Documento descargado de http://www.elsevier.es el 17/11/2016. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. Actas Urol Esp. 2011;35(8):446---447 Actas Urológicas Españolas www.elsevier.es/actasuro COMMENTARY Comment to ‘‘Photodynamic Diagnosis With Hexaminolevulinaate in Non-Muscle-Invasive Bladder Cancer. Experience of the BLUE GROUP’’夽 Comentario a «Diagnóstico fotodinámico con hexaminolevulinato en el cáncer vesical no músculo invasivo: experiencia del grupo B.L.U.E.» M. Burger Department of Urology, Caritas St. Josef Medical Center, University of Regensburg, Germany In the present analysis, Burgués and the B.L.U.E. Group present data on the Hexvix® fluorescence guided TUR.1 The authors must be congratulated on their outstanding report, which transmits new and wonderful concepts about this technique. Recently, there have been many data on Hexvix supporting the value of this complement to white light. The current guideline of the European Association of Urology supports its use,2 as well as the recommendations of an international commission.3 In fact, many factors suggest the extensive use of Hexvix. All the documents on Hexvix are unanimous about the best detection and reduced relapse rates; the simple bladder cancer epidemiology justifies the use of techniques that can mitigate the enormous impact of this disease on overall health, especially since the associated costs appear to reduce the global financial burden.3,4 However, there are, of course, many aspects to clarify.4,5 To what extent is the advantage of the detection the basis of the Hexvix feasibility? The B.L.U.E. Group presents a very detailed and rigorous analysis on the diagnostic accuracy of Hexvix. Certainly, I am aware of a comparable single series by the group Munich de Dirk Zaak et al.6 They presented data on about 4500 samples of 1700 TURs in 800 patients over 7 years of age at their center, and they conducted a photodynamic diagnosis to overcome the sensitivity of white light 夽 Please cite this article as: Burger M. Comentario a ‘‘Diagnóstico fotodinámico con hexaminolevulinato en el cáncer vesical no músculo invasivo: experiencia del grupo’’. Actas Urol Esp. 2011;35: 446---7. E-mail address: [email protected] decisively (92% vs. 76%); 24% of the lesions were identified exclusively by photodynamic diagnosis. However, the present contribution of the B.L.U.E. Group is unique in two aspects. On the one hand, we compare three different approaches, i.e., white light versus Hexvixassisted TUR versus random biopsies, whereas Zaak et al. compared visually identified lesions only with white light versus blue light. I have no knowledge of any comparative assessment of random sampling versus the photodynamic diagnosis in the diagnosis of CIS. Secondly, this series uses Hexvix, this is, hexaminolevulinic acid as a fluorescent dye instead of 5-aminolevulinic acid. This latter substance has never been approved for its use in the TUR and, as Burgués and the B.L.U.E. Group state in their manuscript, it has been suggested as disadvantageous compared with Hexvix due to its reduced bioavailability and its less stable pharmacodynamics. Therefore, the present series reflects the current state of the technique. What is interesting of these findings? Hexvix overall sensitivity was 94% versus 78%; as Hexvix complements white light, almost all malignant lesions are detected by photodynamic diagnosis. But they would have avoided 22 of the 600 total lesions, which were only detected by random biopsy; 20 of these lesions were CIS. While it has not been revealed how many of the lesions detected by random biopsy were concomitant to CIS in other areas of the bladder diagnosed by white light and Hexvix, it would mean that none of the patients with high-grade bladder cancer and/or CIS would have remained without such a diagnosis after Hexvix-TUR, even with the omission of the random biopsies. 2173-5786/$ – see front matter © 2011 AEU. Published by Elsevier España, S.L. All rights reserved. Documento descargado de http://www.elsevier.es el 17/11/2016. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. Comment to ‘‘Photodynamic Diagnosis With Hexaminolevulinaate in Non-Muscle-Invasive Bladder Cancer But what is the price of the sensitivity achieved by Hexvix? Obviously, the specificity is reduced. The B.L.U.E. Group clearly indicates that although the photodynamics is less specific than white light, the difference is not more than 9%. This finding is consistent with the broadest and potentially most representative multicenter randomized trial carried out in accordance with the FDA standards. Stenzl et al. reveal that the rate of false positives of white and blue lights does not vary significantly.7 We like it or not, our evaluation of white light is not perfectly specific either. Thus, the price of the sensitivity achieved by Hexvix seems right, as shown by Burgués and the B.L.U.E. group. Nevertheless, we still have some questions. Does that advantage have any relevant impact on the evolution of all bladder cancers? Which patients benefit decisively and should be considered for this methodology? What is the place of Hexvix in the management of long-term bladder cancer? I’m sure we’ll find out and I am even more confident that the B.L.U.E. Group will find more answers. References 1. Burgués JP, Conde G, Oliva J, Abascal JM, Iborra I, Puertas M, et al. Diagnóstico fotodinámico con hexaminolevulinato en 2. 3. 4. 5. 6. 7. 447 el cáncer vesical no músculo invasivo: experiencia del grupo B.L.U.E. Actas Urol Esp. 2011;35:439---45. Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Böhle A, Palou-Redorta J, et al. EAU Guidelines on Non-Muscle-Invasive Urothelial Carcinoma of the Bladder, the 2011 Update. Actas Urol Esp. 2011;35:373---88. Witjes JA, Redorta JP, Jacqmin D, Sofras F, Malmström PU, Riedl C, et al. Hexaminolevulinate-guided fluorescence cystoscopy in the diagnosis and follow-up of patients with non-muscle-invasive bladder cancer: review of the evidence and recommendations. Eur Urol. 2010;57:607---14. Oliva Encina J, Rioja Sanz C. Photodynamic diagnosis (PDD) in non-muscle invasive bladder cancer. Literature review. Actas Urol Esp. 2009;33:965---75. Oliva Encina J, Marco Valdenebro A, Pelegrí Gabarró J, Rioja Sanz C. Beyond the photodynamic diagnosis: searching for excellence in the diagnosis of non-muscle-invasive bladder cancer. Actas Urol Esp. 2010;34:657---68. Hungerhuber E, Stepp H, Kriegmair M, Stief C, Hofstetter A, Hartmann A, et al. Seven years’ experience with 5-aminolevulinic acid in detection of transitional cell carcinoma of the bladder. Urology. 2007;69:260---4. Stenzl A, Burger M, Fradet Y, Mynderse LA, Soloway MS, Witjes JA, et al. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol. 2010;184:1907---13.