J Alfred Witjes1, Leonard G Gomella2, Arnulf Stenzl3, Sam S Chang4, Dirk Zaak5, H Barton Grossman6. 1. Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. Electronic address: f.witjes@uro.umcn.nl. 2. Department of Urology, Thomas Jefferson University, Philadelphia, PA. 3. Department of Urology, Eberhard-Karls University, Tübingen, Germany. 4. Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, TN. 5. Department of Urology, Clinic Traunstein, Traunstein, Germany. 6. Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Abstract
OBJECTIVE: To detail and put into perspective, safety of hexaminolevulinate blue light cystoscopy (HAL-BLC), including repeated use, based on combined data of controlled trials used for registration of HAL and postmarketing experience. METHODS: Safety data of 2 randomized comparative studies (group 1) and 4 within patient control studies (group 2) were combined. Postmarketing data from >200,000 patients were analyzed. RESULTS: In group 1, 533 patients were examined with HAL-BLC and 499 with white light (WL) cystoscopy. In group 2, 791 patients were examined with both WL and HAL-BLC. Between 73% and 93% of these patients had concomitant diseases. Between 41% and 58% of the patients had at least 1 adverse event (AE), although predominantly mild to moderate. The majority was considered as not related to HAL-BLC and reported in the urinary tract. No serious adverse events (SAEs) were considered definitely related to HAL-BLC, but in 6 patients serious AEs were of an uncertain relationship. Four possibly related hypersensitivity reactions have been reported. Repeated use did not reveal additional toxicity, also supported by data from 3 European centers. CONCLUSION: This combined and detailed analysis of patients from 6 HAL-BLC studies with very comparable criteria shows that HAL-BLC is safe and poses very little additional risks other than expected for WL cystoscopy for bladder tumor resection in this specific patient population. This is supported by 9 years of postmarketing experience. Repeated use also seems safe.
OBJECTIVE: To detail and put into perspective, safety of hexaminolevulinate blue light cystoscopy (HAL-BLC), including repeated use, based on combined data of controlled trials used for registration of HAL and postmarketing experience. METHODS: Safety data of 2 randomized comparative studies (group 1) and 4 within patient control studies (group 2) were combined. Postmarketing data from >200,000 patients were analyzed. RESULTS: In group 1, 533 patients were examined with HAL-BLC and 499 with white light (WL) cystoscopy. In group 2, 791 patients were examined with both WL and HAL-BLC. Between 73% and 93% of these patients had concomitant diseases. Between 41% and 58% of the patients had at least 1 adverse event (AE), although predominantly mild to moderate. The majority was considered as not related to HAL-BLC and reported in the urinary tract. No serious adverse events (SAEs) were considered definitely related to HAL-BLC, but in 6 patients serious AEs were of an uncertain relationship. Four possibly related hypersensitivity reactions have been reported. Repeated use did not reveal additional toxicity, also supported by data from 3 European centers. CONCLUSION: This combined and detailed analysis of patients from 6 HAL-BLC studies with very comparable criteria shows that HAL-BLC is safe and poses very little additional risks other than expected for WL cystoscopy for bladder tumor resection in this specific patient population. This is supported by 9 years of postmarketing experience. Repeated use also seems safe.
Authors: Siamak Daneshmand; Anne K Schuckman; Bernard H Bochner; Michael S Cookson; Tracy M Downs; Leonard G Gomella; H Barton Grossman; Ashish M Kamat; Badrinath R Konety; Cheryl T Lee; Kamal S Pohar; Raj S Pruthi; Matthew J Resnick; Norm D Smith; J Alfred Witjes; Mark P Schoenberg; Gary D Steinberg Journal: Nat Rev Urol Date: 2014-09-23 Impact factor: 14.432