| Published Version Download ( PDF | 631kB) | License: Creative Commons Attribution 4.0 |
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.
Alternative links to fulltext
Involved Institutions
Details
| Item type | Article | ||||
| 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 |
| ||||
| 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 | ||||
| URN of the UB Regensburg | urn:nbn:de:bvb:355-epub-458143 | ||||
| Item ID | 45814 |
Download Statistics
Download Statistics