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Gierth, Michael ; Breyer, Johannes ; Zeman, Florian ; Fritsche, Hans-Martin ; Cordes, J. ; Karl, A. ; Zaak, D. ; Stenzl, A. ; Kausch von Schmeling, I. ; Sommerhuber, A. ; Zierer, Thomas ; Burger, Maximilian ; Mayr, Roman

The HELENA study: Hexvix®-TURB vs. white-light TURB followed by intravesical adjuvant chemotherapy—a prospective randomized controlled open-label multicenter non-inferiority study

Gierth, Michael , Breyer, Johannes, Zeman, Florian, Fritsche, Hans-Martin, Cordes, J., Karl, A., Zaak, D., Stenzl, A., Kausch von Schmeling, I., Sommerhuber, A., Zierer, Thomas, Burger, Maximilian and Mayr, Roman (2021) The HELENA study: Hexvix®-TURB vs. white-light TURB followed by intravesical adjuvant chemotherapy—a prospective randomized controlled open-label multicenter non-inferiority study. World Journal of Urology 39, pp. 3799-3805.

Date of publication of this fulltext: 19 May 2021 05:47
Article
DOI to cite this document: 10.5283/epub.45814


Abstract

Purpose Photodynamic diagnosis and white-light TURB with adjuvant intravesical chemotherapy (ICT) is widely used in treatment of bladder cancer. This non-inferiority trial is designed to demonstrate non-inferiority regarding recurrence-free survival (RFS) of Hexvix(R) TURB followed by immediate instillation compared to white-light TURB with immediate instillation followed by maintenance ICT. ...

Purpose Photodynamic diagnosis and white-light TURB with adjuvant intravesical chemotherapy (ICT) is widely used in treatment of bladder cancer. This non-inferiority trial is designed to demonstrate non-inferiority regarding recurrence-free survival (RFS) of Hexvix(R) TURB followed by immediate instillation compared to white-light TURB with immediate instillation followed by maintenance ICT. Methods Between 07/2010 and 12/2016, 129 patients with EORTC intermediate risk non-muscle invasive bladder cancer treated with TURB were included in this multicentre phase III study. Patients were randomized and received either white-light TURB with immediate ICT followed by maintenance ICT (n = 62, 20 mg Mitomycin weekly for 6 weeks as induction phase, afterwards 20 mg/month for 6 months) or Hexvix (R) TURB with immediate ICT only (n = 67, 40 mg Mitomycin). Primary study endpoint was RFS after 12 months. Hexvix (R) TURB was counted as non-inferior to white light alone if the upper limit of the one-sided 95% confidence interval of hazard ratio was lower than 1.676. Due to the non-inferiority design, the per-protocol population was used as the primary analysis population (n = 113) Results Median follow-up was 1.81 years. Hexvix (R) group showed more events (recurrence or death) than white-light group (19 vs. 10) resulting in a HR of 1.29 (upper limit of one-sided 95%-CI = 2.45; p(non-inferiority) = 0.249). The ITT population yielded similar results (HR = 1.67); 3.18], p(non-inferiority) = 0.493). There was no significant difference in overall survival between both groups (p = 0.257). Conclusion Non-inferiority of Hexvix (R) TURB relative to white-light TURB with maintenance Mitomycin instillation in intermediate risk urothelial carcinoma of the bladder was not proven. Hence a higher effect of maintenance ICT is to assume compared to a Hexvix (R)-improved TURB only, confirming its important role in patient treatment.



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Details

Item typeArticle
Journal or Publication TitleWorld Journal of Urology
Publisher:Springer
Place of Publication:NEW YORK
Volume:39
Page Range:pp. 3799-3805
Date17 May 2021
InstitutionsMedicine > Lehrstuhl für Urologie
Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number
ValueType
10.1007/s00345-021-03719-0DOI
KeywordsINVASIVE BLADDER-CANCER; GUIDED FLUORESCENCE CYSTOSCOPY; PHOTODYNAMIC DIAGNOSIS; TRANSURETHRAL RESECTION; RECURRENCE RATE; TA; CARCINOMA; RISK; METAANALYSIS; Urothelial carcinoma; Bladder cancer; Intravesical chemotherapy; Transurethral resection
Dewey Decimal Classification600 Technology > 610 Medical sciences Medicine
StatusPublished
RefereedYes, this version has been refereed
Created at the University of RegensburgPartially
URN of the UB Regensburgurn:nbn:de:bvb:355-epub-458143
Item ID45814

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