Safety of hexaminolevulinate for blue light cystoscopy in bladder cancer. A combined analysis of the trials used for registration and postmarketing data.

Authors

J Alfred Witjes, Radboud University, Nijmegen Medical Centre, Nijmegen, Netherlands
Leonard G. Gomella, Department of Urology, Kimmel Cancer Center, Thomas Jefferson University, 1025 Walnut Street, Philadelphia, PA, 19107, USAFollow
Arnulf Stenzl, Eberhard-Karls University, Tübingen, Germany
Sam S. Chang, Vanderbilt University Medical Center, Nashville, TN
Dirk Zaak, Clinic Traunstein, Traunstein, Germany
H Barton Grossman, University of Texas, MD Anderson Cancer Center, Houston, TX

Document Type

Audio File

Publication Date

7-2014

Comments

This article has been peer reviewed. It is the authors' final version prior to publication in Urology

Volume 84, Issue 1, July 2014, Pages 122-126.

The published version is available at DOI: 10.1016/j.urology.2014.03.006. Copyright ©

Elsevier Inc.

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.

Recommended Citation

Witjes, J Alfred; Gomella, Leonard G.; Stenzl, Arnulf; Chang, Sam S.; Zaak, Dirk; and Grossman, H Barton, "Safety of hexaminolevulinate for blue light cystoscopy in bladder cancer. A combined analysis of the trials used for registration and postmarketing data." (2014). Department of Urology Faculty Papers. Paper 24.
https://jdc.jefferson.edu/urologyfp/24

PubMed ID

24768013