; Aged, 80 and over; Aminolevulinic Acid; Antibiotics, Antineoplastic - therapeutic use; Bladder cancer; Carcinoma, Transitional Cell - pathology; Carcinoma, Transitional Cell - therapy; Cystoscopy - methods; Disease-Free Survival; Doxorubicin - therapeutic use; Female; Fluorescence; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Muscle, Smooth - pathology; Neoplasm Invasiveness; Neoplasm Recurrence, Local - epidemiology; Nephrology; Oncology; Original Article; Photosensitizing Agents; Proportional Hazards Models; Prospective Studies; Survival Rate; Urinary Bladder Neoplasms - pathology; Urinary Bladder Neoplasms - therapy; Urology
• ISSN: 0724-4983; 1433-8726
• DOI: 10.1007/s00345-016-1927-y

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.