Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study

Kamal S Pohar; Sanjay Patel; Yair Lotan; Edouard Trabulsi; Michael Woods; Tracy Downs; William C Huang; Jeffrey Jones; Jennifer Taylor; Michael O'Donnell; Trinity J Bivalacqua; Joel DeCastro; Gary Steinberg; Ashish M Kamat; Matthew J Resnick; Badrinath Konety; Mark Schoenberg; J Stephen Jones; Siamak Daneshmand

doi:10.1016/j.urolonc.2022.04.012

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Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study

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Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study

Kamal S Pohar, Sanjay Patel, Yair Lotan, Edouard Trabulsi, Michael Woods, Tracy Downs, William C Huang, Jeffrey Jones, Jennifer Taylor, Michael O'Donnell, …

Urologic oncology, Vol.40(8), pp.382.e1-382.e6

08/01/2022

DOI: 10.1016/j.urolonc.2022.04.012

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Abstract

PURPOSEThe therapeutic benefit of intravesical instillation of hexaminolevulinate (HAL) at the time of transurethral resection of bladder tumor (TURBT) has been demonstrated in multiple studies. The purpose of this study was to prospectively assess the safety of repeated administration of HAL from a phase III pre-trial planned analysis. MATERIALS AND METHODSAll patients evaluated in the study received at least 1 dose of HAL at the time of office cystoscopy, and a subset of these patients (n = 103, 33.2%) received a second dose a few weeks later at the time of TURBT. Adverse events (AEs) were recorded, and the safety of repeat use of HAL was determined by comparing the proportion of patients with AEs considered causally related to HAL in the surveillance examination compared to the OR examination. Association between categorical variables was tested using Fisher's Exact Test, and a P < 0.05 was considered statistically significant. RESULTSHAL-related AEs were experienced by 6 patients (2.2%) during surveillance cystoscopy and 3 patients (3.4%) following TURBT (P = 0.76); 181 patients (59.5%) had prior exposure to HAL before enrolling in the study with no difference in the number of AEs when comparing prior exposure to HAL to no prior exposure (P = 0.76). Of the patients who previously received intravesical therapy, 8 (2.9%) had at least 1 AE during surveillance compared to 3 (9.7%) who had no prior intravesical therapy (P = 0.09). CONCLUSIONSRepeat use of HAL is safe even when administered within a few weeks of receiving a dose of intravesical therapy.

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Title: Subtitle: Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study
Creators: Kamal S Pohar - The Ohio State University
Sanjay Patel - University of Oklahoma
Yair Lotan - Southwestern Medical Center
Edouard Trabulsi - Thomas Jefferson University
Michael Woods - Loyola University Chicago
Tracy Downs - University of Virginia
William C Huang - New York University
Jeffrey Jones - Michael E. DeBakey VA Medical Center
Jennifer Taylor - Michael E. DeBakey VA Medical Center
Michael O'Donnell - University of Iowa
Trinity J Bivalacqua - University of Pennsylvania
Joel DeCastro - Columbia University Irving Medical Center
Gary Steinberg - NYU Langone Health
Ashish M Kamat - The University of Texas MD Anderson Cancer Center
Matthew J Resnick - Vanderbilt University
Badrinath Konety - University of Minnesota
Mark Schoenberg - Montefiore Medical Center
J Stephen Jones - Inova Health System
Siamak Daneshmand - University of Southern California
Resource Type: Journal article
Publication Details: Urologic oncology, Vol.40(8), pp.382.e1-382.e6
DOI: 10.1016/j.urolonc.2022.04.012
ISSN: 1078-1439
eISSN: 1873-2496
Language: English
Date published: 08/01/2022
Academic Unit: Urology
Record Identifier: 9984320858602771

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