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.
OBJECTIVE
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.


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.
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus. alexander.rolevich@gmail.com.
Alexander I
AI
Rolevich
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus.
Alexander G
AG
Zhegalik
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus.
Andrey A
AA
Mokhort
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus.
Alexander A
AA
Minich
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus.
Vladimir Yu
VY
Vasilevich
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus.
Sergey L
SL
Polyakov
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus.
Sergey A
SA
Krasny
Department of Urology, N.N. Alexandrov National Cancer Centre, Lesnoy, Minsk region, Republic of Belarus.
Oleg G
OG
Sukonko
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000473:pathology / Q000628:therapy*; D003558:Cystoscopy / Q000379:methods*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000627:therapeutic use*; D005260:Female; D005453:Fluorescence; D006801:Humans; D008297:Male; D008875:Middle Aged; D009130:Muscle, Smooth / Q000473:pathology; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D017319:Photosensitizing Agents; D016016:Proportional Hazards Models; D011446:Prospective Studies; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*
D000903:Antibiotics, Antineoplastic; D017319:Photosensitizing Agents; D004317:Doxorubicin; D000622:Aminolevulinic Acid
5-Aminolevulinic acid; Fluorescence cystoscopy; Non-muscle-invasive bladder cancer; Single early instillation of chemotherapeutic drug