NATURE REVIEWS | UROLOGY VOLUME 11 | OCTOBER 2014 | 589 University of Southern California, 1441 Eastlake Avenue, Suite 7416, Los Angeles, CA 90089, USA (S.D., A.K.S.). Memorial Sloan– Kettering Cancer Center, USA (B.H.B.). University of Oklahoma Medical Center, USA (M.S.C.). University of Wisconsin, USA (T.M.D.). Thomas Jefferson University Philadelphia, USA (L.G.G.). MD Anderson Cancer Center, USA (H.B.G., A.M.K.). University of Minnesota, USA (B.R.K.). University of Michigan, USA (C.T.L.). Ohio State University, USA (K.S.P.). University of North Carolina, USA (R.S.P .). Vanderbilt University, USA (M.J.R.). University of Chicago, USA (N.D.S., G.D.S.). Radboud University Medical Center, The Netherlands (J.A.W.). Johns Hopkins University, USA (M.P .S.). Correspondence to: S.D. daneshma@usc.edu EXPERT CONSENSUS DOCUMENT Hexaminolevulinate blue-light cystoscopy in non-muscle- invasive bladder cancer: review of the clinical evidence and consensus statement on appropriate use in the USA 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 and Gary D. Steinberg Abstract | Hexaminolevulinate (HAL) is a tumour photosensitizer that is used in combination with blue-light cystoscopy (BLC) as an adjunct to white-light cystoscopy (WLC) in the diagnosis and management of non- muscle-invasive bladder cancer (NMIBC). Since being licensed in Europe in 2005, HAL has been used in >200,000 procedures, with consistent evidence that it improves detection compared with WLC alone. Current data support an additional role in the reduction of recurrence of NMIBC. Since the approval of HAL by the FDA in 2010, experience of HAL–BLC in the USA continues to expand. To define areas of need and to identify the benefits of HAL–BLC in clinical practice, a focus group of expert urologists specializing in the management of patients with bladder cancer convened to review the clinical evidence, share their experiences and reach a consensus regarding the optimal use of HAL–BLC in the USA. The focus group concluded that HAL–BLC should be considered for initial assessment of NMIBC, surveillance for recurrent tumours, diagnosis in patients with positive urine cytology but negative WLC findings, and for tumour staging. Daneshmand, S. et al. Nat. Rev. Urol. 11, 589–596 (2014); published online 23 September 2014; doi:10.1038/nrurol.2014.245 Introduction Bladder cancer is one of the most frequently diagnosed tumours worldwide: an estimated 74,690 new diagnoses were expected to be made and 15,580 deaths were esti- mated in the USA in 2014. 1 Although most patients are diagnosed at a relatively early stage, with non-muscle- invasive bladder cancer (NMIBC), the risk of dying from high-grade NMIBC remains substantial. Disease prognosis is affected in part by the high risk of tumour recurrence: depending on the grade at initial diagno- sis, up to 61% of patients with NMIBC will experience recurrence within the first year after initial resection, and up to 78% will experience recurrence within 5 years. 2 Moreover, patients with NMIBC are also at risk of progression to muscle-invasive bladder cancer (MIBC), with approximately 17% risk at 1 year and 45% risk at 5 years. 2 Owing to the high risk of both recur- rence and progression, patients require regular follow- up monitoring with cystoscopy after transurethral resection of the bladder tumour (TURBT). 3,4 Both the high prevalence of disease and the need for intensive endoscopic surveillance make bladder cancer one of the most costly cancers to treat. 5 Optimal management of bladder cancer begins with urine cytology and thorough cystoscopic assessment of the bladder. The current standard of care is white-light cystoscopy (WLC), which enables the urologist to map and resect all visible lesions. Tissue specimens are then sent for pathological review to confirm the diagnosis and define the pathological stage. Bladder tumours can display numerous gross morphological features, ranging from erythematous mucosa to papillary tumours or solid masses. 6 However, not all cancerous areas are readily visible using WLC. The current general recommenda- tion, according to the guidelines of urological associ- ations, is to biopsy any area of the urothelium with an abnormal appearance, or if patients have positive urine cytology but no evidence of bladder cancer on WLC, to take random biopsies from normal-looking mucosa. 3 Competing interests S.D. declares that he has been a meeting participant and lecturer for Cubist and Endo. H.B.G. declares that he has served as a consultant for Telormedix and as a scientific advisor for Abbott Molecular and Heat Biologics. A.M.K. declares that he has received grant or research support from Abbott, FKD and Cubist and has served on membership, advisory committee or review panels for Sanofi, Photocure, and Taris. B.R.K. declares that he has served as a consultant for Dendreon, GTx and Photocure, is a stockholder of Axogen and has worked on a clinical trial for Dendreon. M.J.R. declares that he has served as a consultant advisor for Dendreon and has been involved in a clinical trial for Genomic Health. J.A.W. declares that he is an advisor for Photocure and Ipsen. G.D.S. declares that he has served as a consultant, scientific advisor and speaker for Photocure and KARL STORZ. The authors were reimbursed by Photocure and KARL STORZ Endoscopy-America for their attendance at the consensus meeting. The other authors declare no competing interests. CONSENSUS STATEMENTS © 2014 Macmillan Publishers Limited. All rights reserved