Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study
MATERIALS AND METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
J Urol. 2018 May;199(5):1158-1165. doi: 10.1016/j.juro.2017.11.096. Epub 2017 Dec 2.
Authors: Daneshmand S1, Patel S2, Lotan Y3, Pohar K4, Trabulsi E5, Woods M6, Downs T7, Huang W8, Jones J9, O'Donnell M10, Bivalacqua T11, DeCastro J12, Steinberg G13, Kamat A14, Resnick M15, Konety B16, Schoenberg M17, Jones JS18; Flexible Blue Light Study Group Collaborators.
1University of Southern California, Los Angeles, California. 2University of Oklahoma, Oklahoma City, Oklahoma.3University of Texas Southwestern Medical Center, Dallas, Texas.4Ohio State University, Columbus, Ohio.5Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.6University of North Carolina, Chapel Hill, North Carolina.7University of Wisconsin, Madison, Wisconsin.8New York University School of Medicine, New York, New York.9Veterans Affairs Medical Center, Houston, Texas.10University of Iowa, Iowa City, Iowa.11Johns Hopkins University, Baltimore, Maryland.12Columbia University Medical Center, New York, New York.13University of Chicago, Chicago, Illinois.14University of Texas M. D. Anderson Cancer Center, Houston, Texas.15Vanderbilt University, Nashville, Tennessee.16University of Minnesota, Minneapolis, Minnesota.17Montefiore Medical Center, Bronx, New York.18Cleveland Clinic, Cleveland, Ohio.