Tolerability of Repeat Use of Blue Light Cystoscopy with Hexaminolevulinate for Patients with Urothelial Cell Carcinoma

• Published in: The Journal of urology Vol. 197; no. 3; pp. 596 - 601
• Main Authors: Lane, Giulia I, Downs, Tracy M, Soubra, Ayman, Rao, Amrita, Hemsley, Lauren, Laylan, Christopher, Shi, Fangfang, Konety, Badrinath
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2017
• Subjects: aminolevulinic acid; cystoscopy; drug-related side effects and adverse reactions; photochemotherapy; urinary bladder neoplasms; Urology; carcinoma in situ; CTCAE; genitourinary; FDA; NMIBC; TURBT; nonmuscle invasive bladder cancer; drug-related side effects and adverse reactions; WLC; transurethral resection of bladder tumor; cystoscopy; urinary bladder neoplasms; urothelial cell carcinoma; white light cystoscopy with blue light cystoscopy using hexaminolevulinate; Food and Drug Administration; Common Terminology Criteria for Adverse Events; AE; adverse event; CIS; WLC+BLC with HAL; GU; HAL; UCC; hexaminolevulinate hydrochloride; photochemotherapy; white light cystoscopy; blue light cystoscopy; aminolevulinic acid; BLC
• ISSN: 0022-5347; 1527-3792
• DOI: 10.1016/j.juro.2016.09.076

Purpose Hexaminolevulinate hydrochloride with blue light cystoscopy is approved by the U.S. Food and Drug Administration as an adjunct to white light cystoscopy for the detection of urothelial cell carcinoma. In this study we examined the tolerability of the repeat use of white light cystoscopy with blue light cystoscopy. Materials and Methods We retrospectively reviewed the records of all patients who underwent white light cystoscopy with blue light cystoscopy using hexaminolevulinate hydrochloride during a 34-month period at 2 institutions. We compared the incidence of adverse events after initial and subsequent procedures. We grouped, graded and assigned the degree of attribution for all adverse events. Results A total of 180 patients underwent 269 white light cystoscopy with blue light cystoscopy procedures. Of those 180 patients 118 (65%) underwent white light cystoscopy with blue light cystoscopy only 1 time. The other 62 (35%) patients underwent white light cystoscopy with blue light cystoscopy 2 or more times, including 43 (24%) 2 times and 19 (10%) 3 or more times. We noted 89 adverse events out of 269 procedures (33%), of which 66 (74%) occurred after the first white light cystoscopy with blue light cystoscopy; 14 (16%) after the second time and 9 (10%) after the third time or more. We found no statistically significant difference in adverse events between those patients undergoing 1 vs 2 or more white light cystoscopy with blue light cystoscopy procedures (p=0.134). We observed 1 grade 3 adverse event and no grade 4 or 5 adverse events. None of the adverse events were classified as probably or definitely related to hexaminolevulinate hydrochloride. Conclusions In this retrospective study we found no statistically significant difference in the frequency or the grade of adverse events between first and repeat use of white light cystoscopy with blue light cystoscopy using hexaminolevulinate hydrochloride.