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

URN to cite this document:

urn:nbn:de:bvb:355-epub-458143 Copy

DOI to cite this document:

10.5283/epub.45814 Copy

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

Preview

License: Creative Commons Attribution 4.0 PDF - Published Version (631kB)

Date of publication of this fulltext: 19 May 2021 05:47

---

Alternative links to fulltext:DOIPublisher

---

This publication is part of the DEAL contract with Springer.

---

Details

Item type:	Article
Open Access Type:	DEAL (Springer)
Journal or Publication Title:	World Journal of Urology
Publisher:	Springer
Place of Publication:	NEW YORK
Volume:	39
Page Range:	pp. 3799-3805
Date:	17 May 2021
Institutions:	Medicine > Lehrstuhl für Urologie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number:	Value Type 10.1007/s00345-021-03719-0 DOI
Keywords:	INVASIVE 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 Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Partially
Item ID:	45814

Preview

Indexed in

Web of Science

Export bibliographical data

ASCII CitationAtomBibTeXData Cite XMLDataCite XML OAIDublin CoreDublin Core (LZV)EndNoteHTML CitationJSONJSON LDMETSMODSOPENAIREOpenAPCRDF+N-TriplesRDF+N3RDF+XMLReferReference ManagerSimple MetadataXMLopenCostxMetaDissPlus

---

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. ...

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. 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.

---

---

Metadata last modified: 21 Sep 2023 04:37

Owner only: item control page

Download Statistics

Download Statistics

Download Statistics

Download Statistics

Downloads

Downloads per month over past year

Altmetric

Altmetric

Altmetric

Alternative Statistics (altmetrics)

More literature (via CORE)

More literature (via CORE)

More literature (via CORE)

More literature (via CORE)