Skip to main content
SpringerLink
Log in

Senkung des Rezidivrisikos oberflächlicher Harnblasenkarzinome mittels 5-Aminolävulinsäure-induzierter Fluoreszenzdiagnostik

Resultate einer 5-Jahres-Studie

  • Originalien
  • Published:
Der Urologe, Ausgabe A Aims and scope Submit manuscript

Zusammenfassung

Im Rahmen einer unizentrischen randomisierten prospektiven Phase-III-Studie wurde untersucht, ob die transurethrale Resektion (TUR) von oberflächlichen Blasentumoren mittels 5-Aminolävulinsäure- (5-ALA-)induzierter Fluoreszenzdiagnostik (FD) der konventionellen Weißlicht- (WL-)TUR überlegen ist.

Endpunkte der Studie waren die Evaluation der Residualtumorrate und rezidivfreies Überleben. Die Residualtumorrate in der WL-Gruppe (n=103) lag bei 25,2 vs. 4,5% in der FD-Gruppe (n=88, p<0,0001). Das mediane Follow-up im WL-Arm betrug 42 (25–61) Monate im Vergleich zu 43 (24–61) Monate in der FD-Gruppe. In Bezug auf das rezidivfreies Überleben ist FD der WL-TUR statistisch signifikant überlegen (p=0,0005). Die rezidivfreie Überlebensrate nach 12, 24 und 48 Monaten betrug in der WL-Gruppe 78,6%, 69,9% und 60,7 %, in der FD-Gruppe 90,9%, 90,9% und 85 %. Diese Überlegenheit erwies sich als von den Risikogruppen unabhängig. Die adjustierte Hazard-Ratio der FD-TUR im Vergleich zur WL-TUR beträgt 0,29 (95%-Konfidenzintervall (-KI): 0,15; 0,56). Hiernach ist die FD gestützte TUR oberflächlicher Blasentumoren dem konventionellen Verfahren unter Weißlicht überlegen.

Abstract

A prospective monocentre randomized parallel-group Phase III trial was performed to investigate whether primary transurethral resection (TUR) with 5-aminolevulinic acid induced Fluorescence diagnosis (FD) allows for a more thorough TUR of superficial Bladder Carcinoma compared to conventional white light (WL).

Evaluation of residual tumor rate and recurrence free survival were defined as the two primary study endpoints. The residual tumor rate was 25.2% in the WL arm (n=103) vs. 4.5% in the (n=88) FD arm (p<0.0001). Median follow up of the patients in the WL arm was 42 months (range 25–61) compared to 43 (range 24–61) in the FD arm. Recurrence free survival in the fluorescence diagnosis group was 90.9%, 90.9% und 85 % after 12, 24 and 48 months compared with 78.6%, 69.9% und 60.7 %, respectively, in the white light group (p=0.0005). This superiority proved to be independent of risk group. The adjusted hazard ratio of fluorescence diagnosis versus white light transurethral resection was 0.29 (95% CI: [0.15; 0.56]).

ALA induced FD is statistically significantly superior to conventional WL TUR with respect to both residual tumor rate and recurrence-free survival. The differences in RFS imply that FD offers a clinically relevant procedure to reduce the number of tumor recurrences.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Abb. 1.
Abb. 2.
Abb. 3.
Abb. 4a–c.

Literatur

  1. De Dominicis C, Liberti G, Perugia G et al. (2001) Role of 5-aminolevulinic acid in the diagnosis and treatment of superficial bladder cancer: Improvement in diagnostic sensitivity. Urology 57: 1059–1062

    Google Scholar 

  2. Filbeck T, Roessler W, Straub M et al. (1999) Clinical results of the transurethral resection and evaluation of superficial bladder carcinomas by means of FD after intravesical instillation of 5-aminolevulinic acid. J Endourol 13: 117–121

    Google Scholar 

  3. Filbeck T, Pichlmeier U, Knuechel R, Wieland WF, Roessler W (2002) Reduction of recurrence rate of superficial bladder carcinoma after transurethral resection with 5-aminolevulinic acid induced fluorescence diagnosis. J Urol 168: 67–71

    Google Scholar 

  4. Jichlinski P, Forrer M, Mizeret J et al. (1997) Clinical evaluation of a method for detecting superficial surgical transitional cell carcinoma of the bladder by light induced fluorescence of protoporphyrin IX following the topical application of 5-aminolevulinic acid: preliminary results. Lasers Surg Med 20: 402–408

    Google Scholar 

  5. Klän R, Loy V, Huland H (1991) Residual tumor discovered in routine second transurethral resection in patients with stage T1 transitional cell carcinoma of the bladder. J Urol 146: 316–318

    Google Scholar 

  6. Köhrmann KU, Woeste M, Kappes J et al. (1994) Der Wert der transurethralen Nachresektion beim oberflächlichen Harnblasenkarzinom. Akt Urol 25: 208–213

    Google Scholar 

  7. Kriegmair M, Baumgartner R, Knuechel R et al. (1996) Detection of early bladder cancer by 5 aminolevulinic acid induced porphyrin fluorescence. J Urol 155: 105–109

    Google Scholar 

  8. Miller K, Weißbach L (1998) Leitlinien zur Diagnostik und Therapie des Harnblasenkarzinoms. Urologe A 37: 440–457

    Google Scholar 

  9. Murphy WM, Beckwith JB and Farrow GE (1994) Tumors of the kidney, bladder and related urinary structures. In: Rosai J, Sobin LH (eds) Atlas of tumor pathology, 3rd Series, Facsimile 11. Armed Forces Institute of Pathology, Washington, DC

  10. Oosterlinck W, Jakse G, Malmström P, Stöckle M, Sternberg C, Neal D, Clais da Silvam F (2000) Guidelines on bladder carcinoma. Europ Assoc Urol 2000

  11. Riedl CR, Daniltchenko D, Koenig F et al. (2001) Fluorescence endoscopy with 5-aminolevulinic acid reduces early recurrence rate in superficial bladder cancer. J Urol 165: 1121–1123

    Google Scholar 

  12. Rößler W, Filbeck T, Knuechel R, Wieland W (2002) Ergebnisse bei der Resektion oberflächlicher Blasentumoren mittels 5-ALA induzierter Fluoreszenzdiagnostik. Akt Urol 33: 136–140

    Google Scholar 

  13. Schwaibold HE, Treiber U, Kuebler H et al. (2000) Second transurethral resection detects histopathological changes worsening the prognosis in 25% of patients with pT1 bladder cancer. J Urol 163: 153

    Google Scholar 

  14. Sobin LH, Wittekind C (1997) TNM classification of malignant tumours, 5th edn. Wiley-Liss, New York Weinheim

  15. Wechsel HW, Rosenkranz T, Bichler KH, Petri E (1996) Nach- und Sicherheitsresektion beim oberflächlichen, niedriggradigen Blasenkarzinom. Urologe A 35 [Suppl]: 118

  16. Zaak D, Kriegmair M, Stepp H et al. (2001) Endoscopic detection of transitional cell carcinoma with 5-aminolevulinic acid: Results of 1012 fluorescence endoscopies. Urology 57: 690–694

    Google Scholar 

  17. Zaak D, Hofstetter G, Baumgartner R et al. (1999) Die 5-ALA induzierte Fluoreszenzendoskopie des oberflächlichen Harnblasenkarzinoms. Urologe B 39: 113–120

    Google Scholar 

  18. Zaak D, Frimberger D, Mueller-Lisse U et al. (2001) Decrease of early recurrence by means of 5-aminolevulinic induced fluorescence endoscopy in patients with bladder cancer follow up of a randomized phase III trial. J Urol 165: 165

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Urologische Abteilung, Caritas-Krankenhaus St. Josef, Regensburg

    T. Filbeck & W. F. Wieland

  2. Institut für Mathematik und Datenverarbeitung in der Medizin, Universität Hamburg

    U. Pichlmeier

  3. Pathologisches Institut, Universität Regensburg

    R. Knuechel

  4. Urologische Abteilung, Caritas-Krankenhaus St. Josef, Landshuter Straße 65, 93053, Regensburg

    T. Filbeck

Authors
  1. T. Filbeck
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. U. Pichlmeier
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. R. Knuechel
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. W. F. Wieland
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. W. Rößler
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to T. Filbeck.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Filbeck, T., Pichlmeier, U., Knuechel, R. et al. Senkung des Rezidivrisikos oberflächlicher Harnblasenkarzinome mittels 5-Aminolävulinsäure-induzierter Fluoreszenzdiagnostik. Urologe [A] 42, 1366–1373 (2003). https://doi.org/10.1007/s00120-003-0355-y

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00120-003-0355-y

Schlüsselwörter

Keywords

Search

Navigation