The 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.
All 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.
HAL-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).
Repeat use of HAL is safe even when administered within a few weeks of receiving a dose of intravesical therapy.
Urologic oncology. 2022 Jun 21 [Epub ahead of print]
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, Flexible Blue Light Study Group Collaborators
Department of Urology, The Ohio State University, Columbus, OH. Electronic address: ., Department of Urology, University of Oklahoma, Oklahoma City, OK., Department of Urology, UT Southwestern Medical Center, Dallas, TX., Department of Urology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA., Loyola University Chicago, Chicago, IL., Department of Urology, University of Virginia, Charlottesville, VA., Department of Urology, New York University School of Medicine, New York, NY., ME DeBakey VA Medical Center, Houston, TX., Department of Urology, University of Iowa, Iowa City, IA., Department of Urology, University of Pennsylvania, Philadelphia, PA., Department of Urology, Columbia University Medical Center, New York, NY., Department of Urology, New York University Langone Health, New York, NY., Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX., Department of Urology, Vanderbilt University, Nashville, TN., Department of Urology, University of Minnesota, Minneapolis, MN., Department of Urology, Montefiore Medical Center, Bronx, NY., Inova Health System, Falls Church, VA., Department of Urology, University of Southern California, Los Angeles, CA.