Journal article
Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study
The Journal of urology, Vol.199(5), pp.1158-1165
05/2018
DOI: 10.1016/j.juro.2017.11.096
PMID: 29203268
Abstract
We compared blue light flexible cystoscopy with white light flexible cystoscopy for the detection of bladder cancer during surveillance.
Patients at high risk for recurrence received hexaminolevulinate intravesically before white light flexible cystoscopy and randomization to blue light flexible cystoscopy. All suspicious lesions were documented. Patients with suspicious lesions were referred to the operating room for repeat white and blue light cystoscopy. All suspected lesions were biopsied or resected and specimens were examined by an independent pathology consensus panel. The primary study end point was the proportion of patients with histologically confirmed malignancy detected only with blue light flexible cystoscopy. Additional end points were the false-positive rate, carcinoma in situ detection and additional tumors detected only with blue light cystoscopy.
Following surveillance 103 of the 304 patients were referred, including 63 with confirmed malignancy, of whom 26 had carcinoma in situ. In 13 of the 63 patients (20.6%, 95% CI 11.5–32.7) recurrence was seen only with blue light flexible cystoscopy (p <0.0001). Five of these cases were confirmed as carcinoma in situ. Operating room examination confirmed carcinoma in situ in 26 of 63 patients (41%), which was detected only with blue light cystoscopy in 9 of the 26 (34.6%, 95% CI 17.2–55.7, p <0.0001). Blue light cystoscopy identified additional malignant lesions in 29 of the 63 patients (46%). The false-positive rate was 9.1% for white and blue light cystoscopy. None of the 12 adverse events during surveillance were serious.
Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.
Details
- Title: Subtitle
- Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study
- Creators
- Siamak Daneshmand - University of Southern California, Los Angeles, CaliforniaSanjay Patel - University of OklahomaYair Lotan - University of Texas Southwestern Medical Center, Dallas, TexasKamal Pohar - Ohio State University, Columbus, OhioEdouard Trabulsi - Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PennsylvaniaMichael Woods - University of North Carolina, Chapel Hill, North CarolinaTracy Downs - University of Wisconsin, Madison, WisconsinWilliam Huang - New York University School of Medicine, New York, New YorkJeffrey Jones - Veterans Affairs Medical Center, Houston, TexasMichael O’Donnell - University of Iowa, Iowa City, IowaTrinity Bivalacqua - Johns Hopkins University, Baltimore, MarylandJoel DeCastro - Columbia University Medical Center, New York, New YorkGary Steinberg - University of Chicago, Chicago, IllinoisAshish Kamat - University of Texas M. D. Anderson Cancer Center, Houston, TexasMatthew Resnick - Vanderbilt University, Nashville, TennesseeBadrinath Konety - University of Minnesota, Minneapolis, MinnesotaMark Schoenberg - Montefiore Medical Center, Bronx, New YorkJ. Stephen Jones - Cleveland Clinic, Cleveland, OhioSoroush BazarganiHoorman DjaladatAnne SchuckmanMichael CooksonBrian CrossKelley StrattonCostas Dan LallasLeonard GomellaMark MannMichael JohnsonPhillip PierorazioJames McKiernanSven WenskeAlexander SankinMegan MerrillAhmad ShabsighMatthew NielsenRaj PruthiAngela SmithJay B ShahJennifer TaylorChristopher Weight
- Resource Type
- Journal article
- Publication Details
- The Journal of urology, Vol.199(5), pp.1158-1165
- DOI
- 10.1016/j.juro.2017.11.096
- PMID
- 29203268
- NLM abbreviation
- J Urol
- ISSN
- 0022-5347
- eISSN
- 1527-3792
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 05/2018
- Academic Unit
- Urology
- Record Identifier
- 9984051767802771
Metrics
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