title: Effectiveness of hexaminolevulinate fluorescence cystoscopy for the diagnosis of non-muscle-invasive bladder cancer in daily clinical practice: a Spanish multicentre observational study.
abstract: OBJECTIVE
  To assess the sensitivity and specificity of blue-light cystoscopy (BLC) with hexaminolevulinate as an adjunct to white-light cystoscopy (WLC) vs WLC alone for the detection of non-muscle-invasive bladder cancer (NMIBC), in routine clinical practice in Spain.
  
  
  METHODS
  An intra-patient comparative, multicentre, prospective, observational study. Adults with suspected or documented primary or recurrent NMIBC at eight Spanish centres were included in the study. All patients were examined with WLC followed by BLC with hexaminolevulinate. We evaluated the detection rate of bladder cancer lesions by WLC and BLC with hexaminolevulinate, overall and by tumour stage and compared with histological examination of the biopsied lesions. Sensitivity and specificity was calculated.
  
  
  RESULTS
  In all, 1,569 lesions were identified from 283 patients: 621 were tumour lesions according to histology and 948 were false-positives. Of the 621 tumour lesions, 475 were detected by WLC (sensitivity 76.5%, 95% confidence interval [CI] 73.2-79.8) and 579 were detected by BLC (sensitivity 93.2%, 95% CI 91.0-95.1; P < 0.001). There was a significant improvement in the sensitivity in the detection of all types of NMIBC lesions with BLC compared with WLC. Of 219 patients with tumours, 188 had NMIBC [highest grade: carcinoma in situ (CIS), n = 36; Ta, n = 87; T1, n = 65). CIS lesions were identified more with BLC (n = 27) than with WLC [n = 19; sensitivity: BLC 75.0% (95% CI 57.8-87.9) vs WLC 52.8% (95% CI 35.5-69.6); P = 0.021]. Results varied across centres.
  
  
  CONCLUSIONS
  This study shows that improvement in diagnosis of NMIBC, mainly CIS and Ta tumours, obtained with BLC with hexaminolevulinate as an adjunct to WLC vs WLC alone can be shown in routine clinical practice.
authors.affiliation: Fundació Puigvert, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Palou
authors.affiliation: Hospital Gregorio Marañón, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Hernández
authors.affiliation: Instituto Valenciano de Oncología, Valencia, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Solsona
authors.affiliation: Hospital Central de Asturias, Oviedo, Spain.
authors.forename: Ramon
authors.initials: R
authors.lastname: Abascal
authors.affiliation: Hospital Universitari Son Dureta, Palma de Mallorca, Spain.
authors.forename: Juan P
authors.initials: JP
authors.lastname: Burgués
authors.affiliation: Hospital Royo Vilanova, Zaragoza, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Rioja
authors.affiliation: Hospital Central de Defensa Gómez Ulla, Madrid, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Cabrera
authors.affiliation: Hospital Son Llàtzer, Palma de Mallorca, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Gutiérrez
authors.affiliation: Fundació Puigvert, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Oscar
authors.initials: O
authors.lastname: Rodríguez
authors.affiliation: Instituto Valenciano de Oncología, Valencia, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Iborra
authors.affiliation: Hospital Central de Defensa Gómez Ulla, Madrid, Spain.
authors.forename: Felipe
authors.initials: F
authors.lastname: Herranz
authors.affiliation: Hospital Central de Asturias, Oviedo, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Abascal
authors.affiliation: Hospital Son Llàtzer, Palma de Mallorca, Spain.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Conde
authors.affiliation: Hospital Royo Vilanova, Zaragoza, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Oliva
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000031:analogs & derivatives*; D003558:Cystoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D013030:Spain; D001749:Urinary Bladder Neoplasms / Q000473:pathology*
chemical_list: D000622:Aminolevulinic Acid; C419924:5-aminolevulinic acid hexyl ester
keywords: bladder cancer; fluorescence cystoscopy; hexaminolevulinate; multicentre trial; residual tumour