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Environmental & Social Information • Dec 5, 2016

BLUE LIGHT CYSTOSCOPY FOR DIAGNOSIS OF UROTHELIAL BLADDER CANCER: RESULTS FROM A PROSPECTIVE MULTICENTER REGISTRY

Soroush Bazargani MD¹, Hooman Djaladat MD, MS¹, Anne K. Schuckman MD¹, Badri Konety MD, MBA², Trinity Bivalaqua MD³, Jeff Holzbeierlein MD4, Brian Willard MD5, Jennifer Taylor MD, MPH6, Joseph Liao MD7, Kamal Pohar MD8, James Tierney MD? and Siamak Daneshmand MD¹ ¹USC Institute of Urology, Los Angeles, CA; ²University of Minnesota, Minneapolis, Minnesota; ³Johns Hopkins, Baltimore, MD; 4Kansas University, KS; 5Carolina Urology Partners, Lexington SC; 6Michael E. DeBakey VAMC, Houston TX; 7Palo Alto VA, CA; 8Ohio State University, Columbus, OH; ?Charleston Area Medical Center, Wv

Presented by: Soroush Bazargani

Introduction and Objectives: Blue Light Cystoscopy (BLC) using hexaminolevulinate (Cysview) improves the detection of non-muscle invasive bladder cancer (NMIBC). We report on our experience from the prospective BLC Registry and its utility.

Methods: Under IRB approval, we prospectively enrolled consecutive patients undergoing transurethral resection of bladder lesions into the registry at 9 different centers. Patients who refused catheter insertion (8), had pure upper tract or prostatic urethral lesions (7) or were lost to follow up (10) were excluded from the study.

Results: A total of 1060 separate lesions were identified from 415 BLC procedures on 338 patients between April 2014 and July 2016. Mean age was 72 years with 82% being male. 62 patients underwent repeat use (2-4). Using final pathology as the reference standard, the sensitivity of WL, BL and the combination for any malignant lesion was 73%, 89% and 98% respectively. The addition of BL to standard WLC increased the detection rate by 12% for any papillary lesions and 45% for CIS (Table 1). BL resulted in upgrading or upstaging in 52 (15%) patients, resulting in a change in management. Overall false-positive (FP) rate was 22% for WL and 26% for BL. 122 (36%) patients received BCG at least 6 weeks prior to BLC, with a positive predictive value (PPV) of 59% for malignancy (FP=30%). 75 biopsies were taken from margins of a previous resection site (with more than 6 weeks' interval), wherein the PPV of BLC was 52% for malignancy (FP=30%). Among the positive/suspicious cytology patients who had no lesions on WL (113 total), BL was able to detect an extra 50 malignant lesions in 32 patients (sensitivity 91%). There were no hypersensitivity reactions noted. 40 (12%) patients eventually underwent cystectomy, 4 (10%) of whom exclusively because of lesions detected by BLC.

Conclusions: BLC significantly increases detection rates of CIS and papillary lesions over WL cystoscopy alone and can result in a change in management in 15% of patients. Recent BCG therapy appears to have no effect on BLC accuracy. Repeat use of Cysview for BLC appears to be safe.

Detection rate (sensitivity) White light only Blue light only Either white or blue light	Any malignancy. 73% 89% 98%	Any papillary 87% 89% 99%	Low Grade papillary 82% 87% 98%	High Grade papillary 87% 91% 99%	CIS 52% 91% 97%
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Poster #160, 17th Annual Meeting of the Society of Urologic Oncology, 01.12.2016, http://suonet.org/meetings/upcoming-meetings/2016 suo-annual-meeting/online-program-viewer.aspx